PT  - JOURNAL ARTICLE
AU  - Kenneth R. Chapman
AU  - Ekkehard Beck
AU  - Daniel Alcaide
AU  - Esther Garcia Gil
TI  - Overall and cardiovascular safety of aclidinium bromide in patients with COPD: Results of a pooled analysis
DP  - 2014 Sep 01
TA  - European Respiratory Journal
PG  - P893
VI  - 44
IP  - Suppl 58
4099  - http://erj.ersjournals.com/content/44/Suppl_58/P893.short
4100  - http://erj.ersjournals.com/content/44/Suppl_58/P893.full
SO  - Eur Respir J2014 Sep 01; 44
AB  - BackgroundThere has been recent controversy regarding the safety, particularly cardiovascular (CV) safety, of tiotropium, an inhaled anticholinergic, in the treatment of chronic obstructive pulmonary disease (COPD).AimTo evaluate the safety of another anticholinergic, aclidinium bromide 400 µg twice daily (BID), in patients with COPD.MethodsSafety data have been pooled from the placebo and aclidinium 400 µg BID arms of six, Phase III, placebo-controlled, parallel-group studies (≥1 month to 1 year duration) evaluating both aclidinium mono- and combination therapy.ResultsA total of 2781 patients with moderate-to-severe COPD were included. The overall safety profile of aclidinium 400 µg BID was similar to that of placebo (Table). There was no difference between aclidinium and placebo in terms of overall CV safety, including major adverse CV events (MACE: composite of CV death, non-fatal myocardial infarction and non-fatal stroke; Table) and any cerebrovascular event. Moreover, the incidence of cardiac and cerebrovascular events was similar for patients with CV risk factors versus placebo (RR=1.06, 95% CI=0.77, 1.46). The incidence of anticholinergic adverse events with aclidinium was low (<2%), and comparable to placebo.ConclusionsAclidinium has a good safety profile with no evidence of increased CV or cerebrovascular risk compared with placebo.