A new study questions the conventional wisdom of using steroids and anti-inflammatory drugs like ibuprofen to treat low back pain if exercise and other nondrug therapies don’t work right away.

Those medications offer relief from acute pain but may actually increase a person’s chances of developing chronic pain, said the investigators for a study published in Science Translational Medicine. The study results indicate that inflammation is a normal part of recovering from a painful injury and that inhibiting inflammation may result in more-difficult-to-treat chronic pain.

“For many decades it’s been standard medical practice to treat pain with anti-inflammatory drugs,” Jeffrey Mogil, PhD, a psychology professor at McGill University, Montreal, said in a school news release. “But we found that this short-term fix could lead to longer-term problems.”

Researchers looked at low back pain because it’s so common, with 25% of U.S. adults saying they had low back pain in the previous 3 months, according to the Centers for Disease Control and Prevention. Acute back pain is defined as lasting less than 4 weeks while chronic back pain lasts more than 12 weeks.

By examining blood samples, researchers discovered that people whose low back pain was resolved had high inflammation driven by neutrophils, a type of white blood cell that helps the body fight infection, the study said.

“Neutrophils dominate the early stages of inflammation and set the stage for repair of tissue damage. Inflammation occurs for a reason, and it looks like it’s dangerous to interfere with it,” Dr. Mogil said in the news release.

The research team found that blocking neutrophils in mice prolonged pain in the animals up to 10-fold. Pain also was prolonged when the mice were given anti-inflammatory drugs and steroids, the news release says.

McGill University said other studies support the findings. The school cited an analysis of 500,000 people in the United Kingdom. The analysis found that those taking anti-inflammatory drugs for pain were more likely to have pain 2 to 10 years later.

While saying the study suggests it’s time to reconsider how pain is treated, the researchers called for clinical trials on humans, not just observations of people with low back pain.

Experts warned about accepting the results without further investigation.

“It’s intriguing but requires further study,” Steven J. Atlas, MD, director of the Primary Care Research & Quality Improvement Network at Massachusetts General Hospital, Boston, told The New York Times.

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

A new study questions the conventional wisdom of using steroids and anti-inflammatory drugs like ibuprofen to treat low back pain if exercise and other nondrug therapies don’t work right away.

Those medications offer relief from acute pain but may actually increase a person’s chances of developing chronic pain, said the investigators for a study published in Science Translational Medicine. The study results indicate that inflammation is a normal part of recovering from a painful injury and that inhibiting inflammation may result in more-difficult-to-treat chronic pain.

“For many decades it’s been standard medical practice to treat pain with anti-inflammatory drugs,” Jeffrey Mogil, PhD, a psychology professor at McGill University, Montreal, said in a school news release. “But we found that this short-term fix could lead to longer-term problems.”

Researchers looked at low back pain because it’s so common, with 25% of U.S. adults saying they had low back pain in the previous 3 months, according to the Centers for Disease Control and Prevention. Acute back pain is defined as lasting less than 4 weeks while chronic back pain lasts more than 12 weeks.

By examining blood samples, researchers discovered that people whose low back pain was resolved had high inflammation driven by neutrophils, a type of white blood cell that helps the body fight infection, the study said.

“Neutrophils dominate the early stages of inflammation and set the stage for repair of tissue damage. Inflammation occurs for a reason, and it looks like it’s dangerous to interfere with it,” Dr. Mogil said in the news release.

The research team found that blocking neutrophils in mice prolonged pain in the animals up to 10-fold. Pain also was prolonged when the mice were given anti-inflammatory drugs and steroids, the news release says.

McGill University said other studies support the findings. The school cited an analysis of 500,000 people in the United Kingdom. The analysis found that those taking anti-inflammatory drugs for pain were more likely to have pain 2 to 10 years later.

While saying the study suggests it’s time to reconsider how pain is treated, the researchers called for clinical trials on humans, not just observations of people with low back pain.

Experts warned about accepting the results without further investigation.

“It’s intriguing but requires further study,” Steven J. Atlas, MD, director of the Primary Care Research & Quality Improvement Network at Massachusetts General Hospital, Boston, told The New York Times.

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

A new study questions the conventional wisdom of using steroids and anti-inflammatory drugs like ibuprofen to treat low back pain if exercise and other nondrug therapies don’t work right away.

Those medications offer relief from acute pain but may actually increase a person’s chances of developing chronic pain, said the investigators for a study published in Science Translational Medicine. The study results indicate that inflammation is a normal part of recovering from a painful injury and that inhibiting inflammation may result in more-difficult-to-treat chronic pain.

“For many decades it’s been standard medical practice to treat pain with anti-inflammatory drugs,” Jeffrey Mogil, PhD, a psychology professor at McGill University, Montreal, said in a school news release. “But we found that this short-term fix could lead to longer-term problems.”

Researchers looked at low back pain because it’s so common, with 25% of U.S. adults saying they had low back pain in the previous 3 months, according to the Centers for Disease Control and Prevention. Acute back pain is defined as lasting less than 4 weeks while chronic back pain lasts more than 12 weeks.

By examining blood samples, researchers discovered that people whose low back pain was resolved had high inflammation driven by neutrophils, a type of white blood cell that helps the body fight infection, the study said.

“Neutrophils dominate the early stages of inflammation and set the stage for repair of tissue damage. Inflammation occurs for a reason, and it looks like it’s dangerous to interfere with it,” Dr. Mogil said in the news release.

The research team found that blocking neutrophils in mice prolonged pain in the animals up to 10-fold. Pain also was prolonged when the mice were given anti-inflammatory drugs and steroids, the news release says.

McGill University said other studies support the findings. The school cited an analysis of 500,000 people in the United Kingdom. The analysis found that those taking anti-inflammatory drugs for pain were more likely to have pain 2 to 10 years later.

While saying the study suggests it’s time to reconsider how pain is treated, the researchers called for clinical trials on humans, not just observations of people with low back pain.

Experts warned about accepting the results without further investigation.

“It’s intriguing but requires further study,” Steven J. Atlas, MD, director of the Primary Care Research & Quality Improvement Network at Massachusetts General Hospital, Boston, told The New York Times.

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

California researchers are seeking women willing to use sex toys for science.

A group at Cedars-Sinai Medical Center in Los Angeles has launched a study to see whether the current generation of vibrators – powerful, technologically advanced, even Bluetooth-enabled – can improve sexual health, pelvic floor function, and overall well-being.

“We have not had good-quality studies with the use of modern vibrators,” Alexandra Dubinskaya, MD, an obstetrician who is leading the study, said in an interview.

Vibrators of various kinds have been used by women for centuries if not millennia. More than half of women in the United States have at least some experience with the devices.

Victorian-era physicians are said to have routinely prescribed multiple types of vibrators to treat “female hysteria,” although the frequency with which vibrators were recommended for therapeutic purposes has been questioned.

Still, Dr. Dubinskaya said vibrators have a long history of use as therapy – with some evidence of success.

She and her colleagues reviewed the medical literature and found that studies generally supported the use of vibrators for increased blood flow in pelvic tissues, improved sexual function, including orgasms, and possibly urinary incontinence by helping to strengthen the pelvic floor. They also appear to boost desire, arousal, and genital sensation.

For the new study, Dr. Dubinskaya and her colleagues hope to eventually include 100 women between the ages of 18 and 99 years. Each will receive a commercially available genital vibrator and instructions to use the device to reach orgasm three times per week for 3 to 4 months. The researchers will track any changes in sexual function, pelvic prolapse, urinary continence, and other measures of pelvic and sexual health.

The goal of the study, Dr. Dubinskaya said, is to provide prospective data for clinicians who might consider recommending vibrators to their patients – a list that includes urologists, gynecologists, and experts in sexual medicine.

These clinicians “are frequently the first to encounter questions on women’s sexual function, pelvic floor problems, and vulvar health,” Dr. Dubinskaya said. She noted that such questions are common.

Asking women to consider using vibrators might seem too sensitive a subject in a clinical setting, but Dr. Dubinskaya said data indicate that women are receptive to the suggestion.

Debra Lynne Herbenick, PhD, director of the Center for Sexual Health Promotion and a professor of public health at Indiana University, Indianapolis, who has studied vibrator use in the United States, said the research could make a valuable contribution to sexual health.

“This study is an important next step because it is a prospective study and will be able to assess changes in sexual and pelvic floor function over time in relation to vibrator use,” Dr. Herbenick said. Owing to the limited quality of the currently available evidence, these data have the potential “to support clinicians’ recommendations and also their communication with patients.”

Dr. Dubinskaya and Dr. Herbenick reported no relevant financial relationships.

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

California researchers are seeking women willing to use sex toys for science.

A group at Cedars-Sinai Medical Center in Los Angeles has launched a study to see whether the current generation of vibrators – powerful, technologically advanced, even Bluetooth-enabled – can improve sexual health, pelvic floor function, and overall well-being.

“We have not had good-quality studies with the use of modern vibrators,” Alexandra Dubinskaya, MD, an obstetrician who is leading the study, said in an interview.

Vibrators of various kinds have been used by women for centuries if not millennia. More than half of women in the United States have at least some experience with the devices.

Victorian-era physicians are said to have routinely prescribed multiple types of vibrators to treat “female hysteria,” although the frequency with which vibrators were recommended for therapeutic purposes has been questioned.

Still, Dr. Dubinskaya said vibrators have a long history of use as therapy – with some evidence of success.

She and her colleagues reviewed the medical literature and found that studies generally supported the use of vibrators for increased blood flow in pelvic tissues, improved sexual function, including orgasms, and possibly urinary incontinence by helping to strengthen the pelvic floor. They also appear to boost desire, arousal, and genital sensation.

For the new study, Dr. Dubinskaya and her colleagues hope to eventually include 100 women between the ages of 18 and 99 years. Each will receive a commercially available genital vibrator and instructions to use the device to reach orgasm three times per week for 3 to 4 months. The researchers will track any changes in sexual function, pelvic prolapse, urinary continence, and other measures of pelvic and sexual health.

The goal of the study, Dr. Dubinskaya said, is to provide prospective data for clinicians who might consider recommending vibrators to their patients – a list that includes urologists, gynecologists, and experts in sexual medicine.

These clinicians “are frequently the first to encounter questions on women’s sexual function, pelvic floor problems, and vulvar health,” Dr. Dubinskaya said. She noted that such questions are common.

Asking women to consider using vibrators might seem too sensitive a subject in a clinical setting, but Dr. Dubinskaya said data indicate that women are receptive to the suggestion.

Debra Lynne Herbenick, PhD, director of the Center for Sexual Health Promotion and a professor of public health at Indiana University, Indianapolis, who has studied vibrator use in the United States, said the research could make a valuable contribution to sexual health.

“This study is an important next step because it is a prospective study and will be able to assess changes in sexual and pelvic floor function over time in relation to vibrator use,” Dr. Herbenick said. Owing to the limited quality of the currently available evidence, these data have the potential “to support clinicians’ recommendations and also their communication with patients.”

Dr. Dubinskaya and Dr. Herbenick reported no relevant financial relationships.

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

California researchers are seeking women willing to use sex toys for science.

A group at Cedars-Sinai Medical Center in Los Angeles has launched a study to see whether the current generation of vibrators – powerful, technologically advanced, even Bluetooth-enabled – can improve sexual health, pelvic floor function, and overall well-being.

“We have not had good-quality studies with the use of modern vibrators,” Alexandra Dubinskaya, MD, an obstetrician who is leading the study, said in an interview.

Vibrators of various kinds have been used by women for centuries if not millennia. More than half of women in the United States have at least some experience with the devices.

Victorian-era physicians are said to have routinely prescribed multiple types of vibrators to treat “female hysteria,” although the frequency with which vibrators were recommended for therapeutic purposes has been questioned.

Still, Dr. Dubinskaya said vibrators have a long history of use as therapy – with some evidence of success.

She and her colleagues reviewed the medical literature and found that studies generally supported the use of vibrators for increased blood flow in pelvic tissues, improved sexual function, including orgasms, and possibly urinary incontinence by helping to strengthen the pelvic floor. They also appear to boost desire, arousal, and genital sensation.

For the new study, Dr. Dubinskaya and her colleagues hope to eventually include 100 women between the ages of 18 and 99 years. Each will receive a commercially available genital vibrator and instructions to use the device to reach orgasm three times per week for 3 to 4 months. The researchers will track any changes in sexual function, pelvic prolapse, urinary continence, and other measures of pelvic and sexual health.

The goal of the study, Dr. Dubinskaya said, is to provide prospective data for clinicians who might consider recommending vibrators to their patients – a list that includes urologists, gynecologists, and experts in sexual medicine.

These clinicians “are frequently the first to encounter questions on women’s sexual function, pelvic floor problems, and vulvar health,” Dr. Dubinskaya said. She noted that such questions are common.

Asking women to consider using vibrators might seem too sensitive a subject in a clinical setting, but Dr. Dubinskaya said data indicate that women are receptive to the suggestion.

Debra Lynne Herbenick, PhD, director of the Center for Sexual Health Promotion and a professor of public health at Indiana University, Indianapolis, who has studied vibrator use in the United States, said the research could make a valuable contribution to sexual health.

“This study is an important next step because it is a prospective study and will be able to assess changes in sexual and pelvic floor function over time in relation to vibrator use,” Dr. Herbenick said. Owing to the limited quality of the currently available evidence, these data have the potential “to support clinicians’ recommendations and also their communication with patients.”

Dr. Dubinskaya and Dr. Herbenick reported no relevant financial relationships.

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

The “twincretin” era for treating patients with type 2 diabetes has begun, with the Food and Drug Administration’s approval of tirzepatide for this indication on May 13, making it the first approved agent that works as a dual agonist for the two principal human incretins.

Tirzepatide represents “an important advance in the treatment of type 2 diabetes,” the FDA’s Patrick Archdeacon, MD, associate director of the division of diabetes, lipid disorders, and obesity, said in a statement released by the agency.

That advance is based on tirzepatide’s engineering, which gives it agonist properties for both the glucagonlike peptide–1 (GLP-1) receptor, as well as the glucose-dependent insulinotropic polypeptide (GIP). Several agents are already approved for U.S. use from the class with single-agonist activity on the GLP-1 receptor, including semaglutide (Ozempic for treating patients with type 2 diabetes; Wegovy for weight loss).

The FDA’s approved label includes all three dosages of tirzepatide that underwent testing in the pivotal trials: 5 mg, 10 mg, and 15 mg, each delivered by subcutaneous injection once a week. Also approved was the 2.5-mg/week dose used when starting a patient on the agent. Gradual up-titration appears to minimize possible gastrointestinal adverse effects during initial tirzepatide use.

Tirzepatide, which will be marketed by Lilly as Mounjaro, will hit the U.S. market with much anticipation, based on results from five pivotal trials, all reported during the past year or so, that established the drug’s unprecedented efficacy for reducing hemoglobin A1c levels as well as triggering significant weight loss in most patients with a generally benign safety profile.
 

‘Impressive’ effects

The effects from tirzepatide on A1c and weight seen in these studies was “impressive, and will likely drive use of this agent,” commented Carol H. Wysham, MD, an endocrinologist at the MultiCare Rockwood Clinic in Spokane, Wash.

Tirzepatide received good notices in several editorials that accompanied the published reports of the pivotal trials. The first of these, a commentary from two U.K.-based endocrinologists, said that “tirzepatide appears to represent an advancement over current GLP-1 analogues, providing enhanced glycemic and weight benefits without an added penalty in terms of gastrointestinal adverse effects.”

The pivotal trials included head-to-head comparisons between tirzepatide and a 1.0-mg/week dose of semaglutide, as well as comparisons with each of two long-acting insulin analogs, insulin glargine (Lantus) and insulin degludec (Tresiba).

“These are the most important comparators,” Dr. Wysham said.

“Tirzepatide was appropriately compared with the best-in-class and most effective glucose-lowering agents currently available,” said Ildiko Lingvay, MD, an endocrinologist and professor at the University of Texas Southwestern Medical Center in Dallas.

“Given its outstanding efficacy at both lowering glucose and weight, I expect tirzepatide to have quick uptake among patients with diabetes,” Dr. Lingvay said. “The only limiting factor will be cost,” she added in an interview, highlighting the major stumbling block that could limit tirzepatide’s uptake.

“As with any new medication, access will be the biggest barrier to uptake,” agreed Alice Y.Y. Cheng, MD, an endocrinologist at the University of Toronto.
 

Lingering uncertainties

The timing of the comparison with semaglutide leaves some unanswered questions. The SURPASS-2 trial compared the three primary tirzepatide regimens (5 mg, 10 mg, and 15 mg/week) with a 1.0-mg/week dose of semaglutide, which was at the time the only approved dosage of semaglutide for patients with type 2 diabetes. Since then, a 2.0-mg/week dosage of semaglutide (Ozempic) received U.S. approval for treating patients with type 2 diabetes, and a 2.4-mg/week dosage (Wegovy) received an FDA nod for treating people with obesity.

The lack of head-to-head data for tirzepatide against the 2.0-mg/week dose of semaglutide “leaves a clinical gap,” said Dr. Cheng. Tirzepatide “represents an advance over semaglutide at the 1-mg/week dose, but we do not know for sure compared to the higher dose.”

Another important limitation for tirzepatide right now is that the agent’s obligatory cardiovascular outcome trial, SURPASS CVOT, with about 12,500 enrolled patients, will not have findings out until about 2025, leaving uncertainty until then about tirzepatide’s cardiovascular effects.

“We are missing the cardiovascular outcome data – very important data will come” from that trial, noted Dr. Wysham. “There will be some reluctance to use the agent in high-risk patients until we see the results.”

Given tirzepatide’s proven efficacy so far, the missing cardiovascular results “are not a limitation for most patients, but for patients with preexisting cardiovascular disease I will continue to use agents with proven benefits until the SURPASS CVOT results come out,” Dr. Lingvay said.

And then there is the cost issue, something that Lilly had not yet publicly addressed at the time that the FDA announced its decision.

An analysis of cost effectiveness published by the U.S. Institute for Clinical and Economic Review in February 2022 concluded that tirzepatide had a better impact on patient quality of life, compared with 1.0 mg/week semaglutide for treating patients with type 2 diabetes, which gave it a modest pricing cushion, compared with semaglutide of about $5,500 per quality-adjusted life-year gained. But the researchers who prepared the report admitted that tirzepatide’s cost-effectiveness was hard to estimate without knowing the drug’s actual price.  

Dr. Wysham has financial ties to AstraZeneca, Abbott, Boehringer Ingelheim, Intercept, Janssen, Mylan, Novo Nordisk, and Sanofi. Dr. Lingvay has dies to Lilly, Novo Nordisk, Sanofi, Boehringer Ingelheim, Merck, Pfizer, and Mylan, Intarcia, MannKind, Valeritas, and several other drug and device makers.

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

The “twincretin” era for treating patients with type 2 diabetes has begun, with the Food and Drug Administration’s approval of tirzepatide for this indication on May 13, making it the first approved agent that works as a dual agonist for the two principal human incretins.

Tirzepatide represents “an important advance in the treatment of type 2 diabetes,” the FDA’s Patrick Archdeacon, MD, associate director of the division of diabetes, lipid disorders, and obesity, said in a statement released by the agency.

That advance is based on tirzepatide’s engineering, which gives it agonist properties for both the glucagonlike peptide–1 (GLP-1) receptor, as well as the glucose-dependent insulinotropic polypeptide (GIP). Several agents are already approved for U.S. use from the class with single-agonist activity on the GLP-1 receptor, including semaglutide (Ozempic for treating patients with type 2 diabetes; Wegovy for weight loss).

The FDA’s approved label includes all three dosages of tirzepatide that underwent testing in the pivotal trials: 5 mg, 10 mg, and 15 mg, each delivered by subcutaneous injection once a week. Also approved was the 2.5-mg/week dose used when starting a patient on the agent. Gradual up-titration appears to minimize possible gastrointestinal adverse effects during initial tirzepatide use.

Tirzepatide, which will be marketed by Lilly as Mounjaro, will hit the U.S. market with much anticipation, based on results from five pivotal trials, all reported during the past year or so, that established the drug’s unprecedented efficacy for reducing hemoglobin A1c levels as well as triggering significant weight loss in most patients with a generally benign safety profile.
 

‘Impressive’ effects

The effects from tirzepatide on A1c and weight seen in these studies was “impressive, and will likely drive use of this agent,” commented Carol H. Wysham, MD, an endocrinologist at the MultiCare Rockwood Clinic in Spokane, Wash.

Tirzepatide received good notices in several editorials that accompanied the published reports of the pivotal trials. The first of these, a commentary from two U.K.-based endocrinologists, said that “tirzepatide appears to represent an advancement over current GLP-1 analogues, providing enhanced glycemic and weight benefits without an added penalty in terms of gastrointestinal adverse effects.”

The pivotal trials included head-to-head comparisons between tirzepatide and a 1.0-mg/week dose of semaglutide, as well as comparisons with each of two long-acting insulin analogs, insulin glargine (Lantus) and insulin degludec (Tresiba).

“These are the most important comparators,” Dr. Wysham said.

“Tirzepatide was appropriately compared with the best-in-class and most effective glucose-lowering agents currently available,” said Ildiko Lingvay, MD, an endocrinologist and professor at the University of Texas Southwestern Medical Center in Dallas.

“Given its outstanding efficacy at both lowering glucose and weight, I expect tirzepatide to have quick uptake among patients with diabetes,” Dr. Lingvay said. “The only limiting factor will be cost,” she added in an interview, highlighting the major stumbling block that could limit tirzepatide’s uptake.

“As with any new medication, access will be the biggest barrier to uptake,” agreed Alice Y.Y. Cheng, MD, an endocrinologist at the University of Toronto.
 

Lingering uncertainties

The timing of the comparison with semaglutide leaves some unanswered questions. The SURPASS-2 trial compared the three primary tirzepatide regimens (5 mg, 10 mg, and 15 mg/week) with a 1.0-mg/week dose of semaglutide, which was at the time the only approved dosage of semaglutide for patients with type 2 diabetes. Since then, a 2.0-mg/week dosage of semaglutide (Ozempic) received U.S. approval for treating patients with type 2 diabetes, and a 2.4-mg/week dosage (Wegovy) received an FDA nod for treating people with obesity.

The lack of head-to-head data for tirzepatide against the 2.0-mg/week dose of semaglutide “leaves a clinical gap,” said Dr. Cheng. Tirzepatide “represents an advance over semaglutide at the 1-mg/week dose, but we do not know for sure compared to the higher dose.”

Another important limitation for tirzepatide right now is that the agent’s obligatory cardiovascular outcome trial, SURPASS CVOT, with about 12,500 enrolled patients, will not have findings out until about 2025, leaving uncertainty until then about tirzepatide’s cardiovascular effects.

“We are missing the cardiovascular outcome data – very important data will come” from that trial, noted Dr. Wysham. “There will be some reluctance to use the agent in high-risk patients until we see the results.”

Given tirzepatide’s proven efficacy so far, the missing cardiovascular results “are not a limitation for most patients, but for patients with preexisting cardiovascular disease I will continue to use agents with proven benefits until the SURPASS CVOT results come out,” Dr. Lingvay said.

And then there is the cost issue, something that Lilly had not yet publicly addressed at the time that the FDA announced its decision.

An analysis of cost effectiveness published by the U.S. Institute for Clinical and Economic Review in February 2022 concluded that tirzepatide had a better impact on patient quality of life, compared with 1.0 mg/week semaglutide for treating patients with type 2 diabetes, which gave it a modest pricing cushion, compared with semaglutide of about $5,500 per quality-adjusted life-year gained. But the researchers who prepared the report admitted that tirzepatide’s cost-effectiveness was hard to estimate without knowing the drug’s actual price.  

Dr. Wysham has financial ties to AstraZeneca, Abbott, Boehringer Ingelheim, Intercept, Janssen, Mylan, Novo Nordisk, and Sanofi. Dr. Lingvay has dies to Lilly, Novo Nordisk, Sanofi, Boehringer Ingelheim, Merck, Pfizer, and Mylan, Intarcia, MannKind, Valeritas, and several other drug and device makers.

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

The “twincretin” era for treating patients with type 2 diabetes has begun, with the Food and Drug Administration’s approval of tirzepatide for this indication on May 13, making it the first approved agent that works as a dual agonist for the two principal human incretins.

Tirzepatide represents “an important advance in the treatment of type 2 diabetes,” the FDA’s Patrick Archdeacon, MD, associate director of the division of diabetes, lipid disorders, and obesity, said in a statement released by the agency.

That advance is based on tirzepatide’s engineering, which gives it agonist properties for both the glucagonlike peptide–1 (GLP-1) receptor, as well as the glucose-dependent insulinotropic polypeptide (GIP). Several agents are already approved for U.S. use from the class with single-agonist activity on the GLP-1 receptor, including semaglutide (Ozempic for treating patients with type 2 diabetes; Wegovy for weight loss).

The FDA’s approved label includes all three dosages of tirzepatide that underwent testing in the pivotal trials: 5 mg, 10 mg, and 15 mg, each delivered by subcutaneous injection once a week. Also approved was the 2.5-mg/week dose used when starting a patient on the agent. Gradual up-titration appears to minimize possible gastrointestinal adverse effects during initial tirzepatide use.

Tirzepatide, which will be marketed by Lilly as Mounjaro, will hit the U.S. market with much anticipation, based on results from five pivotal trials, all reported during the past year or so, that established the drug’s unprecedented efficacy for reducing hemoglobin A1c levels as well as triggering significant weight loss in most patients with a generally benign safety profile.
 

‘Impressive’ effects

The effects from tirzepatide on A1c and weight seen in these studies was “impressive, and will likely drive use of this agent,” commented Carol H. Wysham, MD, an endocrinologist at the MultiCare Rockwood Clinic in Spokane, Wash.

Tirzepatide received good notices in several editorials that accompanied the published reports of the pivotal trials. The first of these, a commentary from two U.K.-based endocrinologists, said that “tirzepatide appears to represent an advancement over current GLP-1 analogues, providing enhanced glycemic and weight benefits without an added penalty in terms of gastrointestinal adverse effects.”

The pivotal trials included head-to-head comparisons between tirzepatide and a 1.0-mg/week dose of semaglutide, as well as comparisons with each of two long-acting insulin analogs, insulin glargine (Lantus) and insulin degludec (Tresiba).

“These are the most important comparators,” Dr. Wysham said.

“Tirzepatide was appropriately compared with the best-in-class and most effective glucose-lowering agents currently available,” said Ildiko Lingvay, MD, an endocrinologist and professor at the University of Texas Southwestern Medical Center in Dallas.

“Given its outstanding efficacy at both lowering glucose and weight, I expect tirzepatide to have quick uptake among patients with diabetes,” Dr. Lingvay said. “The only limiting factor will be cost,” she added in an interview, highlighting the major stumbling block that could limit tirzepatide’s uptake.

“As with any new medication, access will be the biggest barrier to uptake,” agreed Alice Y.Y. Cheng, MD, an endocrinologist at the University of Toronto.
 

Lingering uncertainties

The timing of the comparison with semaglutide leaves some unanswered questions. The SURPASS-2 trial compared the three primary tirzepatide regimens (5 mg, 10 mg, and 15 mg/week) with a 1.0-mg/week dose of semaglutide, which was at the time the only approved dosage of semaglutide for patients with type 2 diabetes. Since then, a 2.0-mg/week dosage of semaglutide (Ozempic) received U.S. approval for treating patients with type 2 diabetes, and a 2.4-mg/week dosage (Wegovy) received an FDA nod for treating people with obesity.

The lack of head-to-head data for tirzepatide against the 2.0-mg/week dose of semaglutide “leaves a clinical gap,” said Dr. Cheng. Tirzepatide “represents an advance over semaglutide at the 1-mg/week dose, but we do not know for sure compared to the higher dose.”

Another important limitation for tirzepatide right now is that the agent’s obligatory cardiovascular outcome trial, SURPASS CVOT, with about 12,500 enrolled patients, will not have findings out until about 2025, leaving uncertainty until then about tirzepatide’s cardiovascular effects.

“We are missing the cardiovascular outcome data – very important data will come” from that trial, noted Dr. Wysham. “There will be some reluctance to use the agent in high-risk patients until we see the results.”

Given tirzepatide’s proven efficacy so far, the missing cardiovascular results “are not a limitation for most patients, but for patients with preexisting cardiovascular disease I will continue to use agents with proven benefits until the SURPASS CVOT results come out,” Dr. Lingvay said.

And then there is the cost issue, something that Lilly had not yet publicly addressed at the time that the FDA announced its decision.

An analysis of cost effectiveness published by the U.S. Institute for Clinical and Economic Review in February 2022 concluded that tirzepatide had a better impact on patient quality of life, compared with 1.0 mg/week semaglutide for treating patients with type 2 diabetes, which gave it a modest pricing cushion, compared with semaglutide of about $5,500 per quality-adjusted life-year gained. But the researchers who prepared the report admitted that tirzepatide’s cost-effectiveness was hard to estimate without knowing the drug’s actual price.  

Dr. Wysham has financial ties to AstraZeneca, Abbott, Boehringer Ingelheim, Intercept, Janssen, Mylan, Novo Nordisk, and Sanofi. Dr. Lingvay has dies to Lilly, Novo Nordisk, Sanofi, Boehringer Ingelheim, Merck, Pfizer, and Mylan, Intarcia, MannKind, Valeritas, and several other drug and device makers.

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

The annual cost of Lyme disease in the United States could be nearly $970 million, according to new research. But not all cases of Lyme disease are equally costly. Costs for patients with disseminated Lyme disease were more than twice as high as those for patients with localized disease.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

“These findings emphasize the importance of early and accurate diagnosis to reduce both illness and its associated personal and societal costs,” the study’s authors write. The analysis was published  in Emerging Infectious Diseases. The authors are from the Centers for Disease Control and Prevention, the Yale School of Public Health, and the Departments of Health of Minnesota, Maryland, and New York State.

Lyme disease is the most reported vector-borne disease in the United States; an estimated 476,000 Americans are diagnosed with the infection every year. Though the highest incidences are in the Northeast and in Minnesota and Wisconsin, the CDC has recorded cases in all 50 states. Over the past 20 years, estimates of the total cost of treating Lyme disease have varied from $203 million to nearly $1.3 billion. A major limitation to these studies, however, is that they may not accurately identify patients with Lyme disease or capture many of the nonmedical costs associated with treatment, the authors write, such as costs associated with time taken off work and travel to appointments.

To better capture the comprehensive cost of Lyme disease in the United States, researchers conducted a prospective study from September 2014 to January 2016 and followed reported cases in four states with high rates of Lyme disease: Connecticut, Maryland, Minnesota, and New York. The team conducted monthly patient surveys and queried billing codes from participants’ clinicians to estimate both the personal expenses and societal costs – such as total costs to the health care system – of Lyme disease.

Participants were variously assigned to one of three categories: those with confirmed local disease (such as patients with erythema migrans); those with confirmed disseminated disease, with symptoms including arthritis, lymphocytic meningitis, and encephalomyelitis; and those with probable cases with reported symptoms.

The researchers surveyed 901 participants with clinician-diagnosed Lyme disease: 402 with localized disease, 238 with disseminated disease, and 261 with probable cases. Nearly all participants (94%) were White, 57% were men, and 71% had an annual household income above $60,000. About 28% of participants were younger than 18 years, 16% were aged 18-45 years, 36% were aged 46-65, and 19% were older than 65 years. For most participants (68%), complete medical cost data were available. Those data were used to calculate societal costs.

Costs per patient varied dramatically, from $0.46 to $30,628. On average, patients spent $1,252 during the study period on expenses related to Lyme disease treatment, including expenses associated with travel and time taken off work. The median cost to patients was notably smaller, at $244. Patients with disseminated disease had the highest median ($358) and mean ($1,692) costs, followed by participants with probable disease (median, $315; mean, $1,277). Participants with localized disease had the lowest median ($170) and mean ($1,070) costs.

Societal costs ranged from $54 to $122,766 per patient; the median was $690, and the mean was $2,032. Multiplying these numbers by the estimated cases diagnosed nationally each year, researchers determined that the total cost of Lyme disease in the United States is between $345 million and $968 million.

The study “pointed out the tremendous variability in costs” associated with Lyme disease treatment, Brian Fallon, MD, MPH, director of the Lyme and Tick-Borne Diseases Research Center at the Columbia University Irving Medical Center, New York, told this news organization. He was not involved with the research. Some patients continued having health expenses after the end of the study, which means their costs would be even higher, he noted. Though most patients fully recovered after 1 year, about 4% still reported symptoms, and 3% were still incurring costs.

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

The annual cost of Lyme disease in the United States could be nearly $970 million, according to new research. But not all cases of Lyme disease are equally costly. Costs for patients with disseminated Lyme disease were more than twice as high as those for patients with localized disease.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

“These findings emphasize the importance of early and accurate diagnosis to reduce both illness and its associated personal and societal costs,” the study’s authors write. The analysis was published  in Emerging Infectious Diseases. The authors are from the Centers for Disease Control and Prevention, the Yale School of Public Health, and the Departments of Health of Minnesota, Maryland, and New York State.

Lyme disease is the most reported vector-borne disease in the United States; an estimated 476,000 Americans are diagnosed with the infection every year. Though the highest incidences are in the Northeast and in Minnesota and Wisconsin, the CDC has recorded cases in all 50 states. Over the past 20 years, estimates of the total cost of treating Lyme disease have varied from $203 million to nearly $1.3 billion. A major limitation to these studies, however, is that they may not accurately identify patients with Lyme disease or capture many of the nonmedical costs associated with treatment, the authors write, such as costs associated with time taken off work and travel to appointments.

To better capture the comprehensive cost of Lyme disease in the United States, researchers conducted a prospective study from September 2014 to January 2016 and followed reported cases in four states with high rates of Lyme disease: Connecticut, Maryland, Minnesota, and New York. The team conducted monthly patient surveys and queried billing codes from participants’ clinicians to estimate both the personal expenses and societal costs – such as total costs to the health care system – of Lyme disease.

Participants were variously assigned to one of three categories: those with confirmed local disease (such as patients with erythema migrans); those with confirmed disseminated disease, with symptoms including arthritis, lymphocytic meningitis, and encephalomyelitis; and those with probable cases with reported symptoms.

The researchers surveyed 901 participants with clinician-diagnosed Lyme disease: 402 with localized disease, 238 with disseminated disease, and 261 with probable cases. Nearly all participants (94%) were White, 57% were men, and 71% had an annual household income above $60,000. About 28% of participants were younger than 18 years, 16% were aged 18-45 years, 36% were aged 46-65, and 19% were older than 65 years. For most participants (68%), complete medical cost data were available. Those data were used to calculate societal costs.

Costs per patient varied dramatically, from $0.46 to $30,628. On average, patients spent $1,252 during the study period on expenses related to Lyme disease treatment, including expenses associated with travel and time taken off work. The median cost to patients was notably smaller, at $244. Patients with disseminated disease had the highest median ($358) and mean ($1,692) costs, followed by participants with probable disease (median, $315; mean, $1,277). Participants with localized disease had the lowest median ($170) and mean ($1,070) costs.

Societal costs ranged from $54 to $122,766 per patient; the median was $690, and the mean was $2,032. Multiplying these numbers by the estimated cases diagnosed nationally each year, researchers determined that the total cost of Lyme disease in the United States is between $345 million and $968 million.

The study “pointed out the tremendous variability in costs” associated with Lyme disease treatment, Brian Fallon, MD, MPH, director of the Lyme and Tick-Borne Diseases Research Center at the Columbia University Irving Medical Center, New York, told this news organization. He was not involved with the research. Some patients continued having health expenses after the end of the study, which means their costs would be even higher, he noted. Though most patients fully recovered after 1 year, about 4% still reported symptoms, and 3% were still incurring costs.

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

The annual cost of Lyme disease in the United States could be nearly $970 million, according to new research. But not all cases of Lyme disease are equally costly. Costs for patients with disseminated Lyme disease were more than twice as high as those for patients with localized disease.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

“These findings emphasize the importance of early and accurate diagnosis to reduce both illness and its associated personal and societal costs,” the study’s authors write. The analysis was published  in Emerging Infectious Diseases. The authors are from the Centers for Disease Control and Prevention, the Yale School of Public Health, and the Departments of Health of Minnesota, Maryland, and New York State.

Lyme disease is the most reported vector-borne disease in the United States; an estimated 476,000 Americans are diagnosed with the infection every year. Though the highest incidences are in the Northeast and in Minnesota and Wisconsin, the CDC has recorded cases in all 50 states. Over the past 20 years, estimates of the total cost of treating Lyme disease have varied from $203 million to nearly $1.3 billion. A major limitation to these studies, however, is that they may not accurately identify patients with Lyme disease or capture many of the nonmedical costs associated with treatment, the authors write, such as costs associated with time taken off work and travel to appointments.

To better capture the comprehensive cost of Lyme disease in the United States, researchers conducted a prospective study from September 2014 to January 2016 and followed reported cases in four states with high rates of Lyme disease: Connecticut, Maryland, Minnesota, and New York. The team conducted monthly patient surveys and queried billing codes from participants’ clinicians to estimate both the personal expenses and societal costs – such as total costs to the health care system – of Lyme disease.

Participants were variously assigned to one of three categories: those with confirmed local disease (such as patients with erythema migrans); those with confirmed disseminated disease, with symptoms including arthritis, lymphocytic meningitis, and encephalomyelitis; and those with probable cases with reported symptoms.

The researchers surveyed 901 participants with clinician-diagnosed Lyme disease: 402 with localized disease, 238 with disseminated disease, and 261 with probable cases. Nearly all participants (94%) were White, 57% were men, and 71% had an annual household income above $60,000. About 28% of participants were younger than 18 years, 16% were aged 18-45 years, 36% were aged 46-65, and 19% were older than 65 years. For most participants (68%), complete medical cost data were available. Those data were used to calculate societal costs.

Costs per patient varied dramatically, from $0.46 to $30,628. On average, patients spent $1,252 during the study period on expenses related to Lyme disease treatment, including expenses associated with travel and time taken off work. The median cost to patients was notably smaller, at $244. Patients with disseminated disease had the highest median ($358) and mean ($1,692) costs, followed by participants with probable disease (median, $315; mean, $1,277). Participants with localized disease had the lowest median ($170) and mean ($1,070) costs.

Societal costs ranged from $54 to $122,766 per patient; the median was $690, and the mean was $2,032. Multiplying these numbers by the estimated cases diagnosed nationally each year, researchers determined that the total cost of Lyme disease in the United States is between $345 million and $968 million.

The study “pointed out the tremendous variability in costs” associated with Lyme disease treatment, Brian Fallon, MD, MPH, director of the Lyme and Tick-Borne Diseases Research Center at the Columbia University Irving Medical Center, New York, told this news organization. He was not involved with the research. Some patients continued having health expenses after the end of the study, which means their costs would be even higher, he noted. Though most patients fully recovered after 1 year, about 4% still reported symptoms, and 3% were still incurring costs.

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

People with nonalcoholic fatty liver disease (NAFLD) and a lean or healthy body mass index are at increased risk for peripheral vascular disease, stroke, and cardiovascular disease, a surprise finding from a new study reveals.

“Our team had expected to see that those with a normal BMI would have a lower prevalence of any metabolic or cardiovascular conditions,” lead researcher Karn Wijarnpreecha, MD, MPH, said during a media briefing that previewed select research for Digestive Disease Week^® (DDW) 2022. “So, we were very surprised to find this link to cardiovascular disease.”

The investigators saw this increased risk of cardiovascular disease despite this group having a lower prevalence of atherosclerotic risk factors and metabolic disease.

This first study of its kind suggests physicians should consider the risk of cardiovascular disease in all patients with NAFLD, not just in those who are overweight or living with obesity – groups traditionally thought to carry more risk.

NAFLD in lean individuals is not a benign disease.

“NAFLD patients with a normal BMI are often overlooked because we assume that the risk for more serious conditions is lower than for those who are overweight or obese. But this way of thinking may be putting these patients at risk,” added Dr. Wijarnpreecha, who is a transplant hepatology fellow at the University of Michigan, Ann Arbor.

Key findings

Approximately 25% of U.S. adults live with NAFLD, an umbrella term for liver conditions in people who drink little to no alcohol. It is characterized by too much fat stored in the liver. Although most people have no symptoms, the condition can lead to other dangerous conditions, such as diabetes, cardiovascular disease, and cirrhosis of the liver, Dr. Wijarnpreecha said.

The investigators retrospectively studied a cohort of 18,793 adults diagnosed with NAFLD at the University of Michigan Hospital from 2012-2021. One aim was to compare the prevalence of cirrhosis, cardiovascular disease, metabolic diseases, and chronic kidney disease in relation to BMI.

They also classified people into four BMI categories: lean, overweight, obesity class 1, and obesity class 2-3.

Compared with non-lean patients, lean patients had a higher prevalence of peripheral arterial disease and stroke and a similar rate of cardiovascular disease based on identification of ICD codes.

Almost 6% of lean patients had peripheral arterial disease, compared with rates of approximately 4%-5% in overweight people and people with obesity. Similarly, more than 6% of the lean group experienced a stroke compared with 5% or less of the other BMI groups.

“We found that lean patients with NAFLD also had a significant higher prevalence of cardiovascular disease, independent of age, sex, race, smoking status, diabetes, hypertension, and dyslipidemia,” Dr. Wijarnpreecha said.

At the same time, compared with non-lean patients, lean patients had a lower prevalence of cirrhosis, diabetes mellitus, hypertension, dyslipidemia, and chronic kidney disease in an analysis that adjusted for confounders.
 

Exploring the unknown

Researchers now have a mystery on their hands: What is causing this unexpected higher risk of cardiovascular disease in lean people with NAFLD?

Loren Laine, MD, chief of the section of digestive diseases at Yale University School of Medicine, New Haven, Conn., and moderator of the media briefing, asked Wijarnpreecha for his leading theory behind this connection.

“We think that could be from a difference in lifestyle, diet, exercise, genetics, or even gut microbiota,” Dr. Wijarnpreecha replied. “But these are factors that we did not capture from this current study.”

“We are preparing to conduct additional research with longitudinal data to better understand NAFLD in lean patients,” Dr. Wijarnpreecha added.

“It’s an interesting finding, but there are some questions from this retrospective study,” said Arun J. Sanyal, MD, when asked to comment on the study.

Identifying and quantifying any alcohol use, smoking, or hypertension that could also have contributed to increased cardiovascular risk would be useful. Another question relates to how the population with NAFLD was identified. Was NAFLD an incidental finding in their diagnosis, asked Dr. Sanyal, director of the Stravitz-Sanyal Institute for Liver Disease & Metabolic Health at Virginia Commonwealth University, Richmond.

“I’m not dissing the study,” he said, “But like all the observations like this, I think we have to kick the tires.”

It’s an “important new observation” that requires further study to fully understand what it means and what the therapeutic implications might be. It is also important to assess any possible confounders and any causal relationship among these factors, Dr. Sanyal added.

“There’s no question it is important to continue to do these types of studies,” he added. “Through this kind of research we find new things that lead to the science that can then significantly change how we approach these issues.”

A version of this article first appeared on Medscape.com. This article was updated on May 18, 2022.

People with nonalcoholic fatty liver disease (NAFLD) and a lean or healthy body mass index are at increased risk for peripheral vascular disease, stroke, and cardiovascular disease, a surprise finding from a new study reveals.

“Our team had expected to see that those with a normal BMI would have a lower prevalence of any metabolic or cardiovascular conditions,” lead researcher Karn Wijarnpreecha, MD, MPH, said during a media briefing that previewed select research for Digestive Disease Week^® (DDW) 2022. “So, we were very surprised to find this link to cardiovascular disease.”

The investigators saw this increased risk of cardiovascular disease despite this group having a lower prevalence of atherosclerotic risk factors and metabolic disease.

This first study of its kind suggests physicians should consider the risk of cardiovascular disease in all patients with NAFLD, not just in those who are overweight or living with obesity – groups traditionally thought to carry more risk.

NAFLD in lean individuals is not a benign disease.

“NAFLD patients with a normal BMI are often overlooked because we assume that the risk for more serious conditions is lower than for those who are overweight or obese. But this way of thinking may be putting these patients at risk,” added Dr. Wijarnpreecha, who is a transplant hepatology fellow at the University of Michigan, Ann Arbor.

Key findings

Approximately 25% of U.S. adults live with NAFLD, an umbrella term for liver conditions in people who drink little to no alcohol. It is characterized by too much fat stored in the liver. Although most people have no symptoms, the condition can lead to other dangerous conditions, such as diabetes, cardiovascular disease, and cirrhosis of the liver, Dr. Wijarnpreecha said.

The investigators retrospectively studied a cohort of 18,793 adults diagnosed with NAFLD at the University of Michigan Hospital from 2012-2021. One aim was to compare the prevalence of cirrhosis, cardiovascular disease, metabolic diseases, and chronic kidney disease in relation to BMI.

They also classified people into four BMI categories: lean, overweight, obesity class 1, and obesity class 2-3.

Compared with non-lean patients, lean patients had a higher prevalence of peripheral arterial disease and stroke and a similar rate of cardiovascular disease based on identification of ICD codes.

Almost 6% of lean patients had peripheral arterial disease, compared with rates of approximately 4%-5% in overweight people and people with obesity. Similarly, more than 6% of the lean group experienced a stroke compared with 5% or less of the other BMI groups.

“We found that lean patients with NAFLD also had a significant higher prevalence of cardiovascular disease, independent of age, sex, race, smoking status, diabetes, hypertension, and dyslipidemia,” Dr. Wijarnpreecha said.

At the same time, compared with non-lean patients, lean patients had a lower prevalence of cirrhosis, diabetes mellitus, hypertension, dyslipidemia, and chronic kidney disease in an analysis that adjusted for confounders.
 

Exploring the unknown

Researchers now have a mystery on their hands: What is causing this unexpected higher risk of cardiovascular disease in lean people with NAFLD?

Loren Laine, MD, chief of the section of digestive diseases at Yale University School of Medicine, New Haven, Conn., and moderator of the media briefing, asked Wijarnpreecha for his leading theory behind this connection.

“We think that could be from a difference in lifestyle, diet, exercise, genetics, or even gut microbiota,” Dr. Wijarnpreecha replied. “But these are factors that we did not capture from this current study.”

“We are preparing to conduct additional research with longitudinal data to better understand NAFLD in lean patients,” Dr. Wijarnpreecha added.

“It’s an interesting finding, but there are some questions from this retrospective study,” said Arun J. Sanyal, MD, when asked to comment on the study.

Identifying and quantifying any alcohol use, smoking, or hypertension that could also have contributed to increased cardiovascular risk would be useful. Another question relates to how the population with NAFLD was identified. Was NAFLD an incidental finding in their diagnosis, asked Dr. Sanyal, director of the Stravitz-Sanyal Institute for Liver Disease & Metabolic Health at Virginia Commonwealth University, Richmond.

“I’m not dissing the study,” he said, “But like all the observations like this, I think we have to kick the tires.”

It’s an “important new observation” that requires further study to fully understand what it means and what the therapeutic implications might be. It is also important to assess any possible confounders and any causal relationship among these factors, Dr. Sanyal added.

“There’s no question it is important to continue to do these types of studies,” he added. “Through this kind of research we find new things that lead to the science that can then significantly change how we approach these issues.”

A version of this article first appeared on Medscape.com. This article was updated on May 18, 2022.

People with nonalcoholic fatty liver disease (NAFLD) and a lean or healthy body mass index are at increased risk for peripheral vascular disease, stroke, and cardiovascular disease, a surprise finding from a new study reveals.

“Our team had expected to see that those with a normal BMI would have a lower prevalence of any metabolic or cardiovascular conditions,” lead researcher Karn Wijarnpreecha, MD, MPH, said during a media briefing that previewed select research for Digestive Disease Week^® (DDW) 2022. “So, we were very surprised to find this link to cardiovascular disease.”

The investigators saw this increased risk of cardiovascular disease despite this group having a lower prevalence of atherosclerotic risk factors and metabolic disease.

This first study of its kind suggests physicians should consider the risk of cardiovascular disease in all patients with NAFLD, not just in those who are overweight or living with obesity – groups traditionally thought to carry more risk.

NAFLD in lean individuals is not a benign disease.

“NAFLD patients with a normal BMI are often overlooked because we assume that the risk for more serious conditions is lower than for those who are overweight or obese. But this way of thinking may be putting these patients at risk,” added Dr. Wijarnpreecha, who is a transplant hepatology fellow at the University of Michigan, Ann Arbor.

Key findings

Approximately 25% of U.S. adults live with NAFLD, an umbrella term for liver conditions in people who drink little to no alcohol. It is characterized by too much fat stored in the liver. Although most people have no symptoms, the condition can lead to other dangerous conditions, such as diabetes, cardiovascular disease, and cirrhosis of the liver, Dr. Wijarnpreecha said.

The investigators retrospectively studied a cohort of 18,793 adults diagnosed with NAFLD at the University of Michigan Hospital from 2012-2021. One aim was to compare the prevalence of cirrhosis, cardiovascular disease, metabolic diseases, and chronic kidney disease in relation to BMI.

They also classified people into four BMI categories: lean, overweight, obesity class 1, and obesity class 2-3.

Compared with non-lean patients, lean patients had a higher prevalence of peripheral arterial disease and stroke and a similar rate of cardiovascular disease based on identification of ICD codes.

Almost 6% of lean patients had peripheral arterial disease, compared with rates of approximately 4%-5% in overweight people and people with obesity. Similarly, more than 6% of the lean group experienced a stroke compared with 5% or less of the other BMI groups.

“We found that lean patients with NAFLD also had a significant higher prevalence of cardiovascular disease, independent of age, sex, race, smoking status, diabetes, hypertension, and dyslipidemia,” Dr. Wijarnpreecha said.

At the same time, compared with non-lean patients, lean patients had a lower prevalence of cirrhosis, diabetes mellitus, hypertension, dyslipidemia, and chronic kidney disease in an analysis that adjusted for confounders.
 

Exploring the unknown

Researchers now have a mystery on their hands: What is causing this unexpected higher risk of cardiovascular disease in lean people with NAFLD?

Loren Laine, MD, chief of the section of digestive diseases at Yale University School of Medicine, New Haven, Conn., and moderator of the media briefing, asked Wijarnpreecha for his leading theory behind this connection.

“We think that could be from a difference in lifestyle, diet, exercise, genetics, or even gut microbiota,” Dr. Wijarnpreecha replied. “But these are factors that we did not capture from this current study.”

“We are preparing to conduct additional research with longitudinal data to better understand NAFLD in lean patients,” Dr. Wijarnpreecha added.

“It’s an interesting finding, but there are some questions from this retrospective study,” said Arun J. Sanyal, MD, when asked to comment on the study.

Identifying and quantifying any alcohol use, smoking, or hypertension that could also have contributed to increased cardiovascular risk would be useful. Another question relates to how the population with NAFLD was identified. Was NAFLD an incidental finding in their diagnosis, asked Dr. Sanyal, director of the Stravitz-Sanyal Institute for Liver Disease & Metabolic Health at Virginia Commonwealth University, Richmond.

“I’m not dissing the study,” he said, “But like all the observations like this, I think we have to kick the tires.”

It’s an “important new observation” that requires further study to fully understand what it means and what the therapeutic implications might be. It is also important to assess any possible confounders and any causal relationship among these factors, Dr. Sanyal added.

“There’s no question it is important to continue to do these types of studies,” he added. “Through this kind of research we find new things that lead to the science that can then significantly change how we approach these issues.”

A version of this article first appeared on Medscape.com. This article was updated on May 18, 2022.

Ultrasound-guided endometrial polypectomy could be a lower-cost, easily accessible alternative to hysteroscopy for women with abnormal uterine bleeding and polyps, researchers reported at the 2022 annual meeting of the American College of Obstetricians and Gynecologists.

The prospective study of 30 patients who underwent the experimental procedure showed that clinicians were able to remove all the polyps they identified quickly and without sedation.

The technique is a “clever way to address endometrial polyps,” said Lara Harvey, MD, MPH, a minimally invasive gynecologic surgeon at Vanderbilt University Medical Center, Nashville, Tenn., who was not involved in the study.

“If you’re a physician with access to in-office ultrasound and you’re familiar with saline infusion sonohysterogram, then this might be a useful approach without a lot of added expense, but more research is needed to validate the technique,” Dr. Harvey said in an interview. 

The new technique was initially developed at the University of South Florida as an alternative to surgery for patients with medical comorbidities that placed them at an increased risk of complications with general anesthesia, according to Lauri Hochberg, MD, director of gynecologic imaging at the University of South Florida, Tampa. 

However, “we found that it was effective and well-tolerated in general and began offering it to all patients with endometrial polyps, even if they were healthy and at low risk for surgical complications,” Dr. Hochberg told this news organization.  

The procedure is performed by introducing pediatric grasping forceps into the uterus with ultrasound guidance. Doctors direct patients to take ibuprofen prior to the procedure, in addition to administering misoprostol intravaginally the night prior in cases of cervical stenosis. Lidocaine is also injected into the cervix and uterine cavity prior to polyp removal, both for anesthesia and to help visualize polyps on an ultrasound.

The 30 patients included in the study had polyps 5 cm or smaller in size and abnormal uterine bleeding. Dr. Hochberg said she chose 5 cm as a cut-off because larger lesions require more procedure time over potentially two visits to remove using the new approach. Patients were mean age 55 years, mean body mass index of 31, and 70% had postmenopausal bleeding.

According to Dr. Hochberg and Papri Sarkar, MD, a 4th-year resident working with her, procedures lasted an average of 12 minutes and allowed for complete polypectomy in all cases. The average polyp volume was 1.26 cm³ and pathologists found two cancerous lesions.

Patients reported median pain and satisfaction scores of 5 and 10 on 10-point scales, respectively. In addition, 13 of 16 patients who returned 3 months later for a saline infusion sonography showed no evidence of polyp recurrence and 14 patients reported complete resolution of symptoms.

Although a direct comparison of the in-office procedure and conventional hysteroscopy would help better define the role of the procedure, the findings indicate it is “safe and effective” and “would be a great tool to help patients” with abnormal uterine bleeding, Dr. Hochberg said. 

“Physicians would need to learn the skill of ultrasound-guided removal, but this can be accomplished with study,” she added.  

Dr. Harvey also expressed concern that because the new procedure does not allow for direct visualization of the base of the polyp, physicians may not excise the entire lesion. Providers interested in the procedure should “proceed with caution” until there are larger studies published, she said.

“I think widely deploying this technique for postmenopausal bleeding in particular, where there is a higher chance of endometrial cancer, would require really good data comparing it to the gold standard of hysteroscopy and showing that, yes, it is as good at removing polyps and also at diagnosing cancer,” Dr. Harvey said. 

Dr. Harvey, Dr. Hochberg, and Dr. Sarkar have disclosed no relevant financial relationships.

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

Ultrasound-guided endometrial polypectomy could be a lower-cost, easily accessible alternative to hysteroscopy for women with abnormal uterine bleeding and polyps, researchers reported at the 2022 annual meeting of the American College of Obstetricians and Gynecologists.

The prospective study of 30 patients who underwent the experimental procedure showed that clinicians were able to remove all the polyps they identified quickly and without sedation.

The technique is a “clever way to address endometrial polyps,” said Lara Harvey, MD, MPH, a minimally invasive gynecologic surgeon at Vanderbilt University Medical Center, Nashville, Tenn., who was not involved in the study.

“If you’re a physician with access to in-office ultrasound and you’re familiar with saline infusion sonohysterogram, then this might be a useful approach without a lot of added expense, but more research is needed to validate the technique,” Dr. Harvey said in an interview. 

The new technique was initially developed at the University of South Florida as an alternative to surgery for patients with medical comorbidities that placed them at an increased risk of complications with general anesthesia, according to Lauri Hochberg, MD, director of gynecologic imaging at the University of South Florida, Tampa. 

However, “we found that it was effective and well-tolerated in general and began offering it to all patients with endometrial polyps, even if they were healthy and at low risk for surgical complications,” Dr. Hochberg told this news organization.  

The procedure is performed by introducing pediatric grasping forceps into the uterus with ultrasound guidance. Doctors direct patients to take ibuprofen prior to the procedure, in addition to administering misoprostol intravaginally the night prior in cases of cervical stenosis. Lidocaine is also injected into the cervix and uterine cavity prior to polyp removal, both for anesthesia and to help visualize polyps on an ultrasound.

The 30 patients included in the study had polyps 5 cm or smaller in size and abnormal uterine bleeding. Dr. Hochberg said she chose 5 cm as a cut-off because larger lesions require more procedure time over potentially two visits to remove using the new approach. Patients were mean age 55 years, mean body mass index of 31, and 70% had postmenopausal bleeding.

According to Dr. Hochberg and Papri Sarkar, MD, a 4th-year resident working with her, procedures lasted an average of 12 minutes and allowed for complete polypectomy in all cases. The average polyp volume was 1.26 cm³ and pathologists found two cancerous lesions.

Patients reported median pain and satisfaction scores of 5 and 10 on 10-point scales, respectively. In addition, 13 of 16 patients who returned 3 months later for a saline infusion sonography showed no evidence of polyp recurrence and 14 patients reported complete resolution of symptoms.

Although a direct comparison of the in-office procedure and conventional hysteroscopy would help better define the role of the procedure, the findings indicate it is “safe and effective” and “would be a great tool to help patients” with abnormal uterine bleeding, Dr. Hochberg said. 

“Physicians would need to learn the skill of ultrasound-guided removal, but this can be accomplished with study,” she added.  

Dr. Harvey also expressed concern that because the new procedure does not allow for direct visualization of the base of the polyp, physicians may not excise the entire lesion. Providers interested in the procedure should “proceed with caution” until there are larger studies published, she said.

“I think widely deploying this technique for postmenopausal bleeding in particular, where there is a higher chance of endometrial cancer, would require really good data comparing it to the gold standard of hysteroscopy and showing that, yes, it is as good at removing polyps and also at diagnosing cancer,” Dr. Harvey said. 

Dr. Harvey, Dr. Hochberg, and Dr. Sarkar have disclosed no relevant financial relationships.

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

Ultrasound-guided endometrial polypectomy could be a lower-cost, easily accessible alternative to hysteroscopy for women with abnormal uterine bleeding and polyps, researchers reported at the 2022 annual meeting of the American College of Obstetricians and Gynecologists.

The prospective study of 30 patients who underwent the experimental procedure showed that clinicians were able to remove all the polyps they identified quickly and without sedation.

The technique is a “clever way to address endometrial polyps,” said Lara Harvey, MD, MPH, a minimally invasive gynecologic surgeon at Vanderbilt University Medical Center, Nashville, Tenn., who was not involved in the study.

“If you’re a physician with access to in-office ultrasound and you’re familiar with saline infusion sonohysterogram, then this might be a useful approach without a lot of added expense, but more research is needed to validate the technique,” Dr. Harvey said in an interview. 

The new technique was initially developed at the University of South Florida as an alternative to surgery for patients with medical comorbidities that placed them at an increased risk of complications with general anesthesia, according to Lauri Hochberg, MD, director of gynecologic imaging at the University of South Florida, Tampa. 

However, “we found that it was effective and well-tolerated in general and began offering it to all patients with endometrial polyps, even if they were healthy and at low risk for surgical complications,” Dr. Hochberg told this news organization.  

The procedure is performed by introducing pediatric grasping forceps into the uterus with ultrasound guidance. Doctors direct patients to take ibuprofen prior to the procedure, in addition to administering misoprostol intravaginally the night prior in cases of cervical stenosis. Lidocaine is also injected into the cervix and uterine cavity prior to polyp removal, both for anesthesia and to help visualize polyps on an ultrasound.

The 30 patients included in the study had polyps 5 cm or smaller in size and abnormal uterine bleeding. Dr. Hochberg said she chose 5 cm as a cut-off because larger lesions require more procedure time over potentially two visits to remove using the new approach. Patients were mean age 55 years, mean body mass index of 31, and 70% had postmenopausal bleeding.

According to Dr. Hochberg and Papri Sarkar, MD, a 4th-year resident working with her, procedures lasted an average of 12 minutes and allowed for complete polypectomy in all cases. The average polyp volume was 1.26 cm³ and pathologists found two cancerous lesions.

Patients reported median pain and satisfaction scores of 5 and 10 on 10-point scales, respectively. In addition, 13 of 16 patients who returned 3 months later for a saline infusion sonography showed no evidence of polyp recurrence and 14 patients reported complete resolution of symptoms.

Although a direct comparison of the in-office procedure and conventional hysteroscopy would help better define the role of the procedure, the findings indicate it is “safe and effective” and “would be a great tool to help patients” with abnormal uterine bleeding, Dr. Hochberg said. 

“Physicians would need to learn the skill of ultrasound-guided removal, but this can be accomplished with study,” she added.  

Dr. Harvey also expressed concern that because the new procedure does not allow for direct visualization of the base of the polyp, physicians may not excise the entire lesion. Providers interested in the procedure should “proceed with caution” until there are larger studies published, she said.

“I think widely deploying this technique for postmenopausal bleeding in particular, where there is a higher chance of endometrial cancer, would require really good data comparing it to the gold standard of hysteroscopy and showing that, yes, it is as good at removing polyps and also at diagnosing cancer,” Dr. Harvey said. 

Dr. Harvey, Dr. Hochberg, and Dr. Sarkar have disclosed no relevant financial relationships.

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

The Food and Drug Administration has approved an orally administered version of edaravone (Radicava ORS, Mitsubishi Tanabe Pharma America) for adults with amyotrophic lateral sclerosis (ALS). Edaravone is a pyrazolone free-radical scavenger thought to lessen the effects of oxidative stress, which is a probable factor in ALS onset and progression. The drug was first approved in 2017 as an intravenous (IV) infusion to treat ALS.

Radicava ORS is self-administered and can be taken at home. After fasting overnight, Radicava ORS should be taken in the morning orally or through a feeding tube. The oral version has the same dosing regimen as the original IV version, with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period and subsequent treatment cycles consisting of daily dosing for 10 out of 14-day periods, followed by 14-day drug-free periods.

Compared with the IV formation of Radicava, Radicava ORS has been shown to generate comparable levels of active drug in the bloodstream, the FDA said.

The FDA determined that IV Radicava was effective based on a 6-month clinical trial in Japan involving 137 individuals who were randomly chosen to receive either the drug or a placebo. At 24 weeks, individuals receiving Radicava showed less decline on a clinical assessment of daily functioning, compared with those receiving placebo.

The most common side effects of Radicava are bruising, problems walking, and headache. Fatigue is also a possible side effect from Radicava ORS. Both formulations can have serious side effects associated with allergic reactions, including hives, rash, and shortness of breath.

Full prescribing information, including additional information on risks associated with Radicava ORS, is available online.

The FDA granted Radicava ORS orphan drug status, priority review, and Fast Track designations.

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

The Food and Drug Administration has approved an orally administered version of edaravone (Radicava ORS, Mitsubishi Tanabe Pharma America) for adults with amyotrophic lateral sclerosis (ALS). Edaravone is a pyrazolone free-radical scavenger thought to lessen the effects of oxidative stress, which is a probable factor in ALS onset and progression. The drug was first approved in 2017 as an intravenous (IV) infusion to treat ALS.

Radicava ORS is self-administered and can be taken at home. After fasting overnight, Radicava ORS should be taken in the morning orally or through a feeding tube. The oral version has the same dosing regimen as the original IV version, with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period and subsequent treatment cycles consisting of daily dosing for 10 out of 14-day periods, followed by 14-day drug-free periods.

Compared with the IV formation of Radicava, Radicava ORS has been shown to generate comparable levels of active drug in the bloodstream, the FDA said.

The FDA determined that IV Radicava was effective based on a 6-month clinical trial in Japan involving 137 individuals who were randomly chosen to receive either the drug or a placebo. At 24 weeks, individuals receiving Radicava showed less decline on a clinical assessment of daily functioning, compared with those receiving placebo.

The most common side effects of Radicava are bruising, problems walking, and headache. Fatigue is also a possible side effect from Radicava ORS. Both formulations can have serious side effects associated with allergic reactions, including hives, rash, and shortness of breath.

Full prescribing information, including additional information on risks associated with Radicava ORS, is available online.

The FDA granted Radicava ORS orphan drug status, priority review, and Fast Track designations.

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

The Food and Drug Administration has approved an orally administered version of edaravone (Radicava ORS, Mitsubishi Tanabe Pharma America) for adults with amyotrophic lateral sclerosis (ALS). Edaravone is a pyrazolone free-radical scavenger thought to lessen the effects of oxidative stress, which is a probable factor in ALS onset and progression. The drug was first approved in 2017 as an intravenous (IV) infusion to treat ALS.

Radicava ORS is self-administered and can be taken at home. After fasting overnight, Radicava ORS should be taken in the morning orally or through a feeding tube. The oral version has the same dosing regimen as the original IV version, with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period and subsequent treatment cycles consisting of daily dosing for 10 out of 14-day periods, followed by 14-day drug-free periods.

Compared with the IV formation of Radicava, Radicava ORS has been shown to generate comparable levels of active drug in the bloodstream, the FDA said.

The FDA determined that IV Radicava was effective based on a 6-month clinical trial in Japan involving 137 individuals who were randomly chosen to receive either the drug or a placebo. At 24 weeks, individuals receiving Radicava showed less decline on a clinical assessment of daily functioning, compared with those receiving placebo.

The most common side effects of Radicava are bruising, problems walking, and headache. Fatigue is also a possible side effect from Radicava ORS. Both formulations can have serious side effects associated with allergic reactions, including hives, rash, and shortness of breath.

Full prescribing information, including additional information on risks associated with Radicava ORS, is available online.

The FDA granted Radicava ORS orphan drug status, priority review, and Fast Track designations.

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

Being identified as someone that was advised to stay at home and shield, or keep away from face-to-face interactions with others, during the COVID-19 pandemic was indicative of an increased risk for dying from COVID-19 within 28 days of infection, a U.K. study of inflammatory arthritis patients versus the general population suggests.

In fact, shielding status was the highest ranked of all the risk factors identified for early mortality from COVID-19, with a hazard ratio of 1.52 (95% confidence interval, 1.40-1.64) comparing people with and without inflammatory arthritis (IA) who had tested positive.

The list of risk factors associated with higher mortality in the IA patients versus the general population also included diabetes (HR, 1.38), smoking (HR, 1.27), hypertension (HR, 1.19), glucocorticoid use (HR, 1.17), and cancer (HR, 1.10), as well as increasing age (HR, 1.08) and body mass index (HR, 1.01).

Also important was the person’s prior hospitalization history, with those needing in-hospital care in the year running up to their admission for COVID-19 associated with a 34% higher risk for death, and being hospitalized previously with a serious infection was associated with a 20% higher risk.

This has more to do people’s overall vulnerability than their IA, suggested the team behind the findings, who also found that the risk of catching COVID-19 was significantly lower among patients with IA than the general population (3.5% vs. 6%), presumably because of shielding.

Examining the risks for COVID-19 in real-life practice

“COVID-19 has caused over 10 million deaths,” Roxanne Cooksey, PhD, said at the annual meeting of the British Society for Rheumatology. “It’s greatly affected vulnerable individuals, which includes individuals with IA, this is due to their compromised immune system and increased risk of infection and the medications that they take to manage their conditions.

“Previous studies have had mixed results about whether people with IA have an increased risk of poor outcome,” added Dr. Cooksey, who is a postdoctoral researcher in the division of infection and immunity at Cardiff (Wales) University.

“So, our research question looks to investigate inflammatory arthritis – that’s rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis – to see whether the conditions themselves or indeed their medications predispose individuals to an increased risk of contracting COVID or even more adverse outcomes.”

Dr. Cooksey and colleagues looked specifically at COVID-19 infection rates and outcomes in adults living in Wales during the first year of the pandemic (March 2020 to May 2021). As such they used routinely collected, anonymized health data from the SAIL Databank and performed a retrospective, population-based cohort study. In total, there were 1,966 people with inflammatory arthritis identified as having COVID-19 and 166,602 people without IA but who had COVID-19 in the study population.

As might be expected, people with inflammatory arthritis who tested positive for COVID-19 were older than those testing positive in the general population, at a mean of 62 years versus 46 years. They were also more likely to have been advised to shield (49.4% versus 4.6%), which in the United Kingdom constituted of receiving a letter telling them about the importance of social distancing, wearing a mask when out in public, and quarantining themselves at home whenever possible.

The main outcomes were hospitalizations and mortality within 28 days of COVID-19 infection. Considering the overall inflammatory arthritis population, rates of both outcomes were higher versus the general population. And when the researchers analyzed the risks according to the type of inflammatory arthritis, the associations were not statistically significant in a multivariable analysis for people with any of the inflammatory arthritis diagnoses: rheumatoid arthritis (n = 1,283), psoriatic arthritis (n = 514), or ankylosing spondylitis (n = 246). Some patients had more than one inflammatory arthritis diagnosis.
 

What does this all mean?

Dr. Cooksey conceded that there were lots of limitations to the data collected – from misclassification bias to data possibly not have been recorded completely or missing because of the disruption to health care services during the early stages of the pandemic. Patients may have been told to shield but not actually shielded, she observed, and maybe because a lack of testing COVID-19 cases were missed or people could have been asymptomatic or unable to be tested.

“The study supports the role of shielding in inflammatory arthritis,” Dr. Cooksey said, particularly in those with RA and the risk factors associated with an increased risk in death. However, that may not mean the entire population, she suggested, saying that “refining the criteria for shielding will help mitigate the negative effects of the entire IA population.”

Senior team member Ernest Choy, MD, added his thoughts, saying that, rather than giving generic shielding recommendations to all IA patients, not everyone has the same risk, so maybe not everyone needs to shield to the same level.

“Psoriatic arthritis patients and ankylosing spondylitis patients are younger, so they really don’t have as high a risk like patients with rheumatoid arthritis,” he said.

Dr. Choy, who is professor of rheumatology at the Cardiff Institute of Infection & Immunity, commented that it was not surprising to find that a prior serious infection was a risk for COVID-19 mortality. This risk factor was examined because of the known association between biologic use and the risk for serious infection.

Moreover, he said that, “if you have a serious comorbidity that requires you to get admitted to hospital, that is a reflection of your vulnerability.”

Dr. Cooksey and Dr. Choy had no relevant conflicts of interest to disclose.

Being identified as someone that was advised to stay at home and shield, or keep away from face-to-face interactions with others, during the COVID-19 pandemic was indicative of an increased risk for dying from COVID-19 within 28 days of infection, a U.K. study of inflammatory arthritis patients versus the general population suggests.

In fact, shielding status was the highest ranked of all the risk factors identified for early mortality from COVID-19, with a hazard ratio of 1.52 (95% confidence interval, 1.40-1.64) comparing people with and without inflammatory arthritis (IA) who had tested positive.

The list of risk factors associated with higher mortality in the IA patients versus the general population also included diabetes (HR, 1.38), smoking (HR, 1.27), hypertension (HR, 1.19), glucocorticoid use (HR, 1.17), and cancer (HR, 1.10), as well as increasing age (HR, 1.08) and body mass index (HR, 1.01).

Also important was the person’s prior hospitalization history, with those needing in-hospital care in the year running up to their admission for COVID-19 associated with a 34% higher risk for death, and being hospitalized previously with a serious infection was associated with a 20% higher risk.

This has more to do people’s overall vulnerability than their IA, suggested the team behind the findings, who also found that the risk of catching COVID-19 was significantly lower among patients with IA than the general population (3.5% vs. 6%), presumably because of shielding.

Examining the risks for COVID-19 in real-life practice

“COVID-19 has caused over 10 million deaths,” Roxanne Cooksey, PhD, said at the annual meeting of the British Society for Rheumatology. “It’s greatly affected vulnerable individuals, which includes individuals with IA, this is due to their compromised immune system and increased risk of infection and the medications that they take to manage their conditions.

“Previous studies have had mixed results about whether people with IA have an increased risk of poor outcome,” added Dr. Cooksey, who is a postdoctoral researcher in the division of infection and immunity at Cardiff (Wales) University.

“So, our research question looks to investigate inflammatory arthritis – that’s rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis – to see whether the conditions themselves or indeed their medications predispose individuals to an increased risk of contracting COVID or even more adverse outcomes.”

Dr. Cooksey and colleagues looked specifically at COVID-19 infection rates and outcomes in adults living in Wales during the first year of the pandemic (March 2020 to May 2021). As such they used routinely collected, anonymized health data from the SAIL Databank and performed a retrospective, population-based cohort study. In total, there were 1,966 people with inflammatory arthritis identified as having COVID-19 and 166,602 people without IA but who had COVID-19 in the study population.

As might be expected, people with inflammatory arthritis who tested positive for COVID-19 were older than those testing positive in the general population, at a mean of 62 years versus 46 years. They were also more likely to have been advised to shield (49.4% versus 4.6%), which in the United Kingdom constituted of receiving a letter telling them about the importance of social distancing, wearing a mask when out in public, and quarantining themselves at home whenever possible.

The main outcomes were hospitalizations and mortality within 28 days of COVID-19 infection. Considering the overall inflammatory arthritis population, rates of both outcomes were higher versus the general population. And when the researchers analyzed the risks according to the type of inflammatory arthritis, the associations were not statistically significant in a multivariable analysis for people with any of the inflammatory arthritis diagnoses: rheumatoid arthritis (n = 1,283), psoriatic arthritis (n = 514), or ankylosing spondylitis (n = 246). Some patients had more than one inflammatory arthritis diagnosis.
 

What does this all mean?

Dr. Cooksey conceded that there were lots of limitations to the data collected – from misclassification bias to data possibly not have been recorded completely or missing because of the disruption to health care services during the early stages of the pandemic. Patients may have been told to shield but not actually shielded, she observed, and maybe because a lack of testing COVID-19 cases were missed or people could have been asymptomatic or unable to be tested.

“The study supports the role of shielding in inflammatory arthritis,” Dr. Cooksey said, particularly in those with RA and the risk factors associated with an increased risk in death. However, that may not mean the entire population, she suggested, saying that “refining the criteria for shielding will help mitigate the negative effects of the entire IA population.”

Senior team member Ernest Choy, MD, added his thoughts, saying that, rather than giving generic shielding recommendations to all IA patients, not everyone has the same risk, so maybe not everyone needs to shield to the same level.

“Psoriatic arthritis patients and ankylosing spondylitis patients are younger, so they really don’t have as high a risk like patients with rheumatoid arthritis,” he said.

Dr. Choy, who is professor of rheumatology at the Cardiff Institute of Infection & Immunity, commented that it was not surprising to find that a prior serious infection was a risk for COVID-19 mortality. This risk factor was examined because of the known association between biologic use and the risk for serious infection.

Moreover, he said that, “if you have a serious comorbidity that requires you to get admitted to hospital, that is a reflection of your vulnerability.”

Dr. Cooksey and Dr. Choy had no relevant conflicts of interest to disclose.

Being identified as someone that was advised to stay at home and shield, or keep away from face-to-face interactions with others, during the COVID-19 pandemic was indicative of an increased risk for dying from COVID-19 within 28 days of infection, a U.K. study of inflammatory arthritis patients versus the general population suggests.

In fact, shielding status was the highest ranked of all the risk factors identified for early mortality from COVID-19, with a hazard ratio of 1.52 (95% confidence interval, 1.40-1.64) comparing people with and without inflammatory arthritis (IA) who had tested positive.

The list of risk factors associated with higher mortality in the IA patients versus the general population also included diabetes (HR, 1.38), smoking (HR, 1.27), hypertension (HR, 1.19), glucocorticoid use (HR, 1.17), and cancer (HR, 1.10), as well as increasing age (HR, 1.08) and body mass index (HR, 1.01).

Also important was the person’s prior hospitalization history, with those needing in-hospital care in the year running up to their admission for COVID-19 associated with a 34% higher risk for death, and being hospitalized previously with a serious infection was associated with a 20% higher risk.

This has more to do people’s overall vulnerability than their IA, suggested the team behind the findings, who also found that the risk of catching COVID-19 was significantly lower among patients with IA than the general population (3.5% vs. 6%), presumably because of shielding.

Examining the risks for COVID-19 in real-life practice

“COVID-19 has caused over 10 million deaths,” Roxanne Cooksey, PhD, said at the annual meeting of the British Society for Rheumatology. “It’s greatly affected vulnerable individuals, which includes individuals with IA, this is due to their compromised immune system and increased risk of infection and the medications that they take to manage their conditions.

“Previous studies have had mixed results about whether people with IA have an increased risk of poor outcome,” added Dr. Cooksey, who is a postdoctoral researcher in the division of infection and immunity at Cardiff (Wales) University.

“So, our research question looks to investigate inflammatory arthritis – that’s rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis – to see whether the conditions themselves or indeed their medications predispose individuals to an increased risk of contracting COVID or even more adverse outcomes.”

Dr. Cooksey and colleagues looked specifically at COVID-19 infection rates and outcomes in adults living in Wales during the first year of the pandemic (March 2020 to May 2021). As such they used routinely collected, anonymized health data from the SAIL Databank and performed a retrospective, population-based cohort study. In total, there were 1,966 people with inflammatory arthritis identified as having COVID-19 and 166,602 people without IA but who had COVID-19 in the study population.

As might be expected, people with inflammatory arthritis who tested positive for COVID-19 were older than those testing positive in the general population, at a mean of 62 years versus 46 years. They were also more likely to have been advised to shield (49.4% versus 4.6%), which in the United Kingdom constituted of receiving a letter telling them about the importance of social distancing, wearing a mask when out in public, and quarantining themselves at home whenever possible.

The main outcomes were hospitalizations and mortality within 28 days of COVID-19 infection. Considering the overall inflammatory arthritis population, rates of both outcomes were higher versus the general population. And when the researchers analyzed the risks according to the type of inflammatory arthritis, the associations were not statistically significant in a multivariable analysis for people with any of the inflammatory arthritis diagnoses: rheumatoid arthritis (n = 1,283), psoriatic arthritis (n = 514), or ankylosing spondylitis (n = 246). Some patients had more than one inflammatory arthritis diagnosis.
 

What does this all mean?

Dr. Cooksey conceded that there were lots of limitations to the data collected – from misclassification bias to data possibly not have been recorded completely or missing because of the disruption to health care services during the early stages of the pandemic. Patients may have been told to shield but not actually shielded, she observed, and maybe because a lack of testing COVID-19 cases were missed or people could have been asymptomatic or unable to be tested.

“The study supports the role of shielding in inflammatory arthritis,” Dr. Cooksey said, particularly in those with RA and the risk factors associated with an increased risk in death. However, that may not mean the entire population, she suggested, saying that “refining the criteria for shielding will help mitigate the negative effects of the entire IA population.”

Senior team member Ernest Choy, MD, added his thoughts, saying that, rather than giving generic shielding recommendations to all IA patients, not everyone has the same risk, so maybe not everyone needs to shield to the same level.

“Psoriatic arthritis patients and ankylosing spondylitis patients are younger, so they really don’t have as high a risk like patients with rheumatoid arthritis,” he said.

Dr. Choy, who is professor of rheumatology at the Cardiff Institute of Infection & Immunity, commented that it was not surprising to find that a prior serious infection was a risk for COVID-19 mortality. This risk factor was examined because of the known association between biologic use and the risk for serious infection.

Moreover, he said that, “if you have a serious comorbidity that requires you to get admitted to hospital, that is a reflection of your vulnerability.”

Dr. Cooksey and Dr. Choy had no relevant conflicts of interest to disclose.

Approximately 20% of the population is affected by IBS. When looking at IBS with constipation specifically, how important is diet in relieving symptoms? Is there a specific type of diet recommended for patients to consider?

Dr. Menees: Dietary therapy can be really important for patients with IBS. It’s something they can control, and it can be empowering to them. When I first meet a patient with IBS, I always take a diet history. I want to know what they're putting in their mouth including the beverages that they are drinking.

When it comes to IBS, for a long time, fiber has been first-line treatment, particularly when constipation is the predominant complaint. As you know, fiber is classified into 2 different categories: soluble and insoluble. The soluble fiber is found in psyllium, oat bran, barley, and beans, whereas the insoluble fiber is found in wheat bran, some vegetables, and whole grains.

Soluble fiber exerts its laxative effect as it is hydrophilic, so it brings the water to the stool and increases the stool water content. It also resists colonic fermentation. Insoluble fiber is fermentable and loses its water holding capacity, produces gas that aggravates patients with bloating and flatulence. I always recommend soluble fiber.

When we're thinking about those properties that I just described, the ability to improve stool viscosity and frequency argues for the use of fiber in patients with IBS-C, although there are few studies to support this. There have been a lot of trials, but only a few that have been done within  IBS-C patients. The most recent meta-analysis was done by Moayyedi and colleagues. Here they looked at 15 RCTs of which only 6 had sub-typed the different types of IBS that were in the trials. Only 2 were IBS-C. So, the key takeaway for this meta-analysis was that-- and per the ACG guidelines-- the use of soluble, viscous, nonfermentable fiber provides benefits for global IBS symptoms.

There's also a general lack of side effects with this intervention. It’s important to instruct patients to titrate up on the soluble fiber slowly. Soluble fiber is a very reasonable first-line therapy for patients with IBS.

There are other dietary interventions that we can talk about. In 2015, the National Institute for Health Care Excellence issued their own IBS guideline recommendations. These are common sense things that I discuss with my patients, such as moderation in their diet: don't drink too much alcohol or don't drink too much caffeine. I go over these with patients as the guidelines specifically talk about soluble fiber. It can be helpful for patients to look at what they're doing on a daily basis.

The other important dietary intervention that we have utilized in IBS is the low-FODMAP diet.  This diet is based on restricting fermentable carbohydrates that bacteria work on, producing short chain fatty acids which cause an osmotic shift, bringing water into the colon, producing gases that lead to luminal dissension, and triggering meal-related symptoms in patients with IBS.

A recent meta-analysis of 7 randomized clinical trials looked at low FODMAP diet versus several different comparators. The low-FODMAP diet was associated with a significant reduction in global IBS symptoms compared with the different comparators. However, there are no data on a low-FODMAP diet strictly in IBS-C patients. So, stay tuned on that. We are doing a trial in IBS-C only.

If you are planning on using the low-FODMAP diet in your IBS patients, it's also important to utilize a GI trained dietician, because it can be overwhelming for patients to figure out what's an oligosaccharides, disaccharide, monosaccharides, and polyols. Having a wealth of knowledge available to these patients is critical.

Are there recent studies that show the effectiveness of diet as an approach to managing patients with IBS/CIC and what has been your in-practice experience?

Dr. Menees: Yes.  For IBS and CIC, the initial approach, which is soluble fiber, is what I use in practice for both disorders. However, that response can vary between the 2 conditions, and the next step you chose varies by the disorder.

As far as for my patients, soluble fiber is well accepted, but I do make sure that they are adequately hydrated. Hydration alone doesn't seem to change the incidence of constipation for patients, although there is some evidence for mineral water. Believe it or not, there are 3 randomized controlled trials showing the efficacy of mineral water in patients with CIC. However, it's also important in the chronic constipation patients that you find out how often they're having a bowel movement. If they are having a bm every 7 to 10 days, I'm afraid that fiber will actually worsen their symptoms. In those patients, fiber will not be my first-line treatment.

As far as other dietary options that I use specifically in patients with CIC, we now have data for fruit fibers. Specifically, we have data for prunes and kiwifruit, both green and golden kiwifruit. Chey and colleagues compared the efficacy of psyllium, 2 green kiwi per day, and prunes, 6 twice-daily in patients with CIC.  All 3 arms - kiwifruit (45%), psyllium (64%) and prunes (67%)- were found to be effective. Despite the primary endpoint results, patients randomized to the kiwi arm were most likely to be satisfied with treatment compared to the other arms. There was another trial performed in 32 patients, comparing the gold kiwifruit to psyllium. The kiwifruit resulted in significant improvement in BM frequency and GI discomfort as compared to psyllium. I use all of these as tools for my patients in clinical practice. 

We talked about symptoms, but how important is diet in preventing other diseases or conditions in patients with IBS-C?

Dr. Menees: For diet management, since soluble fibers are the gold standard and our first-line treatment, I discuss the general health benefits of fiber. Fiber is associated with reduced cardiovascular mortality, stroke, diabetes, and colorectal cancer. So that's important.

Being on a high fiber diet can improve the patient's overall general health. It is also helpful for other GI diseases. It helps reduce the risk of diverticulitis and diverticular bleeding. People who are on a high fiber diet are the least likely to have fecal incontinence. These are all excellent benefits of one of our first-line treatments.

Are there first-line therapies you recommend in conjunction with diet to help?

Dr. Menees: When it comes to chronic intermittent constipation, I certainly use osmotic laxatives after at least a 6- to 8-week trial of fiber. When you're adding fiber to your diet, its important to add slowly, about 5 grams per week.

I also tell the patient that it's not going to be quick. It takes at least 6 to 8 weeks for it to kick in. I will use osmotics, PEG 3350 and milk of magnesia which are very cheap and over the counter if they're not reaching the stool consistency and frequency. I also use stimulant and laxatives in my chronic intermittent constipation.

Now, for IBS, PEG 3350 osmotic laxatives are not recommended as it only changes stool frequency, but it has no impact on abdominal discomfort or abdominal pain. For IBS patients, I will utilize the secretagogues, the chloride channel activator, such as lubiprostone or guanylate cyclase activator, such as linaclotide or plecanatide.

Are there specific demographics more susceptible to constipation? What are your standards for dietary considerations for these populations? 

Dr. Menees: There are specific demographics that are susceptible to constipation. Women are more likely than men to have constipation. Women have a longer colon due to reproductive organs. This increases the surface area for absorption of water, which can predispose women to constipation.

In the US and UK, self-reported constipation is definitely more prevalent in women and those over age 60. When you adjust for those factors, you'll see it in patients who have low income, poor education, and little physical activity.

We also know that the prevalence of chronic constipation rises with age, and most dramatically in patients who are 65 and older. Over a quarter of males and almost a third of females will complain of constipation. Now, this age factor can be  compounded by other medical problems, such as hypertension. Additionally, in those over 65, there seems to be a correlation with decreased calories, but not with fluid or fiber.

Other populations that one must consider include any neurologic diseases, such as Parkinson Disease. We have to think of patients with chronic pain as they can be on opioids. But even those with chronic pain who are not on opioids will be on NSAIDs, which can also cause constipation. There are many different factors that make patients susceptible to constipation.

Approximately 20% of the population is affected by IBS. When looking at IBS with constipation specifically, how important is diet in relieving symptoms? Is there a specific type of diet recommended for patients to consider?

Dr. Menees: Dietary therapy can be really important for patients with IBS. It’s something they can control, and it can be empowering to them. When I first meet a patient with IBS, I always take a diet history. I want to know what they're putting in their mouth including the beverages that they are drinking.

When it comes to IBS, for a long time, fiber has been first-line treatment, particularly when constipation is the predominant complaint. As you know, fiber is classified into 2 different categories: soluble and insoluble. The soluble fiber is found in psyllium, oat bran, barley, and beans, whereas the insoluble fiber is found in wheat bran, some vegetables, and whole grains.

Soluble fiber exerts its laxative effect as it is hydrophilic, so it brings the water to the stool and increases the stool water content. It also resists colonic fermentation. Insoluble fiber is fermentable and loses its water holding capacity, produces gas that aggravates patients with bloating and flatulence. I always recommend soluble fiber.

When we're thinking about those properties that I just described, the ability to improve stool viscosity and frequency argues for the use of fiber in patients with IBS-C, although there are few studies to support this. There have been a lot of trials, but only a few that have been done within  IBS-C patients. The most recent meta-analysis was done by Moayyedi and colleagues. Here they looked at 15 RCTs of which only 6 had sub-typed the different types of IBS that were in the trials. Only 2 were IBS-C. So, the key takeaway for this meta-analysis was that-- and per the ACG guidelines-- the use of soluble, viscous, nonfermentable fiber provides benefits for global IBS symptoms.

There's also a general lack of side effects with this intervention. It’s important to instruct patients to titrate up on the soluble fiber slowly. Soluble fiber is a very reasonable first-line therapy for patients with IBS.

There are other dietary interventions that we can talk about. In 2015, the National Institute for Health Care Excellence issued their own IBS guideline recommendations. These are common sense things that I discuss with my patients, such as moderation in their diet: don't drink too much alcohol or don't drink too much caffeine. I go over these with patients as the guidelines specifically talk about soluble fiber. It can be helpful for patients to look at what they're doing on a daily basis.

The other important dietary intervention that we have utilized in IBS is the low-FODMAP diet.  This diet is based on restricting fermentable carbohydrates that bacteria work on, producing short chain fatty acids which cause an osmotic shift, bringing water into the colon, producing gases that lead to luminal dissension, and triggering meal-related symptoms in patients with IBS.

A recent meta-analysis of 7 randomized clinical trials looked at low FODMAP diet versus several different comparators. The low-FODMAP diet was associated with a significant reduction in global IBS symptoms compared with the different comparators. However, there are no data on a low-FODMAP diet strictly in IBS-C patients. So, stay tuned on that. We are doing a trial in IBS-C only.

If you are planning on using the low-FODMAP diet in your IBS patients, it's also important to utilize a GI trained dietician, because it can be overwhelming for patients to figure out what's an oligosaccharides, disaccharide, monosaccharides, and polyols. Having a wealth of knowledge available to these patients is critical.

Are there recent studies that show the effectiveness of diet as an approach to managing patients with IBS/CIC and what has been your in-practice experience?

Dr. Menees: Yes.  For IBS and CIC, the initial approach, which is soluble fiber, is what I use in practice for both disorders. However, that response can vary between the 2 conditions, and the next step you chose varies by the disorder.

As far as for my patients, soluble fiber is well accepted, but I do make sure that they are adequately hydrated. Hydration alone doesn't seem to change the incidence of constipation for patients, although there is some evidence for mineral water. Believe it or not, there are 3 randomized controlled trials showing the efficacy of mineral water in patients with CIC. However, it's also important in the chronic constipation patients that you find out how often they're having a bowel movement. If they are having a bm every 7 to 10 days, I'm afraid that fiber will actually worsen their symptoms. In those patients, fiber will not be my first-line treatment.

As far as other dietary options that I use specifically in patients with CIC, we now have data for fruit fibers. Specifically, we have data for prunes and kiwifruit, both green and golden kiwifruit. Chey and colleagues compared the efficacy of psyllium, 2 green kiwi per day, and prunes, 6 twice-daily in patients with CIC.  All 3 arms - kiwifruit (45%), psyllium (64%) and prunes (67%)- were found to be effective. Despite the primary endpoint results, patients randomized to the kiwi arm were most likely to be satisfied with treatment compared to the other arms. There was another trial performed in 32 patients, comparing the gold kiwifruit to psyllium. The kiwifruit resulted in significant improvement in BM frequency and GI discomfort as compared to psyllium. I use all of these as tools for my patients in clinical practice. 

We talked about symptoms, but how important is diet in preventing other diseases or conditions in patients with IBS-C?

Dr. Menees: For diet management, since soluble fibers are the gold standard and our first-line treatment, I discuss the general health benefits of fiber. Fiber is associated with reduced cardiovascular mortality, stroke, diabetes, and colorectal cancer. So that's important.

Being on a high fiber diet can improve the patient's overall general health. It is also helpful for other GI diseases. It helps reduce the risk of diverticulitis and diverticular bleeding. People who are on a high fiber diet are the least likely to have fecal incontinence. These are all excellent benefits of one of our first-line treatments.

Are there first-line therapies you recommend in conjunction with diet to help?

Dr. Menees: When it comes to chronic intermittent constipation, I certainly use osmotic laxatives after at least a 6- to 8-week trial of fiber. When you're adding fiber to your diet, its important to add slowly, about 5 grams per week.

I also tell the patient that it's not going to be quick. It takes at least 6 to 8 weeks for it to kick in. I will use osmotics, PEG 3350 and milk of magnesia which are very cheap and over the counter if they're not reaching the stool consistency and frequency. I also use stimulant and laxatives in my chronic intermittent constipation.

Now, for IBS, PEG 3350 osmotic laxatives are not recommended as it only changes stool frequency, but it has no impact on abdominal discomfort or abdominal pain. For IBS patients, I will utilize the secretagogues, the chloride channel activator, such as lubiprostone or guanylate cyclase activator, such as linaclotide or plecanatide.

Are there specific demographics more susceptible to constipation? What are your standards for dietary considerations for these populations? 

Dr. Menees: There are specific demographics that are susceptible to constipation. Women are more likely than men to have constipation. Women have a longer colon due to reproductive organs. This increases the surface area for absorption of water, which can predispose women to constipation.

In the US and UK, self-reported constipation is definitely more prevalent in women and those over age 60. When you adjust for those factors, you'll see it in patients who have low income, poor education, and little physical activity.

We also know that the prevalence of chronic constipation rises with age, and most dramatically in patients who are 65 and older. Over a quarter of males and almost a third of females will complain of constipation. Now, this age factor can be  compounded by other medical problems, such as hypertension. Additionally, in those over 65, there seems to be a correlation with decreased calories, but not with fluid or fiber.

Other populations that one must consider include any neurologic diseases, such as Parkinson Disease. We have to think of patients with chronic pain as they can be on opioids. But even those with chronic pain who are not on opioids will be on NSAIDs, which can also cause constipation. There are many different factors that make patients susceptible to constipation.

Approximately 20% of the population is affected by IBS. When looking at IBS with constipation specifically, how important is diet in relieving symptoms? Is there a specific type of diet recommended for patients to consider?

Dr. Menees: Dietary therapy can be really important for patients with IBS. It’s something they can control, and it can be empowering to them. When I first meet a patient with IBS, I always take a diet history. I want to know what they're putting in their mouth including the beverages that they are drinking.

When it comes to IBS, for a long time, fiber has been first-line treatment, particularly when constipation is the predominant complaint. As you know, fiber is classified into 2 different categories: soluble and insoluble. The soluble fiber is found in psyllium, oat bran, barley, and beans, whereas the insoluble fiber is found in wheat bran, some vegetables, and whole grains.

Soluble fiber exerts its laxative effect as it is hydrophilic, so it brings the water to the stool and increases the stool water content. It also resists colonic fermentation. Insoluble fiber is fermentable and loses its water holding capacity, produces gas that aggravates patients with bloating and flatulence. I always recommend soluble fiber.

When we're thinking about those properties that I just described, the ability to improve stool viscosity and frequency argues for the use of fiber in patients with IBS-C, although there are few studies to support this. There have been a lot of trials, but only a few that have been done within  IBS-C patients. The most recent meta-analysis was done by Moayyedi and colleagues. Here they looked at 15 RCTs of which only 6 had sub-typed the different types of IBS that were in the trials. Only 2 were IBS-C. So, the key takeaway for this meta-analysis was that-- and per the ACG guidelines-- the use of soluble, viscous, nonfermentable fiber provides benefits for global IBS symptoms.

There's also a general lack of side effects with this intervention. It’s important to instruct patients to titrate up on the soluble fiber slowly. Soluble fiber is a very reasonable first-line therapy for patients with IBS.

There are other dietary interventions that we can talk about. In 2015, the National Institute for Health Care Excellence issued their own IBS guideline recommendations. These are common sense things that I discuss with my patients, such as moderation in their diet: don't drink too much alcohol or don't drink too much caffeine. I go over these with patients as the guidelines specifically talk about soluble fiber. It can be helpful for patients to look at what they're doing on a daily basis.

The other important dietary intervention that we have utilized in IBS is the low-FODMAP diet.  This diet is based on restricting fermentable carbohydrates that bacteria work on, producing short chain fatty acids which cause an osmotic shift, bringing water into the colon, producing gases that lead to luminal dissension, and triggering meal-related symptoms in patients with IBS.

A recent meta-analysis of 7 randomized clinical trials looked at low FODMAP diet versus several different comparators. The low-FODMAP diet was associated with a significant reduction in global IBS symptoms compared with the different comparators. However, there are no data on a low-FODMAP diet strictly in IBS-C patients. So, stay tuned on that. We are doing a trial in IBS-C only.

If you are planning on using the low-FODMAP diet in your IBS patients, it's also important to utilize a GI trained dietician, because it can be overwhelming for patients to figure out what's an oligosaccharides, disaccharide, monosaccharides, and polyols. Having a wealth of knowledge available to these patients is critical.

Are there recent studies that show the effectiveness of diet as an approach to managing patients with IBS/CIC and what has been your in-practice experience?

Dr. Menees: Yes.  For IBS and CIC, the initial approach, which is soluble fiber, is what I use in practice for both disorders. However, that response can vary between the 2 conditions, and the next step you chose varies by the disorder.

As far as for my patients, soluble fiber is well accepted, but I do make sure that they are adequately hydrated. Hydration alone doesn't seem to change the incidence of constipation for patients, although there is some evidence for mineral water. Believe it or not, there are 3 randomized controlled trials showing the efficacy of mineral water in patients with CIC. However, it's also important in the chronic constipation patients that you find out how often they're having a bowel movement. If they are having a bm every 7 to 10 days, I'm afraid that fiber will actually worsen their symptoms. In those patients, fiber will not be my first-line treatment.

As far as other dietary options that I use specifically in patients with CIC, we now have data for fruit fibers. Specifically, we have data for prunes and kiwifruit, both green and golden kiwifruit. Chey and colleagues compared the efficacy of psyllium, 2 green kiwi per day, and prunes, 6 twice-daily in patients with CIC.  All 3 arms - kiwifruit (45%), psyllium (64%) and prunes (67%)- were found to be effective. Despite the primary endpoint results, patients randomized to the kiwi arm were most likely to be satisfied with treatment compared to the other arms. There was another trial performed in 32 patients, comparing the gold kiwifruit to psyllium. The kiwifruit resulted in significant improvement in BM frequency and GI discomfort as compared to psyllium. I use all of these as tools for my patients in clinical practice. 

We talked about symptoms, but how important is diet in preventing other diseases or conditions in patients with IBS-C?

Dr. Menees: For diet management, since soluble fibers are the gold standard and our first-line treatment, I discuss the general health benefits of fiber. Fiber is associated with reduced cardiovascular mortality, stroke, diabetes, and colorectal cancer. So that's important.

Being on a high fiber diet can improve the patient's overall general health. It is also helpful for other GI diseases. It helps reduce the risk of diverticulitis and diverticular bleeding. People who are on a high fiber diet are the least likely to have fecal incontinence. These are all excellent benefits of one of our first-line treatments.

Are there first-line therapies you recommend in conjunction with diet to help?

Dr. Menees: When it comes to chronic intermittent constipation, I certainly use osmotic laxatives after at least a 6- to 8-week trial of fiber. When you're adding fiber to your diet, its important to add slowly, about 5 grams per week.

I also tell the patient that it's not going to be quick. It takes at least 6 to 8 weeks for it to kick in. I will use osmotics, PEG 3350 and milk of magnesia which are very cheap and over the counter if they're not reaching the stool consistency and frequency. I also use stimulant and laxatives in my chronic intermittent constipation.

Now, for IBS, PEG 3350 osmotic laxatives are not recommended as it only changes stool frequency, but it has no impact on abdominal discomfort or abdominal pain. For IBS patients, I will utilize the secretagogues, the chloride channel activator, such as lubiprostone or guanylate cyclase activator, such as linaclotide or plecanatide.

Are there specific demographics more susceptible to constipation? What are your standards for dietary considerations for these populations? 

Dr. Menees: There are specific demographics that are susceptible to constipation. Women are more likely than men to have constipation. Women have a longer colon due to reproductive organs. This increases the surface area for absorption of water, which can predispose women to constipation.

In the US and UK, self-reported constipation is definitely more prevalent in women and those over age 60. When you adjust for those factors, you'll see it in patients who have low income, poor education, and little physical activity.

We also know that the prevalence of chronic constipation rises with age, and most dramatically in patients who are 65 and older. Over a quarter of males and almost a third of females will complain of constipation. Now, this age factor can be  compounded by other medical problems, such as hypertension. Additionally, in those over 65, there seems to be a correlation with decreased calories, but not with fluid or fiber.

Other populations that one must consider include any neurologic diseases, such as Parkinson Disease. We have to think of patients with chronic pain as they can be on opioids. But even those with chronic pain who are not on opioids will be on NSAIDs, which can also cause constipation. There are many different factors that make patients susceptible to constipation.

Regardless of the severity of their initial illness, 89% of people who were hospitalized with COVID-19 had returned to their original work 2 years later, a new study shows.

The burden of persistent COVID-19 symptoms appeared to improve over time, but a higher percentage of former patients reported poor health, compared with the general population. This suggests that some patients need more time to completely recover from COVID-19, wrote the authors of the new study, which was published in The Lancet Respiratory Medicine. Previous research has shown that the health effects of COVID-19 last for up to a year, but data from longer-term studies are limited, said Lixue Huang, MD, of Capital Medical University, Beijing, one of the study authors, and colleagues.

Methods and results

In the new study, the researchers reviewed data from 1,192 adult patients who were discharged from the hospital after surviving COVID-19 between Jan. 7, 2020, and May 29, 2020. The researchers measured the participants’ health outcomes at 6 months, 12 months, and 2 years after their onset of symptoms. A community-based dataset of 3,383 adults with no history of COVID-19 served as controls to measure the recovery of the COVID-19 patients. The median age of the patients at the time of hospital discharge was 57 years, and 46% were women. The median follow-up time after the onset of symptoms was 185 days, 349 days, and 685 days for the 6-month, 12-month, and 2-year visits, respectively. The researchers measured health outcomes using a 6-min walking distance (6MWD) test, laboratory tests, and questionnaires about symptoms, mental health, health-related quality of life, returning to work, and health care use since leaving the hospital.

Overall, the proportion of COVID-19 survivors with at least one symptom decreased from 68% at 6 months to 55% at 2 years (P < .0001). The most frequent symptoms were fatigue and muscle weakness, reported by approximately one-third of the patients (31%); sleep problems also were reported by 31% of the patients.

The proportion of individuals with poor results on the 6MWD decreased continuously over time, not only in COVID-19 survivors overall, but also in three subgroups of varying initial disease severity. Of the 494 survivors who reported working before becoming ill, 438 (89%) had returned to their original jobs 2 years later. The most common reasons for not returning to work were decreased physical function, unwillingness to return, and unemployment, the researchers noted.

However, at 2 years, COVID-19 survivors reported more pain and discomfort, as well as more anxiety and depression, compared with the controls (23% vs. 5% and 12% vs. 5%, respectively).

In addition, significantly more survivors who needed high levels of respiratory support while hospitalized had lung diffusion impairment (65%), reduced residual volume (62%), and total lung capacity (39%), compared with matched controls (36%, 20%, and 6%, respectively) at 2 years.

Long-COVID concerns

Approximately half of the survivors had symptoms of long COVID at 2 years. These individuals were more likely to report pain or discomfort or anxiety or depression, as well as mobility problems, compared to survivors without long COVID. Participants with long-COVID symptoms were more than twice as likely to have an outpatient clinic visit (odds ratio, 2.82), and not quite twice as likely to be rehospitalized (OR, 1.64).

“We found that [health-related quality of life], exercise capacity, and mental health continued to improve throughout the 2 years regardless of initial disease severity, but about half still had symptomatic sequelae at 2 years,” the researchers wrote in their paper.

Findings can inform doctor-patient discussions

“We are increasingly recognizing that the health effects of COVID-19 may persist beyond acute illness, therefore this is a timely study to assess the long-term impact of COVID-19 with a long follow-up period,” said Suman Pal, MD, an internal medicine physician at the University of New Mexico, Albuquerque, in an interview.

The findings are consistent with the existing literature, said Dr. Pal, who was not involved in the study.  The data from the study “can help clinicians have discussions regarding expected recovery and long-term prognosis for patients with COVID-19,” he noted.

What patients should know is that “studies such as this can help COVID-19 survivors understand and monitor persistent symptoms they may experience, and bring them to the attention of their clinicians,” said Dr. Pal.

However, “As a single-center study with high attrition of subjects during the study period, the findings may not be generalizable,” Dr. Pal emphasized. “Larger-scale studies and patient registries distributed over different geographical areas and time periods will help obtain a better understanding of the nature and prevalence of long COVID,” he said.

The study findings were limited by several factors, including the lack of formerly hospitalized controls with respiratory infections other than COVID-19 to determine which outcomes are COVID-19 specific, the researchers noted. Other limitations included the use of data from only patients at a single center, and from the early stages of the pandemic, as well as the use of self-reports for comorbidities and health outcomes, they said.

However, the results represent the longest-known published longitudinal follow-up of patients who recovered from acute COVID-19, the researchers emphasized. Study strengths included the large sample size, longitudinal design, and long-term follow-up with non-COVID controls to determine outcomes. The researchers noted their plans to conduct annual follow-ups in the current study population. They added that more research is needed to explore rehabilitation programs to promote recovery for COVID-19 survivors and to reduce the effects of long COVID.

The study was supported by the Chinese Academy of Medical Sciences, National Natural Science Foundation of China, National Key Research and Development Program of China, National Administration of Traditional Chinese Medicine, Major Projects of National Science and Technology on New Drug Creation and Development of Pulmonary Tuberculosis, China Evergrande Group, Jack Ma Foundation, Sino Biopharmaceutical, Ping An Insurance (Group), and New Sunshine Charity Foundation. The researchers and Dr. Pal had no financial conflicts to disclose.

This article was updated on 5/16/2022.

Regardless of the severity of their initial illness, 89% of people who were hospitalized with COVID-19 had returned to their original work 2 years later, a new study shows.

The burden of persistent COVID-19 symptoms appeared to improve over time, but a higher percentage of former patients reported poor health, compared with the general population. This suggests that some patients need more time to completely recover from COVID-19, wrote the authors of the new study, which was published in The Lancet Respiratory Medicine. Previous research has shown that the health effects of COVID-19 last for up to a year, but data from longer-term studies are limited, said Lixue Huang, MD, of Capital Medical University, Beijing, one of the study authors, and colleagues.

Methods and results

In the new study, the researchers reviewed data from 1,192 adult patients who were discharged from the hospital after surviving COVID-19 between Jan. 7, 2020, and May 29, 2020. The researchers measured the participants’ health outcomes at 6 months, 12 months, and 2 years after their onset of symptoms. A community-based dataset of 3,383 adults with no history of COVID-19 served as controls to measure the recovery of the COVID-19 patients. The median age of the patients at the time of hospital discharge was 57 years, and 46% were women. The median follow-up time after the onset of symptoms was 185 days, 349 days, and 685 days for the 6-month, 12-month, and 2-year visits, respectively. The researchers measured health outcomes using a 6-min walking distance (6MWD) test, laboratory tests, and questionnaires about symptoms, mental health, health-related quality of life, returning to work, and health care use since leaving the hospital.

Overall, the proportion of COVID-19 survivors with at least one symptom decreased from 68% at 6 months to 55% at 2 years (P < .0001). The most frequent symptoms were fatigue and muscle weakness, reported by approximately one-third of the patients (31%); sleep problems also were reported by 31% of the patients.

The proportion of individuals with poor results on the 6MWD decreased continuously over time, not only in COVID-19 survivors overall, but also in three subgroups of varying initial disease severity. Of the 494 survivors who reported working before becoming ill, 438 (89%) had returned to their original jobs 2 years later. The most common reasons for not returning to work were decreased physical function, unwillingness to return, and unemployment, the researchers noted.

However, at 2 years, COVID-19 survivors reported more pain and discomfort, as well as more anxiety and depression, compared with the controls (23% vs. 5% and 12% vs. 5%, respectively).

In addition, significantly more survivors who needed high levels of respiratory support while hospitalized had lung diffusion impairment (65%), reduced residual volume (62%), and total lung capacity (39%), compared with matched controls (36%, 20%, and 6%, respectively) at 2 years.

Long-COVID concerns

Approximately half of the survivors had symptoms of long COVID at 2 years. These individuals were more likely to report pain or discomfort or anxiety or depression, as well as mobility problems, compared to survivors without long COVID. Participants with long-COVID symptoms were more than twice as likely to have an outpatient clinic visit (odds ratio, 2.82), and not quite twice as likely to be rehospitalized (OR, 1.64).

“We found that [health-related quality of life], exercise capacity, and mental health continued to improve throughout the 2 years regardless of initial disease severity, but about half still had symptomatic sequelae at 2 years,” the researchers wrote in their paper.

Findings can inform doctor-patient discussions

“We are increasingly recognizing that the health effects of COVID-19 may persist beyond acute illness, therefore this is a timely study to assess the long-term impact of COVID-19 with a long follow-up period,” said Suman Pal, MD, an internal medicine physician at the University of New Mexico, Albuquerque, in an interview.

The findings are consistent with the existing literature, said Dr. Pal, who was not involved in the study.  The data from the study “can help clinicians have discussions regarding expected recovery and long-term prognosis for patients with COVID-19,” he noted.

What patients should know is that “studies such as this can help COVID-19 survivors understand and monitor persistent symptoms they may experience, and bring them to the attention of their clinicians,” said Dr. Pal.

However, “As a single-center study with high attrition of subjects during the study period, the findings may not be generalizable,” Dr. Pal emphasized. “Larger-scale studies and patient registries distributed over different geographical areas and time periods will help obtain a better understanding of the nature and prevalence of long COVID,” he said.

The study findings were limited by several factors, including the lack of formerly hospitalized controls with respiratory infections other than COVID-19 to determine which outcomes are COVID-19 specific, the researchers noted. Other limitations included the use of data from only patients at a single center, and from the early stages of the pandemic, as well as the use of self-reports for comorbidities and health outcomes, they said.

However, the results represent the longest-known published longitudinal follow-up of patients who recovered from acute COVID-19, the researchers emphasized. Study strengths included the large sample size, longitudinal design, and long-term follow-up with non-COVID controls to determine outcomes. The researchers noted their plans to conduct annual follow-ups in the current study population. They added that more research is needed to explore rehabilitation programs to promote recovery for COVID-19 survivors and to reduce the effects of long COVID.

The study was supported by the Chinese Academy of Medical Sciences, National Natural Science Foundation of China, National Key Research and Development Program of China, National Administration of Traditional Chinese Medicine, Major Projects of National Science and Technology on New Drug Creation and Development of Pulmonary Tuberculosis, China Evergrande Group, Jack Ma Foundation, Sino Biopharmaceutical, Ping An Insurance (Group), and New Sunshine Charity Foundation. The researchers and Dr. Pal had no financial conflicts to disclose.

This article was updated on 5/16/2022.

Regardless of the severity of their initial illness, 89% of people who were hospitalized with COVID-19 had returned to their original work 2 years later, a new study shows.

The burden of persistent COVID-19 symptoms appeared to improve over time, but a higher percentage of former patients reported poor health, compared with the general population. This suggests that some patients need more time to completely recover from COVID-19, wrote the authors of the new study, which was published in The Lancet Respiratory Medicine. Previous research has shown that the health effects of COVID-19 last for up to a year, but data from longer-term studies are limited, said Lixue Huang, MD, of Capital Medical University, Beijing, one of the study authors, and colleagues.

Methods and results

In the new study, the researchers reviewed data from 1,192 adult patients who were discharged from the hospital after surviving COVID-19 between Jan. 7, 2020, and May 29, 2020. The researchers measured the participants’ health outcomes at 6 months, 12 months, and 2 years after their onset of symptoms. A community-based dataset of 3,383 adults with no history of COVID-19 served as controls to measure the recovery of the COVID-19 patients. The median age of the patients at the time of hospital discharge was 57 years, and 46% were women. The median follow-up time after the onset of symptoms was 185 days, 349 days, and 685 days for the 6-month, 12-month, and 2-year visits, respectively. The researchers measured health outcomes using a 6-min walking distance (6MWD) test, laboratory tests, and questionnaires about symptoms, mental health, health-related quality of life, returning to work, and health care use since leaving the hospital.

Overall, the proportion of COVID-19 survivors with at least one symptom decreased from 68% at 6 months to 55% at 2 years (P < .0001). The most frequent symptoms were fatigue and muscle weakness, reported by approximately one-third of the patients (31%); sleep problems also were reported by 31% of the patients.

The proportion of individuals with poor results on the 6MWD decreased continuously over time, not only in COVID-19 survivors overall, but also in three subgroups of varying initial disease severity. Of the 494 survivors who reported working before becoming ill, 438 (89%) had returned to their original jobs 2 years later. The most common reasons for not returning to work were decreased physical function, unwillingness to return, and unemployment, the researchers noted.

However, at 2 years, COVID-19 survivors reported more pain and discomfort, as well as more anxiety and depression, compared with the controls (23% vs. 5% and 12% vs. 5%, respectively).

In addition, significantly more survivors who needed high levels of respiratory support while hospitalized had lung diffusion impairment (65%), reduced residual volume (62%), and total lung capacity (39%), compared with matched controls (36%, 20%, and 6%, respectively) at 2 years.

Long-COVID concerns

Approximately half of the survivors had symptoms of long COVID at 2 years. These individuals were more likely to report pain or discomfort or anxiety or depression, as well as mobility problems, compared to survivors without long COVID. Participants with long-COVID symptoms were more than twice as likely to have an outpatient clinic visit (odds ratio, 2.82), and not quite twice as likely to be rehospitalized (OR, 1.64).

“We found that [health-related quality of life], exercise capacity, and mental health continued to improve throughout the 2 years regardless of initial disease severity, but about half still had symptomatic sequelae at 2 years,” the researchers wrote in their paper.

Findings can inform doctor-patient discussions

“We are increasingly recognizing that the health effects of COVID-19 may persist beyond acute illness, therefore this is a timely study to assess the long-term impact of COVID-19 with a long follow-up period,” said Suman Pal, MD, an internal medicine physician at the University of New Mexico, Albuquerque, in an interview.

The findings are consistent with the existing literature, said Dr. Pal, who was not involved in the study.  The data from the study “can help clinicians have discussions regarding expected recovery and long-term prognosis for patients with COVID-19,” he noted.

What patients should know is that “studies such as this can help COVID-19 survivors understand and monitor persistent symptoms they may experience, and bring them to the attention of their clinicians,” said Dr. Pal.

However, “As a single-center study with high attrition of subjects during the study period, the findings may not be generalizable,” Dr. Pal emphasized. “Larger-scale studies and patient registries distributed over different geographical areas and time periods will help obtain a better understanding of the nature and prevalence of long COVID,” he said.

The study findings were limited by several factors, including the lack of formerly hospitalized controls with respiratory infections other than COVID-19 to determine which outcomes are COVID-19 specific, the researchers noted. Other limitations included the use of data from only patients at a single center, and from the early stages of the pandemic, as well as the use of self-reports for comorbidities and health outcomes, they said.

However, the results represent the longest-known published longitudinal follow-up of patients who recovered from acute COVID-19, the researchers emphasized. Study strengths included the large sample size, longitudinal design, and long-term follow-up with non-COVID controls to determine outcomes. The researchers noted their plans to conduct annual follow-ups in the current study population. They added that more research is needed to explore rehabilitation programs to promote recovery for COVID-19 survivors and to reduce the effects of long COVID.

The study was supported by the Chinese Academy of Medical Sciences, National Natural Science Foundation of China, National Key Research and Development Program of China, National Administration of Traditional Chinese Medicine, Major Projects of National Science and Technology on New Drug Creation and Development of Pulmonary Tuberculosis, China Evergrande Group, Jack Ma Foundation, Sino Biopharmaceutical, Ping An Insurance (Group), and New Sunshine Charity Foundation. The researchers and Dr. Pal had no financial conflicts to disclose.

This article was updated on 5/16/2022.