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Tiotropium HandiHaler(®) and Respimat(®) in COPD: a pooled safety analysis.

Abstract

INTRODUCTION

Tiotropium is prescribed for the treatment of chronic obstructive pulmonary disease (COPD) and delivered via HandiHaler(®) (18 μg once daily) or Respimat(®) Soft Mist™ inhaler (5 μg once daily). The recent TIOtropium Safety and Performance In Respimat(®) (TIOSPIR™) study demonstrated that both exhibit similar safety profiles. This analysis provides an updated comprehensive safety evaluation of tiotropium(®) using data from placebo-controlled HandiHaler(®) and Respimat(®) trials.

METHODS

Pooled analysis of adverse event (AE) data from tiotropium HandiHaler(®) 18 μg and Respimat(®) 5 μg randomized, double-blind, parallel-group, placebo-controlled, clinical trials in patients with COPD (treatment duration ≥4 weeks). Incidence rates, rate ratios (RRs), and 95% confidence intervals (CIs) were determined for HandiHaler(®) and Respimat(®) trials, both together and separately.

RESULTS

In the 28 HandiHaler(®) and 7 Respimat(®) trials included in this analysis, 11,626 patients were treated with placebo and 12,929 with tiotropium, totaling 14,909 (12,469 with HandiHaler(®); 2,440 with Respimat(®)) patient-years of tiotropium exposure. Mean age was 65 years, and mean prebronchodilator forced expiratory volume in 1 second (FEV1) was 1.16 L (41% predicted). The risk (RR [95% CI]) of AEs (0.90 [0.87, 0.93]) and of serious AEs (SAEs) (0.94 [0.89, 0.99]) was significantly lower in the tiotropium than in the placebo group (HandiHaler(®) and Respimat(®) pooled results), and there was a numerically lower risk of fatal AEs (FAEs) (0.90 [0.79, 1.01]). The risk of cardiac AEs (0.93 [0.85, 1.02]) was numerically lower in the tiotropium group. Incidences of typical anticholinergic AEs, but not SAEs, were higher with tiotropium. Analyzed separately by inhaler, the risks of AE and SAE in the tiotropium groups remained lower than in placebo and similarly for FAEs.

CONCLUSION

This analysis indicates that tiotropium is associated with lower rates of AEs, SAEs, and similar rates of FAEs than placebo when delivered via HandiHaler(®) or Respimat(®) (overall and separately) in patients with COPD.

Authors+Show Affiliations

Royal Devon and Exeter Hospital, Exeter, Devon, England, UK.Allergy Centre, Odense University Hospital, Odense, Denmark.Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany.Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany.Department of Medicine, David Geffen School of Medicine UCLA, Los Angeles, CA, USA.

Pub Type(s)

Journal Article
Meta-Analysis
Video-Audio Media

Language

eng

PubMed ID

25709423

Citation

Halpin, David Mg, et al. "Tiotropium HandiHaler(®) and Respimat(®) in COPD: a Pooled Safety Analysis." International Journal of Chronic Obstructive Pulmonary Disease, vol. 10, 2015, pp. 239-59.
Halpin DM, Dahl R, Hallmann C, et al. Tiotropium HandiHaler(®) and Respimat(®) in COPD: a pooled safety analysis. Int J Chron Obstruct Pulmon Dis. 2015;10:239-59.
Halpin, D. M., Dahl, R., Hallmann, C., Mueller, A., & Tashkin, D. (2015). Tiotropium HandiHaler(®) and Respimat(®) in COPD: a pooled safety analysis. International Journal of Chronic Obstructive Pulmonary Disease, 10, 239-59. https://doi.org/10.2147/COPD.S75146
Halpin DM, et al. Tiotropium HandiHaler(®) and Respimat(®) in COPD: a Pooled Safety Analysis. Int J Chron Obstruct Pulmon Dis. 2015;10:239-59. PubMed PMID: 25709423.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tiotropium HandiHaler(®) and Respimat(®) in COPD: a pooled safety analysis. AU - Halpin,David Mg, AU - Dahl,Ronald, AU - Hallmann,Christoph, AU - Mueller,Achim, AU - Tashkin,Donald, Y1 - 2015/02/05/ PY - 2015/2/25/entrez PY - 2015/2/25/pubmed PY - 2015/9/16/medline KW - HandiHaler® KW - Respimat® KW - tiotropium SP - 239 EP - 59 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 10 N2 - INTRODUCTION: Tiotropium is prescribed for the treatment of chronic obstructive pulmonary disease (COPD) and delivered via HandiHaler(®) (18 μg once daily) or Respimat(®) Soft Mist™ inhaler (5 μg once daily). The recent TIOtropium Safety and Performance In Respimat(®) (TIOSPIR™) study demonstrated that both exhibit similar safety profiles. This analysis provides an updated comprehensive safety evaluation of tiotropium(®) using data from placebo-controlled HandiHaler(®) and Respimat(®) trials. METHODS: Pooled analysis of adverse event (AE) data from tiotropium HandiHaler(®) 18 μg and Respimat(®) 5 μg randomized, double-blind, parallel-group, placebo-controlled, clinical trials in patients with COPD (treatment duration ≥4 weeks). Incidence rates, rate ratios (RRs), and 95% confidence intervals (CIs) were determined for HandiHaler(®) and Respimat(®) trials, both together and separately. RESULTS: In the 28 HandiHaler(®) and 7 Respimat(®) trials included in this analysis, 11,626 patients were treated with placebo and 12,929 with tiotropium, totaling 14,909 (12,469 with HandiHaler(®); 2,440 with Respimat(®)) patient-years of tiotropium exposure. Mean age was 65 years, and mean prebronchodilator forced expiratory volume in 1 second (FEV1) was 1.16 L (41% predicted). The risk (RR [95% CI]) of AEs (0.90 [0.87, 0.93]) and of serious AEs (SAEs) (0.94 [0.89, 0.99]) was significantly lower in the tiotropium than in the placebo group (HandiHaler(®) and Respimat(®) pooled results), and there was a numerically lower risk of fatal AEs (FAEs) (0.90 [0.79, 1.01]). The risk of cardiac AEs (0.93 [0.85, 1.02]) was numerically lower in the tiotropium group. Incidences of typical anticholinergic AEs, but not SAEs, were higher with tiotropium. Analyzed separately by inhaler, the risks of AE and SAE in the tiotropium groups remained lower than in placebo and similarly for FAEs. CONCLUSION: This analysis indicates that tiotropium is associated with lower rates of AEs, SAEs, and similar rates of FAEs than placebo when delivered via HandiHaler(®) or Respimat(®) (overall and separately) in patients with COPD. SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/25709423/Tiotropium_HandiHaler_®__and_Respimat_®__in_COPD:_a_pooled_safety_analysis_ L2 - https://dx.doi.org/10.2147/COPD.S75146 DB - PRIME DP - Unbound Medicine ER -