Feature

Anna Sutton was shocked when she received a letter from her husband’s job-based health plan stating that Humira, an expensive drug used to treat her daughter’s juvenile arthritis, was now on a long list of medications considered “nonessential benefits.”

The July 2021 letter said the family could either participate in a new effort overseen by a company called SaveOnSP and get the drug free of charge or be saddled with a monthly copayment that could top $1,000.

“It really gave us no choice,” said Mrs. Sutton, of Woodinville, Wash. She added that “every single [Food and Drug Administration]–approved medication for juvenile arthritis” was on the list of nonessential benefits.

Mrs. Sutton had unwittingly become part of a strategy that employers are using to deal with the high cost of drugs prescribed to treat conditions such as arthritis, psoriasis, cancer, and hemophilia.

Those employers are tapping into dollars provided through programs they have previously criticized: patient financial assistance initiatives set up by drugmakers, which some benefit managers have complained encourage patients to stay on expensive brand-name drugs when less expensive options might be available.

Now, though, employers, or the vendors and insurers they hire specifically to oversee such efforts, are seeking that money to offset their own costs. Drugmakers object, saying the money was intended primarily for patients. But some benefit brokers and companies like SaveOnSP say they can help trim employers’ spending on insurance – which, they say, could be the difference between an employer offering coverage to workers or not.

It’s the latest twist in a long-running dispute between the drug industry and insurers over which group is more to blame for rising costs to patients. And patients are, again, caught in the middle.

Patient advocates say the term “nonessential” stresses patients out even though it doesn’t mean the drugs – often called “specialty” drugs because of their high prices or the way they are made – are unnecessary.

Some advocates fear the new strategies could be “a way to weed out those with costly health care needs,” said Rachel Klein, deputy executive director of the AIDS Institute, a nonprofit advocacy group. Workers who rely on the drugs may feel pressured to change insurers or jobs.

Two versions of the new strategy are in play. Both are used mainly by self-insured employers that hire vendors, like SaveOnSP, which then work with the employers’ pharmacy benefit managers, such as Express Scripts/Cigna, to implement the strategy. There are also smaller vendors, like SHARx and Payer Matrix, some of which work directly with employers.

In one approach, insurers or employers continue to cover the drugs but designate them as “nonessential,” which allows the health plans to bypass annual limits set by the Affordable Care Act on how much patients can pay in out-of-pocket costs for drugs. The employer or hired vendor then raises the copay required of the worker, often sharply, but offers to substantially cut or eliminate that copay if the patient participates in the new effort. Workers who agree enroll in drugmaker financial assistance programs meant to cover the drug copays, and the vendor monitoring the effort aims to capture the maximum amount the drugmaker provides annually, according to a lawsuit filed in May by drugmaker Johnson & Johnson against SaveOnSP, which is based in Elma, N.Y.

The employer must still cover part of the cost of the drug, but the amount is reduced by the amount of copay assistance that is accessed. That assistance can vary widely and be as much as $20,000 a year for some drugs.

In the other approach, employers don’t bother naming drugs nonessential; they simply drop coverage for specific drugs or classes of drugs. Then, the outside vendor helps patients provide the financial and other information needed to apply for free medication from drugmakers through charity programs intended for uninsured patients.

“We’re seeing it in every state at this point,” said Becky Burns, chief operating officer and chief financial officer at the Bleeding and Clotting Disorders Institute in Peoria, Ill., a federally funded hemophilia treatment center.

The strategies are mostly being used in self-insured employer health plans, which are governed by federal laws that give broad flexibility to employers in designing health benefits.

Still, some patient advocates say these programs can lead to delays for patients in accessing medications while applications are processed – and sometimes unexpected bills for consumers.

“We have patients get billed after they max out their assistance,” said Kollet Koulianos, vice president of payer relations at the National Hemophilia Foundation. Once she gets involved, vendors often claim the bills were sent in error.

Even though only about 2% of the workforce needs the drugs, which can cost thousands of dollars a dose, they can lead to a hefty financial liability for self-insured employers, said Drew Mann, a benefits consultant in Knoxville, Tenn., whose clientele includes employers that use variations of these programs.

Before employer health plans took advantage of such assistance, patients often signed up for these programs on their own, receiving coupons that covered their share of the drug’s cost. In that circumstance, drugmakers often paid less than they do under the new employer schemes because a patient’s out-of-pocket costs were capped at lower amounts.

Brokers and the CEOs of firms offering the new programs say that in most cases patients continue to get their drugs, often with little or no out-of-pocket costs.

If workers do not qualify for charity because their income is too high, or for another reason, the employer might make an exception and pay the claim or look for an alternative solution, Mr. Mann said. Patient groups noted that some specialty drugs may not have any alternatives.

How this practice will play out in the long run remains uncertain. Drugmakers offer both copay assistance and charity care in part because they know many patients, even those with insurance, cannot afford their products. The programs are also good public relations and a tax write-off. But the new emphasis by some employers on maximizing the amount they or their insurers can collect from the programs could cause some drugmakers to take issue with the new strategies or even reconsider their programs.

“Even though our client, like most manufacturers, provides billions in discounts and rebates to health insurers as part of their negotiations, the insurers also want this additional pool of funds, which is meant to help people who can’t meet the copay,” said Harry Sandick, a lawyer representing J&J.

J&J’s lawsuit, filed in U.S. District Court in New Jersey, alleges that patients are “coerced” into participating in copay assistance programs after their drugs are deemed “nonessential” and therefore are “no longer subject to the ACA’s annual out-of-pocket maximum.”

Once patients enroll, the money from the drugmaker goes to the insurer or employer plan, with SaveOnSP retaining 25%, according to the lawsuit. It claims J&J has lost $100 million to these efforts.

None of that money counts toward patients’ deductibles or out-of-pocket maximums for the year.

In addition to the lawsuit over the copay assistance program efforts, there has been other reaction to the new employer strategies. In an October letter to physicians, the Johnson & Johnson Patient Assistance Foundation, a separate entity, said it will no longer offer free medications to patients with insurance starting in January, citing the rise of such “alternative funding programs.”

Still, J&J spokesperson L.D. Platt said the drugmaker has plans, also in January, to roll out other assistance to patients who may be “underinsured” so they won’t be affected by the foundation’s decision.

In a statement, SaveOnSP said that employers object to drug companies’ “using their employees’ ongoing need for these drugs as an excuse to keep hiking the drugs’ prices” and that the firm simply “advises these employers on how to fight back against rising prices while getting employees the drugs they need at no cost to the employees.”

In a court filing, SaveOnSP said drugmakers have another option if they don’t like efforts by insurers and employers to max out what they can get from the programs: reduce the amount of assistance available. J&J, the filing said, did just that when it recently cut its allotted amount of copay assistance for psoriasis drugs Stelara and Tremfya from $20,000 to $6,000 per participant annually. The filing noted that SaveOnSP participants would still have no copay for those drugs.

For Mrs. Sutton’s part, her family did participate in the program offered through her husband’s work-based insurance plan, agreeing to have SaveOnSP monitor their enrollment and payments from the drugmaker.

So far, her 15-year-old daughter has continued to get Humira, and she has not been billed a copay.

Even so, “the whole process seems kind of slimy to me,” she said. “The patients are caught in the middle between the drug industry and the insurance industry, each trying to get as much money as possible out of the other.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Anna Sutton was shocked when she received a letter from her husband’s job-based health plan stating that Humira, an expensive drug used to treat her daughter’s juvenile arthritis, was now on a long list of medications considered “nonessential benefits.”

The July 2021 letter said the family could either participate in a new effort overseen by a company called SaveOnSP and get the drug free of charge or be saddled with a monthly copayment that could top $1,000.

“It really gave us no choice,” said Mrs. Sutton, of Woodinville, Wash. She added that “every single [Food and Drug Administration]–approved medication for juvenile arthritis” was on the list of nonessential benefits.

Mrs. Sutton had unwittingly become part of a strategy that employers are using to deal with the high cost of drugs prescribed to treat conditions such as arthritis, psoriasis, cancer, and hemophilia.

Those employers are tapping into dollars provided through programs they have previously criticized: patient financial assistance initiatives set up by drugmakers, which some benefit managers have complained encourage patients to stay on expensive brand-name drugs when less expensive options might be available.

Now, though, employers, or the vendors and insurers they hire specifically to oversee such efforts, are seeking that money to offset their own costs. Drugmakers object, saying the money was intended primarily for patients. But some benefit brokers and companies like SaveOnSP say they can help trim employers’ spending on insurance – which, they say, could be the difference between an employer offering coverage to workers or not.

It’s the latest twist in a long-running dispute between the drug industry and insurers over which group is more to blame for rising costs to patients. And patients are, again, caught in the middle.

Patient advocates say the term “nonessential” stresses patients out even though it doesn’t mean the drugs – often called “specialty” drugs because of their high prices or the way they are made – are unnecessary.

Some advocates fear the new strategies could be “a way to weed out those with costly health care needs,” said Rachel Klein, deputy executive director of the AIDS Institute, a nonprofit advocacy group. Workers who rely on the drugs may feel pressured to change insurers or jobs.

Two versions of the new strategy are in play. Both are used mainly by self-insured employers that hire vendors, like SaveOnSP, which then work with the employers’ pharmacy benefit managers, such as Express Scripts/Cigna, to implement the strategy. There are also smaller vendors, like SHARx and Payer Matrix, some of which work directly with employers.

In one approach, insurers or employers continue to cover the drugs but designate them as “nonessential,” which allows the health plans to bypass annual limits set by the Affordable Care Act on how much patients can pay in out-of-pocket costs for drugs. The employer or hired vendor then raises the copay required of the worker, often sharply, but offers to substantially cut or eliminate that copay if the patient participates in the new effort. Workers who agree enroll in drugmaker financial assistance programs meant to cover the drug copays, and the vendor monitoring the effort aims to capture the maximum amount the drugmaker provides annually, according to a lawsuit filed in May by drugmaker Johnson & Johnson against SaveOnSP, which is based in Elma, N.Y.

The employer must still cover part of the cost of the drug, but the amount is reduced by the amount of copay assistance that is accessed. That assistance can vary widely and be as much as $20,000 a year for some drugs.

In the other approach, employers don’t bother naming drugs nonessential; they simply drop coverage for specific drugs or classes of drugs. Then, the outside vendor helps patients provide the financial and other information needed to apply for free medication from drugmakers through charity programs intended for uninsured patients.

“We’re seeing it in every state at this point,” said Becky Burns, chief operating officer and chief financial officer at the Bleeding and Clotting Disorders Institute in Peoria, Ill., a federally funded hemophilia treatment center.

The strategies are mostly being used in self-insured employer health plans, which are governed by federal laws that give broad flexibility to employers in designing health benefits.

Still, some patient advocates say these programs can lead to delays for patients in accessing medications while applications are processed – and sometimes unexpected bills for consumers.

“We have patients get billed after they max out their assistance,” said Kollet Koulianos, vice president of payer relations at the National Hemophilia Foundation. Once she gets involved, vendors often claim the bills were sent in error.

Even though only about 2% of the workforce needs the drugs, which can cost thousands of dollars a dose, they can lead to a hefty financial liability for self-insured employers, said Drew Mann, a benefits consultant in Knoxville, Tenn., whose clientele includes employers that use variations of these programs.

Before employer health plans took advantage of such assistance, patients often signed up for these programs on their own, receiving coupons that covered their share of the drug’s cost. In that circumstance, drugmakers often paid less than they do under the new employer schemes because a patient’s out-of-pocket costs were capped at lower amounts.

Brokers and the CEOs of firms offering the new programs say that in most cases patients continue to get their drugs, often with little or no out-of-pocket costs.

If workers do not qualify for charity because their income is too high, or for another reason, the employer might make an exception and pay the claim or look for an alternative solution, Mr. Mann said. Patient groups noted that some specialty drugs may not have any alternatives.

How this practice will play out in the long run remains uncertain. Drugmakers offer both copay assistance and charity care in part because they know many patients, even those with insurance, cannot afford their products. The programs are also good public relations and a tax write-off. But the new emphasis by some employers on maximizing the amount they or their insurers can collect from the programs could cause some drugmakers to take issue with the new strategies or even reconsider their programs.

“Even though our client, like most manufacturers, provides billions in discounts and rebates to health insurers as part of their negotiations, the insurers also want this additional pool of funds, which is meant to help people who can’t meet the copay,” said Harry Sandick, a lawyer representing J&J.

J&J’s lawsuit, filed in U.S. District Court in New Jersey, alleges that patients are “coerced” into participating in copay assistance programs after their drugs are deemed “nonessential” and therefore are “no longer subject to the ACA’s annual out-of-pocket maximum.”

Once patients enroll, the money from the drugmaker goes to the insurer or employer plan, with SaveOnSP retaining 25%, according to the lawsuit. It claims J&J has lost $100 million to these efforts.

None of that money counts toward patients’ deductibles or out-of-pocket maximums for the year.

In addition to the lawsuit over the copay assistance program efforts, there has been other reaction to the new employer strategies. In an October letter to physicians, the Johnson & Johnson Patient Assistance Foundation, a separate entity, said it will no longer offer free medications to patients with insurance starting in January, citing the rise of such “alternative funding programs.”

Still, J&J spokesperson L.D. Platt said the drugmaker has plans, also in January, to roll out other assistance to patients who may be “underinsured” so they won’t be affected by the foundation’s decision.

In a statement, SaveOnSP said that employers object to drug companies’ “using their employees’ ongoing need for these drugs as an excuse to keep hiking the drugs’ prices” and that the firm simply “advises these employers on how to fight back against rising prices while getting employees the drugs they need at no cost to the employees.”

In a court filing, SaveOnSP said drugmakers have another option if they don’t like efforts by insurers and employers to max out what they can get from the programs: reduce the amount of assistance available. J&J, the filing said, did just that when it recently cut its allotted amount of copay assistance for psoriasis drugs Stelara and Tremfya from $20,000 to $6,000 per participant annually. The filing noted that SaveOnSP participants would still have no copay for those drugs.

For Mrs. Sutton’s part, her family did participate in the program offered through her husband’s work-based insurance plan, agreeing to have SaveOnSP monitor their enrollment and payments from the drugmaker.

So far, her 15-year-old daughter has continued to get Humira, and she has not been billed a copay.

Even so, “the whole process seems kind of slimy to me,” she said. “The patients are caught in the middle between the drug industry and the insurance industry, each trying to get as much money as possible out of the other.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Anna Sutton was shocked when she received a letter from her husband’s job-based health plan stating that Humira, an expensive drug used to treat her daughter’s juvenile arthritis, was now on a long list of medications considered “nonessential benefits.”

The July 2021 letter said the family could either participate in a new effort overseen by a company called SaveOnSP and get the drug free of charge or be saddled with a monthly copayment that could top $1,000.

“It really gave us no choice,” said Mrs. Sutton, of Woodinville, Wash. She added that “every single [Food and Drug Administration]–approved medication for juvenile arthritis” was on the list of nonessential benefits.

Mrs. Sutton had unwittingly become part of a strategy that employers are using to deal with the high cost of drugs prescribed to treat conditions such as arthritis, psoriasis, cancer, and hemophilia.

Those employers are tapping into dollars provided through programs they have previously criticized: patient financial assistance initiatives set up by drugmakers, which some benefit managers have complained encourage patients to stay on expensive brand-name drugs when less expensive options might be available.

Now, though, employers, or the vendors and insurers they hire specifically to oversee such efforts, are seeking that money to offset their own costs. Drugmakers object, saying the money was intended primarily for patients. But some benefit brokers and companies like SaveOnSP say they can help trim employers’ spending on insurance – which, they say, could be the difference between an employer offering coverage to workers or not.

It’s the latest twist in a long-running dispute between the drug industry and insurers over which group is more to blame for rising costs to patients. And patients are, again, caught in the middle.

Patient advocates say the term “nonessential” stresses patients out even though it doesn’t mean the drugs – often called “specialty” drugs because of their high prices or the way they are made – are unnecessary.

Some advocates fear the new strategies could be “a way to weed out those with costly health care needs,” said Rachel Klein, deputy executive director of the AIDS Institute, a nonprofit advocacy group. Workers who rely on the drugs may feel pressured to change insurers or jobs.

Two versions of the new strategy are in play. Both are used mainly by self-insured employers that hire vendors, like SaveOnSP, which then work with the employers’ pharmacy benefit managers, such as Express Scripts/Cigna, to implement the strategy. There are also smaller vendors, like SHARx and Payer Matrix, some of which work directly with employers.

In one approach, insurers or employers continue to cover the drugs but designate them as “nonessential,” which allows the health plans to bypass annual limits set by the Affordable Care Act on how much patients can pay in out-of-pocket costs for drugs. The employer or hired vendor then raises the copay required of the worker, often sharply, but offers to substantially cut or eliminate that copay if the patient participates in the new effort. Workers who agree enroll in drugmaker financial assistance programs meant to cover the drug copays, and the vendor monitoring the effort aims to capture the maximum amount the drugmaker provides annually, according to a lawsuit filed in May by drugmaker Johnson & Johnson against SaveOnSP, which is based in Elma, N.Y.

The employer must still cover part of the cost of the drug, but the amount is reduced by the amount of copay assistance that is accessed. That assistance can vary widely and be as much as $20,000 a year for some drugs.

In the other approach, employers don’t bother naming drugs nonessential; they simply drop coverage for specific drugs or classes of drugs. Then, the outside vendor helps patients provide the financial and other information needed to apply for free medication from drugmakers through charity programs intended for uninsured patients.

“We’re seeing it in every state at this point,” said Becky Burns, chief operating officer and chief financial officer at the Bleeding and Clotting Disorders Institute in Peoria, Ill., a federally funded hemophilia treatment center.

The strategies are mostly being used in self-insured employer health plans, which are governed by federal laws that give broad flexibility to employers in designing health benefits.

Still, some patient advocates say these programs can lead to delays for patients in accessing medications while applications are processed – and sometimes unexpected bills for consumers.

“We have patients get billed after they max out their assistance,” said Kollet Koulianos, vice president of payer relations at the National Hemophilia Foundation. Once she gets involved, vendors often claim the bills were sent in error.

Even though only about 2% of the workforce needs the drugs, which can cost thousands of dollars a dose, they can lead to a hefty financial liability for self-insured employers, said Drew Mann, a benefits consultant in Knoxville, Tenn., whose clientele includes employers that use variations of these programs.

Before employer health plans took advantage of such assistance, patients often signed up for these programs on their own, receiving coupons that covered their share of the drug’s cost. In that circumstance, drugmakers often paid less than they do under the new employer schemes because a patient’s out-of-pocket costs were capped at lower amounts.

Brokers and the CEOs of firms offering the new programs say that in most cases patients continue to get their drugs, often with little or no out-of-pocket costs.

If workers do not qualify for charity because their income is too high, or for another reason, the employer might make an exception and pay the claim or look for an alternative solution, Mr. Mann said. Patient groups noted that some specialty drugs may not have any alternatives.

How this practice will play out in the long run remains uncertain. Drugmakers offer both copay assistance and charity care in part because they know many patients, even those with insurance, cannot afford their products. The programs are also good public relations and a tax write-off. But the new emphasis by some employers on maximizing the amount they or their insurers can collect from the programs could cause some drugmakers to take issue with the new strategies or even reconsider their programs.

“Even though our client, like most manufacturers, provides billions in discounts and rebates to health insurers as part of their negotiations, the insurers also want this additional pool of funds, which is meant to help people who can’t meet the copay,” said Harry Sandick, a lawyer representing J&J.

J&J’s lawsuit, filed in U.S. District Court in New Jersey, alleges that patients are “coerced” into participating in copay assistance programs after their drugs are deemed “nonessential” and therefore are “no longer subject to the ACA’s annual out-of-pocket maximum.”

Once patients enroll, the money from the drugmaker goes to the insurer or employer plan, with SaveOnSP retaining 25%, according to the lawsuit. It claims J&J has lost $100 million to these efforts.

None of that money counts toward patients’ deductibles or out-of-pocket maximums for the year.

In addition to the lawsuit over the copay assistance program efforts, there has been other reaction to the new employer strategies. In an October letter to physicians, the Johnson & Johnson Patient Assistance Foundation, a separate entity, said it will no longer offer free medications to patients with insurance starting in January, citing the rise of such “alternative funding programs.”

Still, J&J spokesperson L.D. Platt said the drugmaker has plans, also in January, to roll out other assistance to patients who may be “underinsured” so they won’t be affected by the foundation’s decision.

In a statement, SaveOnSP said that employers object to drug companies’ “using their employees’ ongoing need for these drugs as an excuse to keep hiking the drugs’ prices” and that the firm simply “advises these employers on how to fight back against rising prices while getting employees the drugs they need at no cost to the employees.”

In a court filing, SaveOnSP said drugmakers have another option if they don’t like efforts by insurers and employers to max out what they can get from the programs: reduce the amount of assistance available. J&J, the filing said, did just that when it recently cut its allotted amount of copay assistance for psoriasis drugs Stelara and Tremfya from $20,000 to $6,000 per participant annually. The filing noted that SaveOnSP participants would still have no copay for those drugs.

For Mrs. Sutton’s part, her family did participate in the program offered through her husband’s work-based insurance plan, agreeing to have SaveOnSP monitor their enrollment and payments from the drugmaker.

So far, her 15-year-old daughter has continued to get Humira, and she has not been billed a copay.

Even so, “the whole process seems kind of slimy to me,” she said. “The patients are caught in the middle between the drug industry and the insurance industry, each trying to get as much money as possible out of the other.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

For patients with severe arthritis, joint replacement is considered when more conservative treatments have failed. Because patients with obesity have a higher risk of complications during and after surgery, some surgeons, hospitals, and insurance companies have adopted body mass index cutoffs as a basis for deciding whether to offer patients these elective surgeries. But some experts argue that these cutoffs are arbitrary, exclude patients who can still benefit from the surgery, and can increase disparities in care.

“By enforcing cutoffs in general, you’re losing the ability for each surgeon to determine who they want to operate on,” said Daniel Wiznia, MD, assistant professor of orthopedic surgery at Yale University, New Haven, Conn. He is on the leadership committee of the Movement Is Life Caucus, a nonprofit group focused on eliminating disparities in musculoskeletal health. “For every surgeon, it’s up to them to decide if they feel comfortable doing the surgery,” he noted in an interview. “My guidance for that would be, don’t just say no because of the number – look at the patient’s entire medical profile.”

According to the Centers for Disease Control and Prevention, nearly 42% of adults in the United States have a BMI over 30, and 9.2% of adults have a BMI over 40. This excess weight puts additional stress on joints: When a person is walking, experts estimate that the force on the knees can be two to three times someone’s body weight. Over time, this pressure can wear down the cartilage on joints.

As a result, people who are overweight or obese are more likely to develop osteoarthritis and to need joint replacements. According to a Canadian study, patients with a BMI of 30-35 are 3.4 times as likely to require a hip replacement and are 8.5 times as likely to require a knee replacement compared to individuals with a BMI in the “healthy weight” range. With a BMI above 40, individuals were 8.5 times more likely to need a hip replacement and were 32.7 times as likely to need a knee replacement.
 

More complications, greater expense

While there are no universally recommended BMI cutoffs for joint replacement surgery, it is not uncommon for institutions to require that patients have a BMI below a certain value (usually 35-40) to proceed with surgery. A 2013 survey of physicians from the American Association of Hip and Knee Surgeons found that 52% of surgeons required a BMI below 40 to qualify for surgery.

One of the main reasons for these cutoffs is the elevated risk of complications during and after surgery. Research suggests that obesity is associated with higher rates of wound dehiscence, prosthetic joint infection (PJI), and revision total joint arthroplasty. One 2016 study suggests that patients with a BMI of 35-39.9 are twice as likely to experience PJI compared to patients with a BMI below 35. For patients with a BMI of 40 or higher, PJI is four times as likely.

Another study found that patients whose BMI is 35-40 and who undergo total joint arthroplasty have a 6.4-fold greater risk of deep incision infection. For those with a BMI over 40, that rises to a 12.9-fold increased risk compared to patients with a BMI of 18.5-25. Patients with obesity tend to have other comorbidities that can increase the risk of complications during surgery, such as type 2 diabetes, coronary artery disease, and chronic kidney disease.

Because of the increased risk of complications, health care costs tend to be higher for patients with obesity. The growing popularity of bundled health payments can discourage operating on patients who are more likely to experience complications, such as patients with high BMIs, noted Dr. Wiznia.

Research suggests that minorities and people with lower socioeconomic status are disproportionately affected by these cutoffs. According to the CDC, among non-Hispanic Black Americans and Hispanic Americans, rates of obesity are higher than among their White counterparts, and these patients are less likely to undergo joint replacement. Strictly enforcing this eligibility criterion can worsen those disparities. A study involving 21,294 adults over age 50 from the National Health and Nutrition Examination Survey (NHANES) found that requiring a BMI of under 35 for total joint arthroplasty resulted in Black patients being 39% less likely to be eligible for surgery than White patients. And individuals with an annual household income under $45,000 were 19% less likely to qualify for surgery than those with a household income above $45,000.
 

BMI no better than other risk factors

Although high BMI is independently associated with a higher risk of complications, the increased risk of complications conferred by a BMI at or above 40 is similar to or lower than those of other comorbidities that surgeons generally accept, said Nicholas Giori, MD, PhD, professor of orthopedic surgery at Stanford (Calif.) University, and chief of orthopedic surgery at the VA Palo Alto Health Care System. These other comorbidities include age older than 75, hypertension that requires medication, and insulin-controlled diabetes. “The independent risk of just having the diagnosis of insulin-dependent diabetes is actually comparable to the independent risk of having obesity by itself,” he told this news organization, “and all of us operate on [patients with] diabetes.”

Also, there is no BMI at which the risk of complications suddenly increases, according to the American Academy of Orthopaedic Surgeons. “It’s a rising complication rate as you go into higher BMIs,” Dr. Giori said. “If you operate on someone with a BMI of 39 vs. 41, you’re not going to find that much of a difference [in risk].” But if a medical system enforced a hard BMI cutoff of 40, one patient would qualify for surgery while the other would be barred.
 

Weight not as “modifiable” as previously thought

Weight is often considered a “modifiable factor” for a person considering undergoing total joint arthroplasty, but research suggests that the issue is more complicated. “Obesity is tricky, because some people are successful [in weight loss],” said Dr. Giori. Those tend to be the more memorable stories. “But a large majority have a really hard time losing substantial weight – enough to make a difference in risk,” he continued.

A study conducted in North Carolina found that restricting patients with a BMI over 40 from having elective total joint arthroplasty procedures until their weight was optimized did not result in successful weight loss. Only 20% of patients who originally presented with a BMI above this limit eventually underwent surgery after 2 years, and fewer than half of these patients had achieved a BMI of less than 40 at the time of their surgery. A third of all patients in the study did not return to the orthopedic office after their first visit.

“To hold a hard cutoff when it’s very, very hard to modify ... is essentially telling people that they are not going to ever have surgery,” Dr. Giori said; “I think that can be unfair to some patients.”

Bariatric surgery is often suggested for patients with obesity who have not experienced successful weight loss with diet and lifestyle changes alone, but bariatric surgery comes with its own complications. Research on outcomes from total joint arthroplasty among patients with who have lost weight with bariatric surgery has yielded mixed results. “I rarely push anyone hard to go that route but present it as an option for certain patients,” said Benjamin M. Stronach, MD, an orthopedic surgeon at the University of Arkansas for Medical Sciences, in Little Rock. He usually brings up bariatric surgery with patients with a BMI in the high 40s or higher to gauge their interest. If patients are already considering weight loss surgery, his office provides referrals.

But even bariatric surgery does not result in successful long-term weight loss for every patient, Dr. Stronach said. He’s seeing more and more patients who come for consultations after having undergone bariatric surgery 10 to 15 years ago. These patients lost a significant amount of weight, but then gained the weight back. He noted that bariatric surgery can be very successful for some patients who adhere to their postbariatric regimen. “We typically see fairly impressive results in the short term,” he said.
 

Patients with obesity benefit from joint replacement

Although patients with obesity are at higher risk for complications from joint replacement surgery, research suggests that these patients can still benefit greatly from these surgeries and that these surgeries remain cost-effective. Some studies have found that patients with obesity tend to have worse outcomes after surgery than patients who are not obese, but often, patients with high BMIs are starting from a lower point, with greater joint pain and limited mobility, Dr. Giori said. But the improvements – that is, net change in measured outcomes – can be greater for obese patients.

“Several studies have shown equal or greater improvements in validated outcome scores, function, and satisfaction compared with nonobese patients after surgery,” authors wrote in a recent review article in which they discuss how to optimize joint replacement surgery for patients with obesity. The article, published in the November 2022 issue of the Journal of the American Academy of Orthopaedic Surgeon (JAAOS), is part of a collection of review articles by the Movement Is Life Caucus.

Encourage weight loss, but look beyond the number

Rather than adhering to strict BMI cutoffs, some experts urge surgeons to consider the patient as a whole and to evaluate each individual’s overall health and potential risk. Dr. Giori generally considers high BMI as just another comorbidity when assessing a patient’s overall risk. “For a person who only has a high BMI but is otherwise healthy, I see no reason not to go ahead and schedule that person for surgery, because reducing the patient’s BMI will not substantially reduce the patient’s complication risk, and a delay in surgery may adversely affect the patient’s quality of life and ability to earn a living,” he said.

“If someone is between a BMI of 40 and 45, we are definitely going to have a discussion about weight,” Dr. Stronach said. He generally counsels against surgery for any patient with a BMI at 45 or above. He wants patients to have a BMI below 40 before surgery but considers individual cases for exceptions. “We will still move forward at times with someone with a BMI of 41, as an example, who is otherwise healthy,” he said. Similarly, if a patient has lost a significant amount of weight (e.g., the patient’s BMI was reduced from 50 to 41), the patient is actively engaged in improving their health, and surgeons believe the patient has significantly reduced their risk, “a lot of time, we’re not going to draw a line in the sand right at [a BMI of] 40,” he said.

While using a BMI of under 35 or 40 as a guideline when starting to work with patients is reasonable, working toward a weight loss of 5%-10% of total body weight is another goal to consider, authors advise in the JAAOS obesity review article. Research suggests that even a 5% reduction in overall body weight can reduce surgical complications and can improve a patient’s glucose and lipid levels and cardiac profile. Referrals to dietitians and weight loss programs, as well as behavioral counseling, can also be useful in initiating weight loss and keeping patients engaged in the process, the authors wrote.
 

Consider a patient’s comorbidities

Many patients with obesity have comorbidities, such as type 2 diabetes and hypertension, that can also be optimized for surgery so as to lower a patient’s overall risk profile. For patients with diabetes, achieving an A1c of 8% or lower can be a reasonable goal and can reduce risk. “We’ve found that an HbA1c level of 8% or less is something that virtually all diabetics (though not everybody) can reach, and it’s something that can be reached in a reasonable amount of time,” Dr. Giori said. Preoperative use of beta-blockers, continued use of ACE inhibitors or angiotensin receptor blockers, and behavioral modifications can improve a patient’s cardiac health before surgery.

Malnutrition can be a correctable problem for patients, regardless of BMI. In the Movement Is Life collection of optimization articles, experts recommend that orthopedists screen for malnutrition with blood tests for albumin, vitamin D, transferrin, and total lymphocyte count. Patients with malnutrition should be screened for food insecurity, experts advise, and surgical candidates with deficiencies can be given supplements of omega-3 fatty acids, arginine, and protein shakes.

Surgeon comfort and shared decision-making

Dr. Wiznia emphasized that the patient and surgeon need to discuss the risks of surgery, concerns about potential complications, and how a complication could affect the patient’s life moving forward. “Ultimately, the surgeon needs to make the decision [of whether or not to proceed [with surgery] with the patient,” he said, “but not every surgeon is going to feel comfortable operating on these patients, and not every medical institution is going to have the equipment and the investments to support surgeons doing it.”

Dr. Giori agreed that surgeons should proceed only with surgical cases they feel comfortable with. Certain surgeons may decide not to operate on individuals with higher BMIs because of the potential complications and can refer these patients to more specialized care centers. Operating on larger patients is more difficult and requires surgical skills and expertise that the surgeon may not have, he noted. “What I do object to is a system-wide BMI cutoff – for example, if an insurance company won’t pay for you to have a joint replacement, regardless of where you go or who your surgeon is,” Dr. Giori added. “I think that’s wrong, because it’s not patient centered and it’s basically excluding people from having a life-altering operation.”

Dr. Giori and Dr. Wiznia report no relevant financial relationships. Dr. Stronach is a consultant for DJ Orthopaedics, Johnson & Johnson, and MiCare Path.

A version of this article first appeared on Medscape.com.

For patients with severe arthritis, joint replacement is considered when more conservative treatments have failed. Because patients with obesity have a higher risk of complications during and after surgery, some surgeons, hospitals, and insurance companies have adopted body mass index cutoffs as a basis for deciding whether to offer patients these elective surgeries. But some experts argue that these cutoffs are arbitrary, exclude patients who can still benefit from the surgery, and can increase disparities in care.

“By enforcing cutoffs in general, you’re losing the ability for each surgeon to determine who they want to operate on,” said Daniel Wiznia, MD, assistant professor of orthopedic surgery at Yale University, New Haven, Conn. He is on the leadership committee of the Movement Is Life Caucus, a nonprofit group focused on eliminating disparities in musculoskeletal health. “For every surgeon, it’s up to them to decide if they feel comfortable doing the surgery,” he noted in an interview. “My guidance for that would be, don’t just say no because of the number – look at the patient’s entire medical profile.”

According to the Centers for Disease Control and Prevention, nearly 42% of adults in the United States have a BMI over 30, and 9.2% of adults have a BMI over 40. This excess weight puts additional stress on joints: When a person is walking, experts estimate that the force on the knees can be two to three times someone’s body weight. Over time, this pressure can wear down the cartilage on joints.

As a result, people who are overweight or obese are more likely to develop osteoarthritis and to need joint replacements. According to a Canadian study, patients with a BMI of 30-35 are 3.4 times as likely to require a hip replacement and are 8.5 times as likely to require a knee replacement compared to individuals with a BMI in the “healthy weight” range. With a BMI above 40, individuals were 8.5 times more likely to need a hip replacement and were 32.7 times as likely to need a knee replacement.
 

More complications, greater expense

While there are no universally recommended BMI cutoffs for joint replacement surgery, it is not uncommon for institutions to require that patients have a BMI below a certain value (usually 35-40) to proceed with surgery. A 2013 survey of physicians from the American Association of Hip and Knee Surgeons found that 52% of surgeons required a BMI below 40 to qualify for surgery.

One of the main reasons for these cutoffs is the elevated risk of complications during and after surgery. Research suggests that obesity is associated with higher rates of wound dehiscence, prosthetic joint infection (PJI), and revision total joint arthroplasty. One 2016 study suggests that patients with a BMI of 35-39.9 are twice as likely to experience PJI compared to patients with a BMI below 35. For patients with a BMI of 40 or higher, PJI is four times as likely.

Another study found that patients whose BMI is 35-40 and who undergo total joint arthroplasty have a 6.4-fold greater risk of deep incision infection. For those with a BMI over 40, that rises to a 12.9-fold increased risk compared to patients with a BMI of 18.5-25. Patients with obesity tend to have other comorbidities that can increase the risk of complications during surgery, such as type 2 diabetes, coronary artery disease, and chronic kidney disease.

Because of the increased risk of complications, health care costs tend to be higher for patients with obesity. The growing popularity of bundled health payments can discourage operating on patients who are more likely to experience complications, such as patients with high BMIs, noted Dr. Wiznia.

Research suggests that minorities and people with lower socioeconomic status are disproportionately affected by these cutoffs. According to the CDC, among non-Hispanic Black Americans and Hispanic Americans, rates of obesity are higher than among their White counterparts, and these patients are less likely to undergo joint replacement. Strictly enforcing this eligibility criterion can worsen those disparities. A study involving 21,294 adults over age 50 from the National Health and Nutrition Examination Survey (NHANES) found that requiring a BMI of under 35 for total joint arthroplasty resulted in Black patients being 39% less likely to be eligible for surgery than White patients. And individuals with an annual household income under $45,000 were 19% less likely to qualify for surgery than those with a household income above $45,000.
 

BMI no better than other risk factors

Although high BMI is independently associated with a higher risk of complications, the increased risk of complications conferred by a BMI at or above 40 is similar to or lower than those of other comorbidities that surgeons generally accept, said Nicholas Giori, MD, PhD, professor of orthopedic surgery at Stanford (Calif.) University, and chief of orthopedic surgery at the VA Palo Alto Health Care System. These other comorbidities include age older than 75, hypertension that requires medication, and insulin-controlled diabetes. “The independent risk of just having the diagnosis of insulin-dependent diabetes is actually comparable to the independent risk of having obesity by itself,” he told this news organization, “and all of us operate on [patients with] diabetes.”

Also, there is no BMI at which the risk of complications suddenly increases, according to the American Academy of Orthopaedic Surgeons. “It’s a rising complication rate as you go into higher BMIs,” Dr. Giori said. “If you operate on someone with a BMI of 39 vs. 41, you’re not going to find that much of a difference [in risk].” But if a medical system enforced a hard BMI cutoff of 40, one patient would qualify for surgery while the other would be barred.
 

Weight not as “modifiable” as previously thought

Weight is often considered a “modifiable factor” for a person considering undergoing total joint arthroplasty, but research suggests that the issue is more complicated. “Obesity is tricky, because some people are successful [in weight loss],” said Dr. Giori. Those tend to be the more memorable stories. “But a large majority have a really hard time losing substantial weight – enough to make a difference in risk,” he continued.

A study conducted in North Carolina found that restricting patients with a BMI over 40 from having elective total joint arthroplasty procedures until their weight was optimized did not result in successful weight loss. Only 20% of patients who originally presented with a BMI above this limit eventually underwent surgery after 2 years, and fewer than half of these patients had achieved a BMI of less than 40 at the time of their surgery. A third of all patients in the study did not return to the orthopedic office after their first visit.

“To hold a hard cutoff when it’s very, very hard to modify ... is essentially telling people that they are not going to ever have surgery,” Dr. Giori said; “I think that can be unfair to some patients.”

Bariatric surgery is often suggested for patients with obesity who have not experienced successful weight loss with diet and lifestyle changes alone, but bariatric surgery comes with its own complications. Research on outcomes from total joint arthroplasty among patients with who have lost weight with bariatric surgery has yielded mixed results. “I rarely push anyone hard to go that route but present it as an option for certain patients,” said Benjamin M. Stronach, MD, an orthopedic surgeon at the University of Arkansas for Medical Sciences, in Little Rock. He usually brings up bariatric surgery with patients with a BMI in the high 40s or higher to gauge their interest. If patients are already considering weight loss surgery, his office provides referrals.

But even bariatric surgery does not result in successful long-term weight loss for every patient, Dr. Stronach said. He’s seeing more and more patients who come for consultations after having undergone bariatric surgery 10 to 15 years ago. These patients lost a significant amount of weight, but then gained the weight back. He noted that bariatric surgery can be very successful for some patients who adhere to their postbariatric regimen. “We typically see fairly impressive results in the short term,” he said.
 

Patients with obesity benefit from joint replacement

Although patients with obesity are at higher risk for complications from joint replacement surgery, research suggests that these patients can still benefit greatly from these surgeries and that these surgeries remain cost-effective. Some studies have found that patients with obesity tend to have worse outcomes after surgery than patients who are not obese, but often, patients with high BMIs are starting from a lower point, with greater joint pain and limited mobility, Dr. Giori said. But the improvements – that is, net change in measured outcomes – can be greater for obese patients.

“Several studies have shown equal or greater improvements in validated outcome scores, function, and satisfaction compared with nonobese patients after surgery,” authors wrote in a recent review article in which they discuss how to optimize joint replacement surgery for patients with obesity. The article, published in the November 2022 issue of the Journal of the American Academy of Orthopaedic Surgeon (JAAOS), is part of a collection of review articles by the Movement Is Life Caucus.

Encourage weight loss, but look beyond the number

Rather than adhering to strict BMI cutoffs, some experts urge surgeons to consider the patient as a whole and to evaluate each individual’s overall health and potential risk. Dr. Giori generally considers high BMI as just another comorbidity when assessing a patient’s overall risk. “For a person who only has a high BMI but is otherwise healthy, I see no reason not to go ahead and schedule that person for surgery, because reducing the patient’s BMI will not substantially reduce the patient’s complication risk, and a delay in surgery may adversely affect the patient’s quality of life and ability to earn a living,” he said.

“If someone is between a BMI of 40 and 45, we are definitely going to have a discussion about weight,” Dr. Stronach said. He generally counsels against surgery for any patient with a BMI at 45 or above. He wants patients to have a BMI below 40 before surgery but considers individual cases for exceptions. “We will still move forward at times with someone with a BMI of 41, as an example, who is otherwise healthy,” he said. Similarly, if a patient has lost a significant amount of weight (e.g., the patient’s BMI was reduced from 50 to 41), the patient is actively engaged in improving their health, and surgeons believe the patient has significantly reduced their risk, “a lot of time, we’re not going to draw a line in the sand right at [a BMI of] 40,” he said.

While using a BMI of under 35 or 40 as a guideline when starting to work with patients is reasonable, working toward a weight loss of 5%-10% of total body weight is another goal to consider, authors advise in the JAAOS obesity review article. Research suggests that even a 5% reduction in overall body weight can reduce surgical complications and can improve a patient’s glucose and lipid levels and cardiac profile. Referrals to dietitians and weight loss programs, as well as behavioral counseling, can also be useful in initiating weight loss and keeping patients engaged in the process, the authors wrote.
 

Consider a patient’s comorbidities

Many patients with obesity have comorbidities, such as type 2 diabetes and hypertension, that can also be optimized for surgery so as to lower a patient’s overall risk profile. For patients with diabetes, achieving an A1c of 8% or lower can be a reasonable goal and can reduce risk. “We’ve found that an HbA1c level of 8% or less is something that virtually all diabetics (though not everybody) can reach, and it’s something that can be reached in a reasonable amount of time,” Dr. Giori said. Preoperative use of beta-blockers, continued use of ACE inhibitors or angiotensin receptor blockers, and behavioral modifications can improve a patient’s cardiac health before surgery.

Malnutrition can be a correctable problem for patients, regardless of BMI. In the Movement Is Life collection of optimization articles, experts recommend that orthopedists screen for malnutrition with blood tests for albumin, vitamin D, transferrin, and total lymphocyte count. Patients with malnutrition should be screened for food insecurity, experts advise, and surgical candidates with deficiencies can be given supplements of omega-3 fatty acids, arginine, and protein shakes.

Surgeon comfort and shared decision-making

Dr. Wiznia emphasized that the patient and surgeon need to discuss the risks of surgery, concerns about potential complications, and how a complication could affect the patient’s life moving forward. “Ultimately, the surgeon needs to make the decision [of whether or not to proceed [with surgery] with the patient,” he said, “but not every surgeon is going to feel comfortable operating on these patients, and not every medical institution is going to have the equipment and the investments to support surgeons doing it.”

Dr. Giori agreed that surgeons should proceed only with surgical cases they feel comfortable with. Certain surgeons may decide not to operate on individuals with higher BMIs because of the potential complications and can refer these patients to more specialized care centers. Operating on larger patients is more difficult and requires surgical skills and expertise that the surgeon may not have, he noted. “What I do object to is a system-wide BMI cutoff – for example, if an insurance company won’t pay for you to have a joint replacement, regardless of where you go or who your surgeon is,” Dr. Giori added. “I think that’s wrong, because it’s not patient centered and it’s basically excluding people from having a life-altering operation.”

Dr. Giori and Dr. Wiznia report no relevant financial relationships. Dr. Stronach is a consultant for DJ Orthopaedics, Johnson & Johnson, and MiCare Path.

A version of this article first appeared on Medscape.com.

For patients with severe arthritis, joint replacement is considered when more conservative treatments have failed. Because patients with obesity have a higher risk of complications during and after surgery, some surgeons, hospitals, and insurance companies have adopted body mass index cutoffs as a basis for deciding whether to offer patients these elective surgeries. But some experts argue that these cutoffs are arbitrary, exclude patients who can still benefit from the surgery, and can increase disparities in care.

“By enforcing cutoffs in general, you’re losing the ability for each surgeon to determine who they want to operate on,” said Daniel Wiznia, MD, assistant professor of orthopedic surgery at Yale University, New Haven, Conn. He is on the leadership committee of the Movement Is Life Caucus, a nonprofit group focused on eliminating disparities in musculoskeletal health. “For every surgeon, it’s up to them to decide if they feel comfortable doing the surgery,” he noted in an interview. “My guidance for that would be, don’t just say no because of the number – look at the patient’s entire medical profile.”

According to the Centers for Disease Control and Prevention, nearly 42% of adults in the United States have a BMI over 30, and 9.2% of adults have a BMI over 40. This excess weight puts additional stress on joints: When a person is walking, experts estimate that the force on the knees can be two to three times someone’s body weight. Over time, this pressure can wear down the cartilage on joints.

As a result, people who are overweight or obese are more likely to develop osteoarthritis and to need joint replacements. According to a Canadian study, patients with a BMI of 30-35 are 3.4 times as likely to require a hip replacement and are 8.5 times as likely to require a knee replacement compared to individuals with a BMI in the “healthy weight” range. With a BMI above 40, individuals were 8.5 times more likely to need a hip replacement and were 32.7 times as likely to need a knee replacement.
 

More complications, greater expense

While there are no universally recommended BMI cutoffs for joint replacement surgery, it is not uncommon for institutions to require that patients have a BMI below a certain value (usually 35-40) to proceed with surgery. A 2013 survey of physicians from the American Association of Hip and Knee Surgeons found that 52% of surgeons required a BMI below 40 to qualify for surgery.

One of the main reasons for these cutoffs is the elevated risk of complications during and after surgery. Research suggests that obesity is associated with higher rates of wound dehiscence, prosthetic joint infection (PJI), and revision total joint arthroplasty. One 2016 study suggests that patients with a BMI of 35-39.9 are twice as likely to experience PJI compared to patients with a BMI below 35. For patients with a BMI of 40 or higher, PJI is four times as likely.

Another study found that patients whose BMI is 35-40 and who undergo total joint arthroplasty have a 6.4-fold greater risk of deep incision infection. For those with a BMI over 40, that rises to a 12.9-fold increased risk compared to patients with a BMI of 18.5-25. Patients with obesity tend to have other comorbidities that can increase the risk of complications during surgery, such as type 2 diabetes, coronary artery disease, and chronic kidney disease.

Because of the increased risk of complications, health care costs tend to be higher for patients with obesity. The growing popularity of bundled health payments can discourage operating on patients who are more likely to experience complications, such as patients with high BMIs, noted Dr. Wiznia.

Research suggests that minorities and people with lower socioeconomic status are disproportionately affected by these cutoffs. According to the CDC, among non-Hispanic Black Americans and Hispanic Americans, rates of obesity are higher than among their White counterparts, and these patients are less likely to undergo joint replacement. Strictly enforcing this eligibility criterion can worsen those disparities. A study involving 21,294 adults over age 50 from the National Health and Nutrition Examination Survey (NHANES) found that requiring a BMI of under 35 for total joint arthroplasty resulted in Black patients being 39% less likely to be eligible for surgery than White patients. And individuals with an annual household income under $45,000 were 19% less likely to qualify for surgery than those with a household income above $45,000.
 

BMI no better than other risk factors

Although high BMI is independently associated with a higher risk of complications, the increased risk of complications conferred by a BMI at or above 40 is similar to or lower than those of other comorbidities that surgeons generally accept, said Nicholas Giori, MD, PhD, professor of orthopedic surgery at Stanford (Calif.) University, and chief of orthopedic surgery at the VA Palo Alto Health Care System. These other comorbidities include age older than 75, hypertension that requires medication, and insulin-controlled diabetes. “The independent risk of just having the diagnosis of insulin-dependent diabetes is actually comparable to the independent risk of having obesity by itself,” he told this news organization, “and all of us operate on [patients with] diabetes.”

Also, there is no BMI at which the risk of complications suddenly increases, according to the American Academy of Orthopaedic Surgeons. “It’s a rising complication rate as you go into higher BMIs,” Dr. Giori said. “If you operate on someone with a BMI of 39 vs. 41, you’re not going to find that much of a difference [in risk].” But if a medical system enforced a hard BMI cutoff of 40, one patient would qualify for surgery while the other would be barred.
 

Weight not as “modifiable” as previously thought

Weight is often considered a “modifiable factor” for a person considering undergoing total joint arthroplasty, but research suggests that the issue is more complicated. “Obesity is tricky, because some people are successful [in weight loss],” said Dr. Giori. Those tend to be the more memorable stories. “But a large majority have a really hard time losing substantial weight – enough to make a difference in risk,” he continued.

A study conducted in North Carolina found that restricting patients with a BMI over 40 from having elective total joint arthroplasty procedures until their weight was optimized did not result in successful weight loss. Only 20% of patients who originally presented with a BMI above this limit eventually underwent surgery after 2 years, and fewer than half of these patients had achieved a BMI of less than 40 at the time of their surgery. A third of all patients in the study did not return to the orthopedic office after their first visit.

“To hold a hard cutoff when it’s very, very hard to modify ... is essentially telling people that they are not going to ever have surgery,” Dr. Giori said; “I think that can be unfair to some patients.”

Bariatric surgery is often suggested for patients with obesity who have not experienced successful weight loss with diet and lifestyle changes alone, but bariatric surgery comes with its own complications. Research on outcomes from total joint arthroplasty among patients with who have lost weight with bariatric surgery has yielded mixed results. “I rarely push anyone hard to go that route but present it as an option for certain patients,” said Benjamin M. Stronach, MD, an orthopedic surgeon at the University of Arkansas for Medical Sciences, in Little Rock. He usually brings up bariatric surgery with patients with a BMI in the high 40s or higher to gauge their interest. If patients are already considering weight loss surgery, his office provides referrals.

But even bariatric surgery does not result in successful long-term weight loss for every patient, Dr. Stronach said. He’s seeing more and more patients who come for consultations after having undergone bariatric surgery 10 to 15 years ago. These patients lost a significant amount of weight, but then gained the weight back. He noted that bariatric surgery can be very successful for some patients who adhere to their postbariatric regimen. “We typically see fairly impressive results in the short term,” he said.
 

Patients with obesity benefit from joint replacement

Although patients with obesity are at higher risk for complications from joint replacement surgery, research suggests that these patients can still benefit greatly from these surgeries and that these surgeries remain cost-effective. Some studies have found that patients with obesity tend to have worse outcomes after surgery than patients who are not obese, but often, patients with high BMIs are starting from a lower point, with greater joint pain and limited mobility, Dr. Giori said. But the improvements – that is, net change in measured outcomes – can be greater for obese patients.

“Several studies have shown equal or greater improvements in validated outcome scores, function, and satisfaction compared with nonobese patients after surgery,” authors wrote in a recent review article in which they discuss how to optimize joint replacement surgery for patients with obesity. The article, published in the November 2022 issue of the Journal of the American Academy of Orthopaedic Surgeon (JAAOS), is part of a collection of review articles by the Movement Is Life Caucus.

Encourage weight loss, but look beyond the number

Rather than adhering to strict BMI cutoffs, some experts urge surgeons to consider the patient as a whole and to evaluate each individual’s overall health and potential risk. Dr. Giori generally considers high BMI as just another comorbidity when assessing a patient’s overall risk. “For a person who only has a high BMI but is otherwise healthy, I see no reason not to go ahead and schedule that person for surgery, because reducing the patient’s BMI will not substantially reduce the patient’s complication risk, and a delay in surgery may adversely affect the patient’s quality of life and ability to earn a living,” he said.

“If someone is between a BMI of 40 and 45, we are definitely going to have a discussion about weight,” Dr. Stronach said. He generally counsels against surgery for any patient with a BMI at 45 or above. He wants patients to have a BMI below 40 before surgery but considers individual cases for exceptions. “We will still move forward at times with someone with a BMI of 41, as an example, who is otherwise healthy,” he said. Similarly, if a patient has lost a significant amount of weight (e.g., the patient’s BMI was reduced from 50 to 41), the patient is actively engaged in improving their health, and surgeons believe the patient has significantly reduced their risk, “a lot of time, we’re not going to draw a line in the sand right at [a BMI of] 40,” he said.

While using a BMI of under 35 or 40 as a guideline when starting to work with patients is reasonable, working toward a weight loss of 5%-10% of total body weight is another goal to consider, authors advise in the JAAOS obesity review article. Research suggests that even a 5% reduction in overall body weight can reduce surgical complications and can improve a patient’s glucose and lipid levels and cardiac profile. Referrals to dietitians and weight loss programs, as well as behavioral counseling, can also be useful in initiating weight loss and keeping patients engaged in the process, the authors wrote.
 

Consider a patient’s comorbidities

Many patients with obesity have comorbidities, such as type 2 diabetes and hypertension, that can also be optimized for surgery so as to lower a patient’s overall risk profile. For patients with diabetes, achieving an A1c of 8% or lower can be a reasonable goal and can reduce risk. “We’ve found that an HbA1c level of 8% or less is something that virtually all diabetics (though not everybody) can reach, and it’s something that can be reached in a reasonable amount of time,” Dr. Giori said. Preoperative use of beta-blockers, continued use of ACE inhibitors or angiotensin receptor blockers, and behavioral modifications can improve a patient’s cardiac health before surgery.

Malnutrition can be a correctable problem for patients, regardless of BMI. In the Movement Is Life collection of optimization articles, experts recommend that orthopedists screen for malnutrition with blood tests for albumin, vitamin D, transferrin, and total lymphocyte count. Patients with malnutrition should be screened for food insecurity, experts advise, and surgical candidates with deficiencies can be given supplements of omega-3 fatty acids, arginine, and protein shakes.

Surgeon comfort and shared decision-making

Dr. Wiznia emphasized that the patient and surgeon need to discuss the risks of surgery, concerns about potential complications, and how a complication could affect the patient’s life moving forward. “Ultimately, the surgeon needs to make the decision [of whether or not to proceed [with surgery] with the patient,” he said, “but not every surgeon is going to feel comfortable operating on these patients, and not every medical institution is going to have the equipment and the investments to support surgeons doing it.”

Dr. Giori agreed that surgeons should proceed only with surgical cases they feel comfortable with. Certain surgeons may decide not to operate on individuals with higher BMIs because of the potential complications and can refer these patients to more specialized care centers. Operating on larger patients is more difficult and requires surgical skills and expertise that the surgeon may not have, he noted. “What I do object to is a system-wide BMI cutoff – for example, if an insurance company won’t pay for you to have a joint replacement, regardless of where you go or who your surgeon is,” Dr. Giori added. “I think that’s wrong, because it’s not patient centered and it’s basically excluding people from having a life-altering operation.”

Dr. Giori and Dr. Wiznia report no relevant financial relationships. Dr. Stronach is a consultant for DJ Orthopaedics, Johnson & Johnson, and MiCare Path.

A version of this article first appeared on Medscape.com.

Another survey has shown that Americans are largely unaware of the link between alcohol consumption and cancer.

The new findings, from a nationally representative survey that included responses from 3,865 adults, show a low awareness of the cancer risk from alcohol, and also that the risk varies by type of drink. Just under a third (31.2%) of respondents thought that consuming liquor/spirits was associated with a risk of cancer, but this fell to 24.9% for drinking beer and even further, to 20.3%, for drinking wine.

In fact, some respondents though the opposite – that drinking alcohol has health benefits; 10.3% of respondents thought that drinking wine was associated with a decreased cancer risk, while 2.25% thought the same for drinking beer, and 1.7% thought that for drinking liquor.

Most U.S. adults (> 50%) reported not knowing how these beverages affected cancer risk, the authors report.

“This study’s findings underscore the need to develop interventions for educating the public about the cancer risks of alcohol use, particularly in the prevailing context of national dialogue about the purported heart health benefits of wine,” commented senior author William M. P. Klein, PhD, associate director of the National Cancer Institute’s Behavioral Research Program, in a statement.

“All types of alcoholic beverages, including wine, increase cancer risk,” Dr. Klein said.

The findings were published online in Cancer Epidemiology, Biomarkers & Prevention.

The results echo the findings of a previous national survey that also found that the majority of Americans are not aware that alcohol consumption is associated with an increased risk of developing a variety of cancers.

In contrast, within the scientific community, there is long-standing and increasing awareness of alcohol consumption as a leading modifiable risk factor for cancer, and there is a growing movement calling for more public health awareness of the link.

Recently, there has been some public support for adding written warnings about the cancer risk from alcohol. A Citizen Petition was filed in 2021, and in August 2022, The New England Journal of Medicine issued a call for new labeling.

Several cancer organizations are petitioning for warnings to be added to alcoholic beverages. The petition is supported by the American Society of Clinical Oncology, the American Institute for Cancer Research, and Breast Cancer Prevention Partners, all in collaboration with several public health organizations. Proposed labeling would read: “WARNING: According to the Surgeon General, consumption of alcoholic beverages can cause cancer, including breast and colon cancers.”

Dr. Klein and colleagues suggest that public health interventions, including mass media campaigns, cancer warning labels, and patient-provider communications, could help disseminate information about cancer and alcohol. “Educating the public about how alcohol increases cancer risk will not only empower consumers to make more informed decisions but may also prevent and reduce excessive alcohol use, as well as cancer morbidity and mortality,” Dr. Klein said.

The study was supported by the Division of Cancer Control and Population Sciences at the National Cancer Institute. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Another survey has shown that Americans are largely unaware of the link between alcohol consumption and cancer.

The new findings, from a nationally representative survey that included responses from 3,865 adults, show a low awareness of the cancer risk from alcohol, and also that the risk varies by type of drink. Just under a third (31.2%) of respondents thought that consuming liquor/spirits was associated with a risk of cancer, but this fell to 24.9% for drinking beer and even further, to 20.3%, for drinking wine.

In fact, some respondents though the opposite – that drinking alcohol has health benefits; 10.3% of respondents thought that drinking wine was associated with a decreased cancer risk, while 2.25% thought the same for drinking beer, and 1.7% thought that for drinking liquor.

Most U.S. adults (> 50%) reported not knowing how these beverages affected cancer risk, the authors report.

“This study’s findings underscore the need to develop interventions for educating the public about the cancer risks of alcohol use, particularly in the prevailing context of national dialogue about the purported heart health benefits of wine,” commented senior author William M. P. Klein, PhD, associate director of the National Cancer Institute’s Behavioral Research Program, in a statement.

“All types of alcoholic beverages, including wine, increase cancer risk,” Dr. Klein said.

The findings were published online in Cancer Epidemiology, Biomarkers & Prevention.

The results echo the findings of a previous national survey that also found that the majority of Americans are not aware that alcohol consumption is associated with an increased risk of developing a variety of cancers.

In contrast, within the scientific community, there is long-standing and increasing awareness of alcohol consumption as a leading modifiable risk factor for cancer, and there is a growing movement calling for more public health awareness of the link.

Recently, there has been some public support for adding written warnings about the cancer risk from alcohol. A Citizen Petition was filed in 2021, and in August 2022, The New England Journal of Medicine issued a call for new labeling.

Several cancer organizations are petitioning for warnings to be added to alcoholic beverages. The petition is supported by the American Society of Clinical Oncology, the American Institute for Cancer Research, and Breast Cancer Prevention Partners, all in collaboration with several public health organizations. Proposed labeling would read: “WARNING: According to the Surgeon General, consumption of alcoholic beverages can cause cancer, including breast and colon cancers.”

Dr. Klein and colleagues suggest that public health interventions, including mass media campaigns, cancer warning labels, and patient-provider communications, could help disseminate information about cancer and alcohol. “Educating the public about how alcohol increases cancer risk will not only empower consumers to make more informed decisions but may also prevent and reduce excessive alcohol use, as well as cancer morbidity and mortality,” Dr. Klein said.

The study was supported by the Division of Cancer Control and Population Sciences at the National Cancer Institute. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Another survey has shown that Americans are largely unaware of the link between alcohol consumption and cancer.

The new findings, from a nationally representative survey that included responses from 3,865 adults, show a low awareness of the cancer risk from alcohol, and also that the risk varies by type of drink. Just under a third (31.2%) of respondents thought that consuming liquor/spirits was associated with a risk of cancer, but this fell to 24.9% for drinking beer and even further, to 20.3%, for drinking wine.

In fact, some respondents though the opposite – that drinking alcohol has health benefits; 10.3% of respondents thought that drinking wine was associated with a decreased cancer risk, while 2.25% thought the same for drinking beer, and 1.7% thought that for drinking liquor.

Most U.S. adults (> 50%) reported not knowing how these beverages affected cancer risk, the authors report.

“This study’s findings underscore the need to develop interventions for educating the public about the cancer risks of alcohol use, particularly in the prevailing context of national dialogue about the purported heart health benefits of wine,” commented senior author William M. P. Klein, PhD, associate director of the National Cancer Institute’s Behavioral Research Program, in a statement.

“All types of alcoholic beverages, including wine, increase cancer risk,” Dr. Klein said.

The findings were published online in Cancer Epidemiology, Biomarkers & Prevention.

The results echo the findings of a previous national survey that also found that the majority of Americans are not aware that alcohol consumption is associated with an increased risk of developing a variety of cancers.

In contrast, within the scientific community, there is long-standing and increasing awareness of alcohol consumption as a leading modifiable risk factor for cancer, and there is a growing movement calling for more public health awareness of the link.

Recently, there has been some public support for adding written warnings about the cancer risk from alcohol. A Citizen Petition was filed in 2021, and in August 2022, The New England Journal of Medicine issued a call for new labeling.

Several cancer organizations are petitioning for warnings to be added to alcoholic beverages. The petition is supported by the American Society of Clinical Oncology, the American Institute for Cancer Research, and Breast Cancer Prevention Partners, all in collaboration with several public health organizations. Proposed labeling would read: “WARNING: According to the Surgeon General, consumption of alcoholic beverages can cause cancer, including breast and colon cancers.”

Dr. Klein and colleagues suggest that public health interventions, including mass media campaigns, cancer warning labels, and patient-provider communications, could help disseminate information about cancer and alcohol. “Educating the public about how alcohol increases cancer risk will not only empower consumers to make more informed decisions but may also prevent and reduce excessive alcohol use, as well as cancer morbidity and mortality,” Dr. Klein said.

The study was supported by the Division of Cancer Control and Population Sciences at the National Cancer Institute. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Adding a clinical decision support system (CDSS) to team-based diabetes care only modestly improved patients’ cardiovascular risk factors over team-based care alone, a randomized trial in China showed.

The tool required clinicians to enter patient data into a computer in order to generate individualized treatment recommendations, adding to their administrative burdens. It also couldn’t tackle patients’ problems with access and affordability of medications.

Nevertheless, the model could curtail physician burnout and improve the quality of care in primary care clinics with limited resources, the researchers said in a paper published in the Annals of Internal Medicine.

They concluded that the findings support “widespread adoption” of the model in China and other low- or middle-income countries where diabetes is on the rise.

Co–principal investigator Jiang He, MD, PhD, chair of epidemiology at Tulane University, New Orleans, said the findings could apply to federally qualified health care (FQHC) clinics that treat underserved patients in the United States.

“At many FQHC clinics, nurse practitioners have to take care of patients with multiple chronic disease conditions. Team-based care with a computerized clinical decision support system will help them and improve patient care,” Dr. He said.
 

Small improvements

To conduct the trial, called Diabetes Complication Control in Community Clinics (D4C), Dr. He and colleagues randomly assigned 19 out of the 38 community health centers in Xiamen, China, to have a clinical decision support tool installed on the computers of primary care physicians and health coaches.

Starting in October 2016 the researchers recruited 11,132 patients aged 50 and older with uncontrolled diabetes and at least one comorbid condition, with 5,475 patients receiving team-based care with the CDSS and the remainder receiving team-based care alone.

The CDSS generated individualized risk factor summaries and treatment recommendations, including prescriptions based on Chinese and U.S. clinical guidelines. It incorporated data on patients’ insurance plans and local availability of drugs.

At all centers, primary care physicians received training in managing glycemia, blood pressure, and lipids. Nurses were certified as health coaches after receiving training on nutrition, lifestyle changes, and medication adherence. Patients met with their coaches for half an hour every 3 months, and diabetes specialists visited each clinic monthly for team meetings and consultations.

After 18 months, patients undergoing team-based care alone lowered their hemoglobin A1c by 0.6 percentage points (95% confidence interval, –0.7 to –0.5 percentage points), LDL cholesterol by 12.5 mg/dL (95% CI, –13.6 to –11.3 mg/dL), and systolic blood pressure by 7.5 mm Hg (95% CI, –8.4 to –6.6 mm Hg).

The group whose care teams used the CDSS further reduced A1c by 0.2 percentage points (95% CI, –0.3 to –0.1 percentage points), LDL cholesterol by 6.5 mg/dL (95% CI, –8.3 to -4.6 mg/dL), and blood pressure by 1.5 mm Hg (95% CI, –2.8 to –0.3 mm Hg).

All-cause mortality did not differ between the groups. Serious adverse events occurred in 9.1% of the CDSS group, compared with 10.9% of the group whose care team did not use the CDSS.
 

Addressing social needs

Experts who were not involved in the trial said the marginal impact of the CDSS was no surprise given the mixed results of such tools in previous studies.

However, the lackluster result “might be a shock to people investing a lot in clinical decision support,” said Elbert Huang, MD, MPH, director of the Center for Chronic Disease Research and Policy at the University of Chicago.

Anne Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, said the administrative burden of entering each patient’s data into the system would slow down care and frustrate clinicians. “The system has to be smarter than this.”

On the other hand, the findings of the D4C trial align with other research showing that team-based care strategies are effective for diabetes management.

Dr. Huang noted that there is a “well-established history” of diabetes quality improvement programs, health coaches, buddy programs, and community health worker programs. He added that the new findings “might help to remind everyone of the importance of these programs, which are not always well supported.”

“The bottom line of the paper might be that investing in patient engagement programs might get us 90% of the way to our goal of improving diabetes care,” Dr. Huang said.

Still, Dr. Peters said the portion of patients in the trial who benefited from team-based care seemed “disturbingly low.” Just 16.9% of patients who received team-based care and CDSS and 13% of those who received team-based care alone improved in all three measures. “This system doesn’t get you to where you want to be by a long shot.”

She added that a team-based approach, particularly the use of health coaches, would be a “huge improvement” over fragmented care provided in much of the U.S. safety-net system.
 

Another team approach

Many systems are striving to improve diabetes management in response to payment incentives, Dr. Huang said.

In a separate retrospective analysis, published in Annals of Family Medicine, researchers at the Mayo Clinic, Rochester, Minn., reported quality improvement gains among primary care practices that adopted a team-based model called Enhanced Primary Care Diabetes (EPCD). The model deployed a range of strategies, such as empowering nurses to engage with patients outside of scheduled office visits and including pharmacists on care teams.

Mayo’s approach did not specifically target underserved populations. Rather, researchers evaluated the model’s impact on about 17,000 patients treated at 32 Mayo internal medicine and family medicine practices of varying sizes, resources, and community settings.

Among staff clinician practices using the EPCD model improved patients’ scores on a composite quality measure called D5, which incorporates glycemic control, blood pressure control, low-density lipoprotein control, tobacco abstinence, and aspirin use.

Following implementation, the portion of patients in those practices meeting the D5 indicator increased from 42.9% to 45.0% (incident rate ratio, 1.005; P = .001).

Meanwhile, the portion of patients meeting the indicator increased from 38.9% to 42.0% (IRR, 1.011; P = .003) at resident physician practices that used the EPCD model and decreased from 36.2% to 35.5% (IRR, 0.994; P < .001) at staff clinician practices that did not use the model.

In contrast to the team-based approach used in China, the EPCD protocol “is very complex, and it will be difficult to implement in low-resource settings,” Dr. He said.

The D4C trial was funded by the Xiamen Municipal Health Commission. The Mayo study was funded by a National Institutes of Diabetes and Digestive and Kidney Diseases grant. Dr. He, Dr. Peters, and Dr. Huang reported no relevant financial interests.

Adding a clinical decision support system (CDSS) to team-based diabetes care only modestly improved patients’ cardiovascular risk factors over team-based care alone, a randomized trial in China showed.

The tool required clinicians to enter patient data into a computer in order to generate individualized treatment recommendations, adding to their administrative burdens. It also couldn’t tackle patients’ problems with access and affordability of medications.

Nevertheless, the model could curtail physician burnout and improve the quality of care in primary care clinics with limited resources, the researchers said in a paper published in the Annals of Internal Medicine.

They concluded that the findings support “widespread adoption” of the model in China and other low- or middle-income countries where diabetes is on the rise.

Co–principal investigator Jiang He, MD, PhD, chair of epidemiology at Tulane University, New Orleans, said the findings could apply to federally qualified health care (FQHC) clinics that treat underserved patients in the United States.

“At many FQHC clinics, nurse practitioners have to take care of patients with multiple chronic disease conditions. Team-based care with a computerized clinical decision support system will help them and improve patient care,” Dr. He said.
 

Small improvements

To conduct the trial, called Diabetes Complication Control in Community Clinics (D4C), Dr. He and colleagues randomly assigned 19 out of the 38 community health centers in Xiamen, China, to have a clinical decision support tool installed on the computers of primary care physicians and health coaches.

Starting in October 2016 the researchers recruited 11,132 patients aged 50 and older with uncontrolled diabetes and at least one comorbid condition, with 5,475 patients receiving team-based care with the CDSS and the remainder receiving team-based care alone.

The CDSS generated individualized risk factor summaries and treatment recommendations, including prescriptions based on Chinese and U.S. clinical guidelines. It incorporated data on patients’ insurance plans and local availability of drugs.

At all centers, primary care physicians received training in managing glycemia, blood pressure, and lipids. Nurses were certified as health coaches after receiving training on nutrition, lifestyle changes, and medication adherence. Patients met with their coaches for half an hour every 3 months, and diabetes specialists visited each clinic monthly for team meetings and consultations.

After 18 months, patients undergoing team-based care alone lowered their hemoglobin A1c by 0.6 percentage points (95% confidence interval, –0.7 to –0.5 percentage points), LDL cholesterol by 12.5 mg/dL (95% CI, –13.6 to –11.3 mg/dL), and systolic blood pressure by 7.5 mm Hg (95% CI, –8.4 to –6.6 mm Hg).

The group whose care teams used the CDSS further reduced A1c by 0.2 percentage points (95% CI, –0.3 to –0.1 percentage points), LDL cholesterol by 6.5 mg/dL (95% CI, –8.3 to -4.6 mg/dL), and blood pressure by 1.5 mm Hg (95% CI, –2.8 to –0.3 mm Hg).

All-cause mortality did not differ between the groups. Serious adverse events occurred in 9.1% of the CDSS group, compared with 10.9% of the group whose care team did not use the CDSS.
 

Addressing social needs

Experts who were not involved in the trial said the marginal impact of the CDSS was no surprise given the mixed results of such tools in previous studies.

However, the lackluster result “might be a shock to people investing a lot in clinical decision support,” said Elbert Huang, MD, MPH, director of the Center for Chronic Disease Research and Policy at the University of Chicago.

Anne Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, said the administrative burden of entering each patient’s data into the system would slow down care and frustrate clinicians. “The system has to be smarter than this.”

On the other hand, the findings of the D4C trial align with other research showing that team-based care strategies are effective for diabetes management.

Dr. Huang noted that there is a “well-established history” of diabetes quality improvement programs, health coaches, buddy programs, and community health worker programs. He added that the new findings “might help to remind everyone of the importance of these programs, which are not always well supported.”

“The bottom line of the paper might be that investing in patient engagement programs might get us 90% of the way to our goal of improving diabetes care,” Dr. Huang said.

Still, Dr. Peters said the portion of patients in the trial who benefited from team-based care seemed “disturbingly low.” Just 16.9% of patients who received team-based care and CDSS and 13% of those who received team-based care alone improved in all three measures. “This system doesn’t get you to where you want to be by a long shot.”

She added that a team-based approach, particularly the use of health coaches, would be a “huge improvement” over fragmented care provided in much of the U.S. safety-net system.
 

Another team approach

Many systems are striving to improve diabetes management in response to payment incentives, Dr. Huang said.

In a separate retrospective analysis, published in Annals of Family Medicine, researchers at the Mayo Clinic, Rochester, Minn., reported quality improvement gains among primary care practices that adopted a team-based model called Enhanced Primary Care Diabetes (EPCD). The model deployed a range of strategies, such as empowering nurses to engage with patients outside of scheduled office visits and including pharmacists on care teams.

Mayo’s approach did not specifically target underserved populations. Rather, researchers evaluated the model’s impact on about 17,000 patients treated at 32 Mayo internal medicine and family medicine practices of varying sizes, resources, and community settings.

Among staff clinician practices using the EPCD model improved patients’ scores on a composite quality measure called D5, which incorporates glycemic control, blood pressure control, low-density lipoprotein control, tobacco abstinence, and aspirin use.

Following implementation, the portion of patients in those practices meeting the D5 indicator increased from 42.9% to 45.0% (incident rate ratio, 1.005; P = .001).

Meanwhile, the portion of patients meeting the indicator increased from 38.9% to 42.0% (IRR, 1.011; P = .003) at resident physician practices that used the EPCD model and decreased from 36.2% to 35.5% (IRR, 0.994; P < .001) at staff clinician practices that did not use the model.

In contrast to the team-based approach used in China, the EPCD protocol “is very complex, and it will be difficult to implement in low-resource settings,” Dr. He said.

The D4C trial was funded by the Xiamen Municipal Health Commission. The Mayo study was funded by a National Institutes of Diabetes and Digestive and Kidney Diseases grant. Dr. He, Dr. Peters, and Dr. Huang reported no relevant financial interests.

Adding a clinical decision support system (CDSS) to team-based diabetes care only modestly improved patients’ cardiovascular risk factors over team-based care alone, a randomized trial in China showed.

The tool required clinicians to enter patient data into a computer in order to generate individualized treatment recommendations, adding to their administrative burdens. It also couldn’t tackle patients’ problems with access and affordability of medications.

Nevertheless, the model could curtail physician burnout and improve the quality of care in primary care clinics with limited resources, the researchers said in a paper published in the Annals of Internal Medicine.

They concluded that the findings support “widespread adoption” of the model in China and other low- or middle-income countries where diabetes is on the rise.

Co–principal investigator Jiang He, MD, PhD, chair of epidemiology at Tulane University, New Orleans, said the findings could apply to federally qualified health care (FQHC) clinics that treat underserved patients in the United States.

“At many FQHC clinics, nurse practitioners have to take care of patients with multiple chronic disease conditions. Team-based care with a computerized clinical decision support system will help them and improve patient care,” Dr. He said.
 

Small improvements

To conduct the trial, called Diabetes Complication Control in Community Clinics (D4C), Dr. He and colleagues randomly assigned 19 out of the 38 community health centers in Xiamen, China, to have a clinical decision support tool installed on the computers of primary care physicians and health coaches.

Starting in October 2016 the researchers recruited 11,132 patients aged 50 and older with uncontrolled diabetes and at least one comorbid condition, with 5,475 patients receiving team-based care with the CDSS and the remainder receiving team-based care alone.

The CDSS generated individualized risk factor summaries and treatment recommendations, including prescriptions based on Chinese and U.S. clinical guidelines. It incorporated data on patients’ insurance plans and local availability of drugs.

At all centers, primary care physicians received training in managing glycemia, blood pressure, and lipids. Nurses were certified as health coaches after receiving training on nutrition, lifestyle changes, and medication adherence. Patients met with their coaches for half an hour every 3 months, and diabetes specialists visited each clinic monthly for team meetings and consultations.

After 18 months, patients undergoing team-based care alone lowered their hemoglobin A1c by 0.6 percentage points (95% confidence interval, –0.7 to –0.5 percentage points), LDL cholesterol by 12.5 mg/dL (95% CI, –13.6 to –11.3 mg/dL), and systolic blood pressure by 7.5 mm Hg (95% CI, –8.4 to –6.6 mm Hg).

The group whose care teams used the CDSS further reduced A1c by 0.2 percentage points (95% CI, –0.3 to –0.1 percentage points), LDL cholesterol by 6.5 mg/dL (95% CI, –8.3 to -4.6 mg/dL), and blood pressure by 1.5 mm Hg (95% CI, –2.8 to –0.3 mm Hg).

All-cause mortality did not differ between the groups. Serious adverse events occurred in 9.1% of the CDSS group, compared with 10.9% of the group whose care team did not use the CDSS.
 

Addressing social needs

Experts who were not involved in the trial said the marginal impact of the CDSS was no surprise given the mixed results of such tools in previous studies.

However, the lackluster result “might be a shock to people investing a lot in clinical decision support,” said Elbert Huang, MD, MPH, director of the Center for Chronic Disease Research and Policy at the University of Chicago.

Anne Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, said the administrative burden of entering each patient’s data into the system would slow down care and frustrate clinicians. “The system has to be smarter than this.”

On the other hand, the findings of the D4C trial align with other research showing that team-based care strategies are effective for diabetes management.

Dr. Huang noted that there is a “well-established history” of diabetes quality improvement programs, health coaches, buddy programs, and community health worker programs. He added that the new findings “might help to remind everyone of the importance of these programs, which are not always well supported.”

“The bottom line of the paper might be that investing in patient engagement programs might get us 90% of the way to our goal of improving diabetes care,” Dr. Huang said.

Still, Dr. Peters said the portion of patients in the trial who benefited from team-based care seemed “disturbingly low.” Just 16.9% of patients who received team-based care and CDSS and 13% of those who received team-based care alone improved in all three measures. “This system doesn’t get you to where you want to be by a long shot.”

She added that a team-based approach, particularly the use of health coaches, would be a “huge improvement” over fragmented care provided in much of the U.S. safety-net system.
 

Another team approach

Many systems are striving to improve diabetes management in response to payment incentives, Dr. Huang said.

In a separate retrospective analysis, published in Annals of Family Medicine, researchers at the Mayo Clinic, Rochester, Minn., reported quality improvement gains among primary care practices that adopted a team-based model called Enhanced Primary Care Diabetes (EPCD). The model deployed a range of strategies, such as empowering nurses to engage with patients outside of scheduled office visits and including pharmacists on care teams.

Mayo’s approach did not specifically target underserved populations. Rather, researchers evaluated the model’s impact on about 17,000 patients treated at 32 Mayo internal medicine and family medicine practices of varying sizes, resources, and community settings.

Among staff clinician practices using the EPCD model improved patients’ scores on a composite quality measure called D5, which incorporates glycemic control, blood pressure control, low-density lipoprotein control, tobacco abstinence, and aspirin use.

Following implementation, the portion of patients in those practices meeting the D5 indicator increased from 42.9% to 45.0% (incident rate ratio, 1.005; P = .001).

Meanwhile, the portion of patients meeting the indicator increased from 38.9% to 42.0% (IRR, 1.011; P = .003) at resident physician practices that used the EPCD model and decreased from 36.2% to 35.5% (IRR, 0.994; P < .001) at staff clinician practices that did not use the model.

In contrast to the team-based approach used in China, the EPCD protocol “is very complex, and it will be difficult to implement in low-resource settings,” Dr. He said.

The D4C trial was funded by the Xiamen Municipal Health Commission. The Mayo study was funded by a National Institutes of Diabetes and Digestive and Kidney Diseases grant. Dr. He, Dr. Peters, and Dr. Huang reported no relevant financial interests.

Jackie Dishner hasn’t been the same since June 2020, when COVID-19 robbed her of her energy level, ability to think clearly, and sense of taste and smell. Yet at 58, the Arizona writer is in no hurry to get the latest vaccine booster. “I just don’t want to risk getting any sicker,” she said.

Ms. Dishner has had two doses of vaccine plus two boosters. Each time, she had what regulators consider to be mild reactions, including a sore arm, slight fever, nausea, and body aches. Still, there’s some evidence that the newest booster, which protects against some of the later variants, could help people like Ms. Dishner in several ways, said Ziyad Al-Aly, MD, a clinical epidemiologist and prolific long COVID researcher at Washington University in St. Louis.

“A bivalent booster might actually [help with] your long COVID,” he said.

There may be other benefits. “What vaccines or current vaccine boosters do is reduce your risk of progression to severe COVID-19 illness,” Dr. Al-Aly said. “You are avoiding hospital stays or even worse; you’re avoiding potentially fatal outcomes after infection. And that’s really worth it. Who wants to be in the hospital this Christmas holiday?”

Each time people are infected with SARS-CoV-2, the virus that causes COVID-19, they have a fresh risk of not only getting severely ill or dying, but of developing long COVID, Dr. Al-Aly and colleagues found in a study published in Nature Medicine. “If you dodged the bullet the first time and did not get long COVID after the first infection, if you get reinfected, you’re trying your luck again,” Dr. Al-Aly said. “I would advise people not to get reinfected, which is another reason to get the booster.” 

In a recent review in The Lancet eClinicalMedicine, an international team of researchers looked at 11 studies that sought to find out if vaccines affected long COVID symptoms. Seven of those studies found that people’s symptoms improved after they were vaccinated, and four found that symptoms mostly remained the same. One found symptoms got worse in some patients. 

A study of 28,000 people published in the British Medical Journal found more evidence that vaccination may help ease symptoms. “Vaccination may contribute to a reduction in the population health burden of long COVID,” the team at the United Kingdom’s Office for National Statistics concluded. Most studies found vaccination reduced the risk of getting long COVID in the first place.

Vaccines prompt the body to produce antibodies, which stop a microbe from infecting cells. They also prompt the production of immune cells called T cells, which continue to hunt down and attack a pathogen even after infection.

A booster dose could help rev up that immune response in a patient with long COVID, said Stephen J. Thomas, MD, an infectious disease specialist at Upstate Medical Center in Syracuse, N.Y., and the center’s lead principal investigator for Pfizer/BioNTech’s COVID-19 2020 vaccine trial.

Some scientists believe long COVID might be caused when the virus persists in parts of the body where the immune system isn’t particularly active. Although they don’t fully understand the workings of the many and varied long COVID symptoms, they have a good idea about why people with long COVID often do better after receiving a vaccine or booster.

“The theory is that by boosting, the immune system may be able to ‘mop up’ those virus stragglers that have remained behind after your first cleanup attempt,” Dr. Thomas said.

“The vaccine is almost lending a hand or helping your immune response to clear that virus,” Dr. Al-Aly said.

It could be difficult for long COVID patients to make an informed decision about boosters, given the lack of studies that focus exclusively on the relationship between long COVID and boosters, according to Scott Roberts, MD, associate medical director for infection prevention at Yale New Haven (Conn.) Hospital. 

Dr. Roberts recommended that patients speak with their health care providers and read about the bivalent booster on trusted sites such as those sponsored by the Food and Drug Administration and the Centers for Disease Control and Prevention. Long COVID patients should get the latest boosters, especially as there’s no evidence they are unsafe for them. “The antibody response is appropriately boosted, and there is a decent chance this will help reduce the impact of long COVID as well,” he said. “Waiting will only increase the risk of getting infected and increase the chances of long COVID.”

Only 12% of Americans 5 years and older have received the updated booster, according to the CDC, although it’s recommended for everyone. Just over 80% of Americans have gotten at least one vaccine dose. Dr. Thomas understands why the uptake has been so low: Along with people like Ms. Dishner, who fear more side effects or worse symptoms, there are those who believe that hybrid immunity – vaccination immunity plus natural infection – is superior to vaccination alone and that they don’t need a booster.

Studies show that the bivalent boosters, which protect against older and newer variants, can target even the new, predominant COVID-19 strains. Whether that is enough to convince people in the no-booster camp who lost faith when their vaccinated peers started getting COVID-19 is unclear, although, as Dr. Al-Aly has pointed out, vaccinations help keep people from getting so sick that they wind up in the hospital. And, with most of the population having received at least one dose of vaccine, most of those getting infected will naturally come from among the vaccinated.

Thomas describes the expectation that vaccines would prevent everyone from getting sick as “one of the major fails” of the pandemic.

Counting on a vaccine to confer 100% immunity is “a very high bar,” he said. “I think that’s what people expected, and when they weren’t seeing it, they kind of said: ‘Well, what’s the point? You know, things are getting better. I’d rather take my chances than keep going and getting boosted.’ ”

One point – and it’s a critical one – is that vaccination immunity wanes. Plus new variants arise that can evade at least some of the immunity provided by vaccination. That’s why boosters are built into the COVID vaccination program.

While it’s not clear why some long COVID patients see improvements in their symptoms after being vaccinated or boosted and others do not, Dr. Al-Aly said there’s little evidence vaccines can make long COVID worse. “There are some reports out there that some people with long COVID, when they got a vaccine or booster, their symptoms got worse. You’ll read anecdotes on this side,” he said, adding that efforts to see if this is really happening have been inconclusive.

“The general consensus is that vaccines really save lives,” Dr. Al-Aly said. “Getting vaccinated, even if you are a long COVID patient, is better than not getting vaccinated.”

A version of this article first appeared on WebMD.com.

Jackie Dishner hasn’t been the same since June 2020, when COVID-19 robbed her of her energy level, ability to think clearly, and sense of taste and smell. Yet at 58, the Arizona writer is in no hurry to get the latest vaccine booster. “I just don’t want to risk getting any sicker,” she said.

Ms. Dishner has had two doses of vaccine plus two boosters. Each time, she had what regulators consider to be mild reactions, including a sore arm, slight fever, nausea, and body aches. Still, there’s some evidence that the newest booster, which protects against some of the later variants, could help people like Ms. Dishner in several ways, said Ziyad Al-Aly, MD, a clinical epidemiologist and prolific long COVID researcher at Washington University in St. Louis.

“A bivalent booster might actually [help with] your long COVID,” he said.

There may be other benefits. “What vaccines or current vaccine boosters do is reduce your risk of progression to severe COVID-19 illness,” Dr. Al-Aly said. “You are avoiding hospital stays or even worse; you’re avoiding potentially fatal outcomes after infection. And that’s really worth it. Who wants to be in the hospital this Christmas holiday?”

Each time people are infected with SARS-CoV-2, the virus that causes COVID-19, they have a fresh risk of not only getting severely ill or dying, but of developing long COVID, Dr. Al-Aly and colleagues found in a study published in Nature Medicine. “If you dodged the bullet the first time and did not get long COVID after the first infection, if you get reinfected, you’re trying your luck again,” Dr. Al-Aly said. “I would advise people not to get reinfected, which is another reason to get the booster.” 

In a recent review in The Lancet eClinicalMedicine, an international team of researchers looked at 11 studies that sought to find out if vaccines affected long COVID symptoms. Seven of those studies found that people’s symptoms improved after they were vaccinated, and four found that symptoms mostly remained the same. One found symptoms got worse in some patients. 

A study of 28,000 people published in the British Medical Journal found more evidence that vaccination may help ease symptoms. “Vaccination may contribute to a reduction in the population health burden of long COVID,” the team at the United Kingdom’s Office for National Statistics concluded. Most studies found vaccination reduced the risk of getting long COVID in the first place.

Vaccines prompt the body to produce antibodies, which stop a microbe from infecting cells. They also prompt the production of immune cells called T cells, which continue to hunt down and attack a pathogen even after infection.

A booster dose could help rev up that immune response in a patient with long COVID, said Stephen J. Thomas, MD, an infectious disease specialist at Upstate Medical Center in Syracuse, N.Y., and the center’s lead principal investigator for Pfizer/BioNTech’s COVID-19 2020 vaccine trial.

Some scientists believe long COVID might be caused when the virus persists in parts of the body where the immune system isn’t particularly active. Although they don’t fully understand the workings of the many and varied long COVID symptoms, they have a good idea about why people with long COVID often do better after receiving a vaccine or booster.

“The theory is that by boosting, the immune system may be able to ‘mop up’ those virus stragglers that have remained behind after your first cleanup attempt,” Dr. Thomas said.

“The vaccine is almost lending a hand or helping your immune response to clear that virus,” Dr. Al-Aly said.

It could be difficult for long COVID patients to make an informed decision about boosters, given the lack of studies that focus exclusively on the relationship between long COVID and boosters, according to Scott Roberts, MD, associate medical director for infection prevention at Yale New Haven (Conn.) Hospital. 

Dr. Roberts recommended that patients speak with their health care providers and read about the bivalent booster on trusted sites such as those sponsored by the Food and Drug Administration and the Centers for Disease Control and Prevention. Long COVID patients should get the latest boosters, especially as there’s no evidence they are unsafe for them. “The antibody response is appropriately boosted, and there is a decent chance this will help reduce the impact of long COVID as well,” he said. “Waiting will only increase the risk of getting infected and increase the chances of long COVID.”

Only 12% of Americans 5 years and older have received the updated booster, according to the CDC, although it’s recommended for everyone. Just over 80% of Americans have gotten at least one vaccine dose. Dr. Thomas understands why the uptake has been so low: Along with people like Ms. Dishner, who fear more side effects or worse symptoms, there are those who believe that hybrid immunity – vaccination immunity plus natural infection – is superior to vaccination alone and that they don’t need a booster.

Studies show that the bivalent boosters, which protect against older and newer variants, can target even the new, predominant COVID-19 strains. Whether that is enough to convince people in the no-booster camp who lost faith when their vaccinated peers started getting COVID-19 is unclear, although, as Dr. Al-Aly has pointed out, vaccinations help keep people from getting so sick that they wind up in the hospital. And, with most of the population having received at least one dose of vaccine, most of those getting infected will naturally come from among the vaccinated.

Thomas describes the expectation that vaccines would prevent everyone from getting sick as “one of the major fails” of the pandemic.

Counting on a vaccine to confer 100% immunity is “a very high bar,” he said. “I think that’s what people expected, and when they weren’t seeing it, they kind of said: ‘Well, what’s the point? You know, things are getting better. I’d rather take my chances than keep going and getting boosted.’ ”

One point – and it’s a critical one – is that vaccination immunity wanes. Plus new variants arise that can evade at least some of the immunity provided by vaccination. That’s why boosters are built into the COVID vaccination program.

While it’s not clear why some long COVID patients see improvements in their symptoms after being vaccinated or boosted and others do not, Dr. Al-Aly said there’s little evidence vaccines can make long COVID worse. “There are some reports out there that some people with long COVID, when they got a vaccine or booster, their symptoms got worse. You’ll read anecdotes on this side,” he said, adding that efforts to see if this is really happening have been inconclusive.

“The general consensus is that vaccines really save lives,” Dr. Al-Aly said. “Getting vaccinated, even if you are a long COVID patient, is better than not getting vaccinated.”

A version of this article first appeared on WebMD.com.

Jackie Dishner hasn’t been the same since June 2020, when COVID-19 robbed her of her energy level, ability to think clearly, and sense of taste and smell. Yet at 58, the Arizona writer is in no hurry to get the latest vaccine booster. “I just don’t want to risk getting any sicker,” she said.

Ms. Dishner has had two doses of vaccine plus two boosters. Each time, she had what regulators consider to be mild reactions, including a sore arm, slight fever, nausea, and body aches. Still, there’s some evidence that the newest booster, which protects against some of the later variants, could help people like Ms. Dishner in several ways, said Ziyad Al-Aly, MD, a clinical epidemiologist and prolific long COVID researcher at Washington University in St. Louis.

“A bivalent booster might actually [help with] your long COVID,” he said.

There may be other benefits. “What vaccines or current vaccine boosters do is reduce your risk of progression to severe COVID-19 illness,” Dr. Al-Aly said. “You are avoiding hospital stays or even worse; you’re avoiding potentially fatal outcomes after infection. And that’s really worth it. Who wants to be in the hospital this Christmas holiday?”

Each time people are infected with SARS-CoV-2, the virus that causes COVID-19, they have a fresh risk of not only getting severely ill or dying, but of developing long COVID, Dr. Al-Aly and colleagues found in a study published in Nature Medicine. “If you dodged the bullet the first time and did not get long COVID after the first infection, if you get reinfected, you’re trying your luck again,” Dr. Al-Aly said. “I would advise people not to get reinfected, which is another reason to get the booster.” 

In a recent review in The Lancet eClinicalMedicine, an international team of researchers looked at 11 studies that sought to find out if vaccines affected long COVID symptoms. Seven of those studies found that people’s symptoms improved after they were vaccinated, and four found that symptoms mostly remained the same. One found symptoms got worse in some patients. 

A study of 28,000 people published in the British Medical Journal found more evidence that vaccination may help ease symptoms. “Vaccination may contribute to a reduction in the population health burden of long COVID,” the team at the United Kingdom’s Office for National Statistics concluded. Most studies found vaccination reduced the risk of getting long COVID in the first place.

Vaccines prompt the body to produce antibodies, which stop a microbe from infecting cells. They also prompt the production of immune cells called T cells, which continue to hunt down and attack a pathogen even after infection.

A booster dose could help rev up that immune response in a patient with long COVID, said Stephen J. Thomas, MD, an infectious disease specialist at Upstate Medical Center in Syracuse, N.Y., and the center’s lead principal investigator for Pfizer/BioNTech’s COVID-19 2020 vaccine trial.

Some scientists believe long COVID might be caused when the virus persists in parts of the body where the immune system isn’t particularly active. Although they don’t fully understand the workings of the many and varied long COVID symptoms, they have a good idea about why people with long COVID often do better after receiving a vaccine or booster.

“The theory is that by boosting, the immune system may be able to ‘mop up’ those virus stragglers that have remained behind after your first cleanup attempt,” Dr. Thomas said.

“The vaccine is almost lending a hand or helping your immune response to clear that virus,” Dr. Al-Aly said.

It could be difficult for long COVID patients to make an informed decision about boosters, given the lack of studies that focus exclusively on the relationship between long COVID and boosters, according to Scott Roberts, MD, associate medical director for infection prevention at Yale New Haven (Conn.) Hospital. 

Dr. Roberts recommended that patients speak with their health care providers and read about the bivalent booster on trusted sites such as those sponsored by the Food and Drug Administration and the Centers for Disease Control and Prevention. Long COVID patients should get the latest boosters, especially as there’s no evidence they are unsafe for them. “The antibody response is appropriately boosted, and there is a decent chance this will help reduce the impact of long COVID as well,” he said. “Waiting will only increase the risk of getting infected and increase the chances of long COVID.”

Only 12% of Americans 5 years and older have received the updated booster, according to the CDC, although it’s recommended for everyone. Just over 80% of Americans have gotten at least one vaccine dose. Dr. Thomas understands why the uptake has been so low: Along with people like Ms. Dishner, who fear more side effects or worse symptoms, there are those who believe that hybrid immunity – vaccination immunity plus natural infection – is superior to vaccination alone and that they don’t need a booster.

Studies show that the bivalent boosters, which protect against older and newer variants, can target even the new, predominant COVID-19 strains. Whether that is enough to convince people in the no-booster camp who lost faith when their vaccinated peers started getting COVID-19 is unclear, although, as Dr. Al-Aly has pointed out, vaccinations help keep people from getting so sick that they wind up in the hospital. And, with most of the population having received at least one dose of vaccine, most of those getting infected will naturally come from among the vaccinated.

Thomas describes the expectation that vaccines would prevent everyone from getting sick as “one of the major fails” of the pandemic.

Counting on a vaccine to confer 100% immunity is “a very high bar,” he said. “I think that’s what people expected, and when they weren’t seeing it, they kind of said: ‘Well, what’s the point? You know, things are getting better. I’d rather take my chances than keep going and getting boosted.’ ”

One point – and it’s a critical one – is that vaccination immunity wanes. Plus new variants arise that can evade at least some of the immunity provided by vaccination. That’s why boosters are built into the COVID vaccination program.

While it’s not clear why some long COVID patients see improvements in their symptoms after being vaccinated or boosted and others do not, Dr. Al-Aly said there’s little evidence vaccines can make long COVID worse. “There are some reports out there that some people with long COVID, when they got a vaccine or booster, their symptoms got worse. You’ll read anecdotes on this side,” he said, adding that efforts to see if this is really happening have been inconclusive.

“The general consensus is that vaccines really save lives,” Dr. Al-Aly said. “Getting vaccinated, even if you are a long COVID patient, is better than not getting vaccinated.”

A version of this article first appeared on WebMD.com.

Maintaining a diet rich in healthy plant foods and low in unhealthy plant foods is associated with a lower risk for colorectal cancer (CRC) in men, although the strength of the association may vary by race and ethnicity and tumor site, new research shows.

The “take-home message is that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer in men,” Jihye Kim told this news organization.

The findings suggest that “not all plant-based diets are the same with regard to colorectal cancer protection/risk,” said Ms. Kim, a professor in the College of Life and Sciences at Kyung Hee University in South Korea.

The study was published online in BMC Medicine.

The researchers investigated the risk for CRC in association with three plant-based dietary patterns defined by a priori indices: an overall plant-based diet index (PDI), a healthful plant-based diet index (hPDI), and an unhealthful plant-based diet index (uPDI).

All three indices negatively weigh animal foods but weigh plant foods differently depending on their nutritional quality.

Examples of foods contained in the hPDI include whole grains, fruits, vegetables, vegetable oils, nuts, legumes, tea, and coffee. Foods in the uPDI include refined grains, fruit juices, potatoes, and added sugars.

They calculated the PDI, hPDI, and uPDI using data from quantitative food frequency questionnaires provided by 79,952 men (mean age, 60 years at baseline) and 93,475 women (mean age, 59 years at baseline) in the Multiethnic Cohort Study.

During a mean follow-up of about 19 years, 4,976 participants developed CRC.

The plant-based diet indices were significantly inversely associated with the risk for CRC in men.

Researchers found that men with the greatest adherence to PDI and hPDI had a 24% (hazard ratio, 0.76) and 21% (HR, 0.79) lower risk for CRC, respectively, compared with men with the lowest adherence. No significant association was found between the risk for CRC in men and uPDI.

None of the plant-based diet indices was significantly associated with the risk for CRC in women, which could be because of different dietary habits between men and women, the researchers say.

In general, women consume more plant foods and less animal foods than men do, they point out.

In addition, women in the Multiethnic Cohort Study consumed higher amounts of healthy plant foods and lower amounts of less healthy plant foods compared with men, so they may not have further benefits with high scores of plant-based diet indices. Also, men are at higher risk for CRC than women are in general.

These findings suggest that the benefits from plant-based diets may vary by sex, race, and ethnicity, and anatomic subsite of tumor.

In men, the inverse association of overall PDI was greater in Japanese American, Native Hawaiian, and White groups than in African American and Latino groups, and for left colon and rectum tumors than for right colon tumors. The decreased risk with the hPDI was suggested across racial and ethnic groups and was observed for all tumor subsites.

“It was interesting to see that the association of a plant-based diet with CRC varied by race and ethnicity. It is not clear why. It could be nondietary lifestyle factors or genetic factors,” Ms. Kim told this news organization.

“We should investigate that more in the future,” Ms. Kim added.

By way of limitations, it’s possible that residual or unmeasured confounding might exist despite adjustment for key CRC risk factors, the researchers say. However, the subgroup analyses suggest that the impact of residual confounding due to body mass index, smoking status, and alcohol consumption was “minimal,” they note.

Another limitation is that the analysis was based on diet measured only at baseline, but dietary habits might change over time.

Overall, the findings “support that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer,” Ms. Kim and colleagues say.

The study was supported by the National Research Foundation of Korea and the U.S. National Cancer Institute and National Institutes of Health. The authors have declared no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

Maintaining a diet rich in healthy plant foods and low in unhealthy plant foods is associated with a lower risk for colorectal cancer (CRC) in men, although the strength of the association may vary by race and ethnicity and tumor site, new research shows.

The “take-home message is that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer in men,” Jihye Kim told this news organization.

The findings suggest that “not all plant-based diets are the same with regard to colorectal cancer protection/risk,” said Ms. Kim, a professor in the College of Life and Sciences at Kyung Hee University in South Korea.

The study was published online in BMC Medicine.

The researchers investigated the risk for CRC in association with three plant-based dietary patterns defined by a priori indices: an overall plant-based diet index (PDI), a healthful plant-based diet index (hPDI), and an unhealthful plant-based diet index (uPDI).

All three indices negatively weigh animal foods but weigh plant foods differently depending on their nutritional quality.

Examples of foods contained in the hPDI include whole grains, fruits, vegetables, vegetable oils, nuts, legumes, tea, and coffee. Foods in the uPDI include refined grains, fruit juices, potatoes, and added sugars.

They calculated the PDI, hPDI, and uPDI using data from quantitative food frequency questionnaires provided by 79,952 men (mean age, 60 years at baseline) and 93,475 women (mean age, 59 years at baseline) in the Multiethnic Cohort Study.

During a mean follow-up of about 19 years, 4,976 participants developed CRC.

The plant-based diet indices were significantly inversely associated with the risk for CRC in men.

Researchers found that men with the greatest adherence to PDI and hPDI had a 24% (hazard ratio, 0.76) and 21% (HR, 0.79) lower risk for CRC, respectively, compared with men with the lowest adherence. No significant association was found between the risk for CRC in men and uPDI.

None of the plant-based diet indices was significantly associated with the risk for CRC in women, which could be because of different dietary habits between men and women, the researchers say.

In general, women consume more plant foods and less animal foods than men do, they point out.

In addition, women in the Multiethnic Cohort Study consumed higher amounts of healthy plant foods and lower amounts of less healthy plant foods compared with men, so they may not have further benefits with high scores of plant-based diet indices. Also, men are at higher risk for CRC than women are in general.

These findings suggest that the benefits from plant-based diets may vary by sex, race, and ethnicity, and anatomic subsite of tumor.

In men, the inverse association of overall PDI was greater in Japanese American, Native Hawaiian, and White groups than in African American and Latino groups, and for left colon and rectum tumors than for right colon tumors. The decreased risk with the hPDI was suggested across racial and ethnic groups and was observed for all tumor subsites.

“It was interesting to see that the association of a plant-based diet with CRC varied by race and ethnicity. It is not clear why. It could be nondietary lifestyle factors or genetic factors,” Ms. Kim told this news organization.

“We should investigate that more in the future,” Ms. Kim added.

By way of limitations, it’s possible that residual or unmeasured confounding might exist despite adjustment for key CRC risk factors, the researchers say. However, the subgroup analyses suggest that the impact of residual confounding due to body mass index, smoking status, and alcohol consumption was “minimal,” they note.

Another limitation is that the analysis was based on diet measured only at baseline, but dietary habits might change over time.

Overall, the findings “support that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer,” Ms. Kim and colleagues say.

The study was supported by the National Research Foundation of Korea and the U.S. National Cancer Institute and National Institutes of Health. The authors have declared no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

Maintaining a diet rich in healthy plant foods and low in unhealthy plant foods is associated with a lower risk for colorectal cancer (CRC) in men, although the strength of the association may vary by race and ethnicity and tumor site, new research shows.

The “take-home message is that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer in men,” Jihye Kim told this news organization.

The findings suggest that “not all plant-based diets are the same with regard to colorectal cancer protection/risk,” said Ms. Kim, a professor in the College of Life and Sciences at Kyung Hee University in South Korea.

The study was published online in BMC Medicine.

The researchers investigated the risk for CRC in association with three plant-based dietary patterns defined by a priori indices: an overall plant-based diet index (PDI), a healthful plant-based diet index (hPDI), and an unhealthful plant-based diet index (uPDI).

All three indices negatively weigh animal foods but weigh plant foods differently depending on their nutritional quality.

Examples of foods contained in the hPDI include whole grains, fruits, vegetables, vegetable oils, nuts, legumes, tea, and coffee. Foods in the uPDI include refined grains, fruit juices, potatoes, and added sugars.

They calculated the PDI, hPDI, and uPDI using data from quantitative food frequency questionnaires provided by 79,952 men (mean age, 60 years at baseline) and 93,475 women (mean age, 59 years at baseline) in the Multiethnic Cohort Study.

During a mean follow-up of about 19 years, 4,976 participants developed CRC.

The plant-based diet indices were significantly inversely associated with the risk for CRC in men.

Researchers found that men with the greatest adherence to PDI and hPDI had a 24% (hazard ratio, 0.76) and 21% (HR, 0.79) lower risk for CRC, respectively, compared with men with the lowest adherence. No significant association was found between the risk for CRC in men and uPDI.

None of the plant-based diet indices was significantly associated with the risk for CRC in women, which could be because of different dietary habits between men and women, the researchers say.

In general, women consume more plant foods and less animal foods than men do, they point out.

In addition, women in the Multiethnic Cohort Study consumed higher amounts of healthy plant foods and lower amounts of less healthy plant foods compared with men, so they may not have further benefits with high scores of plant-based diet indices. Also, men are at higher risk for CRC than women are in general.

These findings suggest that the benefits from plant-based diets may vary by sex, race, and ethnicity, and anatomic subsite of tumor.

In men, the inverse association of overall PDI was greater in Japanese American, Native Hawaiian, and White groups than in African American and Latino groups, and for left colon and rectum tumors than for right colon tumors. The decreased risk with the hPDI was suggested across racial and ethnic groups and was observed for all tumor subsites.

“It was interesting to see that the association of a plant-based diet with CRC varied by race and ethnicity. It is not clear why. It could be nondietary lifestyle factors or genetic factors,” Ms. Kim told this news organization.

“We should investigate that more in the future,” Ms. Kim added.

By way of limitations, it’s possible that residual or unmeasured confounding might exist despite adjustment for key CRC risk factors, the researchers say. However, the subgroup analyses suggest that the impact of residual confounding due to body mass index, smoking status, and alcohol consumption was “minimal,” they note.

Another limitation is that the analysis was based on diet measured only at baseline, but dietary habits might change over time.

Overall, the findings “support that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer,” Ms. Kim and colleagues say.

The study was supported by the National Research Foundation of Korea and the U.S. National Cancer Institute and National Institutes of Health. The authors have declared no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

Eric Andrew Salata, MD, a 54-year-old internist based in Naples, Florida, made headlines 2 weeks ago when he was arrested by local police and charged with sexual battery on two of his patients, according to a police statement.

A week later, a Collier County Sheriff’s deputy found Dr. Salata’s body near his Naples home with a gunshot wound to the head, according to police. The medical examiner later ruled it a suicide.

Dr. Salata co-owned Pura Vida Medical Spa in Naples with his wife Jill Salata, a certified family nurse practitioner. They specialized in cosmetic treatment and surgery.

Naples police said that they arrested Dr. Salata after two female patients accused the doctor of allegedly drugging and raping them while they were still unconscious.

Both victims described being given nitrous oxide, also called laughing gas, for sedation and pain from the cosmetic procedure. The first victim, age 51, said Dr. Salata prescribed alprazolam (Xanax) to take before the procedure and then also gave her nitrous oxide and tequila, causing her to black out, according to NBC2 News.

The second victim, age 72, told police that as the nitrous oxide was wearing off, she found Dr. Salata performing sexual intercourse. The victim felt shocked after the sedation subsided about what had taken place, contacted police, and submitted to a sexual assault examination, according to the police statement.

At Dr. Salata’s November 22 hearing before Judge Michael Provost, a prosecutor asked the judge whether Dr. Salata should surrender his firearms; Provost reportedly dismissed the idea.

“It is disappointing and frustrating that Dr. Salata has escaped justice,” said one victim’s attorney, Adam Horowitz, in a blog post. “Yet, we are relieved that no other women will be assaulted by Dr. Salata again. It took tremendous courage for my client to tell her truth. She was ready to hold him accountable in court.”

Horowitz says he plans to file a civil lawsuit on behalf of his client against Dr. Salata’s estate. The Naples police are continuing their investigation into the victims’ cases, which now includes a third woman, said spokesman Lt. Bryan McGinn.

Meanwhile, the Pura Vida Medical Spa has closed permanently and its website has been deleted. One reviewer named Soul F. wrote on the spa’s Yelp page: “And now may God have mercy on this rapist’s soul. Amen.”

A version of this article first appeared on Medscape.com.

Eric Andrew Salata, MD, a 54-year-old internist based in Naples, Florida, made headlines 2 weeks ago when he was arrested by local police and charged with sexual battery on two of his patients, according to a police statement.

A week later, a Collier County Sheriff’s deputy found Dr. Salata’s body near his Naples home with a gunshot wound to the head, according to police. The medical examiner later ruled it a suicide.

Dr. Salata co-owned Pura Vida Medical Spa in Naples with his wife Jill Salata, a certified family nurse practitioner. They specialized in cosmetic treatment and surgery.

Naples police said that they arrested Dr. Salata after two female patients accused the doctor of allegedly drugging and raping them while they were still unconscious.

Both victims described being given nitrous oxide, also called laughing gas, for sedation and pain from the cosmetic procedure. The first victim, age 51, said Dr. Salata prescribed alprazolam (Xanax) to take before the procedure and then also gave her nitrous oxide and tequila, causing her to black out, according to NBC2 News.

The second victim, age 72, told police that as the nitrous oxide was wearing off, she found Dr. Salata performing sexual intercourse. The victim felt shocked after the sedation subsided about what had taken place, contacted police, and submitted to a sexual assault examination, according to the police statement.

At Dr. Salata’s November 22 hearing before Judge Michael Provost, a prosecutor asked the judge whether Dr. Salata should surrender his firearms; Provost reportedly dismissed the idea.

“It is disappointing and frustrating that Dr. Salata has escaped justice,” said one victim’s attorney, Adam Horowitz, in a blog post. “Yet, we are relieved that no other women will be assaulted by Dr. Salata again. It took tremendous courage for my client to tell her truth. She was ready to hold him accountable in court.”

Horowitz says he plans to file a civil lawsuit on behalf of his client against Dr. Salata’s estate. The Naples police are continuing their investigation into the victims’ cases, which now includes a third woman, said spokesman Lt. Bryan McGinn.

Meanwhile, the Pura Vida Medical Spa has closed permanently and its website has been deleted. One reviewer named Soul F. wrote on the spa’s Yelp page: “And now may God have mercy on this rapist’s soul. Amen.”

A version of this article first appeared on Medscape.com.

Eric Andrew Salata, MD, a 54-year-old internist based in Naples, Florida, made headlines 2 weeks ago when he was arrested by local police and charged with sexual battery on two of his patients, according to a police statement.

A week later, a Collier County Sheriff’s deputy found Dr. Salata’s body near his Naples home with a gunshot wound to the head, according to police. The medical examiner later ruled it a suicide.

Dr. Salata co-owned Pura Vida Medical Spa in Naples with his wife Jill Salata, a certified family nurse practitioner. They specialized in cosmetic treatment and surgery.

Naples police said that they arrested Dr. Salata after two female patients accused the doctor of allegedly drugging and raping them while they were still unconscious.

Both victims described being given nitrous oxide, also called laughing gas, for sedation and pain from the cosmetic procedure. The first victim, age 51, said Dr. Salata prescribed alprazolam (Xanax) to take before the procedure and then also gave her nitrous oxide and tequila, causing her to black out, according to NBC2 News.

The second victim, age 72, told police that as the nitrous oxide was wearing off, she found Dr. Salata performing sexual intercourse. The victim felt shocked after the sedation subsided about what had taken place, contacted police, and submitted to a sexual assault examination, according to the police statement.

At Dr. Salata’s November 22 hearing before Judge Michael Provost, a prosecutor asked the judge whether Dr. Salata should surrender his firearms; Provost reportedly dismissed the idea.

“It is disappointing and frustrating that Dr. Salata has escaped justice,” said one victim’s attorney, Adam Horowitz, in a blog post. “Yet, we are relieved that no other women will be assaulted by Dr. Salata again. It took tremendous courage for my client to tell her truth. She was ready to hold him accountable in court.”

Horowitz says he plans to file a civil lawsuit on behalf of his client against Dr. Salata’s estate. The Naples police are continuing their investigation into the victims’ cases, which now includes a third woman, said spokesman Lt. Bryan McGinn.

Meanwhile, the Pura Vida Medical Spa has closed permanently and its website has been deleted. One reviewer named Soul F. wrote on the spa’s Yelp page: “And now may God have mercy on this rapist’s soul. Amen.”

A version of this article first appeared on Medscape.com.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin significantly reduces the risk of hospitalization among patients with chronic kidney disease (CKD), a new study finds.

These findings add to a growing body of evidence supporting a range of positive benefits from dapagliflozin, including reduced risks of mortality, cardiovascular events, and kidney events, lead author Meir Schechter, MD, PhD, of the Hebrew University of Jerusalem and colleagues wrote in Annals of Internal Medicine.“Although cardiovascular and kidney outcomes with SGLT2 inhibitors have been studied extensively, there is a paucity of data evaluating the effects of SGLT2 inhibitors on hospitalizations for any cause.”

The findings are based on a post hoc analysis of the DAPA-CKD trial, which involved 4,304 patients with CKD in 21 countries. Patients were randomized in a 1:1 ratio to receive dapagliflozin 10 mg orally once a day or matching placebo. The present analysis quantified first hospitalizations for any cause, all hospitalizations, cause-specific hospitalizations, and several related outcomes.

After a median follow-up of 2.4 years, 28% of the population had been hospitalized a total of 2,072 times.

Compared with placebo, dapagliflozin significantly reduced risk of first hospitalization by 16% (hazard ratio, 0.84; 95% confidence interval, 0.75-0.94) and rate of all hospitalizations by 21% (rate ratio, 0.79; 95% CI, 0.70-0.89). These findings remained significant regardless of type 2 diabetes status, with significant benefits seen across reasons for admission, including renal/urinary disorders, cardiac disorders, neoplasms, and metabolism/nutrition disorders. In addition, dapagliflozin was associated with shorter mean time in hospital (2.3 vs. 2.8 days; P = .027) and longer time alive and out of hospital (354.9 vs. 351.7; P = .023).

“These findings highlight additional benefits of dapagliflozin beyond those seen for cardiovascular and kidney events, all-cause and cause-specific mortality, eGFR [estimated glomerular filtration rate] slope, and albuminuria and should be considered when evaluating the totality of evidence favoring provision of dapagliflozin to patients with CKD,” the investigators concluded.
 

Positive data, positive experiences

Shree Mulay, MD, a nephrologist in private practice in western Tennessee, said this study is “one of several other articles that already exist” demonstrating the broad benefits of SGLT2 inhibitors.

“The evidence is pretty substantial,” Dr. Mulay said in an interview. “I think SGLT2 inhibitors are the new statin of this era. ... I won’t be surprised if in the next year or 2 or 3 they truly become the standard of care.”

Dr. Mulay also speaks from experience working in both the chronic and acute setting, where he’s observed “some magical stuff happening” in patients started on SGLT2 inhibitors, especially those in heart failure who are fluid overloaded.

“It’s phenomenal stuff,” Dr. Mulay said. “You can really stabilize patients’ hemodynamics.”

In the private health care setting, he described widespread enthusiasm among nephrologists, although others still appear skeptical.

“It’s really our cardiology colleagues that I feel are underprescribing it,” Dr. Mulay said. “So, I’m kind of taking it on myself, when I see a heart failure patient, to go ahead and put them on this.”

It’s unclear why some cardiologists seem apprehensive, Dr. Mulay continued, although he suggested that unclear guidelines and a lack of first-hand experience may be to blame.
 

Nephrologists and cardiologists sometimes agree

In the academic arena, Leslie Gewin, MD, associate professor at Washington University in St. Louis and the John Cochran VA Hospital, also in St. Louis, has seen similar support for SGLT2 inhibitors among both nephrologists and cardiologists.

“We had a joint nephrology-cardiology medicine grand rounds at Wash U in St. Louis maybe 2 weeks ago,” Dr. Gewin said in an interview. “The cardiologists and nephrologists tag-teamed to present data about SGLT2 inhibitors, and we kind of joked that this was the one thing we both could get behind and support.”

Still, she has seen some reluctance among non-nephrology clinicians lacking SGLT2 experience, specifically when managing patients who have poor kidney function.

“There can be some hesitancy among physicians if the GFR is low,” Dr. Gewin said. “That’s where I’ve had to sort of push the envelope with non-nephrologists, saying: ‘Look, we feel pretty comfortable starting down to a GFR of about 20.’ ”

Early rises in creatinine may also spook providers, she noted.

“Sometimes, when we start SGLT2 inhibitors, the creatinine increases slightly, and the [primary care provider] gets concerned,” Dr. Gewin said. “We say: ‘No, this is expected. Don’t worry, hold the course, this is a good drug.’ ”

Like Dr. Mulay, Dr. Gewin said the present study offers further encouragement for the efficacy of this drug class. She also said sufficient data have been published to allay earlier concerns about potential safety signals, such as bone fractures and amputations.

“SGLT2 inhibitors seem to be a lot safer than what we initially had thought,” Dr. Gewin said. “That’s very encouraging.”

The study was funded by AstraZeneca. The investigators disclosed additional relationships with Bayer, Janssen, Gilead, and others. Dr. Gewin and Dr. Mulay disclosed no relevant conflicts of interest.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin significantly reduces the risk of hospitalization among patients with chronic kidney disease (CKD), a new study finds.

These findings add to a growing body of evidence supporting a range of positive benefits from dapagliflozin, including reduced risks of mortality, cardiovascular events, and kidney events, lead author Meir Schechter, MD, PhD, of the Hebrew University of Jerusalem and colleagues wrote in Annals of Internal Medicine.“Although cardiovascular and kidney outcomes with SGLT2 inhibitors have been studied extensively, there is a paucity of data evaluating the effects of SGLT2 inhibitors on hospitalizations for any cause.”

The findings are based on a post hoc analysis of the DAPA-CKD trial, which involved 4,304 patients with CKD in 21 countries. Patients were randomized in a 1:1 ratio to receive dapagliflozin 10 mg orally once a day or matching placebo. The present analysis quantified first hospitalizations for any cause, all hospitalizations, cause-specific hospitalizations, and several related outcomes.

After a median follow-up of 2.4 years, 28% of the population had been hospitalized a total of 2,072 times.

Compared with placebo, dapagliflozin significantly reduced risk of first hospitalization by 16% (hazard ratio, 0.84; 95% confidence interval, 0.75-0.94) and rate of all hospitalizations by 21% (rate ratio, 0.79; 95% CI, 0.70-0.89). These findings remained significant regardless of type 2 diabetes status, with significant benefits seen across reasons for admission, including renal/urinary disorders, cardiac disorders, neoplasms, and metabolism/nutrition disorders. In addition, dapagliflozin was associated with shorter mean time in hospital (2.3 vs. 2.8 days; P = .027) and longer time alive and out of hospital (354.9 vs. 351.7; P = .023).

“These findings highlight additional benefits of dapagliflozin beyond those seen for cardiovascular and kidney events, all-cause and cause-specific mortality, eGFR [estimated glomerular filtration rate] slope, and albuminuria and should be considered when evaluating the totality of evidence favoring provision of dapagliflozin to patients with CKD,” the investigators concluded.
 

Positive data, positive experiences

Shree Mulay, MD, a nephrologist in private practice in western Tennessee, said this study is “one of several other articles that already exist” demonstrating the broad benefits of SGLT2 inhibitors.

“The evidence is pretty substantial,” Dr. Mulay said in an interview. “I think SGLT2 inhibitors are the new statin of this era. ... I won’t be surprised if in the next year or 2 or 3 they truly become the standard of care.”

Dr. Mulay also speaks from experience working in both the chronic and acute setting, where he’s observed “some magical stuff happening” in patients started on SGLT2 inhibitors, especially those in heart failure who are fluid overloaded.

“It’s phenomenal stuff,” Dr. Mulay said. “You can really stabilize patients’ hemodynamics.”

In the private health care setting, he described widespread enthusiasm among nephrologists, although others still appear skeptical.

“It’s really our cardiology colleagues that I feel are underprescribing it,” Dr. Mulay said. “So, I’m kind of taking it on myself, when I see a heart failure patient, to go ahead and put them on this.”

It’s unclear why some cardiologists seem apprehensive, Dr. Mulay continued, although he suggested that unclear guidelines and a lack of first-hand experience may be to blame.
 

Nephrologists and cardiologists sometimes agree

In the academic arena, Leslie Gewin, MD, associate professor at Washington University in St. Louis and the John Cochran VA Hospital, also in St. Louis, has seen similar support for SGLT2 inhibitors among both nephrologists and cardiologists.

“We had a joint nephrology-cardiology medicine grand rounds at Wash U in St. Louis maybe 2 weeks ago,” Dr. Gewin said in an interview. “The cardiologists and nephrologists tag-teamed to present data about SGLT2 inhibitors, and we kind of joked that this was the one thing we both could get behind and support.”

Still, she has seen some reluctance among non-nephrology clinicians lacking SGLT2 experience, specifically when managing patients who have poor kidney function.

“There can be some hesitancy among physicians if the GFR is low,” Dr. Gewin said. “That’s where I’ve had to sort of push the envelope with non-nephrologists, saying: ‘Look, we feel pretty comfortable starting down to a GFR of about 20.’ ”

Early rises in creatinine may also spook providers, she noted.

“Sometimes, when we start SGLT2 inhibitors, the creatinine increases slightly, and the [primary care provider] gets concerned,” Dr. Gewin said. “We say: ‘No, this is expected. Don’t worry, hold the course, this is a good drug.’ ”

Like Dr. Mulay, Dr. Gewin said the present study offers further encouragement for the efficacy of this drug class. She also said sufficient data have been published to allay earlier concerns about potential safety signals, such as bone fractures and amputations.

“SGLT2 inhibitors seem to be a lot safer than what we initially had thought,” Dr. Gewin said. “That’s very encouraging.”

The study was funded by AstraZeneca. The investigators disclosed additional relationships with Bayer, Janssen, Gilead, and others. Dr. Gewin and Dr. Mulay disclosed no relevant conflicts of interest.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin significantly reduces the risk of hospitalization among patients with chronic kidney disease (CKD), a new study finds.

These findings add to a growing body of evidence supporting a range of positive benefits from dapagliflozin, including reduced risks of mortality, cardiovascular events, and kidney events, lead author Meir Schechter, MD, PhD, of the Hebrew University of Jerusalem and colleagues wrote in Annals of Internal Medicine.“Although cardiovascular and kidney outcomes with SGLT2 inhibitors have been studied extensively, there is a paucity of data evaluating the effects of SGLT2 inhibitors on hospitalizations for any cause.”

The findings are based on a post hoc analysis of the DAPA-CKD trial, which involved 4,304 patients with CKD in 21 countries. Patients were randomized in a 1:1 ratio to receive dapagliflozin 10 mg orally once a day or matching placebo. The present analysis quantified first hospitalizations for any cause, all hospitalizations, cause-specific hospitalizations, and several related outcomes.

After a median follow-up of 2.4 years, 28% of the population had been hospitalized a total of 2,072 times.

Compared with placebo, dapagliflozin significantly reduced risk of first hospitalization by 16% (hazard ratio, 0.84; 95% confidence interval, 0.75-0.94) and rate of all hospitalizations by 21% (rate ratio, 0.79; 95% CI, 0.70-0.89). These findings remained significant regardless of type 2 diabetes status, with significant benefits seen across reasons for admission, including renal/urinary disorders, cardiac disorders, neoplasms, and metabolism/nutrition disorders. In addition, dapagliflozin was associated with shorter mean time in hospital (2.3 vs. 2.8 days; P = .027) and longer time alive and out of hospital (354.9 vs. 351.7; P = .023).

“These findings highlight additional benefits of dapagliflozin beyond those seen for cardiovascular and kidney events, all-cause and cause-specific mortality, eGFR [estimated glomerular filtration rate] slope, and albuminuria and should be considered when evaluating the totality of evidence favoring provision of dapagliflozin to patients with CKD,” the investigators concluded.
 

Positive data, positive experiences

Shree Mulay, MD, a nephrologist in private practice in western Tennessee, said this study is “one of several other articles that already exist” demonstrating the broad benefits of SGLT2 inhibitors.

“The evidence is pretty substantial,” Dr. Mulay said in an interview. “I think SGLT2 inhibitors are the new statin of this era. ... I won’t be surprised if in the next year or 2 or 3 they truly become the standard of care.”

Dr. Mulay also speaks from experience working in both the chronic and acute setting, where he’s observed “some magical stuff happening” in patients started on SGLT2 inhibitors, especially those in heart failure who are fluid overloaded.

“It’s phenomenal stuff,” Dr. Mulay said. “You can really stabilize patients’ hemodynamics.”

In the private health care setting, he described widespread enthusiasm among nephrologists, although others still appear skeptical.

“It’s really our cardiology colleagues that I feel are underprescribing it,” Dr. Mulay said. “So, I’m kind of taking it on myself, when I see a heart failure patient, to go ahead and put them on this.”

It’s unclear why some cardiologists seem apprehensive, Dr. Mulay continued, although he suggested that unclear guidelines and a lack of first-hand experience may be to blame.
 

Nephrologists and cardiologists sometimes agree

In the academic arena, Leslie Gewin, MD, associate professor at Washington University in St. Louis and the John Cochran VA Hospital, also in St. Louis, has seen similar support for SGLT2 inhibitors among both nephrologists and cardiologists.

“We had a joint nephrology-cardiology medicine grand rounds at Wash U in St. Louis maybe 2 weeks ago,” Dr. Gewin said in an interview. “The cardiologists and nephrologists tag-teamed to present data about SGLT2 inhibitors, and we kind of joked that this was the one thing we both could get behind and support.”

Still, she has seen some reluctance among non-nephrology clinicians lacking SGLT2 experience, specifically when managing patients who have poor kidney function.

“There can be some hesitancy among physicians if the GFR is low,” Dr. Gewin said. “That’s where I’ve had to sort of push the envelope with non-nephrologists, saying: ‘Look, we feel pretty comfortable starting down to a GFR of about 20.’ ”

Early rises in creatinine may also spook providers, she noted.

“Sometimes, when we start SGLT2 inhibitors, the creatinine increases slightly, and the [primary care provider] gets concerned,” Dr. Gewin said. “We say: ‘No, this is expected. Don’t worry, hold the course, this is a good drug.’ ”

Like Dr. Mulay, Dr. Gewin said the present study offers further encouragement for the efficacy of this drug class. She also said sufficient data have been published to allay earlier concerns about potential safety signals, such as bone fractures and amputations.

“SGLT2 inhibitors seem to be a lot safer than what we initially had thought,” Dr. Gewin said. “That’s very encouraging.”

The study was funded by AstraZeneca. The investigators disclosed additional relationships with Bayer, Janssen, Gilead, and others. Dr. Gewin and Dr. Mulay disclosed no relevant conflicts of interest.

As a severe shortage drags on and prices soar, transplant centers have been struggling to cope with the paucity and price of fludarabine, a chemotherapy drug that has become an essential component of stem-cell transplants for some blood cancers.

At Oregon Health and Science University, for example, an extensive algorithm now offers guidance through a thicket of alternative options, from adjusting doses and using substitutes to delaying treatment. Meanwhile, some institutions have enlisted ethicists and attorneys to guide their decisions on which patients will have to wait for potentially life-saving treatment.

Even as surgeons turn to alternatives, advocates for transplantation in hematology have warned about the potential for harm.

“This continued fludarabine shortage is forcing centers to use non–[Food and Drug Administration] approved lymphodepleting regimens that may negatively impact the success of a possibly lifesaving CAR-T therapy,” Brenda Sandmaier, MD, president of the Transplantation and Cellular Therapy American Society, and Jeffery Auletta, MD, a senior vice president with the National Marrow Donor, said in a June 30 letter to the FDA. The physicians added that they “request the FDA to take immediate action on this critical shortage. Many centers currently have no ability to purchase fludarabine through their suppliers and have no estimated time frame for return of availability. Other centers are limited to mere weeks of supply, with continued uncertainty of future availability.”

In October, less than 4 months after that letter was sent, one of the manufacturers of fludarabine – Areva Pharmaceuticals – marked up the price of fludarabine to $2,736 per vial, 10-20 times that of two other makers of the drug.
 

In new treatment era, fludarabine remains crucial

In 2015, ASH Clinical News – a publication of the American Society of Hematology – invited a pair of hematologists to discuss whether fludarabine is “dead” as a front-line treatment for chronic lymphocytic leukemia (CLL). “Fludarabine is not dead yet, but the data from those and other long-term trials may be the final nail in its coffin,” said Mitchell Smith, MD, PhD, who was then with Cleveland Clinic and now works for George Washington University.

Seven years later, the role of fludarabine as a long-term chemotherapeutic agent in blood cancer has definitely evolved. Just as oncologists predicted back in 2015, “the use of fludarabine declined for the primary management of CLL and other B cell malignancies, due to the development of targeted therapies such as BTK inhibitors, venetoclax, and other agents,” Memorial Sloan Kettering hematologic oncologist Anthony Mato, MD, said in an interview.

But the drug “remains a critical agent for conditioning the immune system for cellular therapies such as allogeneic stem cell transplantation and CAR-T cells,” Dr. Mato said.

Nirav Shah, MD, a hematologic oncologist at the Medical College of Wisconsin, explained in an interview that “conditioning” in the stem-cell transplant context refers to “wiping out” the immune system, allowing the donor’s stem cells to avoid rejection. “It’s a commonly used drug,” he said, “and shortage was not really a concern that people faced until this year.”
 

As shortage continues, price hike brings yet another hit

The first reports of fludarabine being in short supply surfaced about a year ago. According to a Nov. 2 update from the American Society of Health-System Pharmacists, five companies now manufacture fludarabine, and all of them report shortages. Areva, which dramatically raised its price, is accepting direct orders. Leucadia and Teva don’t know when the drug will be available; and Fresenius Kabi and Sagent expect availability in early 2023.

Areva, Leucadia, and Teva didn’t provide reasons for their shortages. Fresenius Kabi blamed increased demand, and Sagent pointed to manufacturing delays. Pfizer, another manufacturer, had a tiny market share and stopped making fludarabine in 2020, according to the pharmacist society.

In a May 12 press release, a company called Lannett announced it would take over U.S. distribution of fludarabine for Areva and suggested that the supply shortage would be lucrative: “While total U.S. sales for the 12 months ended March 2022 of Fludarabine Phosphate for injection, USP, 50 mg/2mL were approximately $4.9 million, according to IQVIA, the current market value is believed to be higher due to the recent market disruptions.”

“We were all shocked and outraged when Areva came out with the new, dramatically higher prices,” Bill Greene, PharmD, chief pharmaceutical officer at St. Jude Children’s Research Hospital, said in a recent interview.

In a prior interview, conducted during the summer of 2022, Dr. Greene addressed the topic of hematologic drug shortages. Back then he noted that he was seeking emergency supplies of fludarabine, since all five manufacturers reported having no stock available.

Interviewed again in November 2022, Dr. Greene noted that the hospital “had been able to stay ahead of the need and meet the needs of our patients” through arrangements with Teva and Fresenius Kabi. “In cases of patient need, we certainly are willing to pay a higher product price if that’s what it takes to get it – assuming the product is a quality product.”

The Medical College of Wisconsin’s Dr. Shah said insurers may refuse to cover the higher price, sticking medical institutions with the bill.
 

Alternatives abound, but do they suffice?

There is some good news on the fludarabine shortage front. Areva recently alerted providers that it was releasing fludarabine from non-FDA-approved suppliers with the agency’s permission, and Accord Healthcare said it received permission to sell fludarabine that was marketed in Canada.

Another option – oral fludarabine instead of the standard IV version – remains unavailable in the United States. According to the June letter to the FDA from the American Society for Transplantation and Cellular Therapy and National Marrow Donor Program, it “might be an appropriate alternative” and is available in Europe, Canada and Australia.

The letter warns that “transplant centers have also been forced to move away from fludarabine-based regimens and use alternative drugs such as cladribine or clofarabine, which are both significantly less studied and rely on single-center experience or limited phase II data. ... The limited availability of fludarabine is leading to the use of alternative regimens that are known to be more toxic or understudied alternatives with unknown long-term clinical effects or harms to patients.”

In a November 2022 report published in Transplantation and Cellular Therapy, Dr. Shah and colleagues noted that institutions are adopting strategies such as “(1) pharmacy dose banding and rounding down to save vials, even if a >5% reduction was required; (2) administering all dosing of fludarabine based not on actual body weight but on adjusted body weight; and (3) switching the billing of fludarabine from single-dose vials to billing by dose delivery.”

If the shortage continues, “it becomes necessary for centers to establish algorithms for management now,” they wrote. “Substitution of such agents as bendamustine and cladribine can be considered ... [and] another acceptable solution could be the substitution of clofarabine for fludarabine.”

Still, there are many unanswered questions. “The challenge is that these alternative regimens have not been extensively studied in a large population,” Dr. Shah said. “You have to be more mindful of potential side effects and risks, and the biggest concern is efficacy. Is changing the drug going to be detrimental to a patient’s outcome? To be honest, we don’t know the answer to that.”

Dr. Mato disclosed ties with TG Therapeutics, Pharmacyclics, AbbVie, Acerta, Adaptive Biotechnologies, AstraZeneca, BeiGene, BioPharma, BMS, Curio, Dava, DTRM, Genentech, Genmab, Janssen, Johnson & Johnson, LOXO, Medscape, Nurix, Octapharma, PER, PerView, and Pfizer. Dr. Greene and Dr. Shah have no disclosures.

As a severe shortage drags on and prices soar, transplant centers have been struggling to cope with the paucity and price of fludarabine, a chemotherapy drug that has become an essential component of stem-cell transplants for some blood cancers.

At Oregon Health and Science University, for example, an extensive algorithm now offers guidance through a thicket of alternative options, from adjusting doses and using substitutes to delaying treatment. Meanwhile, some institutions have enlisted ethicists and attorneys to guide their decisions on which patients will have to wait for potentially life-saving treatment.

Even as surgeons turn to alternatives, advocates for transplantation in hematology have warned about the potential for harm.

“This continued fludarabine shortage is forcing centers to use non–[Food and Drug Administration] approved lymphodepleting regimens that may negatively impact the success of a possibly lifesaving CAR-T therapy,” Brenda Sandmaier, MD, president of the Transplantation and Cellular Therapy American Society, and Jeffery Auletta, MD, a senior vice president with the National Marrow Donor, said in a June 30 letter to the FDA. The physicians added that they “request the FDA to take immediate action on this critical shortage. Many centers currently have no ability to purchase fludarabine through their suppliers and have no estimated time frame for return of availability. Other centers are limited to mere weeks of supply, with continued uncertainty of future availability.”

In October, less than 4 months after that letter was sent, one of the manufacturers of fludarabine – Areva Pharmaceuticals – marked up the price of fludarabine to $2,736 per vial, 10-20 times that of two other makers of the drug.
 

In new treatment era, fludarabine remains crucial

In 2015, ASH Clinical News – a publication of the American Society of Hematology – invited a pair of hematologists to discuss whether fludarabine is “dead” as a front-line treatment for chronic lymphocytic leukemia (CLL). “Fludarabine is not dead yet, but the data from those and other long-term trials may be the final nail in its coffin,” said Mitchell Smith, MD, PhD, who was then with Cleveland Clinic and now works for George Washington University.

Seven years later, the role of fludarabine as a long-term chemotherapeutic agent in blood cancer has definitely evolved. Just as oncologists predicted back in 2015, “the use of fludarabine declined for the primary management of CLL and other B cell malignancies, due to the development of targeted therapies such as BTK inhibitors, venetoclax, and other agents,” Memorial Sloan Kettering hematologic oncologist Anthony Mato, MD, said in an interview.

But the drug “remains a critical agent for conditioning the immune system for cellular therapies such as allogeneic stem cell transplantation and CAR-T cells,” Dr. Mato said.

Nirav Shah, MD, a hematologic oncologist at the Medical College of Wisconsin, explained in an interview that “conditioning” in the stem-cell transplant context refers to “wiping out” the immune system, allowing the donor’s stem cells to avoid rejection. “It’s a commonly used drug,” he said, “and shortage was not really a concern that people faced until this year.”
 

As shortage continues, price hike brings yet another hit

The first reports of fludarabine being in short supply surfaced about a year ago. According to a Nov. 2 update from the American Society of Health-System Pharmacists, five companies now manufacture fludarabine, and all of them report shortages. Areva, which dramatically raised its price, is accepting direct orders. Leucadia and Teva don’t know when the drug will be available; and Fresenius Kabi and Sagent expect availability in early 2023.

Areva, Leucadia, and Teva didn’t provide reasons for their shortages. Fresenius Kabi blamed increased demand, and Sagent pointed to manufacturing delays. Pfizer, another manufacturer, had a tiny market share and stopped making fludarabine in 2020, according to the pharmacist society.

In a May 12 press release, a company called Lannett announced it would take over U.S. distribution of fludarabine for Areva and suggested that the supply shortage would be lucrative: “While total U.S. sales for the 12 months ended March 2022 of Fludarabine Phosphate for injection, USP, 50 mg/2mL were approximately $4.9 million, according to IQVIA, the current market value is believed to be higher due to the recent market disruptions.”

“We were all shocked and outraged when Areva came out with the new, dramatically higher prices,” Bill Greene, PharmD, chief pharmaceutical officer at St. Jude Children’s Research Hospital, said in a recent interview.

In a prior interview, conducted during the summer of 2022, Dr. Greene addressed the topic of hematologic drug shortages. Back then he noted that he was seeking emergency supplies of fludarabine, since all five manufacturers reported having no stock available.

Interviewed again in November 2022, Dr. Greene noted that the hospital “had been able to stay ahead of the need and meet the needs of our patients” through arrangements with Teva and Fresenius Kabi. “In cases of patient need, we certainly are willing to pay a higher product price if that’s what it takes to get it – assuming the product is a quality product.”

The Medical College of Wisconsin’s Dr. Shah said insurers may refuse to cover the higher price, sticking medical institutions with the bill.
 

Alternatives abound, but do they suffice?

There is some good news on the fludarabine shortage front. Areva recently alerted providers that it was releasing fludarabine from non-FDA-approved suppliers with the agency’s permission, and Accord Healthcare said it received permission to sell fludarabine that was marketed in Canada.

Another option – oral fludarabine instead of the standard IV version – remains unavailable in the United States. According to the June letter to the FDA from the American Society for Transplantation and Cellular Therapy and National Marrow Donor Program, it “might be an appropriate alternative” and is available in Europe, Canada and Australia.

The letter warns that “transplant centers have also been forced to move away from fludarabine-based regimens and use alternative drugs such as cladribine or clofarabine, which are both significantly less studied and rely on single-center experience or limited phase II data. ... The limited availability of fludarabine is leading to the use of alternative regimens that are known to be more toxic or understudied alternatives with unknown long-term clinical effects or harms to patients.”

In a November 2022 report published in Transplantation and Cellular Therapy, Dr. Shah and colleagues noted that institutions are adopting strategies such as “(1) pharmacy dose banding and rounding down to save vials, even if a >5% reduction was required; (2) administering all dosing of fludarabine based not on actual body weight but on adjusted body weight; and (3) switching the billing of fludarabine from single-dose vials to billing by dose delivery.”

If the shortage continues, “it becomes necessary for centers to establish algorithms for management now,” they wrote. “Substitution of such agents as bendamustine and cladribine can be considered ... [and] another acceptable solution could be the substitution of clofarabine for fludarabine.”

Still, there are many unanswered questions. “The challenge is that these alternative regimens have not been extensively studied in a large population,” Dr. Shah said. “You have to be more mindful of potential side effects and risks, and the biggest concern is efficacy. Is changing the drug going to be detrimental to a patient’s outcome? To be honest, we don’t know the answer to that.”

Dr. Mato disclosed ties with TG Therapeutics, Pharmacyclics, AbbVie, Acerta, Adaptive Biotechnologies, AstraZeneca, BeiGene, BioPharma, BMS, Curio, Dava, DTRM, Genentech, Genmab, Janssen, Johnson & Johnson, LOXO, Medscape, Nurix, Octapharma, PER, PerView, and Pfizer. Dr. Greene and Dr. Shah have no disclosures.

As a severe shortage drags on and prices soar, transplant centers have been struggling to cope with the paucity and price of fludarabine, a chemotherapy drug that has become an essential component of stem-cell transplants for some blood cancers.

At Oregon Health and Science University, for example, an extensive algorithm now offers guidance through a thicket of alternative options, from adjusting doses and using substitutes to delaying treatment. Meanwhile, some institutions have enlisted ethicists and attorneys to guide their decisions on which patients will have to wait for potentially life-saving treatment.

Even as surgeons turn to alternatives, advocates for transplantation in hematology have warned about the potential for harm.

“This continued fludarabine shortage is forcing centers to use non–[Food and Drug Administration] approved lymphodepleting regimens that may negatively impact the success of a possibly lifesaving CAR-T therapy,” Brenda Sandmaier, MD, president of the Transplantation and Cellular Therapy American Society, and Jeffery Auletta, MD, a senior vice president with the National Marrow Donor, said in a June 30 letter to the FDA. The physicians added that they “request the FDA to take immediate action on this critical shortage. Many centers currently have no ability to purchase fludarabine through their suppliers and have no estimated time frame for return of availability. Other centers are limited to mere weeks of supply, with continued uncertainty of future availability.”

In October, less than 4 months after that letter was sent, one of the manufacturers of fludarabine – Areva Pharmaceuticals – marked up the price of fludarabine to $2,736 per vial, 10-20 times that of two other makers of the drug.
 

In new treatment era, fludarabine remains crucial

In 2015, ASH Clinical News – a publication of the American Society of Hematology – invited a pair of hematologists to discuss whether fludarabine is “dead” as a front-line treatment for chronic lymphocytic leukemia (CLL). “Fludarabine is not dead yet, but the data from those and other long-term trials may be the final nail in its coffin,” said Mitchell Smith, MD, PhD, who was then with Cleveland Clinic and now works for George Washington University.

Seven years later, the role of fludarabine as a long-term chemotherapeutic agent in blood cancer has definitely evolved. Just as oncologists predicted back in 2015, “the use of fludarabine declined for the primary management of CLL and other B cell malignancies, due to the development of targeted therapies such as BTK inhibitors, venetoclax, and other agents,” Memorial Sloan Kettering hematologic oncologist Anthony Mato, MD, said in an interview.

But the drug “remains a critical agent for conditioning the immune system for cellular therapies such as allogeneic stem cell transplantation and CAR-T cells,” Dr. Mato said.

Nirav Shah, MD, a hematologic oncologist at the Medical College of Wisconsin, explained in an interview that “conditioning” in the stem-cell transplant context refers to “wiping out” the immune system, allowing the donor’s stem cells to avoid rejection. “It’s a commonly used drug,” he said, “and shortage was not really a concern that people faced until this year.”
 

As shortage continues, price hike brings yet another hit

The first reports of fludarabine being in short supply surfaced about a year ago. According to a Nov. 2 update from the American Society of Health-System Pharmacists, five companies now manufacture fludarabine, and all of them report shortages. Areva, which dramatically raised its price, is accepting direct orders. Leucadia and Teva don’t know when the drug will be available; and Fresenius Kabi and Sagent expect availability in early 2023.

Areva, Leucadia, and Teva didn’t provide reasons for their shortages. Fresenius Kabi blamed increased demand, and Sagent pointed to manufacturing delays. Pfizer, another manufacturer, had a tiny market share and stopped making fludarabine in 2020, according to the pharmacist society.

In a May 12 press release, a company called Lannett announced it would take over U.S. distribution of fludarabine for Areva and suggested that the supply shortage would be lucrative: “While total U.S. sales for the 12 months ended March 2022 of Fludarabine Phosphate for injection, USP, 50 mg/2mL were approximately $4.9 million, according to IQVIA, the current market value is believed to be higher due to the recent market disruptions.”

“We were all shocked and outraged when Areva came out with the new, dramatically higher prices,” Bill Greene, PharmD, chief pharmaceutical officer at St. Jude Children’s Research Hospital, said in a recent interview.

In a prior interview, conducted during the summer of 2022, Dr. Greene addressed the topic of hematologic drug shortages. Back then he noted that he was seeking emergency supplies of fludarabine, since all five manufacturers reported having no stock available.

Interviewed again in November 2022, Dr. Greene noted that the hospital “had been able to stay ahead of the need and meet the needs of our patients” through arrangements with Teva and Fresenius Kabi. “In cases of patient need, we certainly are willing to pay a higher product price if that’s what it takes to get it – assuming the product is a quality product.”

The Medical College of Wisconsin’s Dr. Shah said insurers may refuse to cover the higher price, sticking medical institutions with the bill.
 

Alternatives abound, but do they suffice?

There is some good news on the fludarabine shortage front. Areva recently alerted providers that it was releasing fludarabine from non-FDA-approved suppliers with the agency’s permission, and Accord Healthcare said it received permission to sell fludarabine that was marketed in Canada.

Another option – oral fludarabine instead of the standard IV version – remains unavailable in the United States. According to the June letter to the FDA from the American Society for Transplantation and Cellular Therapy and National Marrow Donor Program, it “might be an appropriate alternative” and is available in Europe, Canada and Australia.

The letter warns that “transplant centers have also been forced to move away from fludarabine-based regimens and use alternative drugs such as cladribine or clofarabine, which are both significantly less studied and rely on single-center experience or limited phase II data. ... The limited availability of fludarabine is leading to the use of alternative regimens that are known to be more toxic or understudied alternatives with unknown long-term clinical effects or harms to patients.”

In a November 2022 report published in Transplantation and Cellular Therapy, Dr. Shah and colleagues noted that institutions are adopting strategies such as “(1) pharmacy dose banding and rounding down to save vials, even if a >5% reduction was required; (2) administering all dosing of fludarabine based not on actual body weight but on adjusted body weight; and (3) switching the billing of fludarabine from single-dose vials to billing by dose delivery.”

If the shortage continues, “it becomes necessary for centers to establish algorithms for management now,” they wrote. “Substitution of such agents as bendamustine and cladribine can be considered ... [and] another acceptable solution could be the substitution of clofarabine for fludarabine.”

Still, there are many unanswered questions. “The challenge is that these alternative regimens have not been extensively studied in a large population,” Dr. Shah said. “You have to be more mindful of potential side effects and risks, and the biggest concern is efficacy. Is changing the drug going to be detrimental to a patient’s outcome? To be honest, we don’t know the answer to that.”

Dr. Mato disclosed ties with TG Therapeutics, Pharmacyclics, AbbVie, Acerta, Adaptive Biotechnologies, AstraZeneca, BeiGene, BioPharma, BMS, Curio, Dava, DTRM, Genentech, Genmab, Janssen, Johnson & Johnson, LOXO, Medscape, Nurix, Octapharma, PER, PerView, and Pfizer. Dr. Greene and Dr. Shah have no disclosures.

Visceral adipose tissue is significantly reduced with the green Mediterranean diet (MED), which consists of polyphenols and reduced red meat intake, according to a new analysis of the 18-month Dietary Intervention Randomized Controlled Trial Polyphenols Unprocessed (DIRECT-PLUS) trial.

The new results indicate that the green Mediterranean diet lowered visceral fat by twice as much as the standard Mediterranean diet (14% vs. 7%), reported Iris Shai, PhD, of Ben-Gurion University of the Negev in Be’er Sheva, Israel, and colleagues.

“This study may suggest an improved dietary protocol for treating visceral adiposity,” the authors wrote in their article, published recently in BMC Medicine.

“A healthy lifestyle is a strong basis for any weight-loss program. We learned from the results of our experiment that the quality of food is no less important than the number of calories consumed and the goal today is to understand the mechanisms of various nutrients, for example, positive ones such as the polyphenols, and negative ones such as empty carbohydrates and processed red meat, on the pace of fat cell differentiation and their aggregation in the viscera,” Dr. Shai said in a press release from Ben‐Gurion University.

“A 14% reduction in visceral fat is a dramatic achievement for making simple changes to your diet and lifestyle. Weight loss is an important goal only if it is accompanied by impressive results in reducing adipose tissue,” added coauthor Hila Zelicha, RD, PhD, also of Ben‐Gurion University of the Negev.

Previous randomized controlled trials have shown that dietary changes with a higher polyphenol content tend to produce better cardiometabolic outcomes and appear to mobilize particular ectopic fat depots, the researchers noted.

The main results of the DIRECT-PLUS trial were published in 2020 in Heart. Almost 300 participants with abdominal obesity/dyslipidemia were randomized to one of three diet groups (all accompanied by physical activity): standard healthy dietary guidelines (HDG), standard Mediterranean diet, and the so-called green Mediterranean diet. The mean age of participants was 51 years, and men comprised 88% of the study cohort.

Participants in both Mediterranean diet groups ate 28 grams/day of walnuts, which accounted for about 440 mg/day of polyphenols. Participants in the green Mediterranean group also ate 100 grams/day of frozen cubes of a Wolffia globosa (duckweed strain) plant green shake, and three to four cups/day of green tea, which contributed to consumption of 800 mg/day of polyphenols, and decreased red meat consumption.

Both the green and standard Mediterranean diet groups achieved similar weight loss (–6.2 kg and –5.4 kg) compared with the HDG group (–1.5 kg; P < .001). However, the green Mediterranean diet group had a greater reduction in waist circumference (–8.6 cm) than the standard Mediterranean diet group (–6.8 cm; P = .033) and HDG group (–4.3 cm; P < .001). Stratification by gender showed these differences were significant only among men.

Explaining the rationale for the study, the researchers noted that visceral adipose tissue accumulation is a key factor that differentiates metabolic healthy and unhealthy obese individuals, is closely related to the development of multiple cardiovascular risk factors, including hypertension, dyslipidemia, and type 2 diabetes, and is an independent marker of mortality.

Now, their latest data show the green Mediterranean diet group lost approximately twice as much visceral adipose tissue compared with the standard Mediterranean diet and HDG groups (−14.1%, −6.0%, and − 4.2%; P < .05 independent of weight loss, sex, waist circumference, or age).

Lower red meat consumption, greater dietary consumption of walnuts, Wolffia globosa, and green tea, increased urine urolithin A polyphenol, and elevated total plasma polyphenols were significantly associated with greater visceral adipose tissue loss (P < .05, multivariate models).

“A green Mediterranean diet enriched with polyphenols and decreased red meat consumption might serve as an improved version of the Mediterranean diet for targeted VAT reduction. Future studies are needed to explore the exact mechanisms of specific polyphenol-rich foods on visceral adiposity,” the study authors concluded.

A version of this article first appeared on Medscape.com.

Visceral adipose tissue is significantly reduced with the green Mediterranean diet (MED), which consists of polyphenols and reduced red meat intake, according to a new analysis of the 18-month Dietary Intervention Randomized Controlled Trial Polyphenols Unprocessed (DIRECT-PLUS) trial.

The new results indicate that the green Mediterranean diet lowered visceral fat by twice as much as the standard Mediterranean diet (14% vs. 7%), reported Iris Shai, PhD, of Ben-Gurion University of the Negev in Be’er Sheva, Israel, and colleagues.

“This study may suggest an improved dietary protocol for treating visceral adiposity,” the authors wrote in their article, published recently in BMC Medicine.

“A healthy lifestyle is a strong basis for any weight-loss program. We learned from the results of our experiment that the quality of food is no less important than the number of calories consumed and the goal today is to understand the mechanisms of various nutrients, for example, positive ones such as the polyphenols, and negative ones such as empty carbohydrates and processed red meat, on the pace of fat cell differentiation and their aggregation in the viscera,” Dr. Shai said in a press release from Ben‐Gurion University.

“A 14% reduction in visceral fat is a dramatic achievement for making simple changes to your diet and lifestyle. Weight loss is an important goal only if it is accompanied by impressive results in reducing adipose tissue,” added coauthor Hila Zelicha, RD, PhD, also of Ben‐Gurion University of the Negev.

Previous randomized controlled trials have shown that dietary changes with a higher polyphenol content tend to produce better cardiometabolic outcomes and appear to mobilize particular ectopic fat depots, the researchers noted.

The main results of the DIRECT-PLUS trial were published in 2020 in Heart. Almost 300 participants with abdominal obesity/dyslipidemia were randomized to one of three diet groups (all accompanied by physical activity): standard healthy dietary guidelines (HDG), standard Mediterranean diet, and the so-called green Mediterranean diet. The mean age of participants was 51 years, and men comprised 88% of the study cohort.

Participants in both Mediterranean diet groups ate 28 grams/day of walnuts, which accounted for about 440 mg/day of polyphenols. Participants in the green Mediterranean group also ate 100 grams/day of frozen cubes of a Wolffia globosa (duckweed strain) plant green shake, and three to four cups/day of green tea, which contributed to consumption of 800 mg/day of polyphenols, and decreased red meat consumption.

Both the green and standard Mediterranean diet groups achieved similar weight loss (–6.2 kg and –5.4 kg) compared with the HDG group (–1.5 kg; P < .001). However, the green Mediterranean diet group had a greater reduction in waist circumference (–8.6 cm) than the standard Mediterranean diet group (–6.8 cm; P = .033) and HDG group (–4.3 cm; P < .001). Stratification by gender showed these differences were significant only among men.

Explaining the rationale for the study, the researchers noted that visceral adipose tissue accumulation is a key factor that differentiates metabolic healthy and unhealthy obese individuals, is closely related to the development of multiple cardiovascular risk factors, including hypertension, dyslipidemia, and type 2 diabetes, and is an independent marker of mortality.

Now, their latest data show the green Mediterranean diet group lost approximately twice as much visceral adipose tissue compared with the standard Mediterranean diet and HDG groups (−14.1%, −6.0%, and − 4.2%; P < .05 independent of weight loss, sex, waist circumference, or age).

Lower red meat consumption, greater dietary consumption of walnuts, Wolffia globosa, and green tea, increased urine urolithin A polyphenol, and elevated total plasma polyphenols were significantly associated with greater visceral adipose tissue loss (P < .05, multivariate models).

“A green Mediterranean diet enriched with polyphenols and decreased red meat consumption might serve as an improved version of the Mediterranean diet for targeted VAT reduction. Future studies are needed to explore the exact mechanisms of specific polyphenol-rich foods on visceral adiposity,” the study authors concluded.

A version of this article first appeared on Medscape.com.

Visceral adipose tissue is significantly reduced with the green Mediterranean diet (MED), which consists of polyphenols and reduced red meat intake, according to a new analysis of the 18-month Dietary Intervention Randomized Controlled Trial Polyphenols Unprocessed (DIRECT-PLUS) trial.

The new results indicate that the green Mediterranean diet lowered visceral fat by twice as much as the standard Mediterranean diet (14% vs. 7%), reported Iris Shai, PhD, of Ben-Gurion University of the Negev in Be’er Sheva, Israel, and colleagues.

“This study may suggest an improved dietary protocol for treating visceral adiposity,” the authors wrote in their article, published recently in BMC Medicine.

“A healthy lifestyle is a strong basis for any weight-loss program. We learned from the results of our experiment that the quality of food is no less important than the number of calories consumed and the goal today is to understand the mechanisms of various nutrients, for example, positive ones such as the polyphenols, and negative ones such as empty carbohydrates and processed red meat, on the pace of fat cell differentiation and their aggregation in the viscera,” Dr. Shai said in a press release from Ben‐Gurion University.

“A 14% reduction in visceral fat is a dramatic achievement for making simple changes to your diet and lifestyle. Weight loss is an important goal only if it is accompanied by impressive results in reducing adipose tissue,” added coauthor Hila Zelicha, RD, PhD, also of Ben‐Gurion University of the Negev.

Previous randomized controlled trials have shown that dietary changes with a higher polyphenol content tend to produce better cardiometabolic outcomes and appear to mobilize particular ectopic fat depots, the researchers noted.

The main results of the DIRECT-PLUS trial were published in 2020 in Heart. Almost 300 participants with abdominal obesity/dyslipidemia were randomized to one of three diet groups (all accompanied by physical activity): standard healthy dietary guidelines (HDG), standard Mediterranean diet, and the so-called green Mediterranean diet. The mean age of participants was 51 years, and men comprised 88% of the study cohort.

Participants in both Mediterranean diet groups ate 28 grams/day of walnuts, which accounted for about 440 mg/day of polyphenols. Participants in the green Mediterranean group also ate 100 grams/day of frozen cubes of a Wolffia globosa (duckweed strain) plant green shake, and three to four cups/day of green tea, which contributed to consumption of 800 mg/day of polyphenols, and decreased red meat consumption.

Both the green and standard Mediterranean diet groups achieved similar weight loss (–6.2 kg and –5.4 kg) compared with the HDG group (–1.5 kg; P < .001). However, the green Mediterranean diet group had a greater reduction in waist circumference (–8.6 cm) than the standard Mediterranean diet group (–6.8 cm; P = .033) and HDG group (–4.3 cm; P < .001). Stratification by gender showed these differences were significant only among men.

Explaining the rationale for the study, the researchers noted that visceral adipose tissue accumulation is a key factor that differentiates metabolic healthy and unhealthy obese individuals, is closely related to the development of multiple cardiovascular risk factors, including hypertension, dyslipidemia, and type 2 diabetes, and is an independent marker of mortality.

Now, their latest data show the green Mediterranean diet group lost approximately twice as much visceral adipose tissue compared with the standard Mediterranean diet and HDG groups (−14.1%, −6.0%, and − 4.2%; P < .05 independent of weight loss, sex, waist circumference, or age).

Lower red meat consumption, greater dietary consumption of walnuts, Wolffia globosa, and green tea, increased urine urolithin A polyphenol, and elevated total plasma polyphenols were significantly associated with greater visceral adipose tissue loss (P < .05, multivariate models).

“A green Mediterranean diet enriched with polyphenols and decreased red meat consumption might serve as an improved version of the Mediterranean diet for targeted VAT reduction. Future studies are needed to explore the exact mechanisms of specific polyphenol-rich foods on visceral adiposity,” the study authors concluded.

A version of this article first appeared on Medscape.com.