Assessment of Cardiovascular Risk Reduction in Adults With Metabolic Syndrome or Type 2 Diabetes Treated With Lorcaserin: A Pooled Cohort Analysis.

Introduction: Obesity is a risk factor for cardiovascular disease (CVD) and even modest weight loss can contribute to its reduction. Lorcaserin, a selective 5HT 2C receptor agonist, is indicated as an adjunct to a reduced-calorie diet and increased physical activity in adults with obesity (BMI≥30 kg/m 2 ) or overweight (BMI 27-29.9 kg/m 2 and at least 1 weight-related comorbidity). Using the 2013 ACC/AHA 10-year CVD risk assessment pooled cohort equation, we examined risk change in patients with metabolic syndrome or type 2 diabetes (T2DM) undergoing treatment with lorcaserin or placebo for weight loss. Methods: We identified patients with metabolic syndrome or T2DM in three randomized, double-blind studies (BLOOM, BLOSSOM, BLOOM-DM) examining the efficacy and safety of lorcaserin 10 mg bid (LOR) vs. placebo (PBO) at one year of treatment. Only patients with lipid values at baseline and one year were included. Once selected, patients were further stratified by weight loss at week 12 of treatment (≥5% vs. 5% was classified as high risk, and a 0.5% change in risk over one year was defined as clinically relevant. CVD risk reduction by cohorts, overall and by gender, was compared. Results: Overall, 43% LOR (n=449/1056) and 20% PBO (n=207/1041) patients had u003e5% weight reduction at week 12 (p Conclusion: The analysis suggests that patients with overweight or obesity and metabolic syndrome/T2DM at risk for CVD, and treated with LOR, experienced a significant CVD risk reduction at one year vs PBO, most notably among men. LOR can effectively reduce weight, which is associated with improvements in CVD risk.