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Safety and Efficacy of Lorcaserin

Oct 20, 2018
Editor: Steve Freed, R.PH., CDE

Author: Angela Reyes, Pharm.D. Candidate, LECOM College of Pharmacy

New study focuses on cardiovascular safety of weight loss drug Lorcaserin in patients with excess weight or obesity.

Obesity is associated with many health complications, including hypertension, type 2 diabetes, dyslipidemia, and coronary artery disease, to name a few. Weight reduction can often correct some of these complications. Lifestyle modification is the most important factor in weight loss programs, but medications are recommended in some cases. There are many weight loss medications available with varying safety issues. A new study researched whether lorcaserin, a selective agonist for 5-hydroxytryptamine 2C serotonin receptor (5-HT2C), is effective as a weight loss medication and safe to use in patients who have excess weight or obesity with atherosclerotic cardiovascular disease or other cardiovascular risk factors.

The CAMELLIA-TIMI 61 (Cardiovascular and Metabolic Effects of Lorcaserin in Patients who have excess weight and/or obesity–Thrombolysis in Myocardial Infarction 61) trial was a long-term trial to study the cardiovascular and metabolic safety of lorcaserin. It was a double-blind, randomized trial using patients from multiple sites across eight countries. Participants had a BMI over 27 and established cardiovascular disease or multiple risk factors. Eligible patients were either given 10 mg of lorcaserin twice a day or a placebo, and group stratification was according to cardiovascular disease status. The primary outcome was a major cardiovascular event like death caused by cardiovascular origin, myocardial infarction, stroke, unstable angina, heart failure, or any coronary revascularization.

Of the 12,000 enrolled, 8,958 participants had confirmed atherosclerotic cardiovascular disease. Groups were followed a median of 3.3 years. At one year, the least squares mean change in weight from baseline was −4.2 kg in the lorcaserin group and −1.4 kg in the placebo group. There was a difference of 2.8 kg between the two groups. Also at one year, weight loss of at least 5% occurred in 38.7% of the lorcaserin group and only in 17.4% of the placebo group. Patients also had a greater reduction from baseline in BMI and waist circumference in the lorcaserin group than in the placebo group.

Among cardiovascular risk factors, the lorcaserin group had slightly lower blood pressure, heart rate, LDL, triglycerides, and glycated hemoglobin than the placebo group. Eight point five percent of participants who had prediabetes at baseline in the lorcaserin group developed diabetes, whereas 10.3% in the placebo group went from prediabetes to diabetes. Major cardiovascular events occurred in 6.1% of lorcaserin group members and 6.2% of placebo participants. Lorcaserin had no increase in cardiovascular risk among individuals who had excess weight or obesity with a high cardiovascular risk.

Practice Pearls:

  • Obesity contributes to many health issues. Weight reduction strategies should include lifestyle modification and in some cases medication.
  • Lorcaserin showed greater reduction in weight over placebo and no increased cardiovascular risk.
  • Patients with obesity and high cardiovascular risk can safely take lorcaserin to reduce weight.


E.A. Bohula, S.D. Wiviott, D.K. McGuire, S.E. Inzucchi, J. Kuder, K.A. Im, C.L. Fanola, A. Qamar, C. Brown, A. Budaj, A. Garcia‑Castillo, M. Gupta, L.A. Leiter, N.J. Weissman, H.D. White, T. Patel, B. Francis, W. Miao, C. Perdomo, S. Dhadda, M.P. Bonaca, C.T. Ruff, A.C. Keech, S.R. Smith, M.S. Sabatine, and B.M. Scirica. Cardiovascular Safety of Lorcaserin in Overweight  or Obese Patients. The New England Journal of Medicine. (2018)379:12; pg1107-1117

Angela Reyes, Pharm.D. Candidate, LECOM College of Pharmacy


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