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

•Two placebo-controlled 1-year studies of tiotropium/olodaterol, combined (5/5 µg and 2.5/5 µg) vs monotherapies, in COPD.•3100 patients with moderate to very severe COPD, including 784 patients with cardiovascular co-morbidities, were included.•AEs were balanced across treatments in the total population and in patient subgroups with cardiovascular co-morbidities.•Independent, adjudicated SAEs analysis in 494/3100 patients: 260 (respiratory), 53 (cardiovascular), 16 (cerebrovascular).•SAE incidences were comparable between treatments: there was no evidence of increased risk for combination vs monotherapy.