RT Journal Article
SR Electronic
T1 Cardiovascular (CV) safety of aclidinium bromide/formoterol fumarate fixed dose combination (FDC) in COPD: Pooled analyses of three Phase III studies
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P287
VO 44
IS Suppl 58
A1 James F. Donohue
A1 Eric D. Bateman
A1 Anthony D'Urzo
A1 Pomy Shrestha
A1 Anne Leselbaum
A1 Alejhandra Lei
YR 2014
UL http://erj.ersjournals.com/content/44/Suppl_58/P287.abstract
AB BackgroundTwice-daily (BID) aclidinium/formoterol FDC is in development for the treatment of COPD. Two 24-week Phase III studies (ACLIFORM and AUGMENT) and a 28-week AUGMENT extension study assessed the CV safety profile of two FDC doses in patients with moderate or severe COPD.MethodThe studies were randomized, double-blind, placebo- and active-controlled. The pooled placebo-controlled safety population included 3398 patients (mean age 64 years; 61% male; 24.8% reported cardiac disorders). Patients with CV risk factors were included in these studies.Patients received placebo, aclidinium 400 µg, formoterol 12 µg, FDC 400/6 µg or FDC 400/12 µg BID. Patients in the extension study remained on the same treatment. The major adverse CV event (MACE) composite of CV death, non-fatal myocardial infarction and non-fatal stroke was assessed by an independent expert committee. CV and cerebrovascular (CBV) AEs were also assessed.ResultsMACEs and CV AEs are shown in the Table. MACE frequency was low and similar across treatments. The frequency of CV and CBV AEs in FDC 400/12 µg was either lower than or comparable with placebo and/or monotherapies, suggesting no additive safety effect.ConclusionOverall, both doses of aclidinium/formoterol FDC BID had CV and CBV safety profiles similar to placebo and/or monotherapies.