Safety of tiotropium and olodaterol fixed-dose combination for COPD in patients on β-blockers

Introduction: The TONADO studies (NCT01431274; NCT01431287) established the efficacy and safety of a new once-daily fixed-dose combination (FDC) with tiotropium (T), a long-acting muscarinic antagonist, and olodaterol (O), a long-acting β 2 -agonist, for the treatment of COPD. This post hoc analysis evaluates T+O safety in the subgroup of patients (pts) receiving β-blockers (BBs) in these studies. Methods: These were randomised, double-blind, parallel-group, 52-week, Phase III trials comparing T+O FDC (2.5/5 µg; 5/5 µg) with the monocomponents. Adverse events (AEs) and serious AEs (SAEs) were recorded and SAEs independently adjudicated. Pooled safety data from pts receiving BBs at baseline are presented. Results: 5162 pts were evaluable: 557 (10.8%) received BBs at baseline. Incidence of AEs was similar between pts receiving BBs and those not receiving BBs for both T+O FDCs (Table). A higher incidence of cardiac, general, musculoskeletal and vascular disorders was reported in pts taking BBs at baseline compared to pts not taking BBs at baseline. Within BB subgroups, frequency of AEs, including respiratory and cardiovascular AEs, was generally similar across treatment arms. Conclusions: Although the number of pts on BBs was relatively small, these data suggest no safety concerns with T+O FDCs in pts receiving BBs at baseline. These data support the use of T+O FDCs in pts receiving BBs. Funding: Boehringer Ingelheim.