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P262 Tiotropium Safety And Performance In Respimat® (tiospir™): Safety And Efficacy In Patients With Tiotropium Handihaler® Use At Baseline
  1. P Calverley1,
  2. A Anzueto2,
  3. R Dahl3,
  4. A Mueller4,
  5. A Fowler5,
  6. N Metzdorf6,
  7. R Wise7,
  8. D Dusser8
  1. 1Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK
  2. 2Pulmonary Critical Care Center, San Antonio, TX, USA
  3. 3Odense University Hospital, Odense, Denmark
  4. 4Boehringer Ingelheim Pharma GmbH and Co KG, Biberach, Germany
  5. 5Boehringer Ingelheim Pharma Ltd, Bracknell, UK
  6. 6Boehringer Ingelheim Pharma GmbH and Co KG, Ingelheim, Germany
  7. 7Johns Hopkins University School of Medicine, Baltimore, MD, USA
  8. 8Service de Pneumologie Hôpital Cochin, AP-HP, Université Paris Descartes, Sorbonne Paris Cité, Paris, France


Introduction The TIOSPIR™ trial showed that tiotropium Respimat® and HandiHaler® have similar safety and exacerbation efficacy profiles in patients with chronic obstructive pulmonary disease (COPD). We present here results for patients from the United States (US) using tiotropium HandiHaler® 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 once-daily HandiHaler® 18 µg in patients with COPD. Primary endpoints were time to death and time to first COPD exacerbation. Safety, including cardiovascular safety, was assessed. Tiotropium Respimat® was unavailable in the US (baseline tiotropium HandiHaler® use only), therefore this subgroup was analysed.

Results Overall, 1779 patients from TIOSPIR™ treated with tiotropium HandiHaler® 18 µg at baseline in the US were randomised and treated (n = 572, n = 602 and n = 605 for tiotropium Respimat® 2.5 and 5 µg and HandiHaler® 18 µg). A numerically lower time to death was observed for patients within the Respimat® groups versus HandiHaler® (vital status follow up: Respimat® 5 µg: hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.53–1.12; Respimat® 2.5 µg: HR, 0.76; 95% CI, 0.52–1.12). Risk of major adverse cardiovascular event (MACE) and fatal MACE was numerically lower for the Respimat® groups versus HandiHaler® (MACE: Respimat® 5 µg: HR, 0.69; 95% CI, 0.41–1.18; Respimat® 2.5 µg: HR, 0.83; 95% CI, 0.50–1.39; fatal MACE: HR, 0.60; 95% CI, 0.26–1.37; Respimat® 2.5 µg: HR, 0.42; 95% CI, 0.16–1.09). Overall incidence of a fatal event (on-treatment) was lower in the Respimat® groups versus HandiHaler® (Respimat® 5 µg: HR, 0.60; 95% CI, 0.39–0.92; Respimat® 2.5 µg: HR, 0.67; 95% CI, 0.44–1.02). Time to first exacerbation was similar across groups (Respimat® 5 µg versus HandiHaler®: HR, 0.94; 95% CI, 0.82–1.08).

Conclusions Patients treated with tiotropium HandiHaler® 18 µg at baseline, and who were randomised and subsequently received tiotropium Respimat® 2.5 or 5 µg, had a similar risk of exacerbation as patients who continued to be treated with tiotropium HandiHaler® 18 µg. In this subgroup of patients, all-cause mortality was similar between tiotropium Respimat® and HandiHaler® 18 µg.

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