Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients

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  • Source:
    New England journal of medicine 2018 379 12, 1107 (1107-1117)
  • Additional Information
    • Author(s):
      Bohula EA, Wiviott SD, McGuire DK, Inzucchi SE, Kuder J, Im K, Fanola CL, Qamar A, Brown C, Budaj A, Garcia-Castillo A, Gupta M, Leiter LA, Weissman NJ, White HD, Patel T, Francis B, Miao W, Perdomo C, Dhadda S, Bonaca MP, Ruff CT, Keech AC, Smith SR, Sabatine MS, Scirica BM, CAMELLIA–TIMI 61 Steering Committee and Investigators
    • Review Group(s):
      Cochrane Hypertension Group Trials in the Group's Specialized Register
    • Language:
      English
    • Publication Type:
      Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
    • Record Status:
      This record is updated this issue.
    • Abstract:
      BACKGROUND: Lorcaserin, a selective serotonin 2C receptor agonist that modulates appetite, has proven efficacy for weight management in overweight or obese patients. The cardiovascular safety and efficacy of lorcaserin are undefined.METHODS: We randomly assigned 12,000 overweight or obese patients with atherosclerotic cardiovascular disease or multiple cardiovascular risk factors to receive either lorcaserin (10 mg twice daily) or placebo. The primary safety outcome of major cardiovascular events (a composite of cardiovascular death, myocardial infarction, or stroke) was assessed at an interim analysis to exclude a noninferiority boundary of 1.4. If noninferiority was met, the primary cardiovascular efficacy outcome (a composite of major cardiovascular events, heart failure, hospitalization for unstable angina, or coronary revascularization [extended major cardiovascular events]) was assessed for superiority at the end of the trial.RESULTS: At 1 year, weight loss of at least 5% had occurred in 1986 of 5135 patients (38.7%) in the lorcaserin group and in 883 of 5083 (17.4%) in the placebo group (odds ratio, 3.01; 95% confidence interval [CI], 2.74 to 3.30; PCONCLUSIONS: In a high-risk population of overweight or obese patients, lorcaserin facilitated sustained weight loss without a higher rate of major cardiovascular events than that with placebo. (Funded by Eisai; CAMELLIA-TIMI 61 ClinicalTrials.gov number, NCT02019264 .).
    • Medical Subject Headings (MeSH):
      Aged
      Female
      Humans
      Male
      Middle Aged
      Anti-Obesity Agents/adverse effects
      Aortic Valve Insufficiency/chemically induced
      Benzazepines/adverse effects
      Cardiovascular Diseases/chemically induced
      Cardiovascular Diseases/epidemiology
      Diabetes Mellitus, Type 2/complications
      Double-Blind Method
      Follow-Up Studies
      Hypertension, Pulmonary/chemically induced
      Obesity/complications
      Overweight/complications
      Risk Factors
      Anti-Obesity Agents/*therapeutic use
      Benzazepines/*therapeutic use
      Cardiovascular Diseases/*complications
      Hypoglycemia/*chemically induced
      Obesity/*drug therapy
      Overweight/*drug therapy
      Weight Loss/*drug effects
    • Source:
      This document should be cited as: Bohula EA Wiviott SD McGuire DK Inzucchi SE Kuder J Im K Fanola CL Qamar A Brown C Budaj A Garcia-Castillo A Gupta M Leiter LA Weissman NJ White HD Patel T Francis B Miao W Perdomo C Dhadda S Bonaca MP Ruff CT Keech AC Smith SR Sabatine MS Scirica BM CAMELLIA–TIMI 61 Steering Committee and Investigators. Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients 2018 (The Cochrane Controlled Trials Register (CCTR/CENTRAL). DOI: 10.1056/NEJMoa1808721. Oxford: Update Software. Updated quarterly.
    • Accession Number:
      CN-01642590
  • Citations
    • ABNT:
      BOHULA EA et al. Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients. New England journal of medicine, [s. l.], v. 379, n. 12, p. 1107–1117, 2018. DOI 10.1056/NEJMoa1808721. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=cgh&AN=CN-01642590. Acesso em: 30 set. 2020.
    • AMA:
      Bohula EA, Wiviott SD, McGuire DK, et al. Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients. New England journal of medicine. 2018;379(12):1107-1117. doi:10.1056/NEJMoa1808721
    • APA:
      Bohula EA, Wiviott SD, McGuire DK, Inzucchi SE, Kuder J, Im K, Fanola CL, Qamar A, Brown C, Budaj A, Garcia-Castillo A, Gupta M, Leiter LA, Weissman NJ, White HD, Patel T, Francis B, Miao W, Perdomo C, … CAMELLIA–TIMI 61 Steering Committee and Investigators. (2018). Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients. New England Journal of Medicine, 379(12), 1107–1117. https://doi.org/10.1056/NEJMoa1808721
    • Chicago/Turabian: Author-Date:
      Bohula EA, Wiviott SD, McGuire DK, Inzucchi SE, Kuder J, Im K, Fanola CL, et al. 2018. “Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients.” New England Journal of Medicine 379 (12): 1107–17. doi:10.1056/NEJMoa1808721.
    • Harvard:
      Bohula EA et al. (2018) ‘Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients’, New England journal of medicine, 379(12), pp. 1107–1117. doi: 10.1056/NEJMoa1808721.
    • Harvard: Australian:
      Bohula EA, Wiviott SD, McGuire DK, Inzucchi SE, Kuder J, Im K, Fanola CL, Qamar A, Brown C, Budaj A, Garcia-Castillo A, Gupta M, Leiter LA, Weissman NJ, White HD, Patel T, Francis B, Miao W, Perdomo C, Dhadda S, Bonaca MP, Ruff CT, Keech AC, Smith SR, Sabatine MS, Scirica BM & CAMELLIA–TIMI 61 Steering Committee and Investigators 2018, ‘Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients’, New England journal of medicine, vol. 379, no. 12, pp. 1107–1117, viewed 30 September 2020, .
    • MLA:
      Bohula EA, et al. “Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients.” New England Journal of Medicine, vol. 379, no. 12, Jan. 2018, pp. 1107–1117. EBSCOhost, doi:10.1056/NEJMoa1808721.
    • Chicago/Turabian: Humanities:
      Bohula EA, Wiviott SD, McGuire DK, Inzucchi SE, Kuder J, Im K, Fanola CL, et al. “Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients.” New England Journal of Medicine 379, no. 12 (January 1, 2018): 1107–17. doi:10.1056/NEJMoa1808721.
    • Vancouver/ICMJE:
      Bohula EA, Wiviott SD, McGuire DK, Inzucchi SE, Kuder J, Im K, et al. Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients. New England journal of medicine [Internet]. 2018 Jan 1 [cited 2020 Sep 30];379(12):1107–17. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=cgh&AN=CN-01642590