Effects of lorcaserin on pre-existing valvulopathy: A pooled analysis of phase 3 trials. - 2017

Available online from MWHC library: 2000 - after 1 year)

CONCLUSIONS: These data suggest that lorcaserin does not adversely affect valvular disease in patients with pre-existing FDA-defined valvulopathy. Copyright � 2016 The Authors. Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS). METHODS: This is a pooled, post hoc analysis of three Phase 3 studies. BLOOM and BLOSSOM patients were 18 to 65 years of age without diabetes and with a body mass index (BMI) of 27 to 29.9 kg/m2 and >1 weight-related comorbidity or a BMI of 30 to 45 kg/m2 . BLOOM-DM patients had a BMI of 27 to 45 kg/m2 and type 2 diabetes. Patients were treated with placebo, lorcaserin 10 mg once daily, or lorcaserin 10 mg twice daily. Serial echocardiographs were obtained at baseline and every 6 months. OBJECTIVE: To evaluate the effects of lorcaserin in patients with pre-existing Food and Drug Administration (FDA)-defined valvulopathy. RESULTS: Included patients (N = 169) had FDA-defined valvulopathy at baseline and a week 52 echocardiogram. At week 52, 35.5% and 52.7% of patients experienced changes from baseline in aortic and mitral regurgitation, respectively. Numerically greater proportions of patients taking lorcaserin versus placebo had decreases in aortic (33.0% vs. 28.3%) or mitral (41.3% vs. 36.7%) regurgitation. Fewer patients taking lorcaserin versus placebo had increases in aortic (2.8% vs. 6.7%) or mitral (8.3% vs. 21.7%) regurgitation. No adverse event-related discontinuation was due to a valve problem.


English

1930-7381


*Anti-Obesity Agents/ad [Administration & Dosage]
*Aortic Valve Insufficiency/dt [Drug Therapy]
*Benzazepines/ad [Administration & Dosage]
*Diabetes Mellitus, Type 2/dt [Drug Therapy]
Adult
Aged
Aortic Valve Insufficiency/co [Complications]
Body Mass Index
Body Weight/de [Drug Effects]
Diabetes Mellitus, Type 2/co [Complications]
Female
Humans
Male
Middle Aged
Obesity/dt [Drug Therapy]
Randomized Controlled Trials as Topic
Weight Loss/de [Drug Effects]


MedStar Heart & Vascular Institute


Journal Article