RT Journal Article
SR Electronic
T1 Comparison of cardiovascular safety in a pooled analysis of COPD trials comparing tiotropium with salmeterol
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P753
VO 42
IS Suppl 57
A1 Claus Vogelmeier
A1 Leonardo Fabbri
A1 Thomas Glaab
A1 Diego Wyszynski
A1 Inge Leimer
A1 Norbert Metzdorf
A1 Kai-Michael Beeh
A1 Klaus Rabe
YR 2013
UL http://erj.ersjournals.com/content/42/Suppl_57/P753.abstract
AB Background: Guidelines recommend long-acting bronchodilators as preferred options for maintenance treatment of COPD. Cardiovascular (CV) safety of these treatments is of interest.Aims and objectives: To compare the CV safety of tiotropium vs the long-acting β2-agonist salmeterol in a large number of patients (pts) with COPD.Methods: Pooled analysis of 4 double-blind, randomized, parallel-group clinical trials comparing the CV adverse event profile of tiotropium HandiHaler® (HH) vs salmeterol metered dose inhaler (MDI). Incidence rates (IR): number of pts with event divided by pt-years at risk. Rate ratios (RR) and 95%CI: derived from Cochran-Mantel-Haenszel test stratified by study.Results: In total, 8836 pts were included; 25.3% had a cardiac disorder and 53.7% used CV medication at baseline. IRs (per 100 pt-yrs) for tiotropium vs salmeterol were: all-cause mortality, 1.74 vs 2.08 (RR: 0.84, 95% CI: 0.61, 1.16); fatal major adverse cardiac events (MACE), including death unknown, 0.72 vs 0.92 (RR: 0.78, 95% CI: 0.47, 1.28). IRs of serious adverse CV events during treatment for selected major CV diagnoses are in the table.View this table:Conclusion: Tiotropium HH once daily showed a comparable CV safety profile to salmeterol MDI treatment in a pooled analysis of double-blind, randomized, parallel group studies.