Pneumologie 2016; 70 - P251
DOI: 10.1055/s-0036-1572049

T Safety And Performance In Respimat® (TIOSPIR™): Safety And Efficacy In Patients With T HH® Use At Baseline

R Koczulla 1, P Calverley 2, A Anzueto 3, R Dahl 4, A Müller 5, A Fowler 6, N Metzdorf 5, R Wise 7, D Dusser 8
  • 1Clinic for Pneumology, University Clinics Gießen and Marburg GmbH
  • 2Institute of Ageing and Chronic Disease, University of Liverpool
  • 3Pulmonary Critical Care Center
  • 4Odense University Hospital
  • 5Boehringer Ingelheim Pharma GmbH & Co. Kg
  • 6Boehringer Ingelheim Pharma Ltd.
  • 7School of Medicine, John Hopkins University
  • 8Université Paris Descartes, Sorbonne Paris Cité, Service de Pneumologie Hopital Cochin, Ap-Hp

Rationale: The TIOSPIR™ trial showed that tiotropium (T) Respimat® (Resp) 5 µg and HandiHaler® (HH) 18 µg have similar safety and exacerbation (exa) efficacy profiles in patients (pts) with COPD. We present results for all pts using T HH® at baseline.

Methods: TIOSPIR™ (n = 17,135) compared safety and efficacy of once-daily T Resp 5 and 2.5 µg with once-daily HH 18 µg in pts with COPD. Primary endpoints were time to death and time to first COPD exa. Safety, incl. cardiovascular (CV) safety, was assessed. Pts receiving T at baseline from countries where T Resp was unavailable at the time of study initiation (baseline T HH use only) were analyzed.

Results: 2784 pts from TIOSPIR™ treated with T HH 18 µg at baseline were randomized and treated (n = 914 and n = 918 for T Resp 2.5 and 5 µg; n = 952 for HH 18 µg). Patient baseline demographics and characteristics were similar in the three T groups. A similar risk of death (time to death) was observed for pts in the Resp groups versus HH (vital status follow up: Resp 5 µg: hazard ratio [HR]: 0.79; 95% confidence interval [CI]: 0.58 – 1.07; Resp 2.5 µg: HR: 0.87; 95% CI: 0.64 – 1.17). Risk of a major adverse CV event (MACE) and fatal MACE was also similar for the Resp groups versus HH (MACE with Resp 5 µg, HR: 0.69; 95% CI: 0.44 – 1.08; Resp 2.5 µg, HR: 0.73; 95% CI: 0.47 – 1.15; fatal MACE with Resp 5 µg, HR: 0.67; 95% CI: 0.33 – 1.34; Resp 2.5 µg, HR: 0.57; 95% CI: 0.27 – 1.19). Overall risk of a fatal event (ontreatment) was lower in the Resp 5 µg group versus HH (Resp 5 µg, HR: 0.62; 95% CI: 0.43 – 0.89; Resp 2.5 µg, HR: 0.78; 95% CI: 0.55 – 1.09). Risk of exa (time to first exa) was similar across groups (Resp 5 µg and 2.5 µg versus HH, HR [95% CI]: 0.96 [0.86 – 1.08] and 1.03 [0.92 – 1.16], respectively).

Conclusions: Pts treated with T HH 18 µg at baseline, and who were randomized and then received T Resp 2.5 or 5 µg, had similar risk of all-cause mortality, fatal MACE, MACE and exa as those pts who continued to be treated with T HH 18 µg.

Funding: Boehringer Ingelheim