Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients - Thrombolysis in Myocardial Infarction 61 - CAMELLIA–TIMI 61

Oct 30, 2018
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Eisai
Date Presented:
08/26/2018
Date Published:
10/04/2018
Date Updated:
10/30/2018
Original Posted Date:
08/26/2018
References

Contribution To Literature:

The CAMELLIA–TIMI 61 trial showed that lorcaserin was effective at promoting weight loss without an increase in adverse cardiovascular events.

Description:

The goal of the trial was to evaluate the cardiovascular safety and efficacy of the selective serotonin 2C receptor agonist lorcaserin compared with placebo among overweight and obese patients.

Study Design

  • Randomized
  • Parallel

Overweight and obese patients with cardiovascular disease or multiple cardiovascular risk factors were randomized to lorcaserin 10 mg twice daily (n = 6,000) versus placebo (n = 6,000).

Inclusion criteria:

  • Overweight and obese patients (body mass index [BMI] >27 kg/m2) with cardiovascular disease or multiple cardiovascular risk factors
  • Total number of enrollees: 12,000
  • Duration of follow-up: median 3.3 years
  • Mean patient age: 64 years
  • Percentage female: 35%
  • Percentage with diabetes: 56%

Principal Findings:

The primary safety outcome, major cardiovascular events (cardiovascular death, myocardial infarction, or stroke), occurred in 2.0% per year in the lorcaserin group compared with 2.1% per year in the placebo group (p for noninferiority < 0.001). Since the condition for noninferiority was met, further analyses focused on superiority testing for cardiovascular efficacy.

The primary efficacy outcome, major cardiovascular events, heart failure, or hospitalization for unstable angina or revascularization, occurred in 4.1% per year in the lorcaserin group compared with 4.2% per year in the placebo group (p = not significant).

Secondary outcomes:

  • Weight loss of ≥5%: 38.7% for lorcaserin vs. 17.4% for placebo (p < 0.001)
  • Cardiovascular death: 0.5% per year for lorcaserin vs. 0.5% per year for placebo (p = not significant)
  • Heart failure: 0.8% per year for lorcaserin vs. 0.8% per year for placebo (p = not significant)
  • Lorcaserin reduced the risk of incident diabetes among those with pre-diabetes by 19% (p = 0.038), and reduced the risk of incident diabetes among those without diabetes by 23% (p = 0.012)

Interpretation:

Among overweight and obese patients with cardiovascular disease or major risk for cardiovascular disease, lorcaserin was safe. Compared with placebeo, lorcaserin was associated with a sustained reduction in weight without an increase in adverse cardiovascular events at a median of 3.3 years. Lorcaserin was associated with a reduction in incident diabetes among those with pre-diabetes and among those without diabetes.

Weight loss drugs have been challenging due to an increase in adverse cardiovascular events (e.g., dexfenfluramine, fenfluramine, and sibutramine). This drug represents an addition to the currently available options for weight loss including lifestyle modification and bariatric surgery.

References:

Bohula EA, Scirica BM, Inzucchi SE, et al. Effect of lorcascerin on prevention and remission of type 2 diabetics in overweight and obese patients (CAMELLIA-TIMI 61): a randomised, placebo-controlled trial. Lancet 2018;Oct 4:[Epub ahead of print].

Bohula EA, Wiviott SD, McGuire DK, et al., on behalf of the CAMELLIA–TIMI 61 Steering Committee and Investigators. Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients. N Engl J Med 2018;379:1107-17.

Editorial: Ingelfinger JR, Rosen CJ. Lorcaserin — Elixir or Liability? N Engl J Med 2018;379:1174-5.

Presented by Dr. Erin Bohula at the European Society of Cardiology Congress, Munich, Germany, August 26, 2018.

Keywords: ESC Congress, ESC18, Angina, Unstable, Anti-Obesity Agents, Body Mass Index, Body Weight, Diabetes Mellitus, Heart Failure, Metabolic Syndrome, Myocardial Infarction, Myocardial Revascularization, Obesity, Overweight, Primary Prevention, Stroke, Vascular Diseases


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