On July 13, the Food and Drug Administration approved the first over-the-counter (OTC) norgestrel birth control pill (Opill). The daily oral contraceptive was approved for prescription use 5 decades ago, providing regulators with a half-century of data to show that the progestin-only drug can be used safely without a prescription. 

The drug is the latest in a series of medications that have made the switch from behind the pharmacy counter to retail shelves. 

Experts say several more classes of drugs to treat high cholesterol, asthma, and other common health problems could be next.
 

Why switch?

When a drug manufacturer submits a proposal for a switch to OTC, the key question that the FDA considers is patient safety. Some risks can be mitigated by approving OTC drugs at lower doses than what is available as the prescription version. 

“There is no drug that doesn’t have risks,” said Almut G. Winterstein, RPh, PhD, a distinguished professor in pharmaceutical outcomes and policy and director of the Center for Drug Evaluation and Safety at the University of Florida, Gainesville. “Risks are mitigated by putting specific constraints around access to those medications.”

Dr. Winterstein, a former chair of the FDA’s Drug Safety and Risk Management Advisory Committee, said that nonprescription drugs are unnecessary in a functional health care system. 

Many patients may struggle with accessing health clinicians, so making medications available OTC fills gaps left by not being able to get a prescription, according to Dr. Winterstein. 

A 2012 paper funded by the Consumer Healthcare Products Association (CHPA), the organization representing manufacturers and distributors of OTC medications, estimated that one quarter of people who bought OTC drugs would not otherwise seek treatment if these treatments were available only via prescription. The CHPA notes that the number of those who experience allergies who use nonprescription antihistamines and allergy-relief drugs increased by about 10% between 2009 and 2015. 
 

Cholesterol drugs

Approximately 80 million U.S. adults are eligible for cholesterol-lowering medications, particularly statins, but nearly half don’t take them, according to the Centers for Disease Control and Prevention. 

Fear of side effects is the most common reason people might avoid taking these drugs. But eliminating the need for a refill may encourage uptake of the statins. 

“It’s refill, refill, refill,” said Allen J. Taylor, MD, chairman of cardiology at MedStar Heart and Vascular Institute, in Washington. “We spend a ton of time refilling statins and it’s a headache for patients, too.” 

The need to secure regular prescriptions for the drug, “doesn’t put enough trust and faith in pharmacists and doesn’t put enough trust and faith in patients,” Dr. Taylor said. 

Moving statins to the front end of a pharmacy might not be the best move given the potential for drug interactions, but a nonprescription behind-the-counter approach could work, according to Dr. Taylor. 

“The concerns are modest at most, to where they can be monitored by a pharmacist,” he said. “There’s probably more people that would take a statin if they had that kind of access.” 

Many statin manufacturers have attempted to make the prescription-to-OTC switch. In 2005, an FDA advisory panel rejected Merck’s proposal for OTC sales of lovastatin after reviewing a study that found only 55% of OTC purchases would have been medically appropriate. 

In 2015, Pfizer pulled its application to make the cholesterol drug atorvastatin available to patients OTC because patients were not using the drug correctly. AstraZeneca is investigating an online platform that would allow patients to self-assess their eligibility for rosuvastatin. 
 

Asthma inhalers 

Inhalers are the main rescue therapy for asthma aside from a visit to the ED. 

The only inhaler available OTC is epinephrine sold under the brand name Primatene Mist, but this type of medicine device is not recommended as a first-line therapy for acute asthma symptoms, according to the American Medical Association. 

“It’s been around for a long time and has stayed over the counter even though newer, safer agents have come onto the market which aren’t available over the counter,” said William B. Feldman, MD, DPhil, MPH, a pulmonologist at Brigham and Women’s Hospital, Boston. 

Patients who have a hard time getting to a doctor or patients who lack insurance often face barriers accessing albuterol inhalers and beta agonist–corticosteroid combinations, according to Dr. Feldman. A switch to OTC distribution would widen access. 

“What we’re advocating is, if they’re going to have access to Primatene Mist, wouldn’t it be sensible to have access to a safer and more effective therapy?” Dr. Feldman said. 
 

Triptans

Migraines affect an estimated 39 million people in the United States, according to the American Migraine Foundation. Several drugs to treat migraine are available OTC, including nonsteroidal anti-inflammatory drugs, aspirin, and acetaminophen. Triptans, drugs used for the short-term treatment of acute symptoms, are prescription-only in the United States. 

But in the United Kingdom, triptans first became available in retail stores in 2006, leading to reduced costs for patients, employers, and the government. One study found that government health expenditures would be reduced by $84 million annually if the OTC switch were made in six European countries. 

However, overuse of the drug and potential contraindications have been cited as concerns with OTC access. 

For Dr. Winterstein, the decision to switch isn’t just about the freedom to buy a drug; it comes down to weighing potential risks and benefits. 

“Drugs are only as good as if they’re used in the context of how they should be used,” Dr. Winterstein said. “It’s not candy.”
 

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

On July 13, the Food and Drug Administration approved the first over-the-counter (OTC) norgestrel birth control pill (Opill). The daily oral contraceptive was approved for prescription use 5 decades ago, providing regulators with a half-century of data to show that the progestin-only drug can be used safely without a prescription. 

The drug is the latest in a series of medications that have made the switch from behind the pharmacy counter to retail shelves. 

Experts say several more classes of drugs to treat high cholesterol, asthma, and other common health problems could be next.
 

Why switch?

When a drug manufacturer submits a proposal for a switch to OTC, the key question that the FDA considers is patient safety. Some risks can be mitigated by approving OTC drugs at lower doses than what is available as the prescription version. 

“There is no drug that doesn’t have risks,” said Almut G. Winterstein, RPh, PhD, a distinguished professor in pharmaceutical outcomes and policy and director of the Center for Drug Evaluation and Safety at the University of Florida, Gainesville. “Risks are mitigated by putting specific constraints around access to those medications.”

Dr. Winterstein, a former chair of the FDA’s Drug Safety and Risk Management Advisory Committee, said that nonprescription drugs are unnecessary in a functional health care system. 

Many patients may struggle with accessing health clinicians, so making medications available OTC fills gaps left by not being able to get a prescription, according to Dr. Winterstein. 

A 2012 paper funded by the Consumer Healthcare Products Association (CHPA), the organization representing manufacturers and distributors of OTC medications, estimated that one quarter of people who bought OTC drugs would not otherwise seek treatment if these treatments were available only via prescription. The CHPA notes that the number of those who experience allergies who use nonprescription antihistamines and allergy-relief drugs increased by about 10% between 2009 and 2015. 
 

Cholesterol drugs

Approximately 80 million U.S. adults are eligible for cholesterol-lowering medications, particularly statins, but nearly half don’t take them, according to the Centers for Disease Control and Prevention. 

Fear of side effects is the most common reason people might avoid taking these drugs. But eliminating the need for a refill may encourage uptake of the statins. 

“It’s refill, refill, refill,” said Allen J. Taylor, MD, chairman of cardiology at MedStar Heart and Vascular Institute, in Washington. “We spend a ton of time refilling statins and it’s a headache for patients, too.” 

The need to secure regular prescriptions for the drug, “doesn’t put enough trust and faith in pharmacists and doesn’t put enough trust and faith in patients,” Dr. Taylor said. 

Moving statins to the front end of a pharmacy might not be the best move given the potential for drug interactions, but a nonprescription behind-the-counter approach could work, according to Dr. Taylor. 

“The concerns are modest at most, to where they can be monitored by a pharmacist,” he said. “There’s probably more people that would take a statin if they had that kind of access.” 

Many statin manufacturers have attempted to make the prescription-to-OTC switch. In 2005, an FDA advisory panel rejected Merck’s proposal for OTC sales of lovastatin after reviewing a study that found only 55% of OTC purchases would have been medically appropriate. 

In 2015, Pfizer pulled its application to make the cholesterol drug atorvastatin available to patients OTC because patients were not using the drug correctly. AstraZeneca is investigating an online platform that would allow patients to self-assess their eligibility for rosuvastatin. 
 

Asthma inhalers 

Inhalers are the main rescue therapy for asthma aside from a visit to the ED. 

The only inhaler available OTC is epinephrine sold under the brand name Primatene Mist, but this type of medicine device is not recommended as a first-line therapy for acute asthma symptoms, according to the American Medical Association. 

“It’s been around for a long time and has stayed over the counter even though newer, safer agents have come onto the market which aren’t available over the counter,” said William B. Feldman, MD, DPhil, MPH, a pulmonologist at Brigham and Women’s Hospital, Boston. 

Patients who have a hard time getting to a doctor or patients who lack insurance often face barriers accessing albuterol inhalers and beta agonist–corticosteroid combinations, according to Dr. Feldman. A switch to OTC distribution would widen access. 

“What we’re advocating is, if they’re going to have access to Primatene Mist, wouldn’t it be sensible to have access to a safer and more effective therapy?” Dr. Feldman said. 
 

Triptans

Migraines affect an estimated 39 million people in the United States, according to the American Migraine Foundation. Several drugs to treat migraine are available OTC, including nonsteroidal anti-inflammatory drugs, aspirin, and acetaminophen. Triptans, drugs used for the short-term treatment of acute symptoms, are prescription-only in the United States. 

But in the United Kingdom, triptans first became available in retail stores in 2006, leading to reduced costs for patients, employers, and the government. One study found that government health expenditures would be reduced by $84 million annually if the OTC switch were made in six European countries. 

However, overuse of the drug and potential contraindications have been cited as concerns with OTC access. 

For Dr. Winterstein, the decision to switch isn’t just about the freedom to buy a drug; it comes down to weighing potential risks and benefits. 

“Drugs are only as good as if they’re used in the context of how they should be used,” Dr. Winterstein said. “It’s not candy.”
 

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

On July 13, the Food and Drug Administration approved the first over-the-counter (OTC) norgestrel birth control pill (Opill). The daily oral contraceptive was approved for prescription use 5 decades ago, providing regulators with a half-century of data to show that the progestin-only drug can be used safely without a prescription. 

The drug is the latest in a series of medications that have made the switch from behind the pharmacy counter to retail shelves. 

Experts say several more classes of drugs to treat high cholesterol, asthma, and other common health problems could be next.
 

Why switch?

When a drug manufacturer submits a proposal for a switch to OTC, the key question that the FDA considers is patient safety. Some risks can be mitigated by approving OTC drugs at lower doses than what is available as the prescription version. 

“There is no drug that doesn’t have risks,” said Almut G. Winterstein, RPh, PhD, a distinguished professor in pharmaceutical outcomes and policy and director of the Center for Drug Evaluation and Safety at the University of Florida, Gainesville. “Risks are mitigated by putting specific constraints around access to those medications.”

Dr. Winterstein, a former chair of the FDA’s Drug Safety and Risk Management Advisory Committee, said that nonprescription drugs are unnecessary in a functional health care system. 

Many patients may struggle with accessing health clinicians, so making medications available OTC fills gaps left by not being able to get a prescription, according to Dr. Winterstein. 

A 2012 paper funded by the Consumer Healthcare Products Association (CHPA), the organization representing manufacturers and distributors of OTC medications, estimated that one quarter of people who bought OTC drugs would not otherwise seek treatment if these treatments were available only via prescription. The CHPA notes that the number of those who experience allergies who use nonprescription antihistamines and allergy-relief drugs increased by about 10% between 2009 and 2015. 
 

Cholesterol drugs

Approximately 80 million U.S. adults are eligible for cholesterol-lowering medications, particularly statins, but nearly half don’t take them, according to the Centers for Disease Control and Prevention. 

Fear of side effects is the most common reason people might avoid taking these drugs. But eliminating the need for a refill may encourage uptake of the statins. 

“It’s refill, refill, refill,” said Allen J. Taylor, MD, chairman of cardiology at MedStar Heart and Vascular Institute, in Washington. “We spend a ton of time refilling statins and it’s a headache for patients, too.” 

The need to secure regular prescriptions for the drug, “doesn’t put enough trust and faith in pharmacists and doesn’t put enough trust and faith in patients,” Dr. Taylor said. 

Moving statins to the front end of a pharmacy might not be the best move given the potential for drug interactions, but a nonprescription behind-the-counter approach could work, according to Dr. Taylor. 

“The concerns are modest at most, to where they can be monitored by a pharmacist,” he said. “There’s probably more people that would take a statin if they had that kind of access.” 

Many statin manufacturers have attempted to make the prescription-to-OTC switch. In 2005, an FDA advisory panel rejected Merck’s proposal for OTC sales of lovastatin after reviewing a study that found only 55% of OTC purchases would have been medically appropriate. 

In 2015, Pfizer pulled its application to make the cholesterol drug atorvastatin available to patients OTC because patients were not using the drug correctly. AstraZeneca is investigating an online platform that would allow patients to self-assess their eligibility for rosuvastatin. 
 

Asthma inhalers 

Inhalers are the main rescue therapy for asthma aside from a visit to the ED. 

The only inhaler available OTC is epinephrine sold under the brand name Primatene Mist, but this type of medicine device is not recommended as a first-line therapy for acute asthma symptoms, according to the American Medical Association. 

“It’s been around for a long time and has stayed over the counter even though newer, safer agents have come onto the market which aren’t available over the counter,” said William B. Feldman, MD, DPhil, MPH, a pulmonologist at Brigham and Women’s Hospital, Boston. 

Patients who have a hard time getting to a doctor or patients who lack insurance often face barriers accessing albuterol inhalers and beta agonist–corticosteroid combinations, according to Dr. Feldman. A switch to OTC distribution would widen access. 

“What we’re advocating is, if they’re going to have access to Primatene Mist, wouldn’t it be sensible to have access to a safer and more effective therapy?” Dr. Feldman said. 
 

Triptans

Migraines affect an estimated 39 million people in the United States, according to the American Migraine Foundation. Several drugs to treat migraine are available OTC, including nonsteroidal anti-inflammatory drugs, aspirin, and acetaminophen. Triptans, drugs used for the short-term treatment of acute symptoms, are prescription-only in the United States. 

But in the United Kingdom, triptans first became available in retail stores in 2006, leading to reduced costs for patients, employers, and the government. One study found that government health expenditures would be reduced by $84 million annually if the OTC switch were made in six European countries. 

However, overuse of the drug and potential contraindications have been cited as concerns with OTC access. 

For Dr. Winterstein, the decision to switch isn’t just about the freedom to buy a drug; it comes down to weighing potential risks and benefits. 

“Drugs are only as good as if they’re used in the context of how they should be used,” Dr. Winterstein said. “It’s not candy.”
 

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

BOSTON – Intermittent fasting is an effective alternative to calorie restriction for shedding extra pounds, according to a new study of people with type 2 diabetes.

For the study, 57 overweight and obese participants with type 2 diabetes were randomly assigned to three different groups: The first group ate between noon and 8 p.m., the second was asked to reduce caloric intake by 25% of maintenance calories, and the third, a control group, continued eating normally.

The calorie-restriction group tracked intake on MyFitnessPal, an app that logs the calorie content of different foods. Both the intermittent-fasting and calorie-restriction groups were assigned a dietitian to help with adherence.

After 6 months, participants in the intermittent-fasting group lost about 4.3% of body weight – the equivalent of 10 pounds of weight loss for a person weighing 230 pounds – whereas participants in the calorie-restriction group lost about 2.5% of body weight.

The difference between the two groups was not significant, so one approach isn’t necessarily better than the other for weight loss.

“Let’s not think of this as an approach that’s better than calorie restriction,” William Yancy, MD, MHS, an internist and weight management specialist at Duke Lifestyle and Weight Management Center, Durham, N.C., said in an interview. “It’s an alternative approach to calorie restriction.”

Participants’ willingness to adhere to the diet likely accounted for the percentage difference between the groups, study author Vasiliki Pavlou, RDN, told this news organization. Ms. Pavlou presented the findings at the Nutrition 2023 conference.

“People that have type 2 diabetes, they’ve already been to the doctor, they’ve already been told to count calories,” said Ms. Pavlou, a doctoral student at the University of Illinois at Chicago. “There were many weeks where they came to us with nothing on MyFitnessPal and we’d have to encourage them to start tracking again.”

The intermittent-fasting group adhered to the eating time window 6 out of 7 days of the week, with a 1-hour grace period for the noon-to-8-p.m. window. In comparison, one-third of the calorie-restriction group didn’t stay within 200 calories of the goal, according to Ms. Pavlou.

That meant the fasting group cut about 100 calories more per day than the calorie-restriction group, which was reflected in their weight loss, Ms. Pavlou said.

A1c levels dropped by about 1% in both the intermittent-fasting and calorie-restriction groups – a meaningful decrease, said Dr. Yancy. “I think a 0.5% difference would have some clinical significance in terms of complications from diabetes,” he said. “So 1% would be even more clinically meaningful.”

However, fewer participants taking insulin in the calorie-restriction group could explain the difference, according to Ms. Pavlou. “Usually, when someone goes on insulin, their pancreas is already not functioning as well,” she said. “And it’s way harder to see improvements in their A1c and glycemic control.”

Up to 90% of people with type 2 diabetes are overweight or obese. Weight loss is one of the major components of type 2 diabetes care, according to the American Diabetes Association, and studies have shown that even a 5% reduction in body weight can reduce blood glucose concentration and A1c. Some studies suggest diabetes remission can occur after a 10% loss in body weight, but Dr. Yancy said it depends on the person.

“It depends on the individual, their metabolic situation, how long they’ve had diabetes, what kind of approach they’re following, maybe what medicines they’re taking,” Dr. Yancy said. “There’s a lot of different factors involved in remission.”

The study cohort generally had advanced diabetes and was taking a mix of medications, so the results might not be applicable to people with a more recent diabetes diagnosis, according to Ms. Pavlou.

Dr. Yancy said intermittent fasting could work well for the right person. The success of the approach could depend on a person’s eating habits and whether their meals usually fall outside the time-restricted window, or it could depend on how well a person follows rules, according to Dr. Yancy.

“Some people might not eat much after 8 o’clock, and some people might skip breakfast,” Dr. Yancy said. “And if that’s the case, then it’s not going to make a big impact on their weight probably.”

Medication is also an important consideration. Not eating can be dangerous for patients taking short-acting insulin or sulfonylureas, according to Dr. Yancy.

Ms. Pavlou said these findings show intermittent fasting is another option for patients with type 2 diabetes trying to lose weight. “If you’ve tried calorie counting, that’s not working for you or if you’re kind of burnt out, this is something else that you could try,” she said.

“We have a lot of patients that need to lose weight, and we have patients who respond differently to different approaches,” said Dr. Yancy. “So having various approaches is really valuable.”

The manuscript is currently under review at JAMA Internal Medicine, said Ms. Pavlou.
 

A version of this article appeared on Medscape.com.

BOSTON – Intermittent fasting is an effective alternative to calorie restriction for shedding extra pounds, according to a new study of people with type 2 diabetes.

For the study, 57 overweight and obese participants with type 2 diabetes were randomly assigned to three different groups: The first group ate between noon and 8 p.m., the second was asked to reduce caloric intake by 25% of maintenance calories, and the third, a control group, continued eating normally.

The calorie-restriction group tracked intake on MyFitnessPal, an app that logs the calorie content of different foods. Both the intermittent-fasting and calorie-restriction groups were assigned a dietitian to help with adherence.

After 6 months, participants in the intermittent-fasting group lost about 4.3% of body weight – the equivalent of 10 pounds of weight loss for a person weighing 230 pounds – whereas participants in the calorie-restriction group lost about 2.5% of body weight.

The difference between the two groups was not significant, so one approach isn’t necessarily better than the other for weight loss.

“Let’s not think of this as an approach that’s better than calorie restriction,” William Yancy, MD, MHS, an internist and weight management specialist at Duke Lifestyle and Weight Management Center, Durham, N.C., said in an interview. “It’s an alternative approach to calorie restriction.”

Participants’ willingness to adhere to the diet likely accounted for the percentage difference between the groups, study author Vasiliki Pavlou, RDN, told this news organization. Ms. Pavlou presented the findings at the Nutrition 2023 conference.

“People that have type 2 diabetes, they’ve already been to the doctor, they’ve already been told to count calories,” said Ms. Pavlou, a doctoral student at the University of Illinois at Chicago. “There were many weeks where they came to us with nothing on MyFitnessPal and we’d have to encourage them to start tracking again.”

The intermittent-fasting group adhered to the eating time window 6 out of 7 days of the week, with a 1-hour grace period for the noon-to-8-p.m. window. In comparison, one-third of the calorie-restriction group didn’t stay within 200 calories of the goal, according to Ms. Pavlou.

That meant the fasting group cut about 100 calories more per day than the calorie-restriction group, which was reflected in their weight loss, Ms. Pavlou said.

A1c levels dropped by about 1% in both the intermittent-fasting and calorie-restriction groups – a meaningful decrease, said Dr. Yancy. “I think a 0.5% difference would have some clinical significance in terms of complications from diabetes,” he said. “So 1% would be even more clinically meaningful.”

However, fewer participants taking insulin in the calorie-restriction group could explain the difference, according to Ms. Pavlou. “Usually, when someone goes on insulin, their pancreas is already not functioning as well,” she said. “And it’s way harder to see improvements in their A1c and glycemic control.”

Up to 90% of people with type 2 diabetes are overweight or obese. Weight loss is one of the major components of type 2 diabetes care, according to the American Diabetes Association, and studies have shown that even a 5% reduction in body weight can reduce blood glucose concentration and A1c. Some studies suggest diabetes remission can occur after a 10% loss in body weight, but Dr. Yancy said it depends on the person.

“It depends on the individual, their metabolic situation, how long they’ve had diabetes, what kind of approach they’re following, maybe what medicines they’re taking,” Dr. Yancy said. “There’s a lot of different factors involved in remission.”

The study cohort generally had advanced diabetes and was taking a mix of medications, so the results might not be applicable to people with a more recent diabetes diagnosis, according to Ms. Pavlou.

Dr. Yancy said intermittent fasting could work well for the right person. The success of the approach could depend on a person’s eating habits and whether their meals usually fall outside the time-restricted window, or it could depend on how well a person follows rules, according to Dr. Yancy.

“Some people might not eat much after 8 o’clock, and some people might skip breakfast,” Dr. Yancy said. “And if that’s the case, then it’s not going to make a big impact on their weight probably.”

Medication is also an important consideration. Not eating can be dangerous for patients taking short-acting insulin or sulfonylureas, according to Dr. Yancy.

Ms. Pavlou said these findings show intermittent fasting is another option for patients with type 2 diabetes trying to lose weight. “If you’ve tried calorie counting, that’s not working for you or if you’re kind of burnt out, this is something else that you could try,” she said.

“We have a lot of patients that need to lose weight, and we have patients who respond differently to different approaches,” said Dr. Yancy. “So having various approaches is really valuable.”

The manuscript is currently under review at JAMA Internal Medicine, said Ms. Pavlou.
 

A version of this article appeared on Medscape.com.

BOSTON – Intermittent fasting is an effective alternative to calorie restriction for shedding extra pounds, according to a new study of people with type 2 diabetes.

For the study, 57 overweight and obese participants with type 2 diabetes were randomly assigned to three different groups: The first group ate between noon and 8 p.m., the second was asked to reduce caloric intake by 25% of maintenance calories, and the third, a control group, continued eating normally.

The calorie-restriction group tracked intake on MyFitnessPal, an app that logs the calorie content of different foods. Both the intermittent-fasting and calorie-restriction groups were assigned a dietitian to help with adherence.

After 6 months, participants in the intermittent-fasting group lost about 4.3% of body weight – the equivalent of 10 pounds of weight loss for a person weighing 230 pounds – whereas participants in the calorie-restriction group lost about 2.5% of body weight.

The difference between the two groups was not significant, so one approach isn’t necessarily better than the other for weight loss.

“Let’s not think of this as an approach that’s better than calorie restriction,” William Yancy, MD, MHS, an internist and weight management specialist at Duke Lifestyle and Weight Management Center, Durham, N.C., said in an interview. “It’s an alternative approach to calorie restriction.”

Participants’ willingness to adhere to the diet likely accounted for the percentage difference between the groups, study author Vasiliki Pavlou, RDN, told this news organization. Ms. Pavlou presented the findings at the Nutrition 2023 conference.

“People that have type 2 diabetes, they’ve already been to the doctor, they’ve already been told to count calories,” said Ms. Pavlou, a doctoral student at the University of Illinois at Chicago. “There were many weeks where they came to us with nothing on MyFitnessPal and we’d have to encourage them to start tracking again.”

The intermittent-fasting group adhered to the eating time window 6 out of 7 days of the week, with a 1-hour grace period for the noon-to-8-p.m. window. In comparison, one-third of the calorie-restriction group didn’t stay within 200 calories of the goal, according to Ms. Pavlou.

That meant the fasting group cut about 100 calories more per day than the calorie-restriction group, which was reflected in their weight loss, Ms. Pavlou said.

A1c levels dropped by about 1% in both the intermittent-fasting and calorie-restriction groups – a meaningful decrease, said Dr. Yancy. “I think a 0.5% difference would have some clinical significance in terms of complications from diabetes,” he said. “So 1% would be even more clinically meaningful.”

However, fewer participants taking insulin in the calorie-restriction group could explain the difference, according to Ms. Pavlou. “Usually, when someone goes on insulin, their pancreas is already not functioning as well,” she said. “And it’s way harder to see improvements in their A1c and glycemic control.”

Up to 90% of people with type 2 diabetes are overweight or obese. Weight loss is one of the major components of type 2 diabetes care, according to the American Diabetes Association, and studies have shown that even a 5% reduction in body weight can reduce blood glucose concentration and A1c. Some studies suggest diabetes remission can occur after a 10% loss in body weight, but Dr. Yancy said it depends on the person.

“It depends on the individual, their metabolic situation, how long they’ve had diabetes, what kind of approach they’re following, maybe what medicines they’re taking,” Dr. Yancy said. “There’s a lot of different factors involved in remission.”

The study cohort generally had advanced diabetes and was taking a mix of medications, so the results might not be applicable to people with a more recent diabetes diagnosis, according to Ms. Pavlou.

Dr. Yancy said intermittent fasting could work well for the right person. The success of the approach could depend on a person’s eating habits and whether their meals usually fall outside the time-restricted window, or it could depend on how well a person follows rules, according to Dr. Yancy.

“Some people might not eat much after 8 o’clock, and some people might skip breakfast,” Dr. Yancy said. “And if that’s the case, then it’s not going to make a big impact on their weight probably.”

Medication is also an important consideration. Not eating can be dangerous for patients taking short-acting insulin or sulfonylureas, according to Dr. Yancy.

Ms. Pavlou said these findings show intermittent fasting is another option for patients with type 2 diabetes trying to lose weight. “If you’ve tried calorie counting, that’s not working for you or if you’re kind of burnt out, this is something else that you could try,” she said.

“We have a lot of patients that need to lose weight, and we have patients who respond differently to different approaches,” said Dr. Yancy. “So having various approaches is really valuable.”

The manuscript is currently under review at JAMA Internal Medicine, said Ms. Pavlou.
 

A version of this article appeared on Medscape.com.

Two newly approved respiratory syncytial virus (RSV) vaccines for adults aged 60 years and older may be able to prevent illness in those at risk for severe RSV disease.

Most adult RSV illness occurs among the older age group and results in an estimated 60,000-160,000 hospitalizations and 6,000-10,000 deaths per year among people aged at least 65 years.

Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinicians, said authors of a Centers for Disease Control and Prevention report.

Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.
 

Two new vaccines

In May, the Food and Drug Administration approved the first of two vaccines for preventing RSV lower respiratory tract disease for adults aged at least 60 years.

On June 21, the Advisory Committee on Immunization Practices (ACIP) recommended that people in that age group receive a single dose of RSV vaccine using shared decision-making.

The recommendation for shared decision-making makes the ACIP decision different from routine and risk-based vaccine recommendations. Rather than targeting all in a particular age group or risk group, the decision calls for consideration of a patients’ risk for disease and their characteristics, preferences, and values; the health care professional’s clinical discretion; and performance of the vaccine.

Dr. Melgar and colleagues reported that vaccination with one dose of the GSK or Pfizer RSV vaccines has proved moderately to highly effective in preventing symptomatic RSV-associated lower respiratory tract disease over two consecutive RSV seasons among people aged 60 and older.

The trials that led to approval weren’t powered to gauge efficacy against RSV-associated hospitalization and death. However, the authors wrote, the prevention of lower respiratory tract disease, including medically attended illness, suggests that the shots might prevent considerable morbidity from RSV disease among those aged 60 and older.

Both vaccines were generally well tolerated with a good safety profile. However, six cases of inflammatory neurologic events (including Guillain-Barré Syndrome, acute disseminated encephalomyelitis, and others) were reported in clinical trials after RSV vaccination.

“Whether these events occurred due to chance, or whether RSV vaccination increases the risk for inflammatory neurologic events, is currently unknown,” the authors wrote.

Postmarketing surveillance may help clarify the existence of any potential risk, but until those results are clearer, the CDC researchers said, RSV vaccinations should be targeted to older adults at highest risk for severe RSV and those most likely to benefit from the shots.
 

At higher risk

Some adults with certain medical conditions have a higher risk for RSV-associated hospitalization, according to the report.

Those conditions include chronic obstructive pulmonary disease, asthma, heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, and chronic kidney disease.

People who are frail and of advanced age also are at higher risk for RSV hospitalization. That risk increases with age and the highest risk is for people aged at least 75 years.

The researchers added that RSV can cause severe disease in those with compromised immunity, including people who have received hematopoietic stem cell transplants and patients taking immunosuppressive drugs such as those used with solid organ transplants, cancer treatment, or other conditions.

As for when physicians should offer the vaccinations, shots are optimally given before the start of the RSV season.

However, the COVID-19 pandemic interrupted the seasonality and the timing has not yet returned to prepandemic patterns.

For the 2023-24 season, this report states, clinicians should offer RSV vaccination to adults aged at least 60 years using shared clinical decision-making as early as vaccine supply is available and should continue to offer vaccination to eligible adults who remain unvaccinated.

RSV vaccines can be administered with other adult vaccines during the same visit, the authors confirmed.
 

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

Two newly approved respiratory syncytial virus (RSV) vaccines for adults aged 60 years and older may be able to prevent illness in those at risk for severe RSV disease.

Most adult RSV illness occurs among the older age group and results in an estimated 60,000-160,000 hospitalizations and 6,000-10,000 deaths per year among people aged at least 65 years.

Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinicians, said authors of a Centers for Disease Control and Prevention report.

Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.
 

Two new vaccines

In May, the Food and Drug Administration approved the first of two vaccines for preventing RSV lower respiratory tract disease for adults aged at least 60 years.

On June 21, the Advisory Committee on Immunization Practices (ACIP) recommended that people in that age group receive a single dose of RSV vaccine using shared decision-making.

The recommendation for shared decision-making makes the ACIP decision different from routine and risk-based vaccine recommendations. Rather than targeting all in a particular age group or risk group, the decision calls for consideration of a patients’ risk for disease and their characteristics, preferences, and values; the health care professional’s clinical discretion; and performance of the vaccine.

Dr. Melgar and colleagues reported that vaccination with one dose of the GSK or Pfizer RSV vaccines has proved moderately to highly effective in preventing symptomatic RSV-associated lower respiratory tract disease over two consecutive RSV seasons among people aged 60 and older.

The trials that led to approval weren’t powered to gauge efficacy against RSV-associated hospitalization and death. However, the authors wrote, the prevention of lower respiratory tract disease, including medically attended illness, suggests that the shots might prevent considerable morbidity from RSV disease among those aged 60 and older.

Both vaccines were generally well tolerated with a good safety profile. However, six cases of inflammatory neurologic events (including Guillain-Barré Syndrome, acute disseminated encephalomyelitis, and others) were reported in clinical trials after RSV vaccination.

“Whether these events occurred due to chance, or whether RSV vaccination increases the risk for inflammatory neurologic events, is currently unknown,” the authors wrote.

Postmarketing surveillance may help clarify the existence of any potential risk, but until those results are clearer, the CDC researchers said, RSV vaccinations should be targeted to older adults at highest risk for severe RSV and those most likely to benefit from the shots.
 

At higher risk

Some adults with certain medical conditions have a higher risk for RSV-associated hospitalization, according to the report.

Those conditions include chronic obstructive pulmonary disease, asthma, heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, and chronic kidney disease.

People who are frail and of advanced age also are at higher risk for RSV hospitalization. That risk increases with age and the highest risk is for people aged at least 75 years.

The researchers added that RSV can cause severe disease in those with compromised immunity, including people who have received hematopoietic stem cell transplants and patients taking immunosuppressive drugs such as those used with solid organ transplants, cancer treatment, or other conditions.

As for when physicians should offer the vaccinations, shots are optimally given before the start of the RSV season.

However, the COVID-19 pandemic interrupted the seasonality and the timing has not yet returned to prepandemic patterns.

For the 2023-24 season, this report states, clinicians should offer RSV vaccination to adults aged at least 60 years using shared clinical decision-making as early as vaccine supply is available and should continue to offer vaccination to eligible adults who remain unvaccinated.

RSV vaccines can be administered with other adult vaccines during the same visit, the authors confirmed.
 

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

Two newly approved respiratory syncytial virus (RSV) vaccines for adults aged 60 years and older may be able to prevent illness in those at risk for severe RSV disease.

Most adult RSV illness occurs among the older age group and results in an estimated 60,000-160,000 hospitalizations and 6,000-10,000 deaths per year among people aged at least 65 years.

Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinicians, said authors of a Centers for Disease Control and Prevention report.

Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.
 

Two new vaccines

In May, the Food and Drug Administration approved the first of two vaccines for preventing RSV lower respiratory tract disease for adults aged at least 60 years.

On June 21, the Advisory Committee on Immunization Practices (ACIP) recommended that people in that age group receive a single dose of RSV vaccine using shared decision-making.

The recommendation for shared decision-making makes the ACIP decision different from routine and risk-based vaccine recommendations. Rather than targeting all in a particular age group or risk group, the decision calls for consideration of a patients’ risk for disease and their characteristics, preferences, and values; the health care professional’s clinical discretion; and performance of the vaccine.

Dr. Melgar and colleagues reported that vaccination with one dose of the GSK or Pfizer RSV vaccines has proved moderately to highly effective in preventing symptomatic RSV-associated lower respiratory tract disease over two consecutive RSV seasons among people aged 60 and older.

The trials that led to approval weren’t powered to gauge efficacy against RSV-associated hospitalization and death. However, the authors wrote, the prevention of lower respiratory tract disease, including medically attended illness, suggests that the shots might prevent considerable morbidity from RSV disease among those aged 60 and older.

Both vaccines were generally well tolerated with a good safety profile. However, six cases of inflammatory neurologic events (including Guillain-Barré Syndrome, acute disseminated encephalomyelitis, and others) were reported in clinical trials after RSV vaccination.

“Whether these events occurred due to chance, or whether RSV vaccination increases the risk for inflammatory neurologic events, is currently unknown,” the authors wrote.

Postmarketing surveillance may help clarify the existence of any potential risk, but until those results are clearer, the CDC researchers said, RSV vaccinations should be targeted to older adults at highest risk for severe RSV and those most likely to benefit from the shots.
 

At higher risk

Some adults with certain medical conditions have a higher risk for RSV-associated hospitalization, according to the report.

Those conditions include chronic obstructive pulmonary disease, asthma, heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, and chronic kidney disease.

People who are frail and of advanced age also are at higher risk for RSV hospitalization. That risk increases with age and the highest risk is for people aged at least 75 years.

The researchers added that RSV can cause severe disease in those with compromised immunity, including people who have received hematopoietic stem cell transplants and patients taking immunosuppressive drugs such as those used with solid organ transplants, cancer treatment, or other conditions.

As for when physicians should offer the vaccinations, shots are optimally given before the start of the RSV season.

However, the COVID-19 pandemic interrupted the seasonality and the timing has not yet returned to prepandemic patterns.

For the 2023-24 season, this report states, clinicians should offer RSV vaccination to adults aged at least 60 years using shared clinical decision-making as early as vaccine supply is available and should continue to offer vaccination to eligible adults who remain unvaccinated.

RSV vaccines can be administered with other adult vaccines during the same visit, the authors confirmed.
 

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

BRISBANE, AUSTRALIA – Statins should be considered for primary prevention in people living with HIV who are at low to moderate risk of cardiovascular disease, according to final data from the REPRIEVE trial that show pitavastatin therapy is associated with a significantly lower risk of cardiovascular events than placebo.

“There was a significant 35% lower risk of major adverse cardiovascular events after a median follow-up of 5.1 years “ said Steven Grinspoon, MD, from Massachusetts General Hospital and Harvard Medical School in Boston, who presented the final analysis of data from the REPRIEVE trial at the International AIDS Society Conference on HIV Science.

The results were simultaneously published in the New England Journal of Medicine. The primary endpoint of major adverse cardiovascular events included a composite of outcomes that included cardiovascular death, stroke, myocardial infarction, hospitalization for unstable angina, and transient ischemic attack among those treated with pitavastatin, compared with placebo (95% confidence interval, 0.48-0.90; P = .002).

The REPRIEVE trial was halted earlier this year for efficacy after an interim analysis pointed to a significantly lower rate of cardiovascular events in the treatment group.

The international double-blind, placebo-controlled trial randomly assigned 7,769 people with HIV infection, who were at low to moderate risk of cardiovascular disease, to either 4 mg daily of pitavastatin calcium or placebo.

The secondary outcome – a composite of major cardiovascular events and all-cause mortality – also showed a significant 21% reduction in risk with pitavastatin treatment, compared with placebo (95% CI, 0.65-0.96).
 

Cardiovascular events in HIV

HIV infection is an independent risk factor for cardiovascular disease, Dr. Grinspoon pointed out, and those living with HIV have about double the risk of myocardial infarction and stroke, compared with the general population.

“There’s an unmet need for people living with HIV who have low to moderate traditional risk, for whom HIV is even considered a risk equivalent but for whom no primary prevention strategy has been tested in a large trial,” Dr. Grinspoon said during an interview.

Those enrolled in the study had a 10-year Atherosclerotic Cardiovascular Disease risk score ranging from 2.1% to 7%, with a median of 4.5%. While LDL cholesterol levels at baseline ranged from 87 to 128 mg/dL, the study showed a similar reduction in cardiovascular risk regardless of LDL.

“These are types of people who, if they came to the doctor’s office right now before REPRIEVE, they would largely be told your risk score is not really making you eligible for a statin,” Dr. Grinspoon said.

He explained that what is most interesting about the reduction in risk is that it was nearly twice what would be expected with LDL lowering, based on what has previously been seen in statin trials in non–HIV-positive populations.

“I think the data are suggesting that it’s certainly in part due to the reduction in LDL – that is very important – but it’s also due to other factors beyond changes in LDL,” Dr. Grinspoon said. He speculated that the statin could be affecting anti-inflammatory and immune pathways, and that this could account for some of the reduction in cardiovascular risk, but “those data are cooking, and they’re being analyzed as we speak.”

In a substudy analysis of REPRIEVE, Markella Zanni, MD, associate professor of medicine at Harvard Medical School and Massachusetts General Hospital, focused on the women in the clinical trial.
 

Women’s risk

In REPRIEVE, 31.1% of the study population were women. Dr. Zanni and her team investigated whether there are differences in the way HIV affects the risk of developing atherosclerotic cardiovascular disease in women, compared with men.

They found that women have both higher levels of inflammatory markers, such as interleukin-6, C-reactive protein, and D-dimer, but a lower prevalence of coronary artery plaques than men.

“This finding represents an interesting paradox given that high levels of select inflammatory markers have been associated with coronary artery plaque, both among women living with HIV and among men living with HIV,” Dr. Zanni explained.

She says the researchers were hoping to further explore whether inflammation is fueling the increased risk for atherosclerotic disease, and particularly the higher risk evident in women living with HIV, compared with men.

“Women living with HIV should discuss with their treating clinicians heart risks and possible prevention strategies, including statin therapy coupled with healthy lifestyle changes addressing modifiable, traditional metabolic risk factors” she said.
 

Time for primary prevention?

All patients in the study were on antiretroviral therapy and investigators report that pitavastatin does not interact with these medications. The median CD4 cell count was 621 cells/mm³, and 87.5% of participants had an HIV viral load below the lower limit of quantification.

Participants were enrolled from 12 countries including the United States, Spain, Brazil, South Africa, and Thailand, and around two-thirds were non-White. Individuals of South Asian ethnicity showed the biggest reduction in cardiovascular risk with pitavastatin treatment.

There was a 74% higher rate of muscle pain and weakness in the pitavastatin group – affecting 91 people in the treatment arm and 53 in the placebo arm – but the majority were low grade. The rate of rhabdomyolysis of grade 3 or above was lower in the statin group, with three cases, compared with four cases in the placebo group.

Commenting on the findings, Laura Waters, MD, a genitourinary and HIV medicine consultant at Central and North West London NHS Foundation Trust’s Mortimer Market Centre, said that, while HIV infection was considered a risk factor for cardiovascular disease, risk calculators don’t specifically adjust for HIV infection.

“Now that we’ve got effective HIV drugs and people can enjoy normal life expectancy, cardiovascular disease is a particular issue for people with HIV,” she said.

Dr. Waters, who was not involved with the study, suggested that people living with HIV should discuss the use of statins with their doctor, but she acknowledged there are some barriers to treatment in people living with HIV. “It’s another pill, and when it’s a borderline [decision] it is easy to say, ‘I have to think about it,’ ” she said, with the result that statin treatment is often deferred.

The REPRIEVE study was supported by grants from the National Institutes of Health, Kowa Pharmaceuticals America, Gilead Sciences, and ViiV Healthcare. Dr. Grinspoon declared institutional grants from National Institutes of Health, Kowa Pharmaceuticals America, Gilead Sciences, and ViiV Healthcare and consultancies unrelated to the study. Dr. Zanni reports no relevant financial relationships.

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

BRISBANE, AUSTRALIA – Statins should be considered for primary prevention in people living with HIV who are at low to moderate risk of cardiovascular disease, according to final data from the REPRIEVE trial that show pitavastatin therapy is associated with a significantly lower risk of cardiovascular events than placebo.

“There was a significant 35% lower risk of major adverse cardiovascular events after a median follow-up of 5.1 years “ said Steven Grinspoon, MD, from Massachusetts General Hospital and Harvard Medical School in Boston, who presented the final analysis of data from the REPRIEVE trial at the International AIDS Society Conference on HIV Science.

The results were simultaneously published in the New England Journal of Medicine. The primary endpoint of major adverse cardiovascular events included a composite of outcomes that included cardiovascular death, stroke, myocardial infarction, hospitalization for unstable angina, and transient ischemic attack among those treated with pitavastatin, compared with placebo (95% confidence interval, 0.48-0.90; P = .002).

The REPRIEVE trial was halted earlier this year for efficacy after an interim analysis pointed to a significantly lower rate of cardiovascular events in the treatment group.

The international double-blind, placebo-controlled trial randomly assigned 7,769 people with HIV infection, who were at low to moderate risk of cardiovascular disease, to either 4 mg daily of pitavastatin calcium or placebo.

The secondary outcome – a composite of major cardiovascular events and all-cause mortality – also showed a significant 21% reduction in risk with pitavastatin treatment, compared with placebo (95% CI, 0.65-0.96).
 

Cardiovascular events in HIV

HIV infection is an independent risk factor for cardiovascular disease, Dr. Grinspoon pointed out, and those living with HIV have about double the risk of myocardial infarction and stroke, compared with the general population.

“There’s an unmet need for people living with HIV who have low to moderate traditional risk, for whom HIV is even considered a risk equivalent but for whom no primary prevention strategy has been tested in a large trial,” Dr. Grinspoon said during an interview.

Those enrolled in the study had a 10-year Atherosclerotic Cardiovascular Disease risk score ranging from 2.1% to 7%, with a median of 4.5%. While LDL cholesterol levels at baseline ranged from 87 to 128 mg/dL, the study showed a similar reduction in cardiovascular risk regardless of LDL.

“These are types of people who, if they came to the doctor’s office right now before REPRIEVE, they would largely be told your risk score is not really making you eligible for a statin,” Dr. Grinspoon said.

He explained that what is most interesting about the reduction in risk is that it was nearly twice what would be expected with LDL lowering, based on what has previously been seen in statin trials in non–HIV-positive populations.

“I think the data are suggesting that it’s certainly in part due to the reduction in LDL – that is very important – but it’s also due to other factors beyond changes in LDL,” Dr. Grinspoon said. He speculated that the statin could be affecting anti-inflammatory and immune pathways, and that this could account for some of the reduction in cardiovascular risk, but “those data are cooking, and they’re being analyzed as we speak.”

In a substudy analysis of REPRIEVE, Markella Zanni, MD, associate professor of medicine at Harvard Medical School and Massachusetts General Hospital, focused on the women in the clinical trial.
 

Women’s risk

In REPRIEVE, 31.1% of the study population were women. Dr. Zanni and her team investigated whether there are differences in the way HIV affects the risk of developing atherosclerotic cardiovascular disease in women, compared with men.

They found that women have both higher levels of inflammatory markers, such as interleukin-6, C-reactive protein, and D-dimer, but a lower prevalence of coronary artery plaques than men.

“This finding represents an interesting paradox given that high levels of select inflammatory markers have been associated with coronary artery plaque, both among women living with HIV and among men living with HIV,” Dr. Zanni explained.

She says the researchers were hoping to further explore whether inflammation is fueling the increased risk for atherosclerotic disease, and particularly the higher risk evident in women living with HIV, compared with men.

“Women living with HIV should discuss with their treating clinicians heart risks and possible prevention strategies, including statin therapy coupled with healthy lifestyle changes addressing modifiable, traditional metabolic risk factors” she said.
 

Time for primary prevention?

All patients in the study were on antiretroviral therapy and investigators report that pitavastatin does not interact with these medications. The median CD4 cell count was 621 cells/mm³, and 87.5% of participants had an HIV viral load below the lower limit of quantification.

Participants were enrolled from 12 countries including the United States, Spain, Brazil, South Africa, and Thailand, and around two-thirds were non-White. Individuals of South Asian ethnicity showed the biggest reduction in cardiovascular risk with pitavastatin treatment.

There was a 74% higher rate of muscle pain and weakness in the pitavastatin group – affecting 91 people in the treatment arm and 53 in the placebo arm – but the majority were low grade. The rate of rhabdomyolysis of grade 3 or above was lower in the statin group, with three cases, compared with four cases in the placebo group.

Commenting on the findings, Laura Waters, MD, a genitourinary and HIV medicine consultant at Central and North West London NHS Foundation Trust’s Mortimer Market Centre, said that, while HIV infection was considered a risk factor for cardiovascular disease, risk calculators don’t specifically adjust for HIV infection.

“Now that we’ve got effective HIV drugs and people can enjoy normal life expectancy, cardiovascular disease is a particular issue for people with HIV,” she said.

Dr. Waters, who was not involved with the study, suggested that people living with HIV should discuss the use of statins with their doctor, but she acknowledged there are some barriers to treatment in people living with HIV. “It’s another pill, and when it’s a borderline [decision] it is easy to say, ‘I have to think about it,’ ” she said, with the result that statin treatment is often deferred.

The REPRIEVE study was supported by grants from the National Institutes of Health, Kowa Pharmaceuticals America, Gilead Sciences, and ViiV Healthcare. Dr. Grinspoon declared institutional grants from National Institutes of Health, Kowa Pharmaceuticals America, Gilead Sciences, and ViiV Healthcare and consultancies unrelated to the study. Dr. Zanni reports no relevant financial relationships.

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

BRISBANE, AUSTRALIA – Statins should be considered for primary prevention in people living with HIV who are at low to moderate risk of cardiovascular disease, according to final data from the REPRIEVE trial that show pitavastatin therapy is associated with a significantly lower risk of cardiovascular events than placebo.

“There was a significant 35% lower risk of major adverse cardiovascular events after a median follow-up of 5.1 years “ said Steven Grinspoon, MD, from Massachusetts General Hospital and Harvard Medical School in Boston, who presented the final analysis of data from the REPRIEVE trial at the International AIDS Society Conference on HIV Science.

The results were simultaneously published in the New England Journal of Medicine. The primary endpoint of major adverse cardiovascular events included a composite of outcomes that included cardiovascular death, stroke, myocardial infarction, hospitalization for unstable angina, and transient ischemic attack among those treated with pitavastatin, compared with placebo (95% confidence interval, 0.48-0.90; P = .002).

The REPRIEVE trial was halted earlier this year for efficacy after an interim analysis pointed to a significantly lower rate of cardiovascular events in the treatment group.

The international double-blind, placebo-controlled trial randomly assigned 7,769 people with HIV infection, who were at low to moderate risk of cardiovascular disease, to either 4 mg daily of pitavastatin calcium or placebo.

The secondary outcome – a composite of major cardiovascular events and all-cause mortality – also showed a significant 21% reduction in risk with pitavastatin treatment, compared with placebo (95% CI, 0.65-0.96).
 

Cardiovascular events in HIV

HIV infection is an independent risk factor for cardiovascular disease, Dr. Grinspoon pointed out, and those living with HIV have about double the risk of myocardial infarction and stroke, compared with the general population.

“There’s an unmet need for people living with HIV who have low to moderate traditional risk, for whom HIV is even considered a risk equivalent but for whom no primary prevention strategy has been tested in a large trial,” Dr. Grinspoon said during an interview.

Those enrolled in the study had a 10-year Atherosclerotic Cardiovascular Disease risk score ranging from 2.1% to 7%, with a median of 4.5%. While LDL cholesterol levels at baseline ranged from 87 to 128 mg/dL, the study showed a similar reduction in cardiovascular risk regardless of LDL.

“These are types of people who, if they came to the doctor’s office right now before REPRIEVE, they would largely be told your risk score is not really making you eligible for a statin,” Dr. Grinspoon said.

He explained that what is most interesting about the reduction in risk is that it was nearly twice what would be expected with LDL lowering, based on what has previously been seen in statin trials in non–HIV-positive populations.

“I think the data are suggesting that it’s certainly in part due to the reduction in LDL – that is very important – but it’s also due to other factors beyond changes in LDL,” Dr. Grinspoon said. He speculated that the statin could be affecting anti-inflammatory and immune pathways, and that this could account for some of the reduction in cardiovascular risk, but “those data are cooking, and they’re being analyzed as we speak.”

In a substudy analysis of REPRIEVE, Markella Zanni, MD, associate professor of medicine at Harvard Medical School and Massachusetts General Hospital, focused on the women in the clinical trial.
 

Women’s risk

In REPRIEVE, 31.1% of the study population were women. Dr. Zanni and her team investigated whether there are differences in the way HIV affects the risk of developing atherosclerotic cardiovascular disease in women, compared with men.

They found that women have both higher levels of inflammatory markers, such as interleukin-6, C-reactive protein, and D-dimer, but a lower prevalence of coronary artery plaques than men.

“This finding represents an interesting paradox given that high levels of select inflammatory markers have been associated with coronary artery plaque, both among women living with HIV and among men living with HIV,” Dr. Zanni explained.

She says the researchers were hoping to further explore whether inflammation is fueling the increased risk for atherosclerotic disease, and particularly the higher risk evident in women living with HIV, compared with men.

“Women living with HIV should discuss with their treating clinicians heart risks and possible prevention strategies, including statin therapy coupled with healthy lifestyle changes addressing modifiable, traditional metabolic risk factors” she said.
 

Time for primary prevention?

All patients in the study were on antiretroviral therapy and investigators report that pitavastatin does not interact with these medications. The median CD4 cell count was 621 cells/mm³, and 87.5% of participants had an HIV viral load below the lower limit of quantification.

Participants were enrolled from 12 countries including the United States, Spain, Brazil, South Africa, and Thailand, and around two-thirds were non-White. Individuals of South Asian ethnicity showed the biggest reduction in cardiovascular risk with pitavastatin treatment.

There was a 74% higher rate of muscle pain and weakness in the pitavastatin group – affecting 91 people in the treatment arm and 53 in the placebo arm – but the majority were low grade. The rate of rhabdomyolysis of grade 3 or above was lower in the statin group, with three cases, compared with four cases in the placebo group.

Commenting on the findings, Laura Waters, MD, a genitourinary and HIV medicine consultant at Central and North West London NHS Foundation Trust’s Mortimer Market Centre, said that, while HIV infection was considered a risk factor for cardiovascular disease, risk calculators don’t specifically adjust for HIV infection.

“Now that we’ve got effective HIV drugs and people can enjoy normal life expectancy, cardiovascular disease is a particular issue for people with HIV,” she said.

Dr. Waters, who was not involved with the study, suggested that people living with HIV should discuss the use of statins with their doctor, but she acknowledged there are some barriers to treatment in people living with HIV. “It’s another pill, and when it’s a borderline [decision] it is easy to say, ‘I have to think about it,’ ” she said, with the result that statin treatment is often deferred.

The REPRIEVE study was supported by grants from the National Institutes of Health, Kowa Pharmaceuticals America, Gilead Sciences, and ViiV Healthcare. Dr. Grinspoon declared institutional grants from National Institutes of Health, Kowa Pharmaceuticals America, Gilead Sciences, and ViiV Healthcare and consultancies unrelated to the study. Dr. Zanni reports no relevant financial relationships.

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

Stable patients who have a diagnostic cardiac catheterization for multivessel disease or two-vessel proximal left anterior descending disease often have percutaneous coronary intervention (PCI) in the same session, possibly without input from a multidisciplinary heart team, a new study suggests.

The study, a retrospective analysis of more than 8,000 catheterization procedures in New York State during 2018 and 2019, was published in JACC: Cardiovascular Interventions.

Among the stable patients with multivessel disease or left main (LM) disease who had PCI, 78.4% of PCIs were performed in the same session as their diagnostic catheterization procedure, known as ad hoc PCI, a “surprisingly high rate,” the authors wrote.

The 2011 clinical guidelines in place during the study period advised coronary artery bypass graft (CABG) surgery as a class 1 recommendation for LM disease, whereas PCI is a lower-class recommendation (J Am Coll Cardiol. 2011;58:e44-e-122), they noted.

“Ad hoc PCI can be inadvisable when guidelines indicate that patients can realize better outcomes with CABG surgery,” lead study author Edward L. Hannan, PhD, MS, said in an interview. “The issue is that ad hoc PCI eliminates the opportunity for a multidisciplinary heart team to evaluate the patient.”

Dr. Hannan is principal investigator for the cardiac services program at the New York State Department of Health in Albany and distinguished professor emeritus at the University of Albany School of Public Health.

The researchers analyzed data from two mandatory New York State PCI and cardiac surgery registries, the Percutaneous Coronary Interventions Reporting System and the Cardiac Surgery Reporting System. A total of 91,146 patients had an index PCI from Dec. 1, 2017, to Nov. 30, 2019.

The study included patients who had two-vessel disease with proximal left anterior descending (PLAD) disease, three-vessel disease or unprotected LM disease. Exclusion criteria included a previous revascularization, among a host of other factors. The analysis also identified 10,122 patients who had coronary artery bypass graft (CABG) surgery in addition to the 8,196 patients who had PCI.

The percentage for ad hoc PCI ranged from 58.7% for those with unprotected LM disease to 85.4% for patients with two-vessel PLAD. Among the patients who had PCI for three-vessel disease, 76.7% had an ad hoc PCI.

Selected subgroups had lower ad hoc PCI rates. When patients who had a myocardial infarction within 1-7 days were excluded, the ad hoc percentage decreased slightly to 77.2%. PCI patients with diabetes were also less likely to have ad hoc PCI (75.7% vs. 80.4%, P < .0001), as were patients with compromised left ventricular ejection fraction (< 35%; 64.6% vs. 80.5%, P < .0001).

When all revascularizations – PCI plus CABG – were taken into account, the rate of ad hoc PCIs was 35.1%. Rates were 63.9% for patients with two-vessel PLAD disease, 32.4% for those with three-vessel disease, and 11.5% for patients with unprotected LM disease.

One potential disadvantage of ad hoc PCI, the authors noted, is that it doesn’t allow time for a multidisciplinary heart team to evaluate the patient for a different treatment, such as CABG or medical therapy. “This multidisciplinary team can evaluate all the pros and cons of different approaches, such as PCI vs. CABG surgery in this case,” Dr. Hannan said.

The study findings imply a potential overutilization of PCI and a greater likelihood of forgoing a more appropriate intervention, he said, “given that we have chosen for the study groups of patients who in general benefit more with CABG surgery.”

The results also showed variability in ad hoc PCI rates among hospitals and physicians. “They are large enough to suggest that there is a fairly large variation across the state in the use of heart teams,” he said.

For unprotected LM disease, the risk adjusted rate for hospitals of ad hoc PCIs among all PCIs ranged from 25.6% in the lowest quartile to 93.7% in the highest. Physician rates of ad hoc PCIs for the same indication, which were ranked by tertile, ranged from 22% for the lowest to 84.3% for the highest (P < .001).

One strength of the study, Dr. Hannan said, is that it is a large population-based study that excluded groups for whom an ad hoc PCI would be appropriate, such as emergency patients. One limitation is that it did not account for legitimate reasons for ad hoc PCI, including contraindications for CABG surgery and patient refusal of CABG surgery.

In an invited editorial comment, James C. Blankenship, MD, and Krishna Patel, MD, wrote that this study shows that “past criticisms of ad hoc PCI have had seemingly little effect.”

“The article provides a striking example of a difference between guideline-directed practice and real-life practice,” Dr. Blankenship said in an interview. “Guideline recommendations for the heart team approach are well known by interventionalists, so the findings of this study do not reflect ignorance of cardiologists.” Dr. Blankenship, a cardiologist and professor of medicine at the University of New Mexico in Albuquerque, is a coauthor of the 2011 PCI guidelines.

It’s more likely the study findings “reflect unconscious biases and sincere beliefs of patients and interventionalists that PCI rather than CABG is in patients’ best interests,” Dr. Blankenship said.

He noted the variation in practice across hospitals and individuals suggests an opportunity for improvement. “If the guidelines are correct, then perhaps interventionalists should be held accountable for making sure the heart team approach is followed,” he said. “Alternatively, perhaps a modified approach that guarantees patient-centered decision making and is ethically acceptable could be identified.”

The study received funding from the New York State Department of Health. Dr. Hannan and Dr. Blankenship and Dr. Patel have no relevant disclosures.

Stable patients who have a diagnostic cardiac catheterization for multivessel disease or two-vessel proximal left anterior descending disease often have percutaneous coronary intervention (PCI) in the same session, possibly without input from a multidisciplinary heart team, a new study suggests.

The study, a retrospective analysis of more than 8,000 catheterization procedures in New York State during 2018 and 2019, was published in JACC: Cardiovascular Interventions.

Among the stable patients with multivessel disease or left main (LM) disease who had PCI, 78.4% of PCIs were performed in the same session as their diagnostic catheterization procedure, known as ad hoc PCI, a “surprisingly high rate,” the authors wrote.

The 2011 clinical guidelines in place during the study period advised coronary artery bypass graft (CABG) surgery as a class 1 recommendation for LM disease, whereas PCI is a lower-class recommendation (J Am Coll Cardiol. 2011;58:e44-e-122), they noted.

“Ad hoc PCI can be inadvisable when guidelines indicate that patients can realize better outcomes with CABG surgery,” lead study author Edward L. Hannan, PhD, MS, said in an interview. “The issue is that ad hoc PCI eliminates the opportunity for a multidisciplinary heart team to evaluate the patient.”

Dr. Hannan is principal investigator for the cardiac services program at the New York State Department of Health in Albany and distinguished professor emeritus at the University of Albany School of Public Health.

The researchers analyzed data from two mandatory New York State PCI and cardiac surgery registries, the Percutaneous Coronary Interventions Reporting System and the Cardiac Surgery Reporting System. A total of 91,146 patients had an index PCI from Dec. 1, 2017, to Nov. 30, 2019.

The study included patients who had two-vessel disease with proximal left anterior descending (PLAD) disease, three-vessel disease or unprotected LM disease. Exclusion criteria included a previous revascularization, among a host of other factors. The analysis also identified 10,122 patients who had coronary artery bypass graft (CABG) surgery in addition to the 8,196 patients who had PCI.

The percentage for ad hoc PCI ranged from 58.7% for those with unprotected LM disease to 85.4% for patients with two-vessel PLAD. Among the patients who had PCI for three-vessel disease, 76.7% had an ad hoc PCI.

Selected subgroups had lower ad hoc PCI rates. When patients who had a myocardial infarction within 1-7 days were excluded, the ad hoc percentage decreased slightly to 77.2%. PCI patients with diabetes were also less likely to have ad hoc PCI (75.7% vs. 80.4%, P < .0001), as were patients with compromised left ventricular ejection fraction (< 35%; 64.6% vs. 80.5%, P < .0001).

When all revascularizations – PCI plus CABG – were taken into account, the rate of ad hoc PCIs was 35.1%. Rates were 63.9% for patients with two-vessel PLAD disease, 32.4% for those with three-vessel disease, and 11.5% for patients with unprotected LM disease.

One potential disadvantage of ad hoc PCI, the authors noted, is that it doesn’t allow time for a multidisciplinary heart team to evaluate the patient for a different treatment, such as CABG or medical therapy. “This multidisciplinary team can evaluate all the pros and cons of different approaches, such as PCI vs. CABG surgery in this case,” Dr. Hannan said.

The study findings imply a potential overutilization of PCI and a greater likelihood of forgoing a more appropriate intervention, he said, “given that we have chosen for the study groups of patients who in general benefit more with CABG surgery.”

The results also showed variability in ad hoc PCI rates among hospitals and physicians. “They are large enough to suggest that there is a fairly large variation across the state in the use of heart teams,” he said.

For unprotected LM disease, the risk adjusted rate for hospitals of ad hoc PCIs among all PCIs ranged from 25.6% in the lowest quartile to 93.7% in the highest. Physician rates of ad hoc PCIs for the same indication, which were ranked by tertile, ranged from 22% for the lowest to 84.3% for the highest (P < .001).

One strength of the study, Dr. Hannan said, is that it is a large population-based study that excluded groups for whom an ad hoc PCI would be appropriate, such as emergency patients. One limitation is that it did not account for legitimate reasons for ad hoc PCI, including contraindications for CABG surgery and patient refusal of CABG surgery.

In an invited editorial comment, James C. Blankenship, MD, and Krishna Patel, MD, wrote that this study shows that “past criticisms of ad hoc PCI have had seemingly little effect.”

“The article provides a striking example of a difference between guideline-directed practice and real-life practice,” Dr. Blankenship said in an interview. “Guideline recommendations for the heart team approach are well known by interventionalists, so the findings of this study do not reflect ignorance of cardiologists.” Dr. Blankenship, a cardiologist and professor of medicine at the University of New Mexico in Albuquerque, is a coauthor of the 2011 PCI guidelines.

It’s more likely the study findings “reflect unconscious biases and sincere beliefs of patients and interventionalists that PCI rather than CABG is in patients’ best interests,” Dr. Blankenship said.

He noted the variation in practice across hospitals and individuals suggests an opportunity for improvement. “If the guidelines are correct, then perhaps interventionalists should be held accountable for making sure the heart team approach is followed,” he said. “Alternatively, perhaps a modified approach that guarantees patient-centered decision making and is ethically acceptable could be identified.”

The study received funding from the New York State Department of Health. Dr. Hannan and Dr. Blankenship and Dr. Patel have no relevant disclosures.

Stable patients who have a diagnostic cardiac catheterization for multivessel disease or two-vessel proximal left anterior descending disease often have percutaneous coronary intervention (PCI) in the same session, possibly without input from a multidisciplinary heart team, a new study suggests.

The study, a retrospective analysis of more than 8,000 catheterization procedures in New York State during 2018 and 2019, was published in JACC: Cardiovascular Interventions.

Among the stable patients with multivessel disease or left main (LM) disease who had PCI, 78.4% of PCIs were performed in the same session as their diagnostic catheterization procedure, known as ad hoc PCI, a “surprisingly high rate,” the authors wrote.

The 2011 clinical guidelines in place during the study period advised coronary artery bypass graft (CABG) surgery as a class 1 recommendation for LM disease, whereas PCI is a lower-class recommendation (J Am Coll Cardiol. 2011;58:e44-e-122), they noted.

“Ad hoc PCI can be inadvisable when guidelines indicate that patients can realize better outcomes with CABG surgery,” lead study author Edward L. Hannan, PhD, MS, said in an interview. “The issue is that ad hoc PCI eliminates the opportunity for a multidisciplinary heart team to evaluate the patient.”

Dr. Hannan is principal investigator for the cardiac services program at the New York State Department of Health in Albany and distinguished professor emeritus at the University of Albany School of Public Health.

The researchers analyzed data from two mandatory New York State PCI and cardiac surgery registries, the Percutaneous Coronary Interventions Reporting System and the Cardiac Surgery Reporting System. A total of 91,146 patients had an index PCI from Dec. 1, 2017, to Nov. 30, 2019.

The study included patients who had two-vessel disease with proximal left anterior descending (PLAD) disease, three-vessel disease or unprotected LM disease. Exclusion criteria included a previous revascularization, among a host of other factors. The analysis also identified 10,122 patients who had coronary artery bypass graft (CABG) surgery in addition to the 8,196 patients who had PCI.

The percentage for ad hoc PCI ranged from 58.7% for those with unprotected LM disease to 85.4% for patients with two-vessel PLAD. Among the patients who had PCI for three-vessel disease, 76.7% had an ad hoc PCI.

Selected subgroups had lower ad hoc PCI rates. When patients who had a myocardial infarction within 1-7 days were excluded, the ad hoc percentage decreased slightly to 77.2%. PCI patients with diabetes were also less likely to have ad hoc PCI (75.7% vs. 80.4%, P < .0001), as were patients with compromised left ventricular ejection fraction (< 35%; 64.6% vs. 80.5%, P < .0001).

When all revascularizations – PCI plus CABG – were taken into account, the rate of ad hoc PCIs was 35.1%. Rates were 63.9% for patients with two-vessel PLAD disease, 32.4% for those with three-vessel disease, and 11.5% for patients with unprotected LM disease.

One potential disadvantage of ad hoc PCI, the authors noted, is that it doesn’t allow time for a multidisciplinary heart team to evaluate the patient for a different treatment, such as CABG or medical therapy. “This multidisciplinary team can evaluate all the pros and cons of different approaches, such as PCI vs. CABG surgery in this case,” Dr. Hannan said.

The study findings imply a potential overutilization of PCI and a greater likelihood of forgoing a more appropriate intervention, he said, “given that we have chosen for the study groups of patients who in general benefit more with CABG surgery.”

The results also showed variability in ad hoc PCI rates among hospitals and physicians. “They are large enough to suggest that there is a fairly large variation across the state in the use of heart teams,” he said.

For unprotected LM disease, the risk adjusted rate for hospitals of ad hoc PCIs among all PCIs ranged from 25.6% in the lowest quartile to 93.7% in the highest. Physician rates of ad hoc PCIs for the same indication, which were ranked by tertile, ranged from 22% for the lowest to 84.3% for the highest (P < .001).

One strength of the study, Dr. Hannan said, is that it is a large population-based study that excluded groups for whom an ad hoc PCI would be appropriate, such as emergency patients. One limitation is that it did not account for legitimate reasons for ad hoc PCI, including contraindications for CABG surgery and patient refusal of CABG surgery.

In an invited editorial comment, James C. Blankenship, MD, and Krishna Patel, MD, wrote that this study shows that “past criticisms of ad hoc PCI have had seemingly little effect.”

“The article provides a striking example of a difference between guideline-directed practice and real-life practice,” Dr. Blankenship said in an interview. “Guideline recommendations for the heart team approach are well known by interventionalists, so the findings of this study do not reflect ignorance of cardiologists.” Dr. Blankenship, a cardiologist and professor of medicine at the University of New Mexico in Albuquerque, is a coauthor of the 2011 PCI guidelines.

It’s more likely the study findings “reflect unconscious biases and sincere beliefs of patients and interventionalists that PCI rather than CABG is in patients’ best interests,” Dr. Blankenship said.

He noted the variation in practice across hospitals and individuals suggests an opportunity for improvement. “If the guidelines are correct, then perhaps interventionalists should be held accountable for making sure the heart team approach is followed,” he said. “Alternatively, perhaps a modified approach that guarantees patient-centered decision making and is ethically acceptable could be identified.”

The study received funding from the New York State Department of Health. Dr. Hannan and Dr. Blankenship and Dr. Patel have no relevant disclosures.

Patients with cancer are at a high risk of venous thromboembolism (VTE)—in fact, it’s one of the leading causes of death in patients who receive systemic therapy for cancer. But as cancer treatment has evolved, have the incidence and risk of VTE changed too?

Researchers from Veterans Affairs Boston Healthcare System in Massachusetts conducted a study with 434,203 veterans to evaluate the pattern of VTE incidence over 16 years, focusing on the types of cancer, treatment, race and ethnicity, and other factors related to cancer-associated thrombosis (CAT).

In contrast with other large population studies, this study found the overall incidence of CAT remained largely stable over time. At 12 months, the incidence was 4.5%, with yearly trends ranging between 4.2% and 4.7%. “As expected,” the researchers say, the subset of patients receiving systemic therapy had a higher incidence of VTE at 12 months (7.7%) than did the overall cohort. The pattern was “particularly pronounced” in gynecologic, testicular, and kidney cancers, where the incidence of VTE was 2 to 3 times higher in the treated cohort compared with the overall cohort. 

Cancer type and diagnosis were the most statistically and clinically significant associations with CAT, with up to a 6-fold difference between cancer subtypes. The patients at the highest risk of VTE were those with pancreatic cancer and acute lymphoblastic leukemia.

Most studies have focused only on patients with solid tumors, but these researchers observed novel patterns among patients with hematologic neoplasms. Specifically, a higher incidence of VTE among patients with aggressive vs indolent leukemias and lymphomas. This trend, the researchers say, may be associated in part with catheter-related events.

Furthermore, the type of system treatment was associated with the risk of VTE, the researchers say, although to a lesser extent. Chemotherapy- and immunotherapy-based regimens had the highest risk of VTE, relative to no treatment. Targeted and endocrine therapy also carried a higher risk compared with no treatment but to a lesser degree.

The researchers found significant heterogeneity by race and ethnicity across cancer types. Non-Hispanic Black patients had about 20% higher risk of VTE compared with non-Hispanic White patients. Asian and Pacific Islander patients had about 20% lower risk compared with non-Hispanic White patients.

Male sex was also associated with VTE. However, “interestingly,” the researchers note, neighborhood-level socioeconomic factors and patients’ comorbidities were not associated with CAT but were associated with mortality.

Their results suggest that patient- and treatment-specific factors play a critical role in assessing the risk of CAT, and “ongoing efforts to identify these patterns are of utmost importance for risk stratification and prognostic assessment.”

Patients with cancer are at a high risk of venous thromboembolism (VTE)—in fact, it’s one of the leading causes of death in patients who receive systemic therapy for cancer. But as cancer treatment has evolved, have the incidence and risk of VTE changed too?

Researchers from Veterans Affairs Boston Healthcare System in Massachusetts conducted a study with 434,203 veterans to evaluate the pattern of VTE incidence over 16 years, focusing on the types of cancer, treatment, race and ethnicity, and other factors related to cancer-associated thrombosis (CAT).

In contrast with other large population studies, this study found the overall incidence of CAT remained largely stable over time. At 12 months, the incidence was 4.5%, with yearly trends ranging between 4.2% and 4.7%. “As expected,” the researchers say, the subset of patients receiving systemic therapy had a higher incidence of VTE at 12 months (7.7%) than did the overall cohort. The pattern was “particularly pronounced” in gynecologic, testicular, and kidney cancers, where the incidence of VTE was 2 to 3 times higher in the treated cohort compared with the overall cohort. 

Cancer type and diagnosis were the most statistically and clinically significant associations with CAT, with up to a 6-fold difference between cancer subtypes. The patients at the highest risk of VTE were those with pancreatic cancer and acute lymphoblastic leukemia.

Most studies have focused only on patients with solid tumors, but these researchers observed novel patterns among patients with hematologic neoplasms. Specifically, a higher incidence of VTE among patients with aggressive vs indolent leukemias and lymphomas. This trend, the researchers say, may be associated in part with catheter-related events.

Furthermore, the type of system treatment was associated with the risk of VTE, the researchers say, although to a lesser extent. Chemotherapy- and immunotherapy-based regimens had the highest risk of VTE, relative to no treatment. Targeted and endocrine therapy also carried a higher risk compared with no treatment but to a lesser degree.

The researchers found significant heterogeneity by race and ethnicity across cancer types. Non-Hispanic Black patients had about 20% higher risk of VTE compared with non-Hispanic White patients. Asian and Pacific Islander patients had about 20% lower risk compared with non-Hispanic White patients.

Male sex was also associated with VTE. However, “interestingly,” the researchers note, neighborhood-level socioeconomic factors and patients’ comorbidities were not associated with CAT but were associated with mortality.

Their results suggest that patient- and treatment-specific factors play a critical role in assessing the risk of CAT, and “ongoing efforts to identify these patterns are of utmost importance for risk stratification and prognostic assessment.”

Patients with cancer are at a high risk of venous thromboembolism (VTE)—in fact, it’s one of the leading causes of death in patients who receive systemic therapy for cancer. But as cancer treatment has evolved, have the incidence and risk of VTE changed too?

Researchers from Veterans Affairs Boston Healthcare System in Massachusetts conducted a study with 434,203 veterans to evaluate the pattern of VTE incidence over 16 years, focusing on the types of cancer, treatment, race and ethnicity, and other factors related to cancer-associated thrombosis (CAT).

In contrast with other large population studies, this study found the overall incidence of CAT remained largely stable over time. At 12 months, the incidence was 4.5%, with yearly trends ranging between 4.2% and 4.7%. “As expected,” the researchers say, the subset of patients receiving systemic therapy had a higher incidence of VTE at 12 months (7.7%) than did the overall cohort. The pattern was “particularly pronounced” in gynecologic, testicular, and kidney cancers, where the incidence of VTE was 2 to 3 times higher in the treated cohort compared with the overall cohort. 

Cancer type and diagnosis were the most statistically and clinically significant associations with CAT, with up to a 6-fold difference between cancer subtypes. The patients at the highest risk of VTE were those with pancreatic cancer and acute lymphoblastic leukemia.

Most studies have focused only on patients with solid tumors, but these researchers observed novel patterns among patients with hematologic neoplasms. Specifically, a higher incidence of VTE among patients with aggressive vs indolent leukemias and lymphomas. This trend, the researchers say, may be associated in part with catheter-related events.

Furthermore, the type of system treatment was associated with the risk of VTE, the researchers say, although to a lesser extent. Chemotherapy- and immunotherapy-based regimens had the highest risk of VTE, relative to no treatment. Targeted and endocrine therapy also carried a higher risk compared with no treatment but to a lesser degree.

The researchers found significant heterogeneity by race and ethnicity across cancer types. Non-Hispanic Black patients had about 20% higher risk of VTE compared with non-Hispanic White patients. Asian and Pacific Islander patients had about 20% lower risk compared with non-Hispanic White patients.

Male sex was also associated with VTE. However, “interestingly,” the researchers note, neighborhood-level socioeconomic factors and patients’ comorbidities were not associated with CAT but were associated with mortality.

Their results suggest that patient- and treatment-specific factors play a critical role in assessing the risk of CAT, and “ongoing efforts to identify these patterns are of utmost importance for risk stratification and prognostic assessment.”

As the number of female veterans continues to grow, the US Department of Veterans Affairs (VA) is adjusting by focusing more on breast/gynecological cancer and referring fewer cases to outside clinicians.

The VA’s effort reflects the reality that female veterans from the wars in Afghanistan and Iraq are approaching the ages—50s, 60s, and 70s—when cancer diagnoses become more common, said Sarah Colonna, MD, national medical director of breast oncology for VA's Breast and Gynecologic Oncology System of Excellence and an oncologist at the Huntsman Cancer Institute and Wahlen VA Medical Center in Salt Lake City, Utah. “This is preparation for the change that we know is coming.”

In response, the Association of VA Hematology/Oncology (AVAHO) is devoting a regional meeting in Tampa, Florida (July 29, 2023) to improving survivorship for patients with women’s cancers. “This meeting is designed to educate both cancer experts and primary care providers on the care of women who have already gone through breast and gynecological cancer treatment,” Colonna explained.

Adherence Challenges

Colonna will speak in a session about the importance of adherence to endocrine therapy. “When we prescribe endocrine therapy for breast cancer, we usually ask women to stay on it for 5 to 10 years, and sometimes that’s hard for them,” she said. “I’ll talk about tips and tricks to help women stay on endocrine therapy for the long haul because we know that is linked to better survival.”

Between two-thirds and three-quarters of women with breast cancer are advised to stay on endocrine drugs, she said, but the medications can be difficult to tolerate due to adverse effects such as hot flashes and sleep disturbances.

In addition, patients are often anxious about the medications. “Women are very leery of anything that changes or makes their hormones different,” Colonna noted. “They feel like it’s messing with something that is natural for them.”

Colonna urges colleagues to focus on their “soft skills,” the ability to absorb and validate the worries of patients. Instead of dismissing them, she said, focus on messages that acknowledge concerns but are also firm: “That’s real, that sucks. But we’ve got to do it.”

It’s also helpful to guide patients away from thinking that taking a pill every day means they’re sick. “I try to flip that paradigm: ‘You’re taking this pill every day because you have power over this thing that happened to you.’”

Education is also key, she said, so that patients “understand very clearly why this medication is important for them: It increases the chance of surviving breast cancer or it increases the chances that the cancer will never come back in your arm or in your breast. Then, whether they make a decision to take it or not, at least they’re making the choice with knowledge.”

As for adverse effects, Colonna said medications such as antidepressants and painkillers can relieve hot flashes, which can disturb sleep.

Identifying the best strategy to address adverse effects “requires keeping in frequent contact with the patient during the first 6 months of endocrine therapy, which are really critical,” she said. “Once they’ve been on it for a year, they can see the light at the end of the tunnel and hang in there even if they have adverse effects.”

Some guidelines suggest that no doctor visits are needed until the 6-month mark, but Colonna prefers to check in at the 4- to 6-week mark, even if it’s just via a phone call. Otherwise, “often they’ll stop taking the pill, and then you won’t know about it until you see them at 6 six months.” At that point, she said, a critical period for treatment has passed.

The Role of Nurse Navigators

In another session at the Tampa regional meeting, AVAHO president-elect Cindy Bowman, MSN, RN, OCN, will moderate a session about the role of nurse navigators in VA cancer care. She is the coordinator of the Cancer Care Navigation Program at the C. W. Bill Young VA Medical Center in Bay Pines, Florida.

“Veterans become survivors the day they’re diagnosed with cancer,” she said. Within the VA, cancer-care navigator teams developed over the past decade aim to help patients find their way forward through survivorship, she said, and nurses are crucial to the effort.

As Sharp and Scheid reported in a 2018 Journal Oncology Navigation Survivorship article, “research demonstrates that navigation can improve access to the cancer care system by addressing barriers, as well as facilitating quality care. The benefits of patient navigation for improving cancer patient outcomes is considerable.” McKenney and colleagues found that “patient navigation has been demonstrated to increase access to screening, shorten time to diagnostic resolution, and improve cancer outcomes, particularly in health disparity populations, such as women of color, rural populations, and poor women.” 

According to Bowman, “it has become standard practice to have nurse navigators be there each step of the way from a high suspicion of cancer to diagnosis and through the clinical workup into active treatment and survivorship.” Within the VA, she said, “the focus right now is to look at standardizing care that all VAs will be able to offer holistic, comprehensive cancer-care navigation teams.”

At the regional meeting, Bowman’s session will include updates from nurse navigators about helping patients through breast/gynecological cancer, abnormal mammograms, and survivorship.

Nurse navigators are typically the second medical professionals who talk to cancer patients after their physicians, Bowman said. The unique knowledge of oncology nurse navigators gives them invaluable insight into treatment plans and cancer drug regimens, she said.

“They’re able to sit down and discuss the actual cancer drug regimen with patients—what each of those drugs do, how they’re administered, the short-term and long-term side effects,” she said. “They have the knowledge about all aspects of cancer care that can really only come from somebody who’s specialty trained.”

Other sessions at the AVAHO regional meeting will highlight breast cancer and lymphedema, breast cancer and bone health; diet, exercise and cancer; sexual health for breast/gynecological cancer survivors; and imaging surveillance after diagnosis.

As the number of female veterans continues to grow, the US Department of Veterans Affairs (VA) is adjusting by focusing more on breast/gynecological cancer and referring fewer cases to outside clinicians.

The VA’s effort reflects the reality that female veterans from the wars in Afghanistan and Iraq are approaching the ages—50s, 60s, and 70s—when cancer diagnoses become more common, said Sarah Colonna, MD, national medical director of breast oncology for VA's Breast and Gynecologic Oncology System of Excellence and an oncologist at the Huntsman Cancer Institute and Wahlen VA Medical Center in Salt Lake City, Utah. “This is preparation for the change that we know is coming.”

In response, the Association of VA Hematology/Oncology (AVAHO) is devoting a regional meeting in Tampa, Florida (July 29, 2023) to improving survivorship for patients with women’s cancers. “This meeting is designed to educate both cancer experts and primary care providers on the care of women who have already gone through breast and gynecological cancer treatment,” Colonna explained.

Adherence Challenges

Colonna will speak in a session about the importance of adherence to endocrine therapy. “When we prescribe endocrine therapy for breast cancer, we usually ask women to stay on it for 5 to 10 years, and sometimes that’s hard for them,” she said. “I’ll talk about tips and tricks to help women stay on endocrine therapy for the long haul because we know that is linked to better survival.”

Between two-thirds and three-quarters of women with breast cancer are advised to stay on endocrine drugs, she said, but the medications can be difficult to tolerate due to adverse effects such as hot flashes and sleep disturbances.

In addition, patients are often anxious about the medications. “Women are very leery of anything that changes or makes their hormones different,” Colonna noted. “They feel like it’s messing with something that is natural for them.”

Colonna urges colleagues to focus on their “soft skills,” the ability to absorb and validate the worries of patients. Instead of dismissing them, she said, focus on messages that acknowledge concerns but are also firm: “That’s real, that sucks. But we’ve got to do it.”

It’s also helpful to guide patients away from thinking that taking a pill every day means they’re sick. “I try to flip that paradigm: ‘You’re taking this pill every day because you have power over this thing that happened to you.’”

Education is also key, she said, so that patients “understand very clearly why this medication is important for them: It increases the chance of surviving breast cancer or it increases the chances that the cancer will never come back in your arm or in your breast. Then, whether they make a decision to take it or not, at least they’re making the choice with knowledge.”

As for adverse effects, Colonna said medications such as antidepressants and painkillers can relieve hot flashes, which can disturb sleep.

Identifying the best strategy to address adverse effects “requires keeping in frequent contact with the patient during the first 6 months of endocrine therapy, which are really critical,” she said. “Once they’ve been on it for a year, they can see the light at the end of the tunnel and hang in there even if they have adverse effects.”

Some guidelines suggest that no doctor visits are needed until the 6-month mark, but Colonna prefers to check in at the 4- to 6-week mark, even if it’s just via a phone call. Otherwise, “often they’ll stop taking the pill, and then you won’t know about it until you see them at 6 six months.” At that point, she said, a critical period for treatment has passed.

The Role of Nurse Navigators

In another session at the Tampa regional meeting, AVAHO president-elect Cindy Bowman, MSN, RN, OCN, will moderate a session about the role of nurse navigators in VA cancer care. She is the coordinator of the Cancer Care Navigation Program at the C. W. Bill Young VA Medical Center in Bay Pines, Florida.

“Veterans become survivors the day they’re diagnosed with cancer,” she said. Within the VA, cancer-care navigator teams developed over the past decade aim to help patients find their way forward through survivorship, she said, and nurses are crucial to the effort.

As Sharp and Scheid reported in a 2018 Journal Oncology Navigation Survivorship article, “research demonstrates that navigation can improve access to the cancer care system by addressing barriers, as well as facilitating quality care. The benefits of patient navigation for improving cancer patient outcomes is considerable.” McKenney and colleagues found that “patient navigation has been demonstrated to increase access to screening, shorten time to diagnostic resolution, and improve cancer outcomes, particularly in health disparity populations, such as women of color, rural populations, and poor women.” 

According to Bowman, “it has become standard practice to have nurse navigators be there each step of the way from a high suspicion of cancer to diagnosis and through the clinical workup into active treatment and survivorship.” Within the VA, she said, “the focus right now is to look at standardizing care that all VAs will be able to offer holistic, comprehensive cancer-care navigation teams.”

At the regional meeting, Bowman’s session will include updates from nurse navigators about helping patients through breast/gynecological cancer, abnormal mammograms, and survivorship.

Nurse navigators are typically the second medical professionals who talk to cancer patients after their physicians, Bowman said. The unique knowledge of oncology nurse navigators gives them invaluable insight into treatment plans and cancer drug regimens, she said.

“They’re able to sit down and discuss the actual cancer drug regimen with patients—what each of those drugs do, how they’re administered, the short-term and long-term side effects,” she said. “They have the knowledge about all aspects of cancer care that can really only come from somebody who’s specialty trained.”

Other sessions at the AVAHO regional meeting will highlight breast cancer and lymphedema, breast cancer and bone health; diet, exercise and cancer; sexual health for breast/gynecological cancer survivors; and imaging surveillance after diagnosis.

As the number of female veterans continues to grow, the US Department of Veterans Affairs (VA) is adjusting by focusing more on breast/gynecological cancer and referring fewer cases to outside clinicians.

The VA’s effort reflects the reality that female veterans from the wars in Afghanistan and Iraq are approaching the ages—50s, 60s, and 70s—when cancer diagnoses become more common, said Sarah Colonna, MD, national medical director of breast oncology for VA's Breast and Gynecologic Oncology System of Excellence and an oncologist at the Huntsman Cancer Institute and Wahlen VA Medical Center in Salt Lake City, Utah. “This is preparation for the change that we know is coming.”

In response, the Association of VA Hematology/Oncology (AVAHO) is devoting a regional meeting in Tampa, Florida (July 29, 2023) to improving survivorship for patients with women’s cancers. “This meeting is designed to educate both cancer experts and primary care providers on the care of women who have already gone through breast and gynecological cancer treatment,” Colonna explained.

Adherence Challenges

Colonna will speak in a session about the importance of adherence to endocrine therapy. “When we prescribe endocrine therapy for breast cancer, we usually ask women to stay on it for 5 to 10 years, and sometimes that’s hard for them,” she said. “I’ll talk about tips and tricks to help women stay on endocrine therapy for the long haul because we know that is linked to better survival.”

Between two-thirds and three-quarters of women with breast cancer are advised to stay on endocrine drugs, she said, but the medications can be difficult to tolerate due to adverse effects such as hot flashes and sleep disturbances.

In addition, patients are often anxious about the medications. “Women are very leery of anything that changes or makes their hormones different,” Colonna noted. “They feel like it’s messing with something that is natural for them.”

Colonna urges colleagues to focus on their “soft skills,” the ability to absorb and validate the worries of patients. Instead of dismissing them, she said, focus on messages that acknowledge concerns but are also firm: “That’s real, that sucks. But we’ve got to do it.”

It’s also helpful to guide patients away from thinking that taking a pill every day means they’re sick. “I try to flip that paradigm: ‘You’re taking this pill every day because you have power over this thing that happened to you.’”

Education is also key, she said, so that patients “understand very clearly why this medication is important for them: It increases the chance of surviving breast cancer or it increases the chances that the cancer will never come back in your arm or in your breast. Then, whether they make a decision to take it or not, at least they’re making the choice with knowledge.”

As for adverse effects, Colonna said medications such as antidepressants and painkillers can relieve hot flashes, which can disturb sleep.

Identifying the best strategy to address adverse effects “requires keeping in frequent contact with the patient during the first 6 months of endocrine therapy, which are really critical,” she said. “Once they’ve been on it for a year, they can see the light at the end of the tunnel and hang in there even if they have adverse effects.”

Some guidelines suggest that no doctor visits are needed until the 6-month mark, but Colonna prefers to check in at the 4- to 6-week mark, even if it’s just via a phone call. Otherwise, “often they’ll stop taking the pill, and then you won’t know about it until you see them at 6 six months.” At that point, she said, a critical period for treatment has passed.

The Role of Nurse Navigators

In another session at the Tampa regional meeting, AVAHO president-elect Cindy Bowman, MSN, RN, OCN, will moderate a session about the role of nurse navigators in VA cancer care. She is the coordinator of the Cancer Care Navigation Program at the C. W. Bill Young VA Medical Center in Bay Pines, Florida.

“Veterans become survivors the day they’re diagnosed with cancer,” she said. Within the VA, cancer-care navigator teams developed over the past decade aim to help patients find their way forward through survivorship, she said, and nurses are crucial to the effort.

As Sharp and Scheid reported in a 2018 Journal Oncology Navigation Survivorship article, “research demonstrates that navigation can improve access to the cancer care system by addressing barriers, as well as facilitating quality care. The benefits of patient navigation for improving cancer patient outcomes is considerable.” McKenney and colleagues found that “patient navigation has been demonstrated to increase access to screening, shorten time to diagnostic resolution, and improve cancer outcomes, particularly in health disparity populations, such as women of color, rural populations, and poor women.” 

According to Bowman, “it has become standard practice to have nurse navigators be there each step of the way from a high suspicion of cancer to diagnosis and through the clinical workup into active treatment and survivorship.” Within the VA, she said, “the focus right now is to look at standardizing care that all VAs will be able to offer holistic, comprehensive cancer-care navigation teams.”

At the regional meeting, Bowman’s session will include updates from nurse navigators about helping patients through breast/gynecological cancer, abnormal mammograms, and survivorship.

Nurse navigators are typically the second medical professionals who talk to cancer patients after their physicians, Bowman said. The unique knowledge of oncology nurse navigators gives them invaluable insight into treatment plans and cancer drug regimens, she said.

“They’re able to sit down and discuss the actual cancer drug regimen with patients—what each of those drugs do, how they’re administered, the short-term and long-term side effects,” she said. “They have the knowledge about all aspects of cancer care that can really only come from somebody who’s specialty trained.”

Other sessions at the AVAHO regional meeting will highlight breast cancer and lymphedema, breast cancer and bone health; diet, exercise and cancer; sexual health for breast/gynecological cancer survivors; and imaging surveillance after diagnosis.

Primary care utilization within a year of emergency general surgery was significantly associated with lower mortality up to 180 days later for older adults, based on data from more than 100,000 individuals.

Although previous research has shown the benefits of routine health and preventive care visits for surgery patients, many individuals in the United States live in areas with a shortage of primary care providers, wrote Sanford E. Roberts, MD, of the University of Pennsylvania, Philadelphia, and colleagues. The effect of primary care use on adverse outcomes after emergency general surgery, including mortality, remains unknown, they said.

In a study published in JAMA Surgery the researchers reviewed data from 102,384 Medicare patients aged 66 years and older who underwent emergency general surgery (EGS) between July 1, 2015, and June 30, 2018. Participants were classified into five EGS categories: colorectal, general abdominal, hepatopancreatobiliary, intestinal obstruction, and upper gastrointestinal. The mean age of the participants was 73.8 years; 8.4% were Black, 91.6% were White.

The primary outcome was mortality in hospital and at 30, 60, 90, and 180 days. In the year before hospitalization for EGS, 88,340 patients (86.3%) had visited a primary care physician.

After adjusting for multiple risk factors, the overall risk of in-hospital mortality was 19% lower for patients who had a history of primary care visits than for those without prior-year exposure to primary care (odds ratio, 0.81).

Mortality at 30 days was 27% lower overall in patients with primary care exposure, compared with those without primary care exposure (OR, 0.73). This trend continued at 60 days (OR, 0.75), 90 days (OR, 0.74), and 180 days (OR, 0.75); mortality rates at each time period were similar for Black and White patients with primary care exposure, both groups had reduced mortality, compared with those without primary care exposure.

However, when analyzed by race, in-hospital mortality was not significantly different for Black patients with and without primary care exposure (OR, 1.09), but in-hospital mortality was 21% less in White patients with primary care exposure (OR, 0.79). Interactions between race and primary care exposure related to mortality were not significantly different at any of the follow-up time points of 30, 60, 90, and 180 days.

“These findings suggest that primary care may be exerting a protective effect on postoperative morbidity and mortality,” the researchers wrote in their discussion. “This protective effect could be mediated through several different paths, such as identifying and managing a patient’s comorbidities, medically optimizing patients preoperatively, earlier detection of the primary EGS condition leading to early referral to treatment, and encouraging better lifestyle decisions,” they said.

The findings were limited by several factors including the retrospective design and inability to extract clinical data from a claims database, the researchers noted. Other limitations included potential confounding of unmeasured factors such as the other beneficial health behaviors often associated with seeking primary care.

Patients who avoid primary care may be more likely to delay presentation to the emergency department, which might promote poorer postoperative outcomes, the researchers said. Consequently, surgeons should consider primary care exposure in preoperative assessment, and perform a more comprehensive presurgical assessment as needed, the researchers said.

More studies are needed to examine trends in racial groups, but the results of the current study suggest that primary care provides similar benefits for Black and White individuals, and therefore could help reduce health disparities, they concluded.
 

Primary care benefits elude many patients

The current study shows a “rather dramatic” association between utilization of primary care within a year before surgery and patient mortality after surgery, wrote Caroline E. Reinke, MD, and David C. Slawson, MD, both of Atrium Health, Charlotte, N.C., in an accompanying editorial. The authors reiterated that possible reasons for the positive effect of primary care on postsurgical mortality included identification and management of comorbidities that could complicate surgery, as well as earlier detection of disease.

However, the editorialists noted that the benefits of primary care exposure depend on patient access to primary care, and on patient adherence to recommendations from their primary care provider. They identified barriers to potential effective interventions with primary care providers including time, money, and transportation.

An unanswered question is “whether the PCP visit itself is the causative factor associated with decreased mortality or if seeing a PCP on an annual basis is a marker of the patient possessing some other ‘magic sauce’ that improves outcomes,” they wrote.

Further, individuals in areas of primary care shortage also are more likely to lack the socioeconomic resources to benefit from primary care, the editorialists said. “Future evaluations of the interaction between PCP visits and social determinants of health may shed light on how to achieve the greatest impact,” they concluded.
 

Study supports value of consistent primary care

The increasingly aging population across the United States may undergo surgical procedures on an emergent basis and the current study provides data on the benefits of established and effective primary care for these individuals, said Noel Deep, MD, in an interview.

“Having data from this study supports the current position of many physicians and health care organizations and medical professional organizations that older individuals in particular, and adults in general, who have regular routine primary care visits tend to lead healthier lives and have better prognosis and quality of life,” said Dr. Deep, a general internist in private practice in Antigo, Wisc., who was not involved in the study. Dr. Deep also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.

The study findings reinforce what most physicians in primary care, himself included, have been advising adult patients, especially older adults about maintaining regular follow-up visits with their physicians for health screening and management of chronic medical conditions, Dr. Deep said in an interview.

However, barriers to the routine use of primary care to improve postsurgical outcomes include health illiteracy, being overwhelmed by a sudden change in health or emergent surgery, and lack of access to primary care physician, as well as issues such as transportation, financial difficulties, and physical limitations, Dr. Deep added.

“Patients who avoid routine health care visits with primary care may be lacking health insurance or financial resources, have time constraints or family responsibilities, or may be unaware of the benefits of routine health care,” he noted.

As for additional research, “I would like to see studies that can document the impact of having primary care physicians comanage these hospitalized patients in the perioperative period with continued follow-up in the postoperative/convalescent period,” said Dr. Deep.

The study was supported by the National Institute on Aging of the National Institutes of Health. Dr. Roberts disclosed grants from the National Institute on Aging and from NIH during the conduct of the study. The editorial author had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose and serves on the Editorial Advisory Board of Internal Medicine News.

Primary care utilization within a year of emergency general surgery was significantly associated with lower mortality up to 180 days later for older adults, based on data from more than 100,000 individuals.

Although previous research has shown the benefits of routine health and preventive care visits for surgery patients, many individuals in the United States live in areas with a shortage of primary care providers, wrote Sanford E. Roberts, MD, of the University of Pennsylvania, Philadelphia, and colleagues. The effect of primary care use on adverse outcomes after emergency general surgery, including mortality, remains unknown, they said.

In a study published in JAMA Surgery the researchers reviewed data from 102,384 Medicare patients aged 66 years and older who underwent emergency general surgery (EGS) between July 1, 2015, and June 30, 2018. Participants were classified into five EGS categories: colorectal, general abdominal, hepatopancreatobiliary, intestinal obstruction, and upper gastrointestinal. The mean age of the participants was 73.8 years; 8.4% were Black, 91.6% were White.

The primary outcome was mortality in hospital and at 30, 60, 90, and 180 days. In the year before hospitalization for EGS, 88,340 patients (86.3%) had visited a primary care physician.

After adjusting for multiple risk factors, the overall risk of in-hospital mortality was 19% lower for patients who had a history of primary care visits than for those without prior-year exposure to primary care (odds ratio, 0.81).

Mortality at 30 days was 27% lower overall in patients with primary care exposure, compared with those without primary care exposure (OR, 0.73). This trend continued at 60 days (OR, 0.75), 90 days (OR, 0.74), and 180 days (OR, 0.75); mortality rates at each time period were similar for Black and White patients with primary care exposure, both groups had reduced mortality, compared with those without primary care exposure.

However, when analyzed by race, in-hospital mortality was not significantly different for Black patients with and without primary care exposure (OR, 1.09), but in-hospital mortality was 21% less in White patients with primary care exposure (OR, 0.79). Interactions between race and primary care exposure related to mortality were not significantly different at any of the follow-up time points of 30, 60, 90, and 180 days.

“These findings suggest that primary care may be exerting a protective effect on postoperative morbidity and mortality,” the researchers wrote in their discussion. “This protective effect could be mediated through several different paths, such as identifying and managing a patient’s comorbidities, medically optimizing patients preoperatively, earlier detection of the primary EGS condition leading to early referral to treatment, and encouraging better lifestyle decisions,” they said.

The findings were limited by several factors including the retrospective design and inability to extract clinical data from a claims database, the researchers noted. Other limitations included potential confounding of unmeasured factors such as the other beneficial health behaviors often associated with seeking primary care.

Patients who avoid primary care may be more likely to delay presentation to the emergency department, which might promote poorer postoperative outcomes, the researchers said. Consequently, surgeons should consider primary care exposure in preoperative assessment, and perform a more comprehensive presurgical assessment as needed, the researchers said.

More studies are needed to examine trends in racial groups, but the results of the current study suggest that primary care provides similar benefits for Black and White individuals, and therefore could help reduce health disparities, they concluded.
 

Primary care benefits elude many patients

The current study shows a “rather dramatic” association between utilization of primary care within a year before surgery and patient mortality after surgery, wrote Caroline E. Reinke, MD, and David C. Slawson, MD, both of Atrium Health, Charlotte, N.C., in an accompanying editorial. The authors reiterated that possible reasons for the positive effect of primary care on postsurgical mortality included identification and management of comorbidities that could complicate surgery, as well as earlier detection of disease.

However, the editorialists noted that the benefits of primary care exposure depend on patient access to primary care, and on patient adherence to recommendations from their primary care provider. They identified barriers to potential effective interventions with primary care providers including time, money, and transportation.

An unanswered question is “whether the PCP visit itself is the causative factor associated with decreased mortality or if seeing a PCP on an annual basis is a marker of the patient possessing some other ‘magic sauce’ that improves outcomes,” they wrote.

Further, individuals in areas of primary care shortage also are more likely to lack the socioeconomic resources to benefit from primary care, the editorialists said. “Future evaluations of the interaction between PCP visits and social determinants of health may shed light on how to achieve the greatest impact,” they concluded.
 

Study supports value of consistent primary care

The increasingly aging population across the United States may undergo surgical procedures on an emergent basis and the current study provides data on the benefits of established and effective primary care for these individuals, said Noel Deep, MD, in an interview.

“Having data from this study supports the current position of many physicians and health care organizations and medical professional organizations that older individuals in particular, and adults in general, who have regular routine primary care visits tend to lead healthier lives and have better prognosis and quality of life,” said Dr. Deep, a general internist in private practice in Antigo, Wisc., who was not involved in the study. Dr. Deep also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.

The study findings reinforce what most physicians in primary care, himself included, have been advising adult patients, especially older adults about maintaining regular follow-up visits with their physicians for health screening and management of chronic medical conditions, Dr. Deep said in an interview.

However, barriers to the routine use of primary care to improve postsurgical outcomes include health illiteracy, being overwhelmed by a sudden change in health or emergent surgery, and lack of access to primary care physician, as well as issues such as transportation, financial difficulties, and physical limitations, Dr. Deep added.

“Patients who avoid routine health care visits with primary care may be lacking health insurance or financial resources, have time constraints or family responsibilities, or may be unaware of the benefits of routine health care,” he noted.

As for additional research, “I would like to see studies that can document the impact of having primary care physicians comanage these hospitalized patients in the perioperative period with continued follow-up in the postoperative/convalescent period,” said Dr. Deep.

The study was supported by the National Institute on Aging of the National Institutes of Health. Dr. Roberts disclosed grants from the National Institute on Aging and from NIH during the conduct of the study. The editorial author had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose and serves on the Editorial Advisory Board of Internal Medicine News.

Primary care utilization within a year of emergency general surgery was significantly associated with lower mortality up to 180 days later for older adults, based on data from more than 100,000 individuals.

Although previous research has shown the benefits of routine health and preventive care visits for surgery patients, many individuals in the United States live in areas with a shortage of primary care providers, wrote Sanford E. Roberts, MD, of the University of Pennsylvania, Philadelphia, and colleagues. The effect of primary care use on adverse outcomes after emergency general surgery, including mortality, remains unknown, they said.

In a study published in JAMA Surgery the researchers reviewed data from 102,384 Medicare patients aged 66 years and older who underwent emergency general surgery (EGS) between July 1, 2015, and June 30, 2018. Participants were classified into five EGS categories: colorectal, general abdominal, hepatopancreatobiliary, intestinal obstruction, and upper gastrointestinal. The mean age of the participants was 73.8 years; 8.4% were Black, 91.6% were White.

The primary outcome was mortality in hospital and at 30, 60, 90, and 180 days. In the year before hospitalization for EGS, 88,340 patients (86.3%) had visited a primary care physician.

After adjusting for multiple risk factors, the overall risk of in-hospital mortality was 19% lower for patients who had a history of primary care visits than for those without prior-year exposure to primary care (odds ratio, 0.81).

Mortality at 30 days was 27% lower overall in patients with primary care exposure, compared with those without primary care exposure (OR, 0.73). This trend continued at 60 days (OR, 0.75), 90 days (OR, 0.74), and 180 days (OR, 0.75); mortality rates at each time period were similar for Black and White patients with primary care exposure, both groups had reduced mortality, compared with those without primary care exposure.

However, when analyzed by race, in-hospital mortality was not significantly different for Black patients with and without primary care exposure (OR, 1.09), but in-hospital mortality was 21% less in White patients with primary care exposure (OR, 0.79). Interactions between race and primary care exposure related to mortality were not significantly different at any of the follow-up time points of 30, 60, 90, and 180 days.

“These findings suggest that primary care may be exerting a protective effect on postoperative morbidity and mortality,” the researchers wrote in their discussion. “This protective effect could be mediated through several different paths, such as identifying and managing a patient’s comorbidities, medically optimizing patients preoperatively, earlier detection of the primary EGS condition leading to early referral to treatment, and encouraging better lifestyle decisions,” they said.

The findings were limited by several factors including the retrospective design and inability to extract clinical data from a claims database, the researchers noted. Other limitations included potential confounding of unmeasured factors such as the other beneficial health behaviors often associated with seeking primary care.

Patients who avoid primary care may be more likely to delay presentation to the emergency department, which might promote poorer postoperative outcomes, the researchers said. Consequently, surgeons should consider primary care exposure in preoperative assessment, and perform a more comprehensive presurgical assessment as needed, the researchers said.

More studies are needed to examine trends in racial groups, but the results of the current study suggest that primary care provides similar benefits for Black and White individuals, and therefore could help reduce health disparities, they concluded.
 

Primary care benefits elude many patients

The current study shows a “rather dramatic” association between utilization of primary care within a year before surgery and patient mortality after surgery, wrote Caroline E. Reinke, MD, and David C. Slawson, MD, both of Atrium Health, Charlotte, N.C., in an accompanying editorial. The authors reiterated that possible reasons for the positive effect of primary care on postsurgical mortality included identification and management of comorbidities that could complicate surgery, as well as earlier detection of disease.

However, the editorialists noted that the benefits of primary care exposure depend on patient access to primary care, and on patient adherence to recommendations from their primary care provider. They identified barriers to potential effective interventions with primary care providers including time, money, and transportation.

An unanswered question is “whether the PCP visit itself is the causative factor associated with decreased mortality or if seeing a PCP on an annual basis is a marker of the patient possessing some other ‘magic sauce’ that improves outcomes,” they wrote.

Further, individuals in areas of primary care shortage also are more likely to lack the socioeconomic resources to benefit from primary care, the editorialists said. “Future evaluations of the interaction between PCP visits and social determinants of health may shed light on how to achieve the greatest impact,” they concluded.
 

Study supports value of consistent primary care

The increasingly aging population across the United States may undergo surgical procedures on an emergent basis and the current study provides data on the benefits of established and effective primary care for these individuals, said Noel Deep, MD, in an interview.

“Having data from this study supports the current position of many physicians and health care organizations and medical professional organizations that older individuals in particular, and adults in general, who have regular routine primary care visits tend to lead healthier lives and have better prognosis and quality of life,” said Dr. Deep, a general internist in private practice in Antigo, Wisc., who was not involved in the study. Dr. Deep also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.

The study findings reinforce what most physicians in primary care, himself included, have been advising adult patients, especially older adults about maintaining regular follow-up visits with their physicians for health screening and management of chronic medical conditions, Dr. Deep said in an interview.

However, barriers to the routine use of primary care to improve postsurgical outcomes include health illiteracy, being overwhelmed by a sudden change in health or emergent surgery, and lack of access to primary care physician, as well as issues such as transportation, financial difficulties, and physical limitations, Dr. Deep added.

“Patients who avoid routine health care visits with primary care may be lacking health insurance or financial resources, have time constraints or family responsibilities, or may be unaware of the benefits of routine health care,” he noted.

As for additional research, “I would like to see studies that can document the impact of having primary care physicians comanage these hospitalized patients in the perioperative period with continued follow-up in the postoperative/convalescent period,” said Dr. Deep.

The study was supported by the National Institute on Aging of the National Institutes of Health. Dr. Roberts disclosed grants from the National Institute on Aging and from NIH during the conduct of the study. The editorial author had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose and serves on the Editorial Advisory Board of Internal Medicine News.

Topline

The risk of venous thromboembolism is so high during neoadjuvant chemotherapy for advanced epithelial ovarian cancer that routine thromboprophylaxis may be warranted.

Methodology

• Investigators reviewed 154 consecutive cases of advanced stage epithelial ovarian cancer treated with neoadjuvant chemotherapy and interval cytoreductive surgery at the Mayo Clinic in Rochester, Minn.
• Their goal was to assess the incidence, timing, and risk factors for venous thromboembolism (VTE) from diagnosis through 6 months following surgery.
• VTEs were discovered due to symptoms, not screening.

Takeaways

• Overall, 33 women (21.4%) developed VTEs; 22 VTEs (66.67%) occurred between diagnosis and surgery; 4 (12.12%) were present at diagnosis, and 7 (21.21%) occurred after surgery.
• The researchers observed no statistically significant differences in risk factors – which included age, body mass index, functional status, histology, Khorana score, and smoking history – between women who did and did not develop a VTE.
• In the cohort, 11 women (33.3%) received a direct-acting oral anticoagulant (DOAC) to treat a VTE between VTE diagnosis and 180 days after interval cytoreductive surgery.  
• There were no significant differences in the number of intraoperative blood transfusions, blood loss, or bleeding complications between women who received and did not receive a DOAC.

In practice

The current study suggests that “two-thirds [of VTEs] may have been preventable” because they occurred between epithelial ovarian cancer diagnosis and interval cytoreductive surgery, the authors wrote. “Our study, like others, did not elucidate specific risk criteria in patients with advanced stage [epithelial ovarian cancer] who do and do not need thromboprophylaxis – begging the question that perhaps they all need thromboprophylaxis.”

Source

The work, led by Anousheh Shafa, MD, of Mayo Clinic’s department of obstetrics and gynecology, was published online in Gynecologic Oncology.  

Limitations

• The study was retrospective and had a small sample size.
• The study was not powered to identify risk factors associated with an increased risk of VTE.
• At Mayo Clinic, neoadjuvant chemotherapy is reserved for patients with large-volume or unresectable disease, poor nutritional status, or poor performance status; the data may not be as applicable in centers with different triage criteria for receiving neoadjuvant chemotherapy.

Disclosures:

Disclosures and funding sources were not reported.
 

A version of this article appeared on Medscape.com.

Topline

The risk of venous thromboembolism is so high during neoadjuvant chemotherapy for advanced epithelial ovarian cancer that routine thromboprophylaxis may be warranted.

Methodology

• Investigators reviewed 154 consecutive cases of advanced stage epithelial ovarian cancer treated with neoadjuvant chemotherapy and interval cytoreductive surgery at the Mayo Clinic in Rochester, Minn.
• Their goal was to assess the incidence, timing, and risk factors for venous thromboembolism (VTE) from diagnosis through 6 months following surgery.
• VTEs were discovered due to symptoms, not screening.

Takeaways

• Overall, 33 women (21.4%) developed VTEs; 22 VTEs (66.67%) occurred between diagnosis and surgery; 4 (12.12%) were present at diagnosis, and 7 (21.21%) occurred after surgery.
• The researchers observed no statistically significant differences in risk factors – which included age, body mass index, functional status, histology, Khorana score, and smoking history – between women who did and did not develop a VTE.
• In the cohort, 11 women (33.3%) received a direct-acting oral anticoagulant (DOAC) to treat a VTE between VTE diagnosis and 180 days after interval cytoreductive surgery.  
• There were no significant differences in the number of intraoperative blood transfusions, blood loss, or bleeding complications between women who received and did not receive a DOAC.

In practice

The current study suggests that “two-thirds [of VTEs] may have been preventable” because they occurred between epithelial ovarian cancer diagnosis and interval cytoreductive surgery, the authors wrote. “Our study, like others, did not elucidate specific risk criteria in patients with advanced stage [epithelial ovarian cancer] who do and do not need thromboprophylaxis – begging the question that perhaps they all need thromboprophylaxis.”

Source

The work, led by Anousheh Shafa, MD, of Mayo Clinic’s department of obstetrics and gynecology, was published online in Gynecologic Oncology.  

Limitations

• The study was retrospective and had a small sample size.
• The study was not powered to identify risk factors associated with an increased risk of VTE.
• At Mayo Clinic, neoadjuvant chemotherapy is reserved for patients with large-volume or unresectable disease, poor nutritional status, or poor performance status; the data may not be as applicable in centers with different triage criteria for receiving neoadjuvant chemotherapy.

Disclosures:

Disclosures and funding sources were not reported.
 

A version of this article appeared on Medscape.com.

Topline

The risk of venous thromboembolism is so high during neoadjuvant chemotherapy for advanced epithelial ovarian cancer that routine thromboprophylaxis may be warranted.

Methodology

• Investigators reviewed 154 consecutive cases of advanced stage epithelial ovarian cancer treated with neoadjuvant chemotherapy and interval cytoreductive surgery at the Mayo Clinic in Rochester, Minn.
• Their goal was to assess the incidence, timing, and risk factors for venous thromboembolism (VTE) from diagnosis through 6 months following surgery.
• VTEs were discovered due to symptoms, not screening.

Takeaways

• Overall, 33 women (21.4%) developed VTEs; 22 VTEs (66.67%) occurred between diagnosis and surgery; 4 (12.12%) were present at diagnosis, and 7 (21.21%) occurred after surgery.
• The researchers observed no statistically significant differences in risk factors – which included age, body mass index, functional status, histology, Khorana score, and smoking history – between women who did and did not develop a VTE.
• In the cohort, 11 women (33.3%) received a direct-acting oral anticoagulant (DOAC) to treat a VTE between VTE diagnosis and 180 days after interval cytoreductive surgery.  
• There were no significant differences in the number of intraoperative blood transfusions, blood loss, or bleeding complications between women who received and did not receive a DOAC.

In practice

The current study suggests that “two-thirds [of VTEs] may have been preventable” because they occurred between epithelial ovarian cancer diagnosis and interval cytoreductive surgery, the authors wrote. “Our study, like others, did not elucidate specific risk criteria in patients with advanced stage [epithelial ovarian cancer] who do and do not need thromboprophylaxis – begging the question that perhaps they all need thromboprophylaxis.”

Source

The work, led by Anousheh Shafa, MD, of Mayo Clinic’s department of obstetrics and gynecology, was published online in Gynecologic Oncology.  

Limitations

• The study was retrospective and had a small sample size.
• The study was not powered to identify risk factors associated with an increased risk of VTE.
• At Mayo Clinic, neoadjuvant chemotherapy is reserved for patients with large-volume or unresectable disease, poor nutritional status, or poor performance status; the data may not be as applicable in centers with different triage criteria for receiving neoadjuvant chemotherapy.

Disclosures:

Disclosures and funding sources were not reported.
 

A version of this article appeared on Medscape.com.

Topline

Short-course hypofractionated palliative radiation therapy improves quality of life in patients with poor-prognosis, high-grade gliomas.

Methodology

• Uncertainty persists about the value of palliative radiation, particularly longer regimens, among patients with high-grade gliomas. 
• To address the uncertainty, investigators administered quality of life (QoL) questionnaires to patients before receiving 35 Gy of palliative radiation in 10 fractions over 2 weeks, then again 1 month after treatment, followed by every 3 months until disease progression or death.
• Overall, 49 of 55 patients (89%) completed radiation treatment, and 42 completed the surveys. 
• QoL was assessed using the 100-point European Organization for Research and Treatment of Cancer QoL core questionnaire (QLQ-C30) and its brain cancer module (BN20).
• Two-thirds of patients were treated with temozolomide chemotherapy following radiation.

Takeaways

• There was clinically and statistically significant improvement 1 month after radiation therapy in patient-reported fatigue and dyspnea on the QLQ-C30.
• A clinically meaningful improvement – meaning a 10-point or greater improvement – was seen for insomnia. Other symptoms, such as nausea/vomiting, loss of appetite, constipation, diarrhea, and financial difficulty, remained stable over time.
• On the BN20, investigators reported clinically and statistically significant improvement in motor function; other symptoms remained stable. 
• Median progression-free survival was 8.4 months; median overall survival was 10.5 months.

In practice

“Short-course palliative hypofractionated radiotherapy in patients with poor-prognosis [high-grade glioma] does not impair QoL in the short term; but is rather associated with stable and/or improved QoL scores in several domains/symptom scales” at 1-3 months after treatment, “making it a viable resource-sparing alternative regimen,” the authors concluded.

Source

The work, led by Y. Baviskar of the Tata Memorial Hospital department of radiation oncology in Mumbai, India, was published July 11 in  Clinical Oncology.

Limitations

• It was a single-center study with no control arm.
• Fewer patients completed QoL forms over time, limiting longitudinal assessment to 3 months.
• Forms might have been completed by caregivers at times, raising questions about the veracity of responses.

Disclosures

• There was no external funding for the work.  
• The investigators report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Topline

Short-course hypofractionated palliative radiation therapy improves quality of life in patients with poor-prognosis, high-grade gliomas.

Methodology

• Uncertainty persists about the value of palliative radiation, particularly longer regimens, among patients with high-grade gliomas. 
• To address the uncertainty, investigators administered quality of life (QoL) questionnaires to patients before receiving 35 Gy of palliative radiation in 10 fractions over 2 weeks, then again 1 month after treatment, followed by every 3 months until disease progression or death.
• Overall, 49 of 55 patients (89%) completed radiation treatment, and 42 completed the surveys. 
• QoL was assessed using the 100-point European Organization for Research and Treatment of Cancer QoL core questionnaire (QLQ-C30) and its brain cancer module (BN20).
• Two-thirds of patients were treated with temozolomide chemotherapy following radiation.

Takeaways

• There was clinically and statistically significant improvement 1 month after radiation therapy in patient-reported fatigue and dyspnea on the QLQ-C30.
• A clinically meaningful improvement – meaning a 10-point or greater improvement – was seen for insomnia. Other symptoms, such as nausea/vomiting, loss of appetite, constipation, diarrhea, and financial difficulty, remained stable over time.
• On the BN20, investigators reported clinically and statistically significant improvement in motor function; other symptoms remained stable. 
• Median progression-free survival was 8.4 months; median overall survival was 10.5 months.

In practice

“Short-course palliative hypofractionated radiotherapy in patients with poor-prognosis [high-grade glioma] does not impair QoL in the short term; but is rather associated with stable and/or improved QoL scores in several domains/symptom scales” at 1-3 months after treatment, “making it a viable resource-sparing alternative regimen,” the authors concluded.

Source

The work, led by Y. Baviskar of the Tata Memorial Hospital department of radiation oncology in Mumbai, India, was published July 11 in  Clinical Oncology.

Limitations

• It was a single-center study with no control arm.
• Fewer patients completed QoL forms over time, limiting longitudinal assessment to 3 months.
• Forms might have been completed by caregivers at times, raising questions about the veracity of responses.

Disclosures

• There was no external funding for the work.  
• The investigators report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Topline

Short-course hypofractionated palliative radiation therapy improves quality of life in patients with poor-prognosis, high-grade gliomas.

Methodology

• Uncertainty persists about the value of palliative radiation, particularly longer regimens, among patients with high-grade gliomas. 
• To address the uncertainty, investigators administered quality of life (QoL) questionnaires to patients before receiving 35 Gy of palliative radiation in 10 fractions over 2 weeks, then again 1 month after treatment, followed by every 3 months until disease progression or death.
• Overall, 49 of 55 patients (89%) completed radiation treatment, and 42 completed the surveys. 
• QoL was assessed using the 100-point European Organization for Research and Treatment of Cancer QoL core questionnaire (QLQ-C30) and its brain cancer module (BN20).
• Two-thirds of patients were treated with temozolomide chemotherapy following radiation.

Takeaways

• There was clinically and statistically significant improvement 1 month after radiation therapy in patient-reported fatigue and dyspnea on the QLQ-C30.
• A clinically meaningful improvement – meaning a 10-point or greater improvement – was seen for insomnia. Other symptoms, such as nausea/vomiting, loss of appetite, constipation, diarrhea, and financial difficulty, remained stable over time.
• On the BN20, investigators reported clinically and statistically significant improvement in motor function; other symptoms remained stable. 
• Median progression-free survival was 8.4 months; median overall survival was 10.5 months.

In practice

“Short-course palliative hypofractionated radiotherapy in patients with poor-prognosis [high-grade glioma] does not impair QoL in the short term; but is rather associated with stable and/or improved QoL scores in several domains/symptom scales” at 1-3 months after treatment, “making it a viable resource-sparing alternative regimen,” the authors concluded.

Source

The work, led by Y. Baviskar of the Tata Memorial Hospital department of radiation oncology in Mumbai, India, was published July 11 in  Clinical Oncology.

Limitations

• It was a single-center study with no control arm.
• Fewer patients completed QoL forms over time, limiting longitudinal assessment to 3 months.
• Forms might have been completed by caregivers at times, raising questions about the veracity of responses.

Disclosures

• There was no external funding for the work.  
• The investigators report no relevant financial relationships.

A version of this article appeared on Medscape.com.