Long-term general and cardiovascular safety of tiotropium/olodaterol in patients with moderate to very severe chronic obstructive pulmonary disease

BACKGROUND: Long-term safety, particularly cardiovascular safety, is of special interest in maintenance treatment of chronic obstructive pulmonary disease (COPD) with long-acting beta2-agonists and long-acting muscarinic antagonists, given potential cardiovascular effects. METHODS: Two 52-week Phase III trials (TONADO(R)) investigated tiotropium/olodaterol (5/5 and 2.5/5 mug) versus tiotropium 2.5, 5 mug and olodaterol 5 mug. In a pre-specified safety analysis, investigator-reported treatment-emergent adverse events (AEs), electrocardiogram and laboratory data were pooled. All serious AE (SAE) reports were reviewed by an independent Adjudication Committee, which assessed whether deaths, hospitalisations or intubations were respiratory, cardiovascular, cerebrovascular or other disease related. Subgroup analyses investigated cardiovascular safety including major cardiac events in patients with cardiovascular co-morbidities. RESULTS: This analysis comprised 3100 patients with moderate to very severe COPD, treated for

Buhl, R.; Magder, S.; Bothner, U.; Tetzlaff, K.; Voss, F.; Loaiza, L.; Vogelmeier, C. F.; McGarvey, L.