20 July 2018 - - Woodcliff Lake, New Jersey-based pharmaceutical business Eisai Inc. has released positive topline results from the CAMELLIA-TIMI 61 cardiovascular outcome trial of Belviq (lorcaserin HCl) CIV 10 mg twice-daily conducted in 12,000 patients at over 400 sites in eight countries in collaboration with the Thrombolysis in Myocardial Infarction (TIMI) Study Group, the company said.
The study, the largest cardiovascular outcome trial to date for a weight loss medication, was conducted as part of a post-marketing requirement by the US FDA with the primary objective to evaluate long-term cardiovascular safety and to assess 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.
CAMELLIA-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.
The study also assessed whether or not Belviq reduced the incidence of cardiovascular events compared to placebo for a broader composite endpoint, MACE+.
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.
Treatment with Belviq also resulted in significant improvements in a number of predefined secondary endpoints, including blood pressure, lipids, blood sugar and renal function, as well as a reduction in conversion to T2DM in patients without diabetes at baseline.
In additional subgroup analyses, on a background of lifestyle modification, it was observed that Belviq improved long-term weight loss, compared to placebo, including in subpopulations of patients with T2DM and obstructive sleep apnea.
The overall safety profile for Belviq in CAMELLIA-TIMI 61 was consistent with that of the approved label, with dizziness, urinary tract infection, and fatigue being the most commonly reported adverse events in CAMELLIA-TIMI61.
Belviq/Belviq XR is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes).
Eisai Inc., the US pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities. The company's US headquarters, commercial and clinical development organizations are located in New Jersey; discovery labs are in Massachusetts and Pennsylvania; and its global demand chain organization resides in Maryland and North Carolina.
The TIMI Study Group is an academic research organization based at Brigham and Women's Hospital that has been leading practice-changing cardiovascular clinical trials for 30 years.
Brigham and Women's Hospital is a 793-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare. BWH has more than 3.5 m annual patient visits, is the largest birthing center in New England and employs nearly 15,000 people.