Article

A new user cohort study comparing the safety of long-acting inhaled bronchodilators in COPD

Acorda Therapeutics, Hawthorne, New York, USA.
BMJ Open (Impact Factor: 2.06). 05/2012; 2(3). DOI: 10.1136/bmjopen-2012-000841
Source: PubMed

ABSTRACT To investigate a possible increased risk observed in tiotropium clinical trials of stroke and other adverse events.
New users of long-acting anticholinergic therapy (tiotropium HandiHaler®) were compared with new users of long-acting β-agonist (LABA) monotherapy, and propensity scores were used to control confounding.
UK healthcare system general practitioner electronic medical record database.
10 840 patients newly prescribed tiotropium (n=4767) or LABA (n=6073), at least 40 years old, and not having asthma as their only respiratory illness. PRIMARY AND SECONDARY OUTCOME MEASURES: Incidence rates of total stroke, myocardial infarction, angina and other adverse events.
Tiotropium was associated with increased rates of stroke (HR=1.49, 95% CI 0.91 to 2.45), angina (HR=1.38, 95% CI 0.88 to 2.16) and myocardial infarction (HR=1.26, 95% CI 0.72 to 2.21). Groups had similar rates of chronic obstructive pulmonary disease exacerbation (HR=0.95, 95% CI 0.80 to 1.12) and pneumonia (HR=0.96, 95% CI 0.58 to 1.58). Tiotropium was associated with a lower rate of total mortality (HR=0.70, 95% CI 0.56 to 0.89) and asthma exacerbations (HR=0.46, 95% CI 0.36 to 0.57) than users of LABA.
Small increased risks of serious ischaemic cardiovascular events have been reported with inhaled anticholinergic medication from randomised and nonrandomized studies of ipratropium, tiotropium HandiHaler® and tiotropium Respimat®. Additional research is needed to understand the full extent of cardiovascular effects of inhaled anticholinergic medications and the patients who may be most susceptible.

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