TY  - BOOK
AU  - Weissman, Neil J
TI  - Echocardiographic assessment of cardiac valvular regurgitation with lorcaserin from analysis of 3 phase 3 clinical trials
SN  - 1941-9651
PY  - 2013///
KW  - *Anti-Obesity Agents/tu [Therapeutic Use]
KW  - *Aortic Valve Insufficiency/pc [Prevention & Control]
KW  - *Aortic Valve Insufficiency/us [Ultrasonography]
KW  - *Benzazepines/tu [Therapeutic Use]
KW  - *Mitral Valve Insufficiency/pc [Prevention & Control]
KW  - *Mitral Valve Insufficiency/us [Ultrasonography]
KW  - *Obesity/dt [Drug Therapy]
KW  - *Receptor, Serotonin, 5-HT2C/de [Drug Effects]
KW  - *Serotonin 5-HT2 Receptor Agonists/tu [Therapeutic Use]
KW  - Adolescent
KW  - Adult
KW  - Aged
KW  - Anti-Obesity Agents/ae [Adverse Effects]
KW  - Aortic Valve Insufficiency/et [Etiology]
KW  - Aortic Valve Insufficiency/me [Metabolism]
KW  - Benzazepines/ae [Adverse Effects]
KW  - Body Mass Index
KW  - Female
KW  - Humans
KW  - Male
KW  - Middle Aged
KW  - Mitral Valve Insufficiency/et [Etiology]
KW  - Mitral Valve Insufficiency/me [Metabolism]
KW  - Obesity/co [Complications]
KW  - Obesity/di [Diagnosis]
KW  - Obesity/me [Metabolism]
KW  - Odds Ratio
KW  - Prospective Studies
KW  - Receptor, Serotonin, 5-HT2C/me [Metabolism]
KW  - Risk Factors
KW  - Serotonin 5-HT2 Receptor Agonists/ae [Adverse Effects]
KW  - Severity of Illness Index
KW  - Time Factors
KW  - Treatment Outcome
KW  - Weight Loss/de [Drug Effects]
KW  - Young Adult
KW  - MedStar Heart & Vascular Institute
KW  - Clinical Trial, Phase III
KW  - Journal Article
KW  - Randomized Controlled Trial
KW  - Research Support, Non-U.S. Gov't
N2  - 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
UR  - http://dx.doi.org/10.1161/CIRCIMAGING.112.000128
ER  -