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Safety and efficacy of tiotropium in patients switching from HandiHaler to Respimat in the TIOSPIR trial.


ABSTRACT: OBJECTIVES:This post hoc analysis of TIOtropium Safety and Performance In Respimat (TIOSPIR) evaluated safety and exacerbation efficacy in patients with stable (? 2 months) use of tiotropium HandiHaler 18 µg (HH18) prior to study entry, to evaluate whether there was a difference in risk for patients who switched from HH18 to tiotropium Respimat 2.5 µg (R2.5) or 5 g (R5). SETTING:TIOSPIR (n=17,135) was an international, Phase IIIb/IV, randomised, double-blind, parallel-group, event-driven trial. PARTICIPANTS:Patients from TIOSPIR with chronic obstructive pulmonary disease (COPD) and postbronchodilator ratio of forced expiratory volume in 1 s to forced vital capacity ? 0.70, receiving HH18 before study entry, were analysed (n=2784). INTERVENTIONS:Patients were randomised to once-daily tiotropium R2.5 (n=914), R5 (n=918) or HH18 (n=952) for 2-3 years. PRIMARY AND SECONDARY OUTCOME MEASURES: PRIMARY OUTCOMES:time to death (safety) and time to first COPD exacerbation (efficacy). SECONDARY OUTCOMES:number of exacerbations and time to first major adverse cardiovascular event (MACE). RESULTS:Baseline characteristics were similar in all groups. Respimat had a similar mortality risk versus HH18 (vital status follow-up, HR; 95% CI R2.5: 0.87; 0.64 to 1.17; R5: 0.79; 0.58 to 1.07) with no significant differences in the risk and rates of exacerbations and severe exacerbations across treatment groups. Risk of MACE and fatal MACE was similar for Respimat versus HH18 (HR; 95% CI MACE R2.5: 0.73; 0.47 to 1.15; R5: 0.69; 0.44 to 1.08; fatal MACE R2.5: 0.57; 0.27 to 1.19; R5: 0.67; 0.33 to 1.34). Overall risk of a fatal event (on treatment) was lower for R5 versus HH18 (HR; 95% CI R2.5: 0.78; 0.55 to 1.09; R5: 0.62; 0.43 to 0.89). CONCLUSIONS:This analysis indicates that it is safe to switch patients from tiotropium HandiHaler to tiotropium Respimat, and that the efficacy is maintained over the switch. TRIAL REGISTRATION NUMBER:NCT01126437; Post-results.

SUBMITTER: Dahl R 

PROVIDER: S-EPMC4710815 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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Safety and efficacy of tiotropium in patients switching from HandiHaler to Respimat in the TIOSPIR trial.

Dahl Ronald R   Calverley Peter M A PM   Anzueto Antonio A   Metzdorf Norbert N   Fowler Andy A   Mueller Achim A   Wise Robert R   Dusser Daniel D  

BMJ open 20151229 12


<h4>Objectives</h4>This post hoc analysis of TIOtropium Safety and Performance In Respimat (TIOSPIR) evaluated safety and exacerbation efficacy in patients with stable (≥ 2 months) use of tiotropium HandiHaler 18 µg (HH18) prior to study entry, to evaluate whether there was a difference in risk for patients who switched from HH18 to tiotropium Respimat 2.5 µg (R2.5) or 5 g (R5).<h4>Setting</h4>TIOSPIR (n=17,135) was an international, Phase IIIb/IV, randomised, double-blind, parallel-group, event  ...[more]

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