Inhaled tiotropium bromide and risk of stroke

Anthony Grosso, Ian Douglas, Aroon D. Hingorani, Raymond MacAllister, Richard Hubbard, Liam Smeeth

Research output: Journal PublicationArticlepeer-review

12 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)731-736
Number of pages6
JournalBritish Journal of Clinical Pharmacology
Issue number5
Publication statusPublished - Nov 2009
Externally publishedYes


  • Anti-cholinergics
  • Drug safety
  • Ipratropium
  • Stroke
  • Tiotroprium

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)


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