Journal of Clinical Outcomes Management

Adequate evidence shows that adding a Janus kinase (JAK) inhibitor to conventional disease-modifying antirheumatic drug therapy provides a net health benefit for patients with rheumatoid arthritis, compared with conventional drugs alone, according to a report by an independent research institute. But the long-term economic value of JAK inhibitors for rheumatoid arthritis is less clear, the report by the Institute for Clinical and Economic Review (ICER) indicates.

ICER on Jan. 9 released a finalized report and policy recommendations on JAK inhibitors and biosimilars for rheumatoid arthritis. The report reviews current evidence for JAK inhibitors for adults with moderately active to severely active rheumatoid arthritis.

Since the nonprofit’s 2017 review of targeted immune modulators for rheumatoid arthritis, two JAK inhibitors, baricitinib (Olumiant) and upadacitinib (Rinvoq), were approved by the Food and Drug Administration. At a December 2019 public meeting of the California Technology Assessment Forum (CTAF), one of ICER’s independent evidence appraisal committees, panelists reviewed recent evidence.
 

A pricey comparator

In ICER’s analysis, the JAK inhibitor upadacitinib reached common thresholds for cost-effectiveness when compared with adalimumab (Humira). Nevertheless, the 14 members of the independent evidence appraisal committee voted that upadacitinib’s long-term economic value was “low” (8 votes) or “intermediate” (6 votes). Concerns about the generalizability of phase 3 clinical trial data to patients in the real world were among the reservations noted by panelists. Furthermore, “legitimate questions remain about whether or not adalimumab, launched 17 years ago, is fairly priced to begin with,” Pamela Bradt, MD, MPH, ICER’s chief scientific officer, said in a news release.

The panel did not vote on the economic value of tofacitinib (Xeljanz) or baricitinib, the two other JAK inhibitors that are approved for rheumatoid arthritis, because head-to-head evidence against adalimumab was insufficient, ICER said.

“Rheumatoid arthritis is a progressively disabling condition, and patients are fortunate to have multiple therapy options – including biosimilars – that effectively slow disease progression,” Dr. Bradt said. “Many economists might expect medicines to become more affordable in an increasingly crowded therapeutic class; however, because the current rebate structure has erected barriers between patients and several emerging RA therapies, traditional market dynamics have been unable to drive down prices.”
 

Weighing efficacy and cost

Panelists found that the net health benefit provided by upadacitinib is superior to that provided by adalimumab. At the same time, they said that there is insufficient head-to-head evidence to distinguish between the net health benefit of upadacitinib and tofacitinib or to demonstrate that tofacitinib is superior to adalimumab. Evidence comparing baricitinib to adalimumab does not exist.

CTAF members unanimously agreed that adequate evidence demonstrates that the biosimilar infliximab-dyyb (Inflectra) is clinically equivalent to its reference biologic, infliximab (Remicade).

Economic modeling demonstrated that upadacitinib plus a conventional drug achieves marginally higher quality of life than adalimumab plus a conventional drug does, at similar costs. “Based on this comparison with adalimumab, ICER’s value-based price benchmark range for upadacitinib is between $44,000 and $45,000,” according to the ICER news release. “This benchmark represents a 25% discount off of upadacitinib’s annual list price of $59,860, a suggested discount that is consistent with the rebates we assume the manufacturer is currently offering.”

After the voting session, various experts, including clinicians, patient advocates, and representatives from manufacturers and insurance companies, made the following policy recommendations:

• Regulatory intervention may be needed to ensure that drug prices do not continue to increase further from reasonable alignment with added benefits for patients.
• Insurers, pharmacy benefit managers, and employers should increase transparency around the role of discounts and rebates in formulary design.
• Policymakers should aim to create a system that rewards lower-priced biosimilar treatment options.

[email protected]

Adequate evidence shows that adding a Janus kinase (JAK) inhibitor to conventional disease-modifying antirheumatic drug therapy provides a net health benefit for patients with rheumatoid arthritis, compared with conventional drugs alone, according to a report by an independent research institute. But the long-term economic value of JAK inhibitors for rheumatoid arthritis is less clear, the report by the Institute for Clinical and Economic Review (ICER) indicates.

ICER on Jan. 9 released a finalized report and policy recommendations on JAK inhibitors and biosimilars for rheumatoid arthritis. The report reviews current evidence for JAK inhibitors for adults with moderately active to severely active rheumatoid arthritis.

Since the nonprofit’s 2017 review of targeted immune modulators for rheumatoid arthritis, two JAK inhibitors, baricitinib (Olumiant) and upadacitinib (Rinvoq), were approved by the Food and Drug Administration. At a December 2019 public meeting of the California Technology Assessment Forum (CTAF), one of ICER’s independent evidence appraisal committees, panelists reviewed recent evidence.
 

A pricey comparator

In ICER’s analysis, the JAK inhibitor upadacitinib reached common thresholds for cost-effectiveness when compared with adalimumab (Humira). Nevertheless, the 14 members of the independent evidence appraisal committee voted that upadacitinib’s long-term economic value was “low” (8 votes) or “intermediate” (6 votes). Concerns about the generalizability of phase 3 clinical trial data to patients in the real world were among the reservations noted by panelists. Furthermore, “legitimate questions remain about whether or not adalimumab, launched 17 years ago, is fairly priced to begin with,” Pamela Bradt, MD, MPH, ICER’s chief scientific officer, said in a news release.

The panel did not vote on the economic value of tofacitinib (Xeljanz) or baricitinib, the two other JAK inhibitors that are approved for rheumatoid arthritis, because head-to-head evidence against adalimumab was insufficient, ICER said.

“Rheumatoid arthritis is a progressively disabling condition, and patients are fortunate to have multiple therapy options – including biosimilars – that effectively slow disease progression,” Dr. Bradt said. “Many economists might expect medicines to become more affordable in an increasingly crowded therapeutic class; however, because the current rebate structure has erected barriers between patients and several emerging RA therapies, traditional market dynamics have been unable to drive down prices.”
 

Weighing efficacy and cost

Panelists found that the net health benefit provided by upadacitinib is superior to that provided by adalimumab. At the same time, they said that there is insufficient head-to-head evidence to distinguish between the net health benefit of upadacitinib and tofacitinib or to demonstrate that tofacitinib is superior to adalimumab. Evidence comparing baricitinib to adalimumab does not exist.

CTAF members unanimously agreed that adequate evidence demonstrates that the biosimilar infliximab-dyyb (Inflectra) is clinically equivalent to its reference biologic, infliximab (Remicade).

Economic modeling demonstrated that upadacitinib plus a conventional drug achieves marginally higher quality of life than adalimumab plus a conventional drug does, at similar costs. “Based on this comparison with adalimumab, ICER’s value-based price benchmark range for upadacitinib is between $44,000 and $45,000,” according to the ICER news release. “This benchmark represents a 25% discount off of upadacitinib’s annual list price of $59,860, a suggested discount that is consistent with the rebates we assume the manufacturer is currently offering.”

After the voting session, various experts, including clinicians, patient advocates, and representatives from manufacturers and insurance companies, made the following policy recommendations:

• Regulatory intervention may be needed to ensure that drug prices do not continue to increase further from reasonable alignment with added benefits for patients.
• Insurers, pharmacy benefit managers, and employers should increase transparency around the role of discounts and rebates in formulary design.
• Policymakers should aim to create a system that rewards lower-priced biosimilar treatment options.

[email protected]

Adequate evidence shows that adding a Janus kinase (JAK) inhibitor to conventional disease-modifying antirheumatic drug therapy provides a net health benefit for patients with rheumatoid arthritis, compared with conventional drugs alone, according to a report by an independent research institute. But the long-term economic value of JAK inhibitors for rheumatoid arthritis is less clear, the report by the Institute for Clinical and Economic Review (ICER) indicates.

ICER on Jan. 9 released a finalized report and policy recommendations on JAK inhibitors and biosimilars for rheumatoid arthritis. The report reviews current evidence for JAK inhibitors for adults with moderately active to severely active rheumatoid arthritis.

Since the nonprofit’s 2017 review of targeted immune modulators for rheumatoid arthritis, two JAK inhibitors, baricitinib (Olumiant) and upadacitinib (Rinvoq), were approved by the Food and Drug Administration. At a December 2019 public meeting of the California Technology Assessment Forum (CTAF), one of ICER’s independent evidence appraisal committees, panelists reviewed recent evidence.
 

A pricey comparator

In ICER’s analysis, the JAK inhibitor upadacitinib reached common thresholds for cost-effectiveness when compared with adalimumab (Humira). Nevertheless, the 14 members of the independent evidence appraisal committee voted that upadacitinib’s long-term economic value was “low” (8 votes) or “intermediate” (6 votes). Concerns about the generalizability of phase 3 clinical trial data to patients in the real world were among the reservations noted by panelists. Furthermore, “legitimate questions remain about whether or not adalimumab, launched 17 years ago, is fairly priced to begin with,” Pamela Bradt, MD, MPH, ICER’s chief scientific officer, said in a news release.

The panel did not vote on the economic value of tofacitinib (Xeljanz) or baricitinib, the two other JAK inhibitors that are approved for rheumatoid arthritis, because head-to-head evidence against adalimumab was insufficient, ICER said.

“Rheumatoid arthritis is a progressively disabling condition, and patients are fortunate to have multiple therapy options – including biosimilars – that effectively slow disease progression,” Dr. Bradt said. “Many economists might expect medicines to become more affordable in an increasingly crowded therapeutic class; however, because the current rebate structure has erected barriers between patients and several emerging RA therapies, traditional market dynamics have been unable to drive down prices.”
 

Weighing efficacy and cost

Panelists found that the net health benefit provided by upadacitinib is superior to that provided by adalimumab. At the same time, they said that there is insufficient head-to-head evidence to distinguish between the net health benefit of upadacitinib and tofacitinib or to demonstrate that tofacitinib is superior to adalimumab. Evidence comparing baricitinib to adalimumab does not exist.

CTAF members unanimously agreed that adequate evidence demonstrates that the biosimilar infliximab-dyyb (Inflectra) is clinically equivalent to its reference biologic, infliximab (Remicade).

Economic modeling demonstrated that upadacitinib plus a conventional drug achieves marginally higher quality of life than adalimumab plus a conventional drug does, at similar costs. “Based on this comparison with adalimumab, ICER’s value-based price benchmark range for upadacitinib is between $44,000 and $45,000,” according to the ICER news release. “This benchmark represents a 25% discount off of upadacitinib’s annual list price of $59,860, a suggested discount that is consistent with the rebates we assume the manufacturer is currently offering.”

After the voting session, various experts, including clinicians, patient advocates, and representatives from manufacturers and insurance companies, made the following policy recommendations:

• Regulatory intervention may be needed to ensure that drug prices do not continue to increase further from reasonable alignment with added benefits for patients.
• Insurers, pharmacy benefit managers, and employers should increase transparency around the role of discounts and rebates in formulary design.
• Policymakers should aim to create a system that rewards lower-priced biosimilar treatment options.

[email protected]

Cognitive screening of 141 clinicians 70 years or older at Yale New Haven (Conn.) Hospital identified 18 with cognitive deficits likely to impair their ability to practice medicine. Six retired and 12 agreed to limit their practice to closely proctored environments, according to a report in JAMA.

It was part of a program to screen all practitioners 70 years or older who apply for reappointment to the medical staff, and every 2 years thereafter, due to “concerns about the potentially compromised ability of older clinicians,” said the authors, Yale rheumatologist and geriatrician Leo M. Cooney Jr., MD, and Thomas Balcezak, MD, Yale New Haven’s chief medical officer.

Yale is not alone. Intermountain Healthcare, Stanford Hospitals and Clinics, Scripps Health Care, Penn Medicine, and the University of California, San Diego, are among the institutions with similar programs.

The move is being driven by the aging of the medical community. About 15% of U.S. physicians are over 65 years old, a tripling from 23,000 in 1980 to 73,000 in 2012-2016, and the number is growing, according to an editorial by Jeffrey L. Saver, MD, professor of neurology and senior associate vice president of neurology at the University of California, Los Angeles.

Mitchel L. Zoler/MDedge News

Photographee.eu

[email protected]

SOURCE: Cooney L et al. JAMA. 2020 Jan 14;323(2):179-80.

Cognitive screening of 141 clinicians 70 years or older at Yale New Haven (Conn.) Hospital identified 18 with cognitive deficits likely to impair their ability to practice medicine. Six retired and 12 agreed to limit their practice to closely proctored environments, according to a report in JAMA.

It was part of a program to screen all practitioners 70 years or older who apply for reappointment to the medical staff, and every 2 years thereafter, due to “concerns about the potentially compromised ability of older clinicians,” said the authors, Yale rheumatologist and geriatrician Leo M. Cooney Jr., MD, and Thomas Balcezak, MD, Yale New Haven’s chief medical officer.

Yale is not alone. Intermountain Healthcare, Stanford Hospitals and Clinics, Scripps Health Care, Penn Medicine, and the University of California, San Diego, are among the institutions with similar programs.

The move is being driven by the aging of the medical community. About 15% of U.S. physicians are over 65 years old, a tripling from 23,000 in 1980 to 73,000 in 2012-2016, and the number is growing, according to an editorial by Jeffrey L. Saver, MD, professor of neurology and senior associate vice president of neurology at the University of California, Los Angeles.

Mitchel L. Zoler/MDedge News

Photographee.eu

[email protected]

SOURCE: Cooney L et al. JAMA. 2020 Jan 14;323(2):179-80.

Cognitive screening of 141 clinicians 70 years or older at Yale New Haven (Conn.) Hospital identified 18 with cognitive deficits likely to impair their ability to practice medicine. Six retired and 12 agreed to limit their practice to closely proctored environments, according to a report in JAMA.

It was part of a program to screen all practitioners 70 years or older who apply for reappointment to the medical staff, and every 2 years thereafter, due to “concerns about the potentially compromised ability of older clinicians,” said the authors, Yale rheumatologist and geriatrician Leo M. Cooney Jr., MD, and Thomas Balcezak, MD, Yale New Haven’s chief medical officer.

Yale is not alone. Intermountain Healthcare, Stanford Hospitals and Clinics, Scripps Health Care, Penn Medicine, and the University of California, San Diego, are among the institutions with similar programs.

The move is being driven by the aging of the medical community. About 15% of U.S. physicians are over 65 years old, a tripling from 23,000 in 1980 to 73,000 in 2012-2016, and the number is growing, according to an editorial by Jeffrey L. Saver, MD, professor of neurology and senior associate vice president of neurology at the University of California, Los Angeles.

Mitchel L. Zoler/MDedge News

Photographee.eu

[email protected]

SOURCE: Cooney L et al. JAMA. 2020 Jan 14;323(2):179-80.

The Food and Drug Administration has approved an additional indication – reduction of cardiovascular (CV) disease risk – for the injectable formulation of the GLP-1 agonist semaglutide (Ozempic, Novo Nordisk) in the treatment of type 2 diabetes and has added new trial data information to the label of the oral version (Rybelsus, Novo Nordisk) pertaining to CV safety.

The agency expanded the once-weekly injectable semaglutide’s label to include an indication for reducing the risk for major adverse cardiovascular events (MACE), including CV death, nonfatal myocardial infarction (MI), or nonfatal stroke, in adults with type 2 diabetes who have established CV disease.

Initially approved for the treatment of type 2 diabetes in adults in December 2017, once-weekly subcutaneously injectable semaglutide comes in 0.5-mg and 1.0-mg doses in a dedicated prefilled pen device.

The approval for the new indication was based on data from the 2-year randomized Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN 6), in which injectable semaglutide or placebo was added to standard of care in 3,297 adults with type 2 diabetes and established CV disease.

As reported by Medscape Medical News in September 2016, patients who underwent treatment with one of the two doses of semaglutide had a significant 26% lower risk for the primary composite outcome of first occurrence of CV death, nonfatal MI, or nonfatal stroke, compared with those who received placebo.

The reduced CV risk was driven primarily by significant reductions in nonfatal stroke and nonfatal MI (39% and 26%, respectively). There was no difference in CV death between drug and placebo groups. Gastrointestinal adverse events were more frequent with semaglutide than placebo, with the majority occurring during the first 30 weeks.

The oral semaglutide formulation, taken daily in 7-mg or 14-mg doses, was approved for the treatment of type 2 diabetes in September 2019, the first orally available GLP-1 agonist.

Now, the FDA has updated the prescribing information in the clinical studies section (section 14) to include results from the randomized, placebo-controlled, 3,183-subject Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes (PIONEER 6), reported in June 2019, which found a nonsignificant 21% reduction in three-component MACE with oral semaglutide. The addition to the label for Rybelsus is with regard to CV safety, not benefit.
 

SOUL: Large ongoing CV outcomes trial for oral semaglutide

In June 2019, Novo Nordisk initiated a larger CV outcomes trial of oral semaglutide, A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes (SOUL). The trial, which includes 9,642 adults with type 2 diabetes and established CV disease, is further investigating the drug’s effects on the incidence of MACE. The estimated completion date is July 2024.

Semaglutide joins a growing list of drugs approved for treating type 2 diabetes that have been granted additional label indications for benefits beyond the lowering of glucose.

These include Novo Nordisk’s other injectable GLP-1 agonist, liraglutide (Victoza), additionally approved for reducing CV events in high-risk patients with type 2 diabetes, and the sodium-glucose transport 2 inhibitors empagliflozin (Jardiance, Boehringer Ingelheim/Lilly), for reducing CV death; canagliflozin (Invokana, Janssen), for reducing major adverse CV events,; kidney disease, CV death, and heart failure hospitalization; and dapagliflozin (Farxiga, AstraZeneca), for reducing heart failure hospitalization.

Recently, in an exclusive Medscape Medical News article, some experts questioned the design of these CV outcomes trials, suggesting that imbalances in glycemic control, blood pressure, and diuretic use between treatment and placebo arms could have biased the CV and renal outcomes of the trials in favor of the study drugs
 

A version of this story originally appeared on Medscape.com.

The Food and Drug Administration has approved an additional indication – reduction of cardiovascular (CV) disease risk – for the injectable formulation of the GLP-1 agonist semaglutide (Ozempic, Novo Nordisk) in the treatment of type 2 diabetes and has added new trial data information to the label of the oral version (Rybelsus, Novo Nordisk) pertaining to CV safety.

The agency expanded the once-weekly injectable semaglutide’s label to include an indication for reducing the risk for major adverse cardiovascular events (MACE), including CV death, nonfatal myocardial infarction (MI), or nonfatal stroke, in adults with type 2 diabetes who have established CV disease.

Initially approved for the treatment of type 2 diabetes in adults in December 2017, once-weekly subcutaneously injectable semaglutide comes in 0.5-mg and 1.0-mg doses in a dedicated prefilled pen device.

The approval for the new indication was based on data from the 2-year randomized Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN 6), in which injectable semaglutide or placebo was added to standard of care in 3,297 adults with type 2 diabetes and established CV disease.

As reported by Medscape Medical News in September 2016, patients who underwent treatment with one of the two doses of semaglutide had a significant 26% lower risk for the primary composite outcome of first occurrence of CV death, nonfatal MI, or nonfatal stroke, compared with those who received placebo.

The reduced CV risk was driven primarily by significant reductions in nonfatal stroke and nonfatal MI (39% and 26%, respectively). There was no difference in CV death between drug and placebo groups. Gastrointestinal adverse events were more frequent with semaglutide than placebo, with the majority occurring during the first 30 weeks.

The oral semaglutide formulation, taken daily in 7-mg or 14-mg doses, was approved for the treatment of type 2 diabetes in September 2019, the first orally available GLP-1 agonist.

Now, the FDA has updated the prescribing information in the clinical studies section (section 14) to include results from the randomized, placebo-controlled, 3,183-subject Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes (PIONEER 6), reported in June 2019, which found a nonsignificant 21% reduction in three-component MACE with oral semaglutide. The addition to the label for Rybelsus is with regard to CV safety, not benefit.
 

SOUL: Large ongoing CV outcomes trial for oral semaglutide

In June 2019, Novo Nordisk initiated a larger CV outcomes trial of oral semaglutide, A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes (SOUL). The trial, which includes 9,642 adults with type 2 diabetes and established CV disease, is further investigating the drug’s effects on the incidence of MACE. The estimated completion date is July 2024.

Semaglutide joins a growing list of drugs approved for treating type 2 diabetes that have been granted additional label indications for benefits beyond the lowering of glucose.

These include Novo Nordisk’s other injectable GLP-1 agonist, liraglutide (Victoza), additionally approved for reducing CV events in high-risk patients with type 2 diabetes, and the sodium-glucose transport 2 inhibitors empagliflozin (Jardiance, Boehringer Ingelheim/Lilly), for reducing CV death; canagliflozin (Invokana, Janssen), for reducing major adverse CV events,; kidney disease, CV death, and heart failure hospitalization; and dapagliflozin (Farxiga, AstraZeneca), for reducing heart failure hospitalization.

Recently, in an exclusive Medscape Medical News article, some experts questioned the design of these CV outcomes trials, suggesting that imbalances in glycemic control, blood pressure, and diuretic use between treatment and placebo arms could have biased the CV and renal outcomes of the trials in favor of the study drugs
 

A version of this story originally appeared on Medscape.com.

The Food and Drug Administration has approved an additional indication – reduction of cardiovascular (CV) disease risk – for the injectable formulation of the GLP-1 agonist semaglutide (Ozempic, Novo Nordisk) in the treatment of type 2 diabetes and has added new trial data information to the label of the oral version (Rybelsus, Novo Nordisk) pertaining to CV safety.

The agency expanded the once-weekly injectable semaglutide’s label to include an indication for reducing the risk for major adverse cardiovascular events (MACE), including CV death, nonfatal myocardial infarction (MI), or nonfatal stroke, in adults with type 2 diabetes who have established CV disease.

Initially approved for the treatment of type 2 diabetes in adults in December 2017, once-weekly subcutaneously injectable semaglutide comes in 0.5-mg and 1.0-mg doses in a dedicated prefilled pen device.

The approval for the new indication was based on data from the 2-year randomized Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN 6), in which injectable semaglutide or placebo was added to standard of care in 3,297 adults with type 2 diabetes and established CV disease.

As reported by Medscape Medical News in September 2016, patients who underwent treatment with one of the two doses of semaglutide had a significant 26% lower risk for the primary composite outcome of first occurrence of CV death, nonfatal MI, or nonfatal stroke, compared with those who received placebo.

The reduced CV risk was driven primarily by significant reductions in nonfatal stroke and nonfatal MI (39% and 26%, respectively). There was no difference in CV death between drug and placebo groups. Gastrointestinal adverse events were more frequent with semaglutide than placebo, with the majority occurring during the first 30 weeks.

The oral semaglutide formulation, taken daily in 7-mg or 14-mg doses, was approved for the treatment of type 2 diabetes in September 2019, the first orally available GLP-1 agonist.

Now, the FDA has updated the prescribing information in the clinical studies section (section 14) to include results from the randomized, placebo-controlled, 3,183-subject Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes (PIONEER 6), reported in June 2019, which found a nonsignificant 21% reduction in three-component MACE with oral semaglutide. The addition to the label for Rybelsus is with regard to CV safety, not benefit.
 

SOUL: Large ongoing CV outcomes trial for oral semaglutide

In June 2019, Novo Nordisk initiated a larger CV outcomes trial of oral semaglutide, A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes (SOUL). The trial, which includes 9,642 adults with type 2 diabetes and established CV disease, is further investigating the drug’s effects on the incidence of MACE. The estimated completion date is July 2024.

Semaglutide joins a growing list of drugs approved for treating type 2 diabetes that have been granted additional label indications for benefits beyond the lowering of glucose.

These include Novo Nordisk’s other injectable GLP-1 agonist, liraglutide (Victoza), additionally approved for reducing CV events in high-risk patients with type 2 diabetes, and the sodium-glucose transport 2 inhibitors empagliflozin (Jardiance, Boehringer Ingelheim/Lilly), for reducing CV death; canagliflozin (Invokana, Janssen), for reducing major adverse CV events,; kidney disease, CV death, and heart failure hospitalization; and dapagliflozin (Farxiga, AstraZeneca), for reducing heart failure hospitalization.

Recently, in an exclusive Medscape Medical News article, some experts questioned the design of these CV outcomes trials, suggesting that imbalances in glycemic control, blood pressure, and diuretic use between treatment and placebo arms could have biased the CV and renal outcomes of the trials in favor of the study drugs
 

A version of this story originally appeared on Medscape.com.

LOS ANGELES – Mounting evidence suggests that decreasing muscle mass with aging is associated with increased cardiometabolic risk.

Doug Brunk/MDedge News

“Loss of lean body mass and function with aging decreases the amount of metabolically active tissue, which can lead to insulin resistance,” Elena Volpi, MD, said at the World Congress on Insulin Resistance, Diabetes and Cardiovascular Disease. “Insulin resistance reduces muscle protein anabolism and accelerates sarcopenia, perpetuating a vicious cycle.”

Sarcopenia, the involuntary loss of muscle mass and function that occurs with aging, is an ICD-10 codable condition that can be diagnosed by measuring muscle strength and quality, said Dr. Volpi, director of the Sealy Center on Aging at the University of Texas Medical Branch at Galveston. In the Health, Aging and Body Composition Study (Health ABC), researchers followed 2,292 relatively healthy adults aged 70-79 years for an average of 4.9 years (J Gerontol A Biol Sci Med. 2006;61[1]:72-7). The researchers used isokinetic dynamometry to measure knee extension strength, isometric dynamometry to measure grip strength, CT scan to measure thigh muscle area, and dual X-ray absorptiometry to determine leg and arm lean soft-tissue mass. “Those individuals who started with the highest levels of muscle strength had the greatest survival, while those who had the lowest levels of muscle strength died earlier,” said Dr. Volpi, who was not affiliated with the study. “That was true for both men and women.”

More recently, researchers conducted a pooled analysis of nine cohort studies involving 34,485 community-dwelling older individuals who were tested with gait speed and followed for 6-21 years (JAMA. 2011;305[1]:50-8). They found that a higher gait speed was associated with higher survival at 5 and 10 years (P less than .001). “Muscle mass also appears to be associated in part with mortality and survival, although the association is not as strong as measures of strength and gait speed,” Dr. Volpi said.

Data from the 2009 Korea National Health and Nutrition Examination Survey of 1,537 participants, aged 65 years and older, found that sarcopenia is independently associated with cardiovascular disease (PLoS One. 2013 Mar 22. doi: 10.1371/journal.pone.0060119). Most of the risk factors for cardiovascular disease – such as age, waist circumference, body mass index, fasting plasma glucose, and total cholesterol – showed significant negative correlations with the ratio between appendicular skeletal muscle mass and body weight. Multiple logistic regression analysis demonstrated that sarcopenia was associated with cardiovascular disease, independent of other well-documented risk factors, renal function, and medications (odds ratio, 1.77; P = .025).

In addition, data from the British Regional Heart Study, which followed 4,252 older men for a mean of 11.3 years, found an association of sarcopenia and adiposity with cardiovascular mortality and all-cause mortality (J Am Geriatr Soc. 2014;62[2]:253-60). Specifically, all-cause mortality risk was significantly greater in men in the sarcopenic and obese groups (HRs, 1.41 and 1.21, respectively), compared with those in the optimal reference group, with the highest risk in sarcopenic obese individuals (HR, 1.72) after adjustment for lifestyle characteristics.

“Diabetes also accelerates loss of lean body mass in older adults,” added Dr. Volpi. “Data from the Health ABC study showed that individuals who did not have diabetes at the beginning of the 6-year observation period ... lost the least amount of muscle, compared with those who had undiagnosed or already diagnosed diabetes.”

The precise way in which sarcopenia is linked to metabolic disease remains elusive, she continued, but current evidence suggests that sarcopenia is characterized by a reduction in the protein synthetic response to metabolic stimulation by amino acids, exercise, and insulin in skeletal muscle. “This reduction in the anabolic response to protein synthesis is called anabolic resistance of aging, and it is mediated by reduced acute activation of mTORC1 [mTOR complex 1] signaling,” Dr. Volpi said. “There’s another step upstream of the mTORC1, in which the amino acids and insulin have to cross the blood-muscle barrier. Amino acids need to be transported into the muscle actively, like glucose. That is an important unexplored area that may contribute to sarcopenia.”

Dr. Volpi went on to note that endothelial dysfunction underlies muscle anabolic resistance and cardiovascular risk and is likely to be a fundamental cause of both problems. Recent studies have shown that increased levels of physical activity improve endothelial function, enhance insulin sensitivity and anabolic sensitivity to nutrients, and reduce cardiovascular risk.

For example, in a cohort of 45 nonfrail older adults with a mean age of 72 years, Dr. Volpi and colleagues carried out a phase 1, double-blind, placebo-controlled, randomized clinical trial to determine if chronic essential amino acid supplementation, aerobic exercise training, or a combination of the two interventions could improve muscle mass and function by stimulating muscle protein synthesis over the course of 24 weeks (J Gerontol A Biol Sci Med Sci. 2019;74[10]:1598-604). “We found that exercise supervised three times per week on a treadmill for 6 months improved physical function in both groups randomized to exercise,” Dr. Volpi said. “Disappointingly, there was no change in total lean mass with any of the interventions. There was a decrease in fat mass with exercise alone, and no change with exercise and amino acids. [Of note is that] the individuals who were randomized to the amino acids plus exercise group had a significant increase in leg strength, whereas the others did not.”

Preliminary findings from ongoing work by Dr. Volpi and colleagues suggest that, in diabetes, muscle protein synthesis and blood flow really “are not different in response to insulin in healthy older adults and diabetic older adults because they don’t change at all. However, we did find alterations in amino acid trafficking in diabetes. We found that older individuals with type 2 diabetes had a reduction of amino acid transport and a higher intracellular amino acid concentration, compared with age-matched, healthier individuals. The intracellular amino acid clearance improved in the healthy, nondiabetic older adults with hyperinsulinemia, whereas it did not change in diabetic older adults. As a result, the net muscle protein balance improved a little in the nondiabetic patients, but did not change in the diabetic patients.”

The researchers are evaluating older patients with type 2 diabetes to see whether there are alterations in vascular reactivity and protein synthesis and whether those can be overcome by resistance-exercise training. “Preliminary results show that flow-mediated dilation can actually increase in an older diabetic patient with resistance exercise training three times a week for 3 months,” she said. “Exercise can improve both endothelial dysfunction and sarcopenia and therefore improve physical function and reduce cardiovascular risk.”

Dr. Volpi reported having no relevant disclosures.

[email protected]

LOS ANGELES – Mounting evidence suggests that decreasing muscle mass with aging is associated with increased cardiometabolic risk.

Doug Brunk/MDedge News

“Loss of lean body mass and function with aging decreases the amount of metabolically active tissue, which can lead to insulin resistance,” Elena Volpi, MD, said at the World Congress on Insulin Resistance, Diabetes and Cardiovascular Disease. “Insulin resistance reduces muscle protein anabolism and accelerates sarcopenia, perpetuating a vicious cycle.”

Sarcopenia, the involuntary loss of muscle mass and function that occurs with aging, is an ICD-10 codable condition that can be diagnosed by measuring muscle strength and quality, said Dr. Volpi, director of the Sealy Center on Aging at the University of Texas Medical Branch at Galveston. In the Health, Aging and Body Composition Study (Health ABC), researchers followed 2,292 relatively healthy adults aged 70-79 years for an average of 4.9 years (J Gerontol A Biol Sci Med. 2006;61[1]:72-7). The researchers used isokinetic dynamometry to measure knee extension strength, isometric dynamometry to measure grip strength, CT scan to measure thigh muscle area, and dual X-ray absorptiometry to determine leg and arm lean soft-tissue mass. “Those individuals who started with the highest levels of muscle strength had the greatest survival, while those who had the lowest levels of muscle strength died earlier,” said Dr. Volpi, who was not affiliated with the study. “That was true for both men and women.”

More recently, researchers conducted a pooled analysis of nine cohort studies involving 34,485 community-dwelling older individuals who were tested with gait speed and followed for 6-21 years (JAMA. 2011;305[1]:50-8). They found that a higher gait speed was associated with higher survival at 5 and 10 years (P less than .001). “Muscle mass also appears to be associated in part with mortality and survival, although the association is not as strong as measures of strength and gait speed,” Dr. Volpi said.

Data from the 2009 Korea National Health and Nutrition Examination Survey of 1,537 participants, aged 65 years and older, found that sarcopenia is independently associated with cardiovascular disease (PLoS One. 2013 Mar 22. doi: 10.1371/journal.pone.0060119). Most of the risk factors for cardiovascular disease – such as age, waist circumference, body mass index, fasting plasma glucose, and total cholesterol – showed significant negative correlations with the ratio between appendicular skeletal muscle mass and body weight. Multiple logistic regression analysis demonstrated that sarcopenia was associated with cardiovascular disease, independent of other well-documented risk factors, renal function, and medications (odds ratio, 1.77; P = .025).

In addition, data from the British Regional Heart Study, which followed 4,252 older men for a mean of 11.3 years, found an association of sarcopenia and adiposity with cardiovascular mortality and all-cause mortality (J Am Geriatr Soc. 2014;62[2]:253-60). Specifically, all-cause mortality risk was significantly greater in men in the sarcopenic and obese groups (HRs, 1.41 and 1.21, respectively), compared with those in the optimal reference group, with the highest risk in sarcopenic obese individuals (HR, 1.72) after adjustment for lifestyle characteristics.

“Diabetes also accelerates loss of lean body mass in older adults,” added Dr. Volpi. “Data from the Health ABC study showed that individuals who did not have diabetes at the beginning of the 6-year observation period ... lost the least amount of muscle, compared with those who had undiagnosed or already diagnosed diabetes.”

The precise way in which sarcopenia is linked to metabolic disease remains elusive, she continued, but current evidence suggests that sarcopenia is characterized by a reduction in the protein synthetic response to metabolic stimulation by amino acids, exercise, and insulin in skeletal muscle. “This reduction in the anabolic response to protein synthesis is called anabolic resistance of aging, and it is mediated by reduced acute activation of mTORC1 [mTOR complex 1] signaling,” Dr. Volpi said. “There’s another step upstream of the mTORC1, in which the amino acids and insulin have to cross the blood-muscle barrier. Amino acids need to be transported into the muscle actively, like glucose. That is an important unexplored area that may contribute to sarcopenia.”

Dr. Volpi went on to note that endothelial dysfunction underlies muscle anabolic resistance and cardiovascular risk and is likely to be a fundamental cause of both problems. Recent studies have shown that increased levels of physical activity improve endothelial function, enhance insulin sensitivity and anabolic sensitivity to nutrients, and reduce cardiovascular risk.

For example, in a cohort of 45 nonfrail older adults with a mean age of 72 years, Dr. Volpi and colleagues carried out a phase 1, double-blind, placebo-controlled, randomized clinical trial to determine if chronic essential amino acid supplementation, aerobic exercise training, or a combination of the two interventions could improve muscle mass and function by stimulating muscle protein synthesis over the course of 24 weeks (J Gerontol A Biol Sci Med Sci. 2019;74[10]:1598-604). “We found that exercise supervised three times per week on a treadmill for 6 months improved physical function in both groups randomized to exercise,” Dr. Volpi said. “Disappointingly, there was no change in total lean mass with any of the interventions. There was a decrease in fat mass with exercise alone, and no change with exercise and amino acids. [Of note is that] the individuals who were randomized to the amino acids plus exercise group had a significant increase in leg strength, whereas the others did not.”

Preliminary findings from ongoing work by Dr. Volpi and colleagues suggest that, in diabetes, muscle protein synthesis and blood flow really “are not different in response to insulin in healthy older adults and diabetic older adults because they don’t change at all. However, we did find alterations in amino acid trafficking in diabetes. We found that older individuals with type 2 diabetes had a reduction of amino acid transport and a higher intracellular amino acid concentration, compared with age-matched, healthier individuals. The intracellular amino acid clearance improved in the healthy, nondiabetic older adults with hyperinsulinemia, whereas it did not change in diabetic older adults. As a result, the net muscle protein balance improved a little in the nondiabetic patients, but did not change in the diabetic patients.”

The researchers are evaluating older patients with type 2 diabetes to see whether there are alterations in vascular reactivity and protein synthesis and whether those can be overcome by resistance-exercise training. “Preliminary results show that flow-mediated dilation can actually increase in an older diabetic patient with resistance exercise training three times a week for 3 months,” she said. “Exercise can improve both endothelial dysfunction and sarcopenia and therefore improve physical function and reduce cardiovascular risk.”

Dr. Volpi reported having no relevant disclosures.

[email protected]

LOS ANGELES – Mounting evidence suggests that decreasing muscle mass with aging is associated with increased cardiometabolic risk.

Doug Brunk/MDedge News

“Loss of lean body mass and function with aging decreases the amount of metabolically active tissue, which can lead to insulin resistance,” Elena Volpi, MD, said at the World Congress on Insulin Resistance, Diabetes and Cardiovascular Disease. “Insulin resistance reduces muscle protein anabolism and accelerates sarcopenia, perpetuating a vicious cycle.”

Sarcopenia, the involuntary loss of muscle mass and function that occurs with aging, is an ICD-10 codable condition that can be diagnosed by measuring muscle strength and quality, said Dr. Volpi, director of the Sealy Center on Aging at the University of Texas Medical Branch at Galveston. In the Health, Aging and Body Composition Study (Health ABC), researchers followed 2,292 relatively healthy adults aged 70-79 years for an average of 4.9 years (J Gerontol A Biol Sci Med. 2006;61[1]:72-7). The researchers used isokinetic dynamometry to measure knee extension strength, isometric dynamometry to measure grip strength, CT scan to measure thigh muscle area, and dual X-ray absorptiometry to determine leg and arm lean soft-tissue mass. “Those individuals who started with the highest levels of muscle strength had the greatest survival, while those who had the lowest levels of muscle strength died earlier,” said Dr. Volpi, who was not affiliated with the study. “That was true for both men and women.”

More recently, researchers conducted a pooled analysis of nine cohort studies involving 34,485 community-dwelling older individuals who were tested with gait speed and followed for 6-21 years (JAMA. 2011;305[1]:50-8). They found that a higher gait speed was associated with higher survival at 5 and 10 years (P less than .001). “Muscle mass also appears to be associated in part with mortality and survival, although the association is not as strong as measures of strength and gait speed,” Dr. Volpi said.

Data from the 2009 Korea National Health and Nutrition Examination Survey of 1,537 participants, aged 65 years and older, found that sarcopenia is independently associated with cardiovascular disease (PLoS One. 2013 Mar 22. doi: 10.1371/journal.pone.0060119). Most of the risk factors for cardiovascular disease – such as age, waist circumference, body mass index, fasting plasma glucose, and total cholesterol – showed significant negative correlations with the ratio between appendicular skeletal muscle mass and body weight. Multiple logistic regression analysis demonstrated that sarcopenia was associated with cardiovascular disease, independent of other well-documented risk factors, renal function, and medications (odds ratio, 1.77; P = .025).

In addition, data from the British Regional Heart Study, which followed 4,252 older men for a mean of 11.3 years, found an association of sarcopenia and adiposity with cardiovascular mortality and all-cause mortality (J Am Geriatr Soc. 2014;62[2]:253-60). Specifically, all-cause mortality risk was significantly greater in men in the sarcopenic and obese groups (HRs, 1.41 and 1.21, respectively), compared with those in the optimal reference group, with the highest risk in sarcopenic obese individuals (HR, 1.72) after adjustment for lifestyle characteristics.

“Diabetes also accelerates loss of lean body mass in older adults,” added Dr. Volpi. “Data from the Health ABC study showed that individuals who did not have diabetes at the beginning of the 6-year observation period ... lost the least amount of muscle, compared with those who had undiagnosed or already diagnosed diabetes.”

The precise way in which sarcopenia is linked to metabolic disease remains elusive, she continued, but current evidence suggests that sarcopenia is characterized by a reduction in the protein synthetic response to metabolic stimulation by amino acids, exercise, and insulin in skeletal muscle. “This reduction in the anabolic response to protein synthesis is called anabolic resistance of aging, and it is mediated by reduced acute activation of mTORC1 [mTOR complex 1] signaling,” Dr. Volpi said. “There’s another step upstream of the mTORC1, in which the amino acids and insulin have to cross the blood-muscle barrier. Amino acids need to be transported into the muscle actively, like glucose. That is an important unexplored area that may contribute to sarcopenia.”

Dr. Volpi went on to note that endothelial dysfunction underlies muscle anabolic resistance and cardiovascular risk and is likely to be a fundamental cause of both problems. Recent studies have shown that increased levels of physical activity improve endothelial function, enhance insulin sensitivity and anabolic sensitivity to nutrients, and reduce cardiovascular risk.

For example, in a cohort of 45 nonfrail older adults with a mean age of 72 years, Dr. Volpi and colleagues carried out a phase 1, double-blind, placebo-controlled, randomized clinical trial to determine if chronic essential amino acid supplementation, aerobic exercise training, or a combination of the two interventions could improve muscle mass and function by stimulating muscle protein synthesis over the course of 24 weeks (J Gerontol A Biol Sci Med Sci. 2019;74[10]:1598-604). “We found that exercise supervised three times per week on a treadmill for 6 months improved physical function in both groups randomized to exercise,” Dr. Volpi said. “Disappointingly, there was no change in total lean mass with any of the interventions. There was a decrease in fat mass with exercise alone, and no change with exercise and amino acids. [Of note is that] the individuals who were randomized to the amino acids plus exercise group had a significant increase in leg strength, whereas the others did not.”

Preliminary findings from ongoing work by Dr. Volpi and colleagues suggest that, in diabetes, muscle protein synthesis and blood flow really “are not different in response to insulin in healthy older adults and diabetic older adults because they don’t change at all. However, we did find alterations in amino acid trafficking in diabetes. We found that older individuals with type 2 diabetes had a reduction of amino acid transport and a higher intracellular amino acid concentration, compared with age-matched, healthier individuals. The intracellular amino acid clearance improved in the healthy, nondiabetic older adults with hyperinsulinemia, whereas it did not change in diabetic older adults. As a result, the net muscle protein balance improved a little in the nondiabetic patients, but did not change in the diabetic patients.”

The researchers are evaluating older patients with type 2 diabetes to see whether there are alterations in vascular reactivity and protein synthesis and whether those can be overcome by resistance-exercise training. “Preliminary results show that flow-mediated dilation can actually increase in an older diabetic patient with resistance exercise training three times a week for 3 months,” she said. “Exercise can improve both endothelial dysfunction and sarcopenia and therefore improve physical function and reduce cardiovascular risk.”

Dr. Volpi reported having no relevant disclosures.

[email protected]

The time shared during clinical encounters provides small peeks into patients’ lives that get documented as episodic snapshots in electronic health records. But there is little information about how patients are doing outside of the office. With increasing emphasis on filling out mandatory parts of the EHR, there is less time available for in-depth, in-office conversations and phone follow-ups.

At the same time, it has become clear that it is not just the medicines we prescribe that affect our patients’ lives. Their behaviors outside of the office – being physically active, eating well, getting a good night’s rest, and adhering to medications – also impact their health outcomes.

The explosion of technology and personal data in our increasingly connected world provides powerful new sources of health and behavior information that generate new understanding of patients’ lives in their everyday settings.

The ubiquity and remarkable technological progress of personal computing devices – including wearables, smartphones, and tablets – along with the multitude of sensor modalities embedded within these devices, has enabled us to establish a continuous connection with people who want to share information about their behavior and daily life.

Such rich, longitudinal information, known as person-generated health data (PGHD), can be searched for physiological and behavioral signatures that can be used in combination with traditional clinical information to predict, diagnose, and treat disease. It can also be used to understand the safety and effectiveness of medical interventions.

PGHD is defined as wellness and/or health-related data created, recorded, or gathered by individuals. It reflects events and interactions that occur during an person’s everyday life. Systematically gathering this information and organizing it to better understand patients’ approach to their health or their unique experience living with disease provides meaningful insights that complement the data traditionally collected as part of clinical trials or periodic office visits.

PGHD can produce a rich picture of a person’s health or symptom burden with disease. It allows the opportunity to measure the real human burden of a patient’s disease and how it changes over time, with an opportunity to detect changes in symptoms in real time.

PGHD can also enable participation in health research.

An example would be the work of Evidation Health in San Mateo, Calif. Evidation provides a platform to run research studies utilizing technology and systems to measure health in everyday life. Its app, Achievement, collects continuous behavior-related data from smartphones, wearables, connected devices, and apps. That provides opportunities for participants to join research studies that develop novel measures designed to quantify health outcomes in a way that more accurately reflects an individual’s day-to-day activities and experience. All data collected are at the direction of and with the permission of the individual.

“Achievers” are given points for taking health-related actions such as tracking steps or their sleep, which convert to cash that can be kept or donated to their favorite charities. Achievement’s 3.5 million diverse participants also receive offers to join research studies. This paradigm shift dramatically expands access to research to increase diversity, shortens the time to first data through rapid recruitment, and enhances retention rates by making it easier to engage. To date, more than 1 million users have chosen to participate in research studies. The technology is bringing new data and insights to health research; it supports important questions about quality of life, medical products’ real-world effectiveness, and the development of hyperpersonalized health care services.

This new type of data is transforming medical research by creating real-world studies of unprecedented size, such as the Apple Heart Study – a virtual study with more than 400,000 enrolled participants – which was designed to test the accuracy of Apple Watches in safely identifying atrial fibrillation. The FDA has cleared two features on the Apple Watch: the device’s ability to detect and notify the user of an irregular heart rhythm, and the ability to take a single-lead EKG feature that can provide a rhythm strip for a clinician to review.

The FDA clearance letters specify that the apps are “not intended to replace traditional methods of diagnosis or treatment.” They provide extra information, and that information might be helpful – but the apps won’t replace a doctor’s visit. It remains to be seen how these data will be used, but they have the potential to identify atrial fibrillation early, leading to treatment that may prevent devastating strokes.

Another example of home-generated health data is a tool that has obtained FDA clearance as a diagnostic device with insurance reimbursement: WatchPAT, a portable sleep apnea diagnostic device. WatchPAT is worn like a simple wristwatch, with no need for belts, wires, or nasal cannulas.

Over time, in-home tests like these that are of minimal inconvenience to the patient and reflect a real-world experience may eclipse traditional sleep studies that require patients to spend the night in a clinic while attached to wires and monitors.

Health data generated by connected populations will yield novel insights that may help us better predict, diagnose, and treat disease. These are examples of innovations that can extend clinicians’ abilities to remotely monitor or diagnose health conditions, and we can expect that more will continue to be integrated into the clinical and research settings in the near future.

In part 2 of this series, we will discuss novel digital measures and studies utilizing PGHD to impact population health.
 

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director, family medicine residency program, Abington (Pa.) Jefferson Health. Dr. Foschini is cofounder and chief data scientist at Evidation Health in San Mateo, Calif. Bray Patrick-Lake is a patient thought leader and director, strategic partnerships, at Evidation Health.

References

Determining real-world data’s fitness for use and the role of reliability, September 2019. Duke-Margolis Center for Health Policy.

N Engl J Med. 2019 Nov 14;381(20):1909-17.

The time shared during clinical encounters provides small peeks into patients’ lives that get documented as episodic snapshots in electronic health records. But there is little information about how patients are doing outside of the office. With increasing emphasis on filling out mandatory parts of the EHR, there is less time available for in-depth, in-office conversations and phone follow-ups.

At the same time, it has become clear that it is not just the medicines we prescribe that affect our patients’ lives. Their behaviors outside of the office – being physically active, eating well, getting a good night’s rest, and adhering to medications – also impact their health outcomes.

The explosion of technology and personal data in our increasingly connected world provides powerful new sources of health and behavior information that generate new understanding of patients’ lives in their everyday settings.

The ubiquity and remarkable technological progress of personal computing devices – including wearables, smartphones, and tablets – along with the multitude of sensor modalities embedded within these devices, has enabled us to establish a continuous connection with people who want to share information about their behavior and daily life.

Such rich, longitudinal information, known as person-generated health data (PGHD), can be searched for physiological and behavioral signatures that can be used in combination with traditional clinical information to predict, diagnose, and treat disease. It can also be used to understand the safety and effectiveness of medical interventions.

PGHD is defined as wellness and/or health-related data created, recorded, or gathered by individuals. It reflects events and interactions that occur during an person’s everyday life. Systematically gathering this information and organizing it to better understand patients’ approach to their health or their unique experience living with disease provides meaningful insights that complement the data traditionally collected as part of clinical trials or periodic office visits.

PGHD can produce a rich picture of a person’s health or symptom burden with disease. It allows the opportunity to measure the real human burden of a patient’s disease and how it changes over time, with an opportunity to detect changes in symptoms in real time.

PGHD can also enable participation in health research.

An example would be the work of Evidation Health in San Mateo, Calif. Evidation provides a platform to run research studies utilizing technology and systems to measure health in everyday life. Its app, Achievement, collects continuous behavior-related data from smartphones, wearables, connected devices, and apps. That provides opportunities for participants to join research studies that develop novel measures designed to quantify health outcomes in a way that more accurately reflects an individual’s day-to-day activities and experience. All data collected are at the direction of and with the permission of the individual.

“Achievers” are given points for taking health-related actions such as tracking steps or their sleep, which convert to cash that can be kept or donated to their favorite charities. Achievement’s 3.5 million diverse participants also receive offers to join research studies. This paradigm shift dramatically expands access to research to increase diversity, shortens the time to first data through rapid recruitment, and enhances retention rates by making it easier to engage. To date, more than 1 million users have chosen to participate in research studies. The technology is bringing new data and insights to health research; it supports important questions about quality of life, medical products’ real-world effectiveness, and the development of hyperpersonalized health care services.

This new type of data is transforming medical research by creating real-world studies of unprecedented size, such as the Apple Heart Study – a virtual study with more than 400,000 enrolled participants – which was designed to test the accuracy of Apple Watches in safely identifying atrial fibrillation. The FDA has cleared two features on the Apple Watch: the device’s ability to detect and notify the user of an irregular heart rhythm, and the ability to take a single-lead EKG feature that can provide a rhythm strip for a clinician to review.

The FDA clearance letters specify that the apps are “not intended to replace traditional methods of diagnosis or treatment.” They provide extra information, and that information might be helpful – but the apps won’t replace a doctor’s visit. It remains to be seen how these data will be used, but they have the potential to identify atrial fibrillation early, leading to treatment that may prevent devastating strokes.

Another example of home-generated health data is a tool that has obtained FDA clearance as a diagnostic device with insurance reimbursement: WatchPAT, a portable sleep apnea diagnostic device. WatchPAT is worn like a simple wristwatch, with no need for belts, wires, or nasal cannulas.

Over time, in-home tests like these that are of minimal inconvenience to the patient and reflect a real-world experience may eclipse traditional sleep studies that require patients to spend the night in a clinic while attached to wires and monitors.

Health data generated by connected populations will yield novel insights that may help us better predict, diagnose, and treat disease. These are examples of innovations that can extend clinicians’ abilities to remotely monitor or diagnose health conditions, and we can expect that more will continue to be integrated into the clinical and research settings in the near future.

In part 2 of this series, we will discuss novel digital measures and studies utilizing PGHD to impact population health.
 

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director, family medicine residency program, Abington (Pa.) Jefferson Health. Dr. Foschini is cofounder and chief data scientist at Evidation Health in San Mateo, Calif. Bray Patrick-Lake is a patient thought leader and director, strategic partnerships, at Evidation Health.

References

Determining real-world data’s fitness for use and the role of reliability, September 2019. Duke-Margolis Center for Health Policy.

N Engl J Med. 2019 Nov 14;381(20):1909-17.

The time shared during clinical encounters provides small peeks into patients’ lives that get documented as episodic snapshots in electronic health records. But there is little information about how patients are doing outside of the office. With increasing emphasis on filling out mandatory parts of the EHR, there is less time available for in-depth, in-office conversations and phone follow-ups.

At the same time, it has become clear that it is not just the medicines we prescribe that affect our patients’ lives. Their behaviors outside of the office – being physically active, eating well, getting a good night’s rest, and adhering to medications – also impact their health outcomes.

The explosion of technology and personal data in our increasingly connected world provides powerful new sources of health and behavior information that generate new understanding of patients’ lives in their everyday settings.

The ubiquity and remarkable technological progress of personal computing devices – including wearables, smartphones, and tablets – along with the multitude of sensor modalities embedded within these devices, has enabled us to establish a continuous connection with people who want to share information about their behavior and daily life.

Such rich, longitudinal information, known as person-generated health data (PGHD), can be searched for physiological and behavioral signatures that can be used in combination with traditional clinical information to predict, diagnose, and treat disease. It can also be used to understand the safety and effectiveness of medical interventions.

PGHD is defined as wellness and/or health-related data created, recorded, or gathered by individuals. It reflects events and interactions that occur during an person’s everyday life. Systematically gathering this information and organizing it to better understand patients’ approach to their health or their unique experience living with disease provides meaningful insights that complement the data traditionally collected as part of clinical trials or periodic office visits.

PGHD can produce a rich picture of a person’s health or symptom burden with disease. It allows the opportunity to measure the real human burden of a patient’s disease and how it changes over time, with an opportunity to detect changes in symptoms in real time.

PGHD can also enable participation in health research.

An example would be the work of Evidation Health in San Mateo, Calif. Evidation provides a platform to run research studies utilizing technology and systems to measure health in everyday life. Its app, Achievement, collects continuous behavior-related data from smartphones, wearables, connected devices, and apps. That provides opportunities for participants to join research studies that develop novel measures designed to quantify health outcomes in a way that more accurately reflects an individual’s day-to-day activities and experience. All data collected are at the direction of and with the permission of the individual.

“Achievers” are given points for taking health-related actions such as tracking steps or their sleep, which convert to cash that can be kept or donated to their favorite charities. Achievement’s 3.5 million diverse participants also receive offers to join research studies. This paradigm shift dramatically expands access to research to increase diversity, shortens the time to first data through rapid recruitment, and enhances retention rates by making it easier to engage. To date, more than 1 million users have chosen to participate in research studies. The technology is bringing new data and insights to health research; it supports important questions about quality of life, medical products’ real-world effectiveness, and the development of hyperpersonalized health care services.

This new type of data is transforming medical research by creating real-world studies of unprecedented size, such as the Apple Heart Study – a virtual study with more than 400,000 enrolled participants – which was designed to test the accuracy of Apple Watches in safely identifying atrial fibrillation. The FDA has cleared two features on the Apple Watch: the device’s ability to detect and notify the user of an irregular heart rhythm, and the ability to take a single-lead EKG feature that can provide a rhythm strip for a clinician to review.

The FDA clearance letters specify that the apps are “not intended to replace traditional methods of diagnosis or treatment.” They provide extra information, and that information might be helpful – but the apps won’t replace a doctor’s visit. It remains to be seen how these data will be used, but they have the potential to identify atrial fibrillation early, leading to treatment that may prevent devastating strokes.

Another example of home-generated health data is a tool that has obtained FDA clearance as a diagnostic device with insurance reimbursement: WatchPAT, a portable sleep apnea diagnostic device. WatchPAT is worn like a simple wristwatch, with no need for belts, wires, or nasal cannulas.

Over time, in-home tests like these that are of minimal inconvenience to the patient and reflect a real-world experience may eclipse traditional sleep studies that require patients to spend the night in a clinic while attached to wires and monitors.

Health data generated by connected populations will yield novel insights that may help us better predict, diagnose, and treat disease. These are examples of innovations that can extend clinicians’ abilities to remotely monitor or diagnose health conditions, and we can expect that more will continue to be integrated into the clinical and research settings in the near future.

In part 2 of this series, we will discuss novel digital measures and studies utilizing PGHD to impact population health.
 

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director, family medicine residency program, Abington (Pa.) Jefferson Health. Dr. Foschini is cofounder and chief data scientist at Evidation Health in San Mateo, Calif. Bray Patrick-Lake is a patient thought leader and director, strategic partnerships, at Evidation Health.

References

Determining real-world data’s fitness for use and the role of reliability, September 2019. Duke-Margolis Center for Health Policy.

N Engl J Med. 2019 Nov 14;381(20):1909-17.

ORLANDO – A small study suggests health care providers may fail to ask patients about heavy menstrual bleeding before or during treatment with oral anticoagulants.

Jennifer Smith/MDedge News

Researchers performed a chart review at a single center, which indicated that 60% of women were not asked about heavy menstrual bleeding before they were prescribed an oral anticoagulant.

Six months after the women started anticoagulant therapy, 29% required treatment for heavy menstrual bleeding. Charts for the remaining 71% of women contained no information about heavy menstrual bleeding.

“We were unable to distinguish between true absence of heavy menstrual bleeding and absence of reporting,” said Bethany T. Samuelson Bannow, MD, of Oregon Health & Science University, Portland.

Dr. Samuelson Bannow presented these findings at the annual meeting of the American Society of Hematology.

She explained that heavy menstrual bleeding is defined as more than 80 mL of blood loss per cycle. It affects 10%-15% of women in their lifetime, and anticoagulants increase the risk of heavy menstrual bleeding.

Studies have shown that heavy menstrual bleeding occurs in 22%-65% of women treated with vitamin K agonists and 20%-27% of women treated with rivaroxaban (Blood. 2017;130[24]:2603-9). However, many anticoagulant studies don’t include heavy menstrual bleeding as an outcome.

To gain more insight, Dr. Samuelson Bannow and colleagues conducted a chart review. Their study included 236 women of reproductive age treated at Oregon Health & Science University between Jan. 1, 2012, and Dec. 31, 2018.

The patients’ median age was 37 years (range, 18-50 years). Most patients (67%) were receiving an oral anticoagulant for venous thromboembolism. The rest were on anticoagulant therapy for arterial thrombosis (6%), atrial fibrillation (6%), a mechanical valve (1%), or “other” reasons (20%).

Dr. Samuelson Bannow said the other group was “almost exclusively women who were receiving prophylaxis” postoperatively or for travel. Most women in this group were receiving rivaroxaban.

Rivaroxaban was the most commonly prescribed anticoagulant in the entire cohort (41%), followed by warfarin (34%) and apixaban (25%).

At the time of anticoagulant prescription, 12% of women reported a history of heavy menstrual bleeding, and 28% did not. For most patients – 60% – there was no discussion of menstrual history documented.

Six months after starting oral anticoagulant therapy, 29% of patients required treatment for heavy menstrual bleeding. For 71% of patients, there was no documentation on the treatment of heavy menstrual bleeding.

Treatment for heavy menstrual bleeding was required in 33% of patients on rivaroxaban, 24% of those on apixaban, and 29% of those on warfarin, a significant difference (P less than .001).

“Rates of heavy menstrual bleeding … are higher in rivaroxaban users,” Dr. Samuelson Bannow said. “This is not the first study to demonstrate this. However, [the rate of heavy menstrual bleeding in this study] is still a lot lower than we would expect based on past levels with warfarin. This tells us we’re probably missing a lot of heavy menstrual bleeding. That’s not too surprising considering how few providers are actually asking about the menses.”

Dr. Samuelson Bannow and colleagues disclosed no conflicts of interest.

[email protected]

SOURCE: Samuelson Bannow BT et al. ASH 2019, Abstract 60.

ORLANDO – A small study suggests health care providers may fail to ask patients about heavy menstrual bleeding before or during treatment with oral anticoagulants.

Jennifer Smith/MDedge News

Researchers performed a chart review at a single center, which indicated that 60% of women were not asked about heavy menstrual bleeding before they were prescribed an oral anticoagulant.

Six months after the women started anticoagulant therapy, 29% required treatment for heavy menstrual bleeding. Charts for the remaining 71% of women contained no information about heavy menstrual bleeding.

“We were unable to distinguish between true absence of heavy menstrual bleeding and absence of reporting,” said Bethany T. Samuelson Bannow, MD, of Oregon Health & Science University, Portland.

Dr. Samuelson Bannow presented these findings at the annual meeting of the American Society of Hematology.

She explained that heavy menstrual bleeding is defined as more than 80 mL of blood loss per cycle. It affects 10%-15% of women in their lifetime, and anticoagulants increase the risk of heavy menstrual bleeding.

Studies have shown that heavy menstrual bleeding occurs in 22%-65% of women treated with vitamin K agonists and 20%-27% of women treated with rivaroxaban (Blood. 2017;130[24]:2603-9). However, many anticoagulant studies don’t include heavy menstrual bleeding as an outcome.

To gain more insight, Dr. Samuelson Bannow and colleagues conducted a chart review. Their study included 236 women of reproductive age treated at Oregon Health & Science University between Jan. 1, 2012, and Dec. 31, 2018.

The patients’ median age was 37 years (range, 18-50 years). Most patients (67%) were receiving an oral anticoagulant for venous thromboembolism. The rest were on anticoagulant therapy for arterial thrombosis (6%), atrial fibrillation (6%), a mechanical valve (1%), or “other” reasons (20%).

Dr. Samuelson Bannow said the other group was “almost exclusively women who were receiving prophylaxis” postoperatively or for travel. Most women in this group were receiving rivaroxaban.

Rivaroxaban was the most commonly prescribed anticoagulant in the entire cohort (41%), followed by warfarin (34%) and apixaban (25%).

At the time of anticoagulant prescription, 12% of women reported a history of heavy menstrual bleeding, and 28% did not. For most patients – 60% – there was no discussion of menstrual history documented.

Six months after starting oral anticoagulant therapy, 29% of patients required treatment for heavy menstrual bleeding. For 71% of patients, there was no documentation on the treatment of heavy menstrual bleeding.

Treatment for heavy menstrual bleeding was required in 33% of patients on rivaroxaban, 24% of those on apixaban, and 29% of those on warfarin, a significant difference (P less than .001).

“Rates of heavy menstrual bleeding … are higher in rivaroxaban users,” Dr. Samuelson Bannow said. “This is not the first study to demonstrate this. However, [the rate of heavy menstrual bleeding in this study] is still a lot lower than we would expect based on past levels with warfarin. This tells us we’re probably missing a lot of heavy menstrual bleeding. That’s not too surprising considering how few providers are actually asking about the menses.”

Dr. Samuelson Bannow and colleagues disclosed no conflicts of interest.

[email protected]

SOURCE: Samuelson Bannow BT et al. ASH 2019, Abstract 60.

ORLANDO – A small study suggests health care providers may fail to ask patients about heavy menstrual bleeding before or during treatment with oral anticoagulants.

Jennifer Smith/MDedge News

Researchers performed a chart review at a single center, which indicated that 60% of women were not asked about heavy menstrual bleeding before they were prescribed an oral anticoagulant.

Six months after the women started anticoagulant therapy, 29% required treatment for heavy menstrual bleeding. Charts for the remaining 71% of women contained no information about heavy menstrual bleeding.

“We were unable to distinguish between true absence of heavy menstrual bleeding and absence of reporting,” said Bethany T. Samuelson Bannow, MD, of Oregon Health & Science University, Portland.

Dr. Samuelson Bannow presented these findings at the annual meeting of the American Society of Hematology.

She explained that heavy menstrual bleeding is defined as more than 80 mL of blood loss per cycle. It affects 10%-15% of women in their lifetime, and anticoagulants increase the risk of heavy menstrual bleeding.

Studies have shown that heavy menstrual bleeding occurs in 22%-65% of women treated with vitamin K agonists and 20%-27% of women treated with rivaroxaban (Blood. 2017;130[24]:2603-9). However, many anticoagulant studies don’t include heavy menstrual bleeding as an outcome.

To gain more insight, Dr. Samuelson Bannow and colleagues conducted a chart review. Their study included 236 women of reproductive age treated at Oregon Health & Science University between Jan. 1, 2012, and Dec. 31, 2018.

The patients’ median age was 37 years (range, 18-50 years). Most patients (67%) were receiving an oral anticoagulant for venous thromboembolism. The rest were on anticoagulant therapy for arterial thrombosis (6%), atrial fibrillation (6%), a mechanical valve (1%), or “other” reasons (20%).

Dr. Samuelson Bannow said the other group was “almost exclusively women who were receiving prophylaxis” postoperatively or for travel. Most women in this group were receiving rivaroxaban.

Rivaroxaban was the most commonly prescribed anticoagulant in the entire cohort (41%), followed by warfarin (34%) and apixaban (25%).

At the time of anticoagulant prescription, 12% of women reported a history of heavy menstrual bleeding, and 28% did not. For most patients – 60% – there was no discussion of menstrual history documented.

Six months after starting oral anticoagulant therapy, 29% of patients required treatment for heavy menstrual bleeding. For 71% of patients, there was no documentation on the treatment of heavy menstrual bleeding.

Treatment for heavy menstrual bleeding was required in 33% of patients on rivaroxaban, 24% of those on apixaban, and 29% of those on warfarin, a significant difference (P less than .001).

“Rates of heavy menstrual bleeding … are higher in rivaroxaban users,” Dr. Samuelson Bannow said. “This is not the first study to demonstrate this. However, [the rate of heavy menstrual bleeding in this study] is still a lot lower than we would expect based on past levels with warfarin. This tells us we’re probably missing a lot of heavy menstrual bleeding. That’s not too surprising considering how few providers are actually asking about the menses.”

Dr. Samuelson Bannow and colleagues disclosed no conflicts of interest.

[email protected]

SOURCE: Samuelson Bannow BT et al. ASH 2019, Abstract 60.

Prescription pricing is a primary reason why Medicaid spending on multiple sclerosis disease-modifying therapies (DMTs) has more than doubled between 2011 and 2017 and the introduction of a generic glatiramer acetate is having nominal effect on pricing and utilization within the class, new research is showing.

Kenishirotie/Thinkstock

“Gross spending on self-administered and infusible MS DMTs in the Medicaid program increased 2.9-fold from $453 million in 2011 to $1.32 billion in 2017,” Daniel Hartung, PharmD, of Oregon Health and Science University, Portland, and his colleagues wrote in a research report published Jan. 15 in Neurology. Net spending after accounting for rebates during this period showed a doubling of spending from $278 million per year to $600 million per year.

Use of MS DMTs during this period overall remained stable, but there was a shift from injectable DMTs to oral DMTs during this time window, the researchers found, with the plurality of utilization attributed to glatiramer acetate.

Sandoz began marketing a generic version of glatiramer acetate 20 mg in the second quarter of 2015, which led to an immediate increase in the cost per prescription of $441 for the branded version of glatiramer acetate 20 mg, although that cost has come down gradually by $52 per prescription over time. Other DMTs saw minimal price changes at that time, Dr. Hartung and his colleagues noted.

The researchers attributed the increased Medicaid spending to rising prices of DMTs.

“Although some of this increase is attributable to the 2014 Medicaid expansion, the primary driver was rising DMT costs per prescription, which doubled over the period,” the researchers wrote. “Thus, we assert that rising prices, not increasing use, are the primary driver of spending for DMTs in the Medicaid program.”

In addition, the introduction of the first generic DMT “appeared to have little effect on the overall trajectory of DMT costs,” they continued. “In fact, the cost of Teva’s 20-mg glatiramer acetate increased significantly following the release of Sandoz’s generic. ... The increase possibly signified efforts to both retain revenue and further push market share to the 40-mg version. Although the costs for generic glatiramer acetate declined over time, its introduction appears not to have fundamentally affected the overall trend in DMT costs.”

Indeed, the researchers’ examination of utilization trends found that Teva executed a successful preemptive strategy of converting 20-mg users of glatiramer acetate to 40-mg users, something that is not interchangeable with the generic product.

“Low generic penetration is also due to the fact that Sandoz’s product was only 15% less expensive than branded glatiramer acetate 20 mg and approximately the same cost as the 40-mg version at launch,” Dr. Hartung and his colleagues stated. “This difference may have been further diminished by rebates that Teva may have provided to maintain preferred status on state Medicaid formularies.”

These factors reflect an “urgent need for robust generic competition within the DMT class,” the authors wrote.

The study was supported by the National Multiple Sclerosis Society. Lead author Dr. Hartung reported receiving research support from AbbVie.

[email protected]

SOURCE: Hartung D et al. Neurology. Jan 15. doi: 10.1212/WNL.0000000000008936.

Prescription pricing is a primary reason why Medicaid spending on multiple sclerosis disease-modifying therapies (DMTs) has more than doubled between 2011 and 2017 and the introduction of a generic glatiramer acetate is having nominal effect on pricing and utilization within the class, new research is showing.

Kenishirotie/Thinkstock

“Gross spending on self-administered and infusible MS DMTs in the Medicaid program increased 2.9-fold from $453 million in 2011 to $1.32 billion in 2017,” Daniel Hartung, PharmD, of Oregon Health and Science University, Portland, and his colleagues wrote in a research report published Jan. 15 in Neurology. Net spending after accounting for rebates during this period showed a doubling of spending from $278 million per year to $600 million per year.

Use of MS DMTs during this period overall remained stable, but there was a shift from injectable DMTs to oral DMTs during this time window, the researchers found, with the plurality of utilization attributed to glatiramer acetate.

Sandoz began marketing a generic version of glatiramer acetate 20 mg in the second quarter of 2015, which led to an immediate increase in the cost per prescription of $441 for the branded version of glatiramer acetate 20 mg, although that cost has come down gradually by $52 per prescription over time. Other DMTs saw minimal price changes at that time, Dr. Hartung and his colleagues noted.

The researchers attributed the increased Medicaid spending to rising prices of DMTs.

“Although some of this increase is attributable to the 2014 Medicaid expansion, the primary driver was rising DMT costs per prescription, which doubled over the period,” the researchers wrote. “Thus, we assert that rising prices, not increasing use, are the primary driver of spending for DMTs in the Medicaid program.”

In addition, the introduction of the first generic DMT “appeared to have little effect on the overall trajectory of DMT costs,” they continued. “In fact, the cost of Teva’s 20-mg glatiramer acetate increased significantly following the release of Sandoz’s generic. ... The increase possibly signified efforts to both retain revenue and further push market share to the 40-mg version. Although the costs for generic glatiramer acetate declined over time, its introduction appears not to have fundamentally affected the overall trend in DMT costs.”

Indeed, the researchers’ examination of utilization trends found that Teva executed a successful preemptive strategy of converting 20-mg users of glatiramer acetate to 40-mg users, something that is not interchangeable with the generic product.

“Low generic penetration is also due to the fact that Sandoz’s product was only 15% less expensive than branded glatiramer acetate 20 mg and approximately the same cost as the 40-mg version at launch,” Dr. Hartung and his colleagues stated. “This difference may have been further diminished by rebates that Teva may have provided to maintain preferred status on state Medicaid formularies.”

These factors reflect an “urgent need for robust generic competition within the DMT class,” the authors wrote.

The study was supported by the National Multiple Sclerosis Society. Lead author Dr. Hartung reported receiving research support from AbbVie.

[email protected]

SOURCE: Hartung D et al. Neurology. Jan 15. doi: 10.1212/WNL.0000000000008936.

Prescription pricing is a primary reason why Medicaid spending on multiple sclerosis disease-modifying therapies (DMTs) has more than doubled between 2011 and 2017 and the introduction of a generic glatiramer acetate is having nominal effect on pricing and utilization within the class, new research is showing.

Kenishirotie/Thinkstock

“Gross spending on self-administered and infusible MS DMTs in the Medicaid program increased 2.9-fold from $453 million in 2011 to $1.32 billion in 2017,” Daniel Hartung, PharmD, of Oregon Health and Science University, Portland, and his colleagues wrote in a research report published Jan. 15 in Neurology. Net spending after accounting for rebates during this period showed a doubling of spending from $278 million per year to $600 million per year.

Use of MS DMTs during this period overall remained stable, but there was a shift from injectable DMTs to oral DMTs during this time window, the researchers found, with the plurality of utilization attributed to glatiramer acetate.

Sandoz began marketing a generic version of glatiramer acetate 20 mg in the second quarter of 2015, which led to an immediate increase in the cost per prescription of $441 for the branded version of glatiramer acetate 20 mg, although that cost has come down gradually by $52 per prescription over time. Other DMTs saw minimal price changes at that time, Dr. Hartung and his colleagues noted.

The researchers attributed the increased Medicaid spending to rising prices of DMTs.

“Although some of this increase is attributable to the 2014 Medicaid expansion, the primary driver was rising DMT costs per prescription, which doubled over the period,” the researchers wrote. “Thus, we assert that rising prices, not increasing use, are the primary driver of spending for DMTs in the Medicaid program.”

In addition, the introduction of the first generic DMT “appeared to have little effect on the overall trajectory of DMT costs,” they continued. “In fact, the cost of Teva’s 20-mg glatiramer acetate increased significantly following the release of Sandoz’s generic. ... The increase possibly signified efforts to both retain revenue and further push market share to the 40-mg version. Although the costs for generic glatiramer acetate declined over time, its introduction appears not to have fundamentally affected the overall trend in DMT costs.”

Indeed, the researchers’ examination of utilization trends found that Teva executed a successful preemptive strategy of converting 20-mg users of glatiramer acetate to 40-mg users, something that is not interchangeable with the generic product.

“Low generic penetration is also due to the fact that Sandoz’s product was only 15% less expensive than branded glatiramer acetate 20 mg and approximately the same cost as the 40-mg version at launch,” Dr. Hartung and his colleagues stated. “This difference may have been further diminished by rebates that Teva may have provided to maintain preferred status on state Medicaid formularies.”

These factors reflect an “urgent need for robust generic competition within the DMT class,” the authors wrote.

The study was supported by the National Multiple Sclerosis Society. Lead author Dr. Hartung reported receiving research support from AbbVie.

[email protected]

SOURCE: Hartung D et al. Neurology. Jan 15. doi: 10.1212/WNL.0000000000008936.

LOS ANGELES – In the clinical experience of Kurt GMM Alberti, DPhil, FRCP, FRCPath, bariatric surgery should be used earlier in the course of diabetes to yield the most benefit. The problem is, far fewer people with diabetes are being referred for the surgery than would benefit from it.

Doug Brunk/MDedge News

At the World Congress on Insulin Resistance, Diabetes, and Cardiovascular Disease, Dr. Alberti said that only about 1% of eligible patients in the United States undergo bariatric surgery, compared with just 0.22% of eligible patients in the United Kingdom.

“Obesity is an increasing problem,” said Dr. Alberti, a senior research investigator in the section of diabetes, endocrinology, and metabolism at Imperial College, London. “The United States is leading the field [in obesity], and it doesn’t seem to be going away. This is in parallel with diabetes. According to the 2019 International Diabetes Federation’s Diabetes Atlas, the diabetes prevalence worldwide is now 463 million. It’s projected to reach 578 million by 2030 and 700 million by 2045. We have a major problem.”

Lifestyle modification with diet and exercise have been the cornerstone of diabetes therapy for more than 100 years, with only modest success. “A range of oral agents have been added [and they] certainly improve glycemic control, but few achieve lasting success, and few achieve remission,” Dr. Alberti said. Findings from DiRECT (Lancet. 2018;391:541-51) and the Look AHEAD (Action for Health in Diabetes) study (N Engl J Med. 2013;369:145-54) have shown dramatic improvements in glycemia, but only in the minority of patients who achieved weight loss of 10 kg or more. “In this group, 80% achieved remission after 2 years in DiRECT,” he said. “It is uncertain whether this can be sustained long term in real life, and how many people will respond. Major community prevention programs are under way in the U.S. and [United Kingdom], but many target individuals with prediabetes. Currently, it is unknown how successful these programs will be.”

The 2018 American Diabetes Association/European Association for the Study of Diabetes clinical guidelines state that bariatric surgery is a recommended treatment option for adults with type 2 diabetes and a body mass index of either 40.0 kg/m² or higher (or 37.5 kg/m² or higher in people of Asian ancestry) or 35.0-39.9 kg/m² (32.5-37.4 kg/m² in people of Asian ancestry) and who do not achieve durable weight loss and improvement in comorbidities with reasonable nonsurgical methods. According to Dr. Alberti, surgery should be an accepted option in people who have type 2 diabetes and a body mass index of 30 kg/m² or higher, and priority should be given to adolescents, young adults, and those with a shorter duration of diabetes.

The main suggestive evidence in favor of bariatric surgery having an impact on diabetes comes from the Swedish Obese Subjects Study, which had a median follow-up of 10 years (J Intern Med. 2013;273[3]:219-34). In patients with diabetes at baseline, 30% were still in remission at 15 years after surgery. After 18 years, cumulative microvascular disease had fallen from 42 to 21 per 1,000 person-years, and macrovascular complications had fallen by 25%. “This was not a randomized, controlled trial, however,” Dr. Alberti said. Several of these studies have now been performed, including the STAMPEDE trial (N Engl J Med. 2017;376:641-51) and recent studies led by Geltrude Mingrone, MD, PhD, which show major glycemic benefit (Lancet. 2015;386[9997]:P964-73) with bariatric surgery.

According to Dr. Alberti, laparoscopic adjustable gastric lap band is the easiest bariatric surgery to perform but it has fallen out of favor because of lower diabetes remission rates, compared with the other procedures. Roux-en-Y gastric bypass, sleeve gastrectomy, and biliary pancreatic diversion are all in use. Slightly higher remission rates have been shown with biliary pancreatic diversion. “There have also been consistent improvements in quality of life and cardiovascular risk factors,” he said. “Long-term follow-up is still [needed], but, in general, it seems that diabetic complications are lower than in medically treated control groups, and mortality may also be lower. The real question is, what is the impact on complications? There we have a problem, because we do not have any good randomized, controlled trials covering a 10- to 20-year period, which would give us clear evidence. There is reasonable evidence from cohort studies, though.”

Added benefits of bariatric surgery include improved quality of life, decreased blood pressure, less sleep apnea, improved cardiovascular risk factors, and better musculoskeletal function. For now, though, an unmet need persists. “The problem is that far fewer people are referred for bariatric surgery than would benefit,” Dr. Alberti said. “There are several barriers to greater use of bariatric surgery in those with diabetes. These include physician attitudes, inadequate referrals, patient perceptions, lack of awareness among patients, inadequate insurance coverage, and particularly health system capacity. There is also a lack of sympathy for overweight people in some places.”

Dr. Alberti reported having no financial disclosures.

[email protected]

LOS ANGELES – In the clinical experience of Kurt GMM Alberti, DPhil, FRCP, FRCPath, bariatric surgery should be used earlier in the course of diabetes to yield the most benefit. The problem is, far fewer people with diabetes are being referred for the surgery than would benefit from it.

Doug Brunk/MDedge News

At the World Congress on Insulin Resistance, Diabetes, and Cardiovascular Disease, Dr. Alberti said that only about 1% of eligible patients in the United States undergo bariatric surgery, compared with just 0.22% of eligible patients in the United Kingdom.

“Obesity is an increasing problem,” said Dr. Alberti, a senior research investigator in the section of diabetes, endocrinology, and metabolism at Imperial College, London. “The United States is leading the field [in obesity], and it doesn’t seem to be going away. This is in parallel with diabetes. According to the 2019 International Diabetes Federation’s Diabetes Atlas, the diabetes prevalence worldwide is now 463 million. It’s projected to reach 578 million by 2030 and 700 million by 2045. We have a major problem.”

Lifestyle modification with diet and exercise have been the cornerstone of diabetes therapy for more than 100 years, with only modest success. “A range of oral agents have been added [and they] certainly improve glycemic control, but few achieve lasting success, and few achieve remission,” Dr. Alberti said. Findings from DiRECT (Lancet. 2018;391:541-51) and the Look AHEAD (Action for Health in Diabetes) study (N Engl J Med. 2013;369:145-54) have shown dramatic improvements in glycemia, but only in the minority of patients who achieved weight loss of 10 kg or more. “In this group, 80% achieved remission after 2 years in DiRECT,” he said. “It is uncertain whether this can be sustained long term in real life, and how many people will respond. Major community prevention programs are under way in the U.S. and [United Kingdom], but many target individuals with prediabetes. Currently, it is unknown how successful these programs will be.”

The 2018 American Diabetes Association/European Association for the Study of Diabetes clinical guidelines state that bariatric surgery is a recommended treatment option for adults with type 2 diabetes and a body mass index of either 40.0 kg/m² or higher (or 37.5 kg/m² or higher in people of Asian ancestry) or 35.0-39.9 kg/m² (32.5-37.4 kg/m² in people of Asian ancestry) and who do not achieve durable weight loss and improvement in comorbidities with reasonable nonsurgical methods. According to Dr. Alberti, surgery should be an accepted option in people who have type 2 diabetes and a body mass index of 30 kg/m² or higher, and priority should be given to adolescents, young adults, and those with a shorter duration of diabetes.

The main suggestive evidence in favor of bariatric surgery having an impact on diabetes comes from the Swedish Obese Subjects Study, which had a median follow-up of 10 years (J Intern Med. 2013;273[3]:219-34). In patients with diabetes at baseline, 30% were still in remission at 15 years after surgery. After 18 years, cumulative microvascular disease had fallen from 42 to 21 per 1,000 person-years, and macrovascular complications had fallen by 25%. “This was not a randomized, controlled trial, however,” Dr. Alberti said. Several of these studies have now been performed, including the STAMPEDE trial (N Engl J Med. 2017;376:641-51) and recent studies led by Geltrude Mingrone, MD, PhD, which show major glycemic benefit (Lancet. 2015;386[9997]:P964-73) with bariatric surgery.

According to Dr. Alberti, laparoscopic adjustable gastric lap band is the easiest bariatric surgery to perform but it has fallen out of favor because of lower diabetes remission rates, compared with the other procedures. Roux-en-Y gastric bypass, sleeve gastrectomy, and biliary pancreatic diversion are all in use. Slightly higher remission rates have been shown with biliary pancreatic diversion. “There have also been consistent improvements in quality of life and cardiovascular risk factors,” he said. “Long-term follow-up is still [needed], but, in general, it seems that diabetic complications are lower than in medically treated control groups, and mortality may also be lower. The real question is, what is the impact on complications? There we have a problem, because we do not have any good randomized, controlled trials covering a 10- to 20-year period, which would give us clear evidence. There is reasonable evidence from cohort studies, though.”

Added benefits of bariatric surgery include improved quality of life, decreased blood pressure, less sleep apnea, improved cardiovascular risk factors, and better musculoskeletal function. For now, though, an unmet need persists. “The problem is that far fewer people are referred for bariatric surgery than would benefit,” Dr. Alberti said. “There are several barriers to greater use of bariatric surgery in those with diabetes. These include physician attitudes, inadequate referrals, patient perceptions, lack of awareness among patients, inadequate insurance coverage, and particularly health system capacity. There is also a lack of sympathy for overweight people in some places.”

Dr. Alberti reported having no financial disclosures.

[email protected]

LOS ANGELES – In the clinical experience of Kurt GMM Alberti, DPhil, FRCP, FRCPath, bariatric surgery should be used earlier in the course of diabetes to yield the most benefit. The problem is, far fewer people with diabetes are being referred for the surgery than would benefit from it.

Doug Brunk/MDedge News

At the World Congress on Insulin Resistance, Diabetes, and Cardiovascular Disease, Dr. Alberti said that only about 1% of eligible patients in the United States undergo bariatric surgery, compared with just 0.22% of eligible patients in the United Kingdom.

“Obesity is an increasing problem,” said Dr. Alberti, a senior research investigator in the section of diabetes, endocrinology, and metabolism at Imperial College, London. “The United States is leading the field [in obesity], and it doesn’t seem to be going away. This is in parallel with diabetes. According to the 2019 International Diabetes Federation’s Diabetes Atlas, the diabetes prevalence worldwide is now 463 million. It’s projected to reach 578 million by 2030 and 700 million by 2045. We have a major problem.”

Lifestyle modification with diet and exercise have been the cornerstone of diabetes therapy for more than 100 years, with only modest success. “A range of oral agents have been added [and they] certainly improve glycemic control, but few achieve lasting success, and few achieve remission,” Dr. Alberti said. Findings from DiRECT (Lancet. 2018;391:541-51) and the Look AHEAD (Action for Health in Diabetes) study (N Engl J Med. 2013;369:145-54) have shown dramatic improvements in glycemia, but only in the minority of patients who achieved weight loss of 10 kg or more. “In this group, 80% achieved remission after 2 years in DiRECT,” he said. “It is uncertain whether this can be sustained long term in real life, and how many people will respond. Major community prevention programs are under way in the U.S. and [United Kingdom], but many target individuals with prediabetes. Currently, it is unknown how successful these programs will be.”

The 2018 American Diabetes Association/European Association for the Study of Diabetes clinical guidelines state that bariatric surgery is a recommended treatment option for adults with type 2 diabetes and a body mass index of either 40.0 kg/m² or higher (or 37.5 kg/m² or higher in people of Asian ancestry) or 35.0-39.9 kg/m² (32.5-37.4 kg/m² in people of Asian ancestry) and who do not achieve durable weight loss and improvement in comorbidities with reasonable nonsurgical methods. According to Dr. Alberti, surgery should be an accepted option in people who have type 2 diabetes and a body mass index of 30 kg/m² or higher, and priority should be given to adolescents, young adults, and those with a shorter duration of diabetes.

The main suggestive evidence in favor of bariatric surgery having an impact on diabetes comes from the Swedish Obese Subjects Study, which had a median follow-up of 10 years (J Intern Med. 2013;273[3]:219-34). In patients with diabetes at baseline, 30% were still in remission at 15 years after surgery. After 18 years, cumulative microvascular disease had fallen from 42 to 21 per 1,000 person-years, and macrovascular complications had fallen by 25%. “This was not a randomized, controlled trial, however,” Dr. Alberti said. Several of these studies have now been performed, including the STAMPEDE trial (N Engl J Med. 2017;376:641-51) and recent studies led by Geltrude Mingrone, MD, PhD, which show major glycemic benefit (Lancet. 2015;386[9997]:P964-73) with bariatric surgery.

According to Dr. Alberti, laparoscopic adjustable gastric lap band is the easiest bariatric surgery to perform but it has fallen out of favor because of lower diabetes remission rates, compared with the other procedures. Roux-en-Y gastric bypass, sleeve gastrectomy, and biliary pancreatic diversion are all in use. Slightly higher remission rates have been shown with biliary pancreatic diversion. “There have also been consistent improvements in quality of life and cardiovascular risk factors,” he said. “Long-term follow-up is still [needed], but, in general, it seems that diabetic complications are lower than in medically treated control groups, and mortality may also be lower. The real question is, what is the impact on complications? There we have a problem, because we do not have any good randomized, controlled trials covering a 10- to 20-year period, which would give us clear evidence. There is reasonable evidence from cohort studies, though.”

Added benefits of bariatric surgery include improved quality of life, decreased blood pressure, less sleep apnea, improved cardiovascular risk factors, and better musculoskeletal function. For now, though, an unmet need persists. “The problem is that far fewer people are referred for bariatric surgery than would benefit,” Dr. Alberti said. “There are several barriers to greater use of bariatric surgery in those with diabetes. These include physician attitudes, inadequate referrals, patient perceptions, lack of awareness among patients, inadequate insurance coverage, and particularly health system capacity. There is also a lack of sympathy for overweight people in some places.”

Dr. Alberti reported having no financial disclosures.

[email protected]

A Food and Drug Administration advisory committee voted 27-0 on Jan. 14 against recommending agency approval of oxycodegol, a new type of opioid molecule designed to slow passage of the drug through the blood-brain barrier and hence cause less of a “high” and potentially blunt the drug’s abuse potential.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

But the panel, which includes members from both the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee, unanimously shared the opinion that the data submitted by the drug developer, Nektar, failed to clearly demonstrate the drug’s safety and efficacy.

“There was a lot of ambiguity [in the data] about safety and efficacy, and this is too important an issue to have so much ambiguity,” summed up Ronald S. Litman, DO, professor of anesthesiology and critical care at the University of Pennsylvania in Philadelphia and chair of the combined committee.

“The subliminal message” that would surround oxycodegol if it received FDA approval would be that it is a “safer” opioid, “and that would make it a blockbuster drug, and for that to happen you need data that [prove] the benefits outweigh risks, but we didn’t see those data. It was all speculation, and we can’t approve a potential blockbuster opioid in the middle of a public health opioid crisis based on speculation,” commented Steve B. Meisel, PharmD, system director of medication safety for Fairview Health Services in Minneapolis and a committee member.

According to Nektar, oxycodegol is a new molecular entity that combines a morphinan pharmacophore, oxycodol, with a six-unit chain of polyethylene glycol, a design that slows movement of the drug into the brain by about an hour after an oral dose when compared with oxycodone. It works as a full mu opioid receptor agonist that inhibits the nociceptive pathways while it reduces reinforcing or euphoric effects and other negative CNS-mediated side effects because of its slowed entry into the central nervous system.

But, as became apparent during the course of the day’s presentations and questions, while the clinical evidence in general supported this mechanism, the data were flawed by many limitations and caveats. FDA staffers critiqued the company’s data set for a variety of issues, including testing dosages that were “arbitrary and flawed,” evidence for “high oral abuse potential” in one study, including “a high rate of euphoria” of 17% even at the recommended dosage level (and a higher euphoria incidence at a higher dosage), limited information on additional pain medications that enrolled patients had used both before enrollment and during the study, and possible enrollment bias. Many panel members also raised concerns that included the efficacy data coming from a single randomized study, incomplete data on possible hepatic toxicity, no data to address potential abuse via injection or inhalation, a very modest demonstrated increment in pain relief, and abuse potential studies that relied on a single dose of the drug.

On the other hand, many committee members, and others in the pain field, applauded the general concept behind oxycodegol and urged the developer to run additional studies and collect more data for a future FDA application.

There has been “a lot of controversy” about oxycodegol, often centered on the question “why do we need another opioid,” commented Steven P. Cohen, MD, professor of anesthesiology, neurology, and pain medicine and chief of pain medicine at Johns Hopkins Health in Baltimore. “Having another opioid on the market with a different pain indication and possibly lower abuse potential” would be welcome and “almost certainly would not result in more prescriptions or abuse,” said Dr. Cohen, who was not a committee member but addressed in an interview the need for new and effective pain medications that offer an alternative to conventional opioids. “Patients who might otherwise be prescribed a different opioid might receive oxycodegol instead,” he suggested. But first, the developing company will need to collect a lot more clinical data than it has reported so far.

[email protected]

A Food and Drug Administration advisory committee voted 27-0 on Jan. 14 against recommending agency approval of oxycodegol, a new type of opioid molecule designed to slow passage of the drug through the blood-brain barrier and hence cause less of a “high” and potentially blunt the drug’s abuse potential.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

But the panel, which includes members from both the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee, unanimously shared the opinion that the data submitted by the drug developer, Nektar, failed to clearly demonstrate the drug’s safety and efficacy.

“There was a lot of ambiguity [in the data] about safety and efficacy, and this is too important an issue to have so much ambiguity,” summed up Ronald S. Litman, DO, professor of anesthesiology and critical care at the University of Pennsylvania in Philadelphia and chair of the combined committee.

“The subliminal message” that would surround oxycodegol if it received FDA approval would be that it is a “safer” opioid, “and that would make it a blockbuster drug, and for that to happen you need data that [prove] the benefits outweigh risks, but we didn’t see those data. It was all speculation, and we can’t approve a potential blockbuster opioid in the middle of a public health opioid crisis based on speculation,” commented Steve B. Meisel, PharmD, system director of medication safety for Fairview Health Services in Minneapolis and a committee member.

According to Nektar, oxycodegol is a new molecular entity that combines a morphinan pharmacophore, oxycodol, with a six-unit chain of polyethylene glycol, a design that slows movement of the drug into the brain by about an hour after an oral dose when compared with oxycodone. It works as a full mu opioid receptor agonist that inhibits the nociceptive pathways while it reduces reinforcing or euphoric effects and other negative CNS-mediated side effects because of its slowed entry into the central nervous system.

But, as became apparent during the course of the day’s presentations and questions, while the clinical evidence in general supported this mechanism, the data were flawed by many limitations and caveats. FDA staffers critiqued the company’s data set for a variety of issues, including testing dosages that were “arbitrary and flawed,” evidence for “high oral abuse potential” in one study, including “a high rate of euphoria” of 17% even at the recommended dosage level (and a higher euphoria incidence at a higher dosage), limited information on additional pain medications that enrolled patients had used both before enrollment and during the study, and possible enrollment bias. Many panel members also raised concerns that included the efficacy data coming from a single randomized study, incomplete data on possible hepatic toxicity, no data to address potential abuse via injection or inhalation, a very modest demonstrated increment in pain relief, and abuse potential studies that relied on a single dose of the drug.

On the other hand, many committee members, and others in the pain field, applauded the general concept behind oxycodegol and urged the developer to run additional studies and collect more data for a future FDA application.

There has been “a lot of controversy” about oxycodegol, often centered on the question “why do we need another opioid,” commented Steven P. Cohen, MD, professor of anesthesiology, neurology, and pain medicine and chief of pain medicine at Johns Hopkins Health in Baltimore. “Having another opioid on the market with a different pain indication and possibly lower abuse potential” would be welcome and “almost certainly would not result in more prescriptions or abuse,” said Dr. Cohen, who was not a committee member but addressed in an interview the need for new and effective pain medications that offer an alternative to conventional opioids. “Patients who might otherwise be prescribed a different opioid might receive oxycodegol instead,” he suggested. But first, the developing company will need to collect a lot more clinical data than it has reported so far.

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A Food and Drug Administration advisory committee voted 27-0 on Jan. 14 against recommending agency approval of oxycodegol, a new type of opioid molecule designed to slow passage of the drug through the blood-brain barrier and hence cause less of a “high” and potentially blunt the drug’s abuse potential.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

But the panel, which includes members from both the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee, unanimously shared the opinion that the data submitted by the drug developer, Nektar, failed to clearly demonstrate the drug’s safety and efficacy.

“There was a lot of ambiguity [in the data] about safety and efficacy, and this is too important an issue to have so much ambiguity,” summed up Ronald S. Litman, DO, professor of anesthesiology and critical care at the University of Pennsylvania in Philadelphia and chair of the combined committee.

“The subliminal message” that would surround oxycodegol if it received FDA approval would be that it is a “safer” opioid, “and that would make it a blockbuster drug, and for that to happen you need data that [prove] the benefits outweigh risks, but we didn’t see those data. It was all speculation, and we can’t approve a potential blockbuster opioid in the middle of a public health opioid crisis based on speculation,” commented Steve B. Meisel, PharmD, system director of medication safety for Fairview Health Services in Minneapolis and a committee member.

According to Nektar, oxycodegol is a new molecular entity that combines a morphinan pharmacophore, oxycodol, with a six-unit chain of polyethylene glycol, a design that slows movement of the drug into the brain by about an hour after an oral dose when compared with oxycodone. It works as a full mu opioid receptor agonist that inhibits the nociceptive pathways while it reduces reinforcing or euphoric effects and other negative CNS-mediated side effects because of its slowed entry into the central nervous system.

But, as became apparent during the course of the day’s presentations and questions, while the clinical evidence in general supported this mechanism, the data were flawed by many limitations and caveats. FDA staffers critiqued the company’s data set for a variety of issues, including testing dosages that were “arbitrary and flawed,” evidence for “high oral abuse potential” in one study, including “a high rate of euphoria” of 17% even at the recommended dosage level (and a higher euphoria incidence at a higher dosage), limited information on additional pain medications that enrolled patients had used both before enrollment and during the study, and possible enrollment bias. Many panel members also raised concerns that included the efficacy data coming from a single randomized study, incomplete data on possible hepatic toxicity, no data to address potential abuse via injection or inhalation, a very modest demonstrated increment in pain relief, and abuse potential studies that relied on a single dose of the drug.

On the other hand, many committee members, and others in the pain field, applauded the general concept behind oxycodegol and urged the developer to run additional studies and collect more data for a future FDA application.

There has been “a lot of controversy” about oxycodegol, often centered on the question “why do we need another opioid,” commented Steven P. Cohen, MD, professor of anesthesiology, neurology, and pain medicine and chief of pain medicine at Johns Hopkins Health in Baltimore. “Having another opioid on the market with a different pain indication and possibly lower abuse potential” would be welcome and “almost certainly would not result in more prescriptions or abuse,” said Dr. Cohen, who was not a committee member but addressed in an interview the need for new and effective pain medications that offer an alternative to conventional opioids. “Patients who might otherwise be prescribed a different opioid might receive oxycodegol instead,” he suggested. But first, the developing company will need to collect a lot more clinical data than it has reported so far.

[email protected]

The Food and Drug Administration has issued a Safety Alert regarding the weight-management medication lorcaserin (Belviq, Belviq XR) after results from a clinical trial assessing the drug’s safety showed a possible increased risk of cancer.

bankrx/Getty Images

“At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk. However, we wanted to make the public aware of this potential risk,” the agency said in a press release.

The agency advised that health care providers consider whether the benefits of taking lorcaserin outweighed the potential cancer risk, and that patients currently taking the medication should talk to their providers about the risks.

“We are continuing to evaluate the clinical trial results and will communicate our final conclusions and recommendations when we have completed our review,” the FDA noted in the statement.

Lorcaserin, a serotonin 2C receptor agonist, was approved by the FDA in 2012 at a dosage of 20 mg once daily for use with a reduced-calorie diet and increased physical activity as a means to improve weight loss in adults who are obese or overweight and have at least one weight-related medical problem, such as such as hypertension, type 2 diabetes, or dyslipidemia. In July 2016, the agency approved a New Drug Application for an extended-release, once-daily formulation.

Headache, dizziness, fatigue, nausea, dry mouth, and constipation are the more common adverse effects in patients without diabetes, whereas hypoglycemia, headache, back pain, cough, and fatigue are more common in patients with diabetes. The treatment is contraindicated for pregnancy.

Lorcaserin is distributed by Eisai.*

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*Correction, 1/15/2020: An earlier version of this story misstated the manufacturer of lorcaserin. 

The Food and Drug Administration has issued a Safety Alert regarding the weight-management medication lorcaserin (Belviq, Belviq XR) after results from a clinical trial assessing the drug’s safety showed a possible increased risk of cancer.

bankrx/Getty Images

“At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk. However, we wanted to make the public aware of this potential risk,” the agency said in a press release.

The agency advised that health care providers consider whether the benefits of taking lorcaserin outweighed the potential cancer risk, and that patients currently taking the medication should talk to their providers about the risks.

“We are continuing to evaluate the clinical trial results and will communicate our final conclusions and recommendations when we have completed our review,” the FDA noted in the statement.

Lorcaserin, a serotonin 2C receptor agonist, was approved by the FDA in 2012 at a dosage of 20 mg once daily for use with a reduced-calorie diet and increased physical activity as a means to improve weight loss in adults who are obese or overweight and have at least one weight-related medical problem, such as such as hypertension, type 2 diabetes, or dyslipidemia. In July 2016, the agency approved a New Drug Application for an extended-release, once-daily formulation.

Headache, dizziness, fatigue, nausea, dry mouth, and constipation are the more common adverse effects in patients without diabetes, whereas hypoglycemia, headache, back pain, cough, and fatigue are more common in patients with diabetes. The treatment is contraindicated for pregnancy.

Lorcaserin is distributed by Eisai.*

[email protected]

*Correction, 1/15/2020: An earlier version of this story misstated the manufacturer of lorcaserin. 

The Food and Drug Administration has issued a Safety Alert regarding the weight-management medication lorcaserin (Belviq, Belviq XR) after results from a clinical trial assessing the drug’s safety showed a possible increased risk of cancer.

bankrx/Getty Images

“At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk. However, we wanted to make the public aware of this potential risk,” the agency said in a press release.

The agency advised that health care providers consider whether the benefits of taking lorcaserin outweighed the potential cancer risk, and that patients currently taking the medication should talk to their providers about the risks.

“We are continuing to evaluate the clinical trial results and will communicate our final conclusions and recommendations when we have completed our review,” the FDA noted in the statement.

Lorcaserin, a serotonin 2C receptor agonist, was approved by the FDA in 2012 at a dosage of 20 mg once daily for use with a reduced-calorie diet and increased physical activity as a means to improve weight loss in adults who are obese or overweight and have at least one weight-related medical problem, such as such as hypertension, type 2 diabetes, or dyslipidemia. In July 2016, the agency approved a New Drug Application for an extended-release, once-daily formulation.

Headache, dizziness, fatigue, nausea, dry mouth, and constipation are the more common adverse effects in patients without diabetes, whereas hypoglycemia, headache, back pain, cough, and fatigue are more common in patients with diabetes. The treatment is contraindicated for pregnancy.

Lorcaserin is distributed by Eisai.*

[email protected]

*Correction, 1/15/2020: An earlier version of this story misstated the manufacturer of lorcaserin.