Inhaled tiotropium bromide and risk of stroke.
OBJECTIVE
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.
Grosso
Anthony
A
Department of Pharmacy, University College London Hospitals NHS Foundation Trust, London, UK. anthony.grosso@uclh.nhs.uk
Douglas
Ian
I
Hingorani
Aroon D
AD
MacAllister
Raymond
R
Hubbard
Richard
R
Smeeth
Liam
L
D000280:Administration, Inhalation; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects*; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000009:adverse effects*; D018680:Cholinergic Antagonists / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D000068298:Fluticasone; D006801:Humans; D009241:Ipratropium / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D000068299:Salmeterol Xinafoate; D012602:Scopolamine Derivatives / Q000008:administration & dosage / Q000009:adverse effects*; D020521:Stroke / Q000139:chemically induced*; D000069447:Tiotropium Bromide; D006113:United Kingdom
D000730:Androstadienes; D001993:Bronchodilator Agents; D018680:Cholinergic Antagonists; D004338:Drug Combinations; D012602:Scopolamine Derivatives; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone; D009241:Ipratropium; D000420:Albuterol; D000069447:Tiotropium Bromide