Abstract
Tiotropium, a long-acting anticholinergic, is delivered via HandiHaler® or via Respimat®. RCTs suggest that use of Tiotropium Respimat® increases the risk of dying. We compared the risk of mortality between tiotropium Respimat® vs. HandiHaler®.
Within the Integrated Primary Care Information database, we defined a source population of patients, ≥40 years, with at least 1 year of follow-up. Based on prescription data, we defined episodes of tiotropium use (Respimat® or Handihaler®). The risk of mortality, within these episodes, was calculated using a Cox proportional hazard regression analysis.
From the source population, 11287 patients provided 24522 episodes of tiotropium use. 496 patients died while being exposed to Handihaler® or Respimat®. Use of Respimat® was associated with almost 30% increased risk of dying (HRadj 1.27, 95% CI 1.03–1.57) with the highest risk for cardiovascular/cerebrovascular death (HRadj 1.56, 95% CI 1.08–2.25). The risk was higher in patients with co-existing cardiovascular disease (HRadj 1.36, 95% CI 1.07–1.73) than in patients without (HRadj 1.02, 95% CI 0.61–1.71).
Use of tiotropium Respimat® was associated with an almost 30% increase of mortality compared to Handihaler® and the association was the strongest for cardiovascular/cerebrovascular death. It is unclear whether this association is causal or due to residual confounding by COPD severity.
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