![]() ![]() ![]() It helps people lose weight without causing an increase in MACE in a population at higher risk for heart attacks and strokes," said Erin Bohula, MD, an investigator with the trial. "We have been able to show for the first time that this weight loss drug does what it is intended to do. Lorcaserin also appeared to reduce the conversion rate to diabetes in those patients with pre-diabetes at baseline, as well as lead to small improvements in levels of triglycerides, blood glucose, heart rate and blood pressure.Īccording to investigators, CAMELLIA-TIMI 61 is notable as it provides the first demonstration of cardiovascular safety of any weight loss agent in a dedicated cardiovascular outcomes trial. The differences between groups remained significant at 3.3 years of follow-up. Additionally, 39 percent of those taking the drug had lost at least 5 percent of their body weight at one year compared with 17 percent of those in the placebo group. Study investigators noted that those patients taking lorcaserin lost an average of 4.2 kg in the first year compared to 1.4 kg for those taking placebo. However, the trial did not meet its superiority endpoint for the composite of MACE plus hospitalization for unstable angina, heart failure, or any coronary revascularization (11.8 percent in lorcaserin group vs. ![]() At study completion, MACE occurred in 6.1 percent of those taking lorcaserin and 6.2 percent of those on placebo. Overall, the study met its primary safety endpoint of noninferiority of the drug compared to placebo for major adverse cardiovascular events (MACE). Participants were randomly assigned (1:1 ratio) to lorcaserin (10 mg/twice a day) or placebo and followed for a median of 3.3 years. All participants had a minimum BMI of 27 kg/m and either established cardiovascular disease (with or without diabetes) or diabetes and at least one cardiovascular risk factor. The CAMELLIA-TIMI 61 Trial enrolled 12,000 adults from 473 centers in eight countries between January 2014 and November 2015. contingent on post-market studies assessing the risk of major cardiovascular events, but not in Europe. The appetite suppressant is approved for use in the U.S. 26 at ESC Congress 2018 and simultaneously published in the New England Journal of Medicine. The weight loss drug lorcaserin did not increase cardiovascular events based on findings from the CAMELLIA-TIMI 61 Trial presented Aug. ![]()
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