Waterlily Heart

Landmark Cardiovascular Outcomes Study for Belviq

For the first time ever, we have direct evidence for the long-term cardiovascular safety of an obesity medication. The drug is Belviq, also known as lorcaserin. Yesterday, Eisai released topline results for the long-awaited CAMILLIA-TIMI 61 trial. This was a five-year cardiovascular outcomes study of 12,000 patients. It was randomized and placebo controlled.

CV Safety Same as Placebo with Less Progression to Diabetes

The primary outcome of the study was to show that Belviq caused no more major heart problems than a placebo. But in addition to good safety, patients taking Belviq achieved better long-term weight loss and were less likely to develop diabetes than patients taking placebo.

That’s not all, though. Patients taking Belviq also had healthier blood pressure, lipids, kidney function, and blood sugar levels. Marc Sabatine, Chairman of the TIMI Study Group, explained the importance of this study:

CAMELLIA-TIMI 61 was 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.

Full Results and Implications

The first public presentation of these results will come August 26 at the European Society for Cardiology meeting. In addition, Eisai will be submitting these results to the U.S. FDA. This may bring favorable revisions to the prescribing information for Belviq.

Without a doubt, this is good news. Never before have we had such solid long-term outcomes data for an obesity medication. Even better, this is very likely the first of many such studies for obesity drugs, which will do much firm up the evidence base for their safety and effectiveness.

Click here for the press release on these results and here for a detailed description of the study design and rationale.

Waterlily Heart, photograph © tanakawho / flickr

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July 18, 2018