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

Neil J Weissman, Steven R Smith, Randi Fain, Nancy Hall, William R Shanahan, Neil J Weissman, Steven R Smith, Randi Fain, Nancy Hall, William R Shanahan

Abstract

Objective: To evaluate the effects of lorcaserin in patients with pre-existing Food and Drug Administration (FDA)-defined valvulopathy.

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.

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.

Conclusions: These data suggest that lorcaserin does not adversely affect valvular disease in patients with pre-existing FDA-defined valvulopathy.

Trial registration: ClinicalTrials.gov NCT00395135 NCT00603902 NCT00603291.

© 2016 The Authors. Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS).

Figures

Figure 1
Figure 1
Shifts in (A) aortic and (B) mitral valvular regurgitation scores in patients with FDA‐defined valvulopathy. BID, twice daily; QD, once daily.

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Source: PubMed

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