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

MedStar author(s):
Citation: Obesity. 25(1):39-44, 2017 JanPMID: 27888609Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *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]Year: 2017Local holdings: Available online from MWHC library: 2000 - after 1 year)ISSN:
  • 1930-7381
Name of journal: Obesity (Silver Spring, Md.)Abstract: 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/m<sup>2</sup> and >1 weight-related comorbidity or a BMI of 30 to 45 kg/m<sup>2</sup> . BLOOM-DM patients had a BMI of 27 to 45 kg/m<sup>2</sup> 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.All authors: Fain R, Hall N, Shanahan WR, Smith SR, Weissman NJFiscal year: FY2017Digital Object Identifier: Date added to catalog: 2017-05-06
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 27888609 Available 27888609

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/m<sup>2</sup> and >1 weight-related comorbidity or a BMI of 30 to 45 kg/m<sup>2</sup> . BLOOM-DM patients had a BMI of 27 to 45 kg/m<sup>2</sup> 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.

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