Overall and Cardiovascular Safety of Aclidinium Bromide in Patients With COPD: A Pooled Analysis of Six Phase III, Placebo-Controlled, Randomized Studies.

ABSTRACT: Background: Aclidinium bromide, an M₃-receptor-selective, twice-daily (BID), long-acting muscarinic antagonist, is rapidly hydrolyzed in human plasma, resulting in low systemic exposure and urinary excretion. We evaluated the overall and cardiovascular (CV) safety of aclidinium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) by pooling data from 6 randomized, double-blind, placebo-controlled, parallel-group studies of ≥1 month's duration.

Methods

Patients were current/former smokers aged ≥40 years with no history of clinically significant CV conditions. Treatment was administered (morning and evening) via Genuair^TM/Pressair.^®a Adverse events (AEs), major adverse CV events (MACE), cardiac and cerebrovascular AEs

SUBMITTER: Chapman KR 

PROVIDER: S-EPMC5559124 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature