title: Tiotropium Handihaler and the risk of cardio- or cerebrovascular events and mortality in patients with COPD.
abstract: BACKGROUND
  Tiotropium has been associated with an increased risk of mortality and/or cardiovascular events. Recent data from RCTs suggests tiotropium Handihaler to be safe, but its safety has not yet been fully investigated under real-life circumstances.
  
  
  METHODS
  We conducted 2 nested case-control studies in a COPD cohort from the Dutch IPCI database. In the first case-control study, cases had a cardiovascular or cerebrovascular endpoint (CCVE): stroke and transient ischemic attack (TIA), myocardial infarction, heart failure and/or ventricular arrhythmia. In the second, cases were all patients who died. Cases were matched to controls on age, sex and index date. Conditional logistic regression analysis was used to calculate adjusted odds ratios (OR(adj)) with 95% confidence intervals (CI) for tiotropium vs. long-acting beta-agonists (LABA).
  
  
  RESULTS
  Within a cohort of 6788 COPD patients, 784 CCVE's and 1032 deaths were reported. Compared to current LABA use, use of tiotropium Handihaler was neither associated with an increased risk of a CCVE (OR(adj) 0.89, 95% 0.55-1.44) nor with an increased risk of death (OR(adj) 0.79, 95% CI 0.49-1.28).
  
  
  CONCLUSIONS
  In real life, use of tiotropium Handihaler in COPD patients is not associated with an increased risk of a CCVE or mortality compared to LABA.
authors: Department of Medical Informatics, Erasmus MC, Rotterdam, The Netherlands. k.verhamme@erasmusmc.nl
authors: K M C
authors: KM
authors: Verhamme
authors: A S M
authors: AS
authors: Afonso
authors: C
authors: C
authors: van Noord
authors: M D
authors: MD
authors: Haag
authors: P J
authors: PJ
authors: Koudstaal
authors: G G O
authors: GG
authors: Brusselle
authors: M C J M
authors: MC
authors: Sturkenboom
mesh_terms: D000318:Adrenergic beta-Agonists / Q000009:adverse effects; D000328:Adult; D000367:Age Factors; D000368:Aged; D001145:Arrhythmias, Cardiac / Q000139:chemically induced / Q000453:epidemiology / Q000401:mortality; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000139:chemically induced* / Q000401:mortality; D016022:Case-Control Studies; D002561:Cerebrovascular Disorders / Q000139:chemically induced* / Q000401:mortality; D015331:Cohort Studies; D016001:Confidence Intervals; D016208:Databases, Factual; D023381:Endpoint Determination; D005260:Female; D006333:Heart Failure / Q000139:chemically induced / Q000453:epidemiology / Q000401:mortality; D006801:Humans; D002546:Ischemic Attack, Transient / Q000139:chemically induced / Q000453:epidemiology / Q000401:mortality; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000139:chemically induced / Q000453:epidemiology / Q000401:mortality; D009330:Nebulizers and Vaporizers; D016017:Odds Ratio; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000401:mortality; D012602:Scopolamine Derivatives / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D012737:Sex Factors; D020521:Stroke / Q000139:chemically induced / Q000453:epidemiology / Q000401:mortality; D000069447:Tiotropium Bromide
chemical_list: D000318:Adrenergic beta-Agonists; D001993:Bronchodilator Agents; D012602:Scopolamine Derivatives; D000069447:Tiotropium Bromide