Design and rationale for the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients–Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) trial

Erin A. Bohula, Benjamin M. Scirica, Christina Fanola, Silvio E. Inzucchi, Anthony Keech, Darren K McGuire, Steven R. Smith, Tim Abrahamsen, Bruce H. Francis, Wenfeng Miao, Carlos A. Perdomo, Andrew Satlin, Stephen D. Wiviott, Marc S. Sabatine

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Objectives: Lorcaserin, a selective serotonin 2C receptor agonist, is an effective pharmacologic weight-loss therapy that improves several cardiovascular risk factors. The long-term clinical cardiovascular and metabolic safety and efficacy in patients with elevated cardiovascular risk are unknown. Research design and methods: CAMELLIA-TIMI 61 (NCT02019264) is a randomized, double-blind, placebo-controlled, multinational clinical trial designed to evaluate the safety and efficacy of lorcaserin with regard to major adverse cardiovascular events and progression to diabetes in overweight or obese patients at high cardiovascular risk. Overweight or obese patients either with established cardiovascular disease or with diabetes and at least 1 other cardiovascular risk factor were randomized in a 1:1 ratio to lorcaserin 10 mg twice daily or matching placebo. The primary safety objective is to assess for noninferiority of lorcaserin for the composite end point of cardiovascular death, myocardial infarction, or stroke (major adverse cardiovascular event [MACE]) (with noninferiority defined as the upper bound of a 1-sided 97.5% CI excluding a hazard ratio of 1.4) compared with placebo assessed at an interim analysis with 460 adjudicated events. The efficacy objectives, assessed at study completion, will evaluate the superiority of lorcaserin for the primary composite end point of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, heart failure, or any coronary revascularization (MACE+) and the key secondary end point of conversion to diabetes. Recruitment began in January 2014 and was completed in November 2015 resulting in a total population of 12,000 patients. The trial is planned to continue until at least 1,401 adjudicated MACE+ events are accrued and the median treatment duration exceeds 2.5 years. Conclusion: CAMELLIA-TIMI 61 is investigating the safety and efficacy of lorcaserin for MACEs and conversion to diabetes in overweight or obese patients with established cardiovascular disease or multiple cardiovascular risk factors.

Original languageEnglish (US)
Pages (from-to)39-48
Number of pages10
JournalAmerican Heart Journal
Volume202
DOIs
StatePublished - Aug 1 2018

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Myocardial Infarction
Safety
Placebos
Cardiovascular Diseases
Stroke
Receptor, Serotonin, 5-HT2C
Serotonin Receptor Agonists
Unstable Angina
Controlled Clinical Trials
lorcaserin
Weight Loss
Hospitalization
Research Design
Heart Failure
Therapeutics
Population

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Design and rationale for the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients–Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) trial. / Bohula, Erin A.; Scirica, Benjamin M.; Fanola, Christina; Inzucchi, Silvio E.; Keech, Anthony; McGuire, Darren K; Smith, Steven R.; Abrahamsen, Tim; Francis, Bruce H.; Miao, Wenfeng; Perdomo, Carlos A.; Satlin, Andrew; Wiviott, Stephen D.; Sabatine, Marc S.

In: American Heart Journal, Vol. 202, 01.08.2018, p. 39-48.

Research output: Contribution to journalArticle

Bohula, EA, Scirica, BM, Fanola, C, Inzucchi, SE, Keech, A, McGuire, DK, Smith, SR, Abrahamsen, T, Francis, BH, Miao, W, Perdomo, CA, Satlin, A, Wiviott, SD & Sabatine, MS 2018, 'Design and rationale for the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients–Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) trial', American Heart Journal, vol. 202, pp. 39-48. https://doi.org/10.1016/j.ahj.2018.03.012
Bohula, Erin A. ; Scirica, Benjamin M. ; Fanola, Christina ; Inzucchi, Silvio E. ; Keech, Anthony ; McGuire, Darren K ; Smith, Steven R. ; Abrahamsen, Tim ; Francis, Bruce H. ; Miao, Wenfeng ; Perdomo, Carlos A. ; Satlin, Andrew ; Wiviott, Stephen D. ; Sabatine, Marc S. / Design and rationale for the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients–Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) trial. In: American Heart Journal. 2018 ; Vol. 202. pp. 39-48.
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AU - Inzucchi, Silvio E.

AU - Keech, Anthony

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AU - Smith, Steven R.

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AU - Francis, Bruce H.

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