Inhaled tiotropium bromide and risk of stroke

Authors


Mr Anthony Grosso, Department of Pharmacy, University College London Hospitals NHS Foundation Trust, London, UK.
Tel: +44 845 155 5000, ext. 2414
Fax: +44 7691 5749
E-mail: anthony.grosso@uclh.nhs.uk

Abstract

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT

• Conflicting studies have raised uncertainty over the vascular effects of the long-acting anticholinergic, tiotropium bromide.

WHAT THIS STUDY ADDS

• Our results show no increased risk of stroke with tiotropium bromide, or with inhaled anticholinergics in general.

AIMS

A recent communication from the United States Food and Drug Administration highlighted a possible increased risk of stroke associated with use of the relatively new inhaled anticholinergic drug, tiotropium bromide. Using the United Kingdom General Practice Research Database, we set out to assess the risk of stroke in individuals exposed to inhaled tiotropium bromide and two other inhaled treatments for airways disease.

METHODS

We used the self-controlled case-series that reduces confounding and minimizes the potential for biases in the quantification of risk estimates.

RESULTS

Of 1043 people with a diagnosis of incident stroke who had had at least one prescription for tiotropium bromide, 980 satisfied inclusion criteria. The age-adjusted incidence rate ratio for all-cause stoke in individuals exposed to tiotropium bromide (n= 980), ipratropium bromide (n= 4181) and fluticasone propionate/salmeterol xinafoate (n= 1000) was 1.1 [95% confidence interval (CI) 0.9, 1.3], 0.8 (95% CI 0.7, 0.9) and 1.0 (95% CI 0.9, 1.2), respectively.

CONCLUSIONS

We found no evidence of an increased risk of all-cause stroke for individuals exposed to commonly prescribed inhaled treatments for chronic obstructive pulmonary disease.

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