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P261 Tiotropium Safety And Performance In Respimat® (tiospir™): Safety And Efficacy In Patients Naïve To Treatment With Anticholinergics
  1. R Wise1,
  2. P Calverley2,
  3. R Dahl3,
  4. D Dusser4,
  5. N Metzdorf5,
  6. A Mueller6,
  7. A Fowler7,
  8. A Anzueto8
  1. 1Johns Hopkins University School of Medicine, Baltimore, MD, USA
  2. 2Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK
  3. 3Odense University Hospital, Odense, Denmark
  4. 4Service de Pneumologie Hôpital Cochin, AP-HP, Université Paris Descartes, Sorbonne Paris Cité, Paris, France
  5. 5Boehringer Ingelheim Pharma GmbH and Co KG, Ingelheim, Germany
  6. 6Boehringer Ingelheim Pharma GmbH and Co KG, Biberach, Germany
  7. 7Boehringer Ingelheim Pharma Ltd, Bracknell, UK
  8. 8Pulmonary Critical Care Center, San Antonio, TX, USA


Introduction The TIOSPIR™ trial showed similar safety and exacerbation efficacy profiles for tiotropium Respimat® and HandiHaler® in patients with chronic obstructive pulmonary disease (COPD). We present here the results for patients who were naïve to anticholinergic treatment at baseline.

Methods TIOSPIR™ (n = 17,135), a 2–3 year, randomised, double-blind, parallel-group, event-driven trial, compared safety and efficacy of once-daily tiotropium Respimat® 5 and 2.5 µg with HandiHaler® 18 µg in patients with COPD. Primary endpoints were time to death (noninferiority of Respimat® 5 or 2.5 μg versus HandiHaler®) and time to first COPD exacerbation (superiority of Respimat® 5 μg versus HandiHaler®). Safety, including cardiovascular safety, was assessed.

Results Overall, 6966 patients from TIOSPIR™, naïve to anticholinergic treatment at baseline, were randomised and treated (n = 2345, n = 2312 and n = 2309 for tiotropium Respimat® 2.5 and 5 µg and HandiHaler® 18 µg). There was similar risk of death (vital status follow up) (measured as time to death) for the Respimat® groups versus HandiHaler® (Respimat® 5 µg: hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.75–1.17; Respimat® 2.5 µg: HR, 1.05; 95% CI, 0.84–1.30) with similar results for the on-treatment sensitivity analysis (Respimat® 5 µg: HR, 0.91; 95% CI, 0.71–1.17; Respimat® 2.5 µg: HR, 1.11; 95% CI, 0.87–1.40). Risk of exacerbation was also similar for the Respimat® groups versus HandiHaler® (measured as time to first exacerbation) (Respimat® 5 µg: HR, 0.99; 95% CI, 0.90–1.08; Respimat® 2.5 µg: HR, 1.04; 95% CI, 0.95–1.14). Risk of major adverse cardiovascular event (MACE) or fatal MACE were similar for the Respimat® groups versus HandiHaler® (MACE: Respimat® 5 µg: HR, 1.20; 95% CI, 0.88–1.63; Respimat® 2.5 µg: HR, 1.11; 95% CI, 0.81–1.51; fatal MACE: Respimat® 5 µg: HR, 1.14; 95% CI, 0.75–1.71, Respimat® 2.5 µg: HR, 1.12; 95% CI, 0.75–1.69).

Conclusions Analogous to the global analysis, patients naïve to anticholinergic treatment and treated with tiotropium Respimat® 2.5 or 5 µg or HandiHaler® in the TIOSPIR™ trial exhibited similar safety and exacerbation efficacy profiles.

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