Although superiority to placebo was not met, BELVIQ was non-inferior to placebo on the MACE+ composite, with similar event rates for BELVIQ and placebo.ĬAMELLIA-TIMI 61 also assessed for effects of BELVIQ on multiple cardiovascular risk factors. Since the study met the primary safety endpoint for MACE, the study also assessed for the primary efficacy endpoint of whether or not BELVIQ reduced the incidence of cardiovascular events compared to placebo for a broader composite endpoint, MACE+, consisting of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization due to unstable angina, heart failure or coronary revascularization. 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 study was conducted as part of a post-marketing requirement by the US Food and Drug Administration (FDA) with the primary objective to evaluate long-term cardiovascular safety and assessed for the incidence of major adverse cardiovascular events (MACE) in overweight and obese adults with existing cardiovascular disease or type 2 diabetes mellitus (T2DM) with cardiovascular risk factors.ĬAMELLIA-TIMI 61 met its primary safety objective, finding that long-term treatment with BELVIQ does not increase incidence of MACE, defined as cardiovascular death or non-fatal myocardial infarction or non-fatal stroke, in overweight and obese patients at high risk for CV events. ![]() This 12,000 patient study of BELVIQ ® (lorcaserin HCl) CIV 10 mg twice-daily was conducted at over 400 sites in eight countries including the United States in collaboration with the Thrombolysis in Myocardial Infarction (TIMI) Study Group and is the largest cardiovascular (CV) outcome trial to date for a weight loss medication. announced positive topline results from the CAMELLIA-TIMI 61 cardiovascular outcome trial. Improvement in multiple cardiovascular risk factors, including lipids, blood pressure, blood glucose and renal function. ![]()
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