Echocardiographic assessment of cardiac valvular regurgitation with lorcaserin from analysis of 3 phase 3 clinical trials.

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Citation: Circulation. Cardiovascular imaging. 6(4):560-7, 2013 Jul.PMID: 23661689Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Clinical Trial, Phase III | Journal Article | Randomized Controlled Trial | Research Support, Non-U.S. Gov'tSubject headings: *Anti-Obesity Agents/tu [Therapeutic Use] | *Aortic Valve Insufficiency/pc [Prevention & Control] | *Aortic Valve Insufficiency/us [Ultrasonography] | *Benzazepines/tu [Therapeutic Use] | *Mitral Valve Insufficiency/pc [Prevention & Control] | *Mitral Valve Insufficiency/us [Ultrasonography] | *Obesity/dt [Drug Therapy] | *Receptor, Serotonin, 5-HT2C/de [Drug Effects] | *Serotonin 5-HT2 Receptor Agonists/tu [Therapeutic Use] | Adolescent | Adult | Aged | Anti-Obesity Agents/ae [Adverse Effects] | Aortic Valve Insufficiency/et [Etiology] | Aortic Valve Insufficiency/me [Metabolism] | Benzazepines/ae [Adverse Effects] | Body Mass Index | Female | Humans | Male | Middle Aged | Mitral Valve Insufficiency/et [Etiology] | Mitral Valve Insufficiency/me [Metabolism] | Obesity/co [Complications] | Obesity/di [Diagnosis] | Obesity/me [Metabolism] | Odds Ratio | Prospective Studies | Receptor, Serotonin, 5-HT2C/me [Metabolism] | Risk Factors | Serotonin 5-HT2 Receptor Agonists/ae [Adverse Effects] | Severity of Illness Index | Time Factors | Treatment Outcome | Weight Loss/de [Drug Effects] | Young AdultYear: 2013ISSN:
  • 1941-9651
Name of journal: Circulation. Cardiovascular imagingAbstract: BACKGROUND: Lorcaserin is a selective 5-HT2C agonist evaluated for weight management in clinical trials. Echocardiographic monitoring was conducted to test the hypothesis that selective 5-HT2C agonism would avoid valvular heart disease.CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00395135, NCT00603291, NCT00603902.CONCLUSIONS: In 3 prospective placebo-controlled trials with integrated data for 5249 patients, the rate of echocardiographic valvulopathy was similar with lorcaserin and placebo. Point estimates for risk ratios ranged from 1.03 to 1.16 and may be at least partially influenced by greater weight loss in the lorcaserin group than in the placebo group.METHODS AND RESULTS: Echocardiographic and weight 131223 data from 5249 obese and overweight patients in 3 phase 3 trials were integrated. Treatment duration with 10 mg lorcaserin twice daily or placebo was 52 weeks. The proportions of patients who developed Food and Drug Administration-defined valvulopathy (>= mild aortic or >= moderate mitral regurgitation) and 131223s in regurgitant grade at each heart valve were evaluated. Possible associations between weight or body mass index 131223 and valvulopathy were explored. New valvulopathy was present in 2.04% of placebo and 2.37% of lorcaserin recipients at 52 weeks (risk difference, 0.33%; 95% confidence interval, -0.46 to 1.13; risk ratio, 1.16 [all patients with sufficient echocardiographic data, last-observation-carried-forward imputation] or 1.03 [patients who completed 52 weeks]). 131223s in weight and body mass index were negatively associated with presence of valvulopathy at week 52 (P=0.02 and P=0.04, respectively); a 5% decrease in weight was associated with an odds ratio of 1.15 for Food and Drug Administration-defined valvulopathy. Most 131223s in regurgitation were +/-1 grade in both treatment groups at all heart valves.All authors: Anderson CM, Koch GG, Sanchez M, Shanahan WR, Smith SR, Weissman NJFiscal year: FY2014Digital Object Identifier: Date added to catalog: 2013-12-24
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Journal Article MedStar Authors Catalog Article 23661689 Available 23661689

BACKGROUND: Lorcaserin is a selective 5-HT2C agonist evaluated for weight management in clinical trials. Echocardiographic monitoring was conducted to test the hypothesis that selective 5-HT2C agonism would avoid valvular heart disease.

CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00395135, NCT00603291, NCT00603902.

CONCLUSIONS: In 3 prospective placebo-controlled trials with integrated data for 5249 patients, the rate of echocardiographic valvulopathy was similar with lorcaserin and placebo. Point estimates for risk ratios ranged from 1.03 to 1.16 and may be at least partially influenced by greater weight loss in the lorcaserin group than in the placebo group.

METHODS AND RESULTS: Echocardiographic and weight 131223 data from 5249 obese and overweight patients in 3 phase 3 trials were integrated. Treatment duration with 10 mg lorcaserin twice daily or placebo was 52 weeks. The proportions of patients who developed Food and Drug Administration-defined valvulopathy (>= mild aortic or >= moderate mitral regurgitation) and 131223s in regurgitant grade at each heart valve were evaluated. Possible associations between weight or body mass index 131223 and valvulopathy were explored. New valvulopathy was present in 2.04% of placebo and 2.37% of lorcaserin recipients at 52 weeks (risk difference, 0.33%; 95% confidence interval, -0.46 to 1.13; risk ratio, 1.16 [all patients with sufficient echocardiographic data, last-observation-carried-forward imputation] or 1.03 [patients who completed 52 weeks]). 131223s in weight and body mass index were negatively associated with presence of valvulopathy at week 52 (P=0.02 and P=0.04, respectively); a 5% decrease in weight was associated with an odds ratio of 1.15 for Food and Drug Administration-defined valvulopathy. Most 131223s in regurgitation were +/-1 grade in both treatment groups at all heart valves.

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