The team sought a primary safety outcome of major cardiovascular events-as defined as either cardiovascular death, myocardial infarction, or stroke-as assessed at an interim analysis, in order to exclude a noninferiority boundary of 1.4. Patients were provided access to and were encouraged to participate in a weight-management program which included behavior therapy, dietary and exercise information, and telephone access to a dietitian. Median age in both treatment groups was 64 years, and the majority of patients were male (64.8% and 63.6%, respectively). Patients were required to have a body mass index (BMI) of at least 27, and reported a median BMI of 35. Bohula, MD, of the Brigham and Women’s Hospital, Boston, MA-randomly assigned 12,000 overweight/obese patients with atherosclerotic cardiovascular disease or multiple cardiovascular risk factors to either treatment or placebo (n = 6000 each). The Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obsese Patients-Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) study, presented at the European Society of Cardiology (ESC) 2018 Congress this weekend, sought a primary safety outcome of major cardiovascular events in patients administered either 10 mg twice daily lorcaserin or placebo.
As worldwide obesity rates have nearly tripled in the past 4 decades, the discovery of an efficacious, safe weight-loss therapy with no added risk for major cardiovascular events is a crucial development. However, data on its long-term cardiovascular and metabolic safety is lacking.
Lorcaserin was previously approved by the US Food and Drug Administration (FDA) as an adjunct therapy to reduced-calorie diet and increased physical activity for patients in need of long-term weight management. In a new study including 12,00 overweight or obese patients with cardiovascular risks, selective serotonin 2C receptor agonist lorcaserin showed benefits as a weight-loss therapy without any increased risks for major cardiovascular risks versus placebo. A selective receptor agonist that modulates appetite with proven benefit for weight management therapy has been shown to be safe and effective for cardiovascular indications.
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