Obesity Drug Belviq Is Heart Safe in Cardiovascular Outcome Study

July 19, 2018

The obesity drug lorcaserin (Belviq, Eisai) does not increase the risk of any major adverse cardiac events (MACE) — including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke — according to top-line results from a 12,000 patient post-marketing safety study mandated by the US Food and Drug Administration (FDA).

The CAMELLIA-TIMI 61 study is the largest double-blind, placebo-controlled, parallel-group cardiovascular outcomes study among weight loss medications. It enrolled overweight and obese patients with established cardiovascular disease, type 2 diabetes, or cardiovascular risk factors.

The FDA approved lorcaserin 10 mg twice daily in 2012. In 2016 the agency approved an extended-release, 20-mg, once-daily dosing option of lorcaserin (Belviq XR).

There were safety concerns around the drug, but the FDA decided to okay it and allow a postmarketing study to be conducted. Such cardiovascular outcomes trials are now required for all obesity drugs, as they are for type 2 diabetes drugs.

Lorcaserin has not, to date, been approved in the European Union, however.

Will Reassuring Data Increase Prescribing of Obesity Medications?

Asked to comment, obesity expert Scott Kahan MD, MPH, of Johns Hopkins University, Baltimore, Maryland, told Medscape Medical News: "This is a groundbreaking study...more so for the field than the medication itself. To be sure, it is a feather in the cap for lorcaserin, adding to solid efficacy and safety data in several prior 1 to 2 year-long studies."

"But for the field of obesity medicine it is vital, as there had been somewhat unfounded beliefs that obesity treatments are risky. Several additional cardiovascular outcomes trials for other obesity medications are in process, and I expect will show positive results as well. This should lead to increased consideration of prescribing FDA-approved medications and increased comfort for patients."

Indeed, a Medscape survey earlier this year indicated that US physicians are very reluctant to prescribe obesity drugs at all. 

Whether this reassurance on cardiovascular safety will improve uptake of lorcaserin remains to be seen.

Kahan noted that one of the potential concerns with lorcaserin was a possible increased risk of heart valve problems, because "lorcaserin has some similarity to the mechanism of action for an older medicine called fenfluramine, which was taken off the market due to heart valve effects."

Although the detailed results of CAMELLIA-TIMI 61 are not yet available, these top-line data seem to indicate that “lorcaserin doesn't appear to have the same risk,” he observed.   

Reduced Risk of Type 2 Diabetes; Full Results at ESC, EASD

As well as showing no increase in cardiovascular events, the top-line results of CAMELLIA-TIMI 61 show a reduction in conversion to type 2 diabetes in patients who did not have diabetes at baseline among those taking lorcaserin 10 mg twice daily compared with those receiving placebo.

There was also an improvement in multiple cardiovascular risk factors, including lipids, blood pressure, blood glucose, and renal function, with lorcaserin, says Eisai in its press release announcing the findings.  

Eisai and the TIMI study group will present the full results of the CAMELLIA-TIMI 61 study at the European Society for Cardiology (ESC) meeting in Munich, Germany, on August 26 and the European Association for Study of Diabetes (EASD) meeting in Berlin, Germany, on October 4. 

"With this result, Belviq is the first-ever weight loss medication approved for chronic weight management to achieve this objective in a dedicated long-term cardiovascular outcome trial," the company notes.   

And CAMELLIA-TIMI 61 investigator Marc Sabatine, MD, MPH, TIMI study group chair, Brigham and Women's Hospital, said the study is "a rigorous evaluation of the safety and efficacy of Belviq as a metabolic intervention on cardiovascular health in a high cardiovascular risk patient population. We look forward to sharing the full results with the scientific community."

Eisai says it now plans to have discussions with the US FDA, including potential revision of the Belviq product label. 

Kahan is on the advisory board for Medscape Diabetes & Endocrinology and has served as a consultant for Novo Nordisk, Orexigen, and Vivus.

Follow Lisa Nainggolan on Twitter: @lisanainggolan1. For more diabetes and endocrinology news, follow us on Twitter and on Facebook.

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