Key result
Lorcaserin yields numerically lower rates of worsening mitral regurgitation versus placebo at 52 weeks.
Why the study?
Does lorcaserin worsen echocardiographic valvular regurgitation compared to placebo in overweight or obese patients with pre-existing FDA-defined valvulopathy?
Does lorcaserin worsen echocardiographic valvular regurgitation compared to placebo in overweight or obese patients with pre-existing FDA-defined valvulopathy?
In this pooled post hoc analysis of Phase 3 trials, 1 year of lorcaserin treatment did not worsen aortic or mitral regurgitation compared with placebo in patients with pre-existing FDA-defined valvulopathy.
Answers are grounded in this paper and cite their sources.
Supports valvular safety in obese patients with pre-existing valvulopathy; extends Phase 3 RCT data to this subgroup.
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/m 2 and ≥1 weight ‐ related comorbidity or a BMI of 30 to 45 kg/m 2 . BLOOM‐DM patients had a BMI of 27 to 45 kg/m 2 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.
No takes yet. Share an insight, caveat, or question.
Weissman et al. (2016) studied Overweight or obesity with pre-existing FDA-defined valvulopathy (mild or greater aortic regurgitation and/or moderate or greater mitral regurgitation) (n=169). Lorcaserin vs. Placebo was evaluated on Worsening (increase) in mitral valvular regurgitation score from baseline to week 52. Lorcaserin resulted in numerically fewer patients experiencing increases in aortic or mitral regurgitation compared with placebo at 52 weeks.
Synapse has enriched 10 related papers. Consider them for comparative context: