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Comparative Study
. 2016 May;25(5):578-89.
doi: 10.1002/pds.3961. Epub 2016 Jan 29.

One-year mortality associated with COPD treatment: a comparison of tiotropium and long-acting beta2-agonists in three Italian regions: results from the OUTPUL study

Ursula Kirchmayer  1 , Silvia Cascini  1 , Nera Agabiti  1 , Mirko Di Martino  1 , Lisa Bauleo  1 , Giulio Formoso  2 , Claudio Voci  2 , Riccardo Pistelli  3 , Elisabetta Patorno  4 , Marina Davoli  1 ; OUTPUL study group
Affiliations
Comparative Study

One-year mortality associated with COPD treatment: a comparison of tiotropium and long-acting beta2-agonists in three Italian regions: results from the OUTPUL study

Ursula Kirchmayer et al. Pharmacoepidemiol Drug Saf. 2016 May.

Abstract

Purpose: Long-acting bronchodilators, i.e. beta-2-agonists (LABA) and tiotropium are commonly used in COPD treatment. Choice of a specific agent is based on effectiveness and safety. Evidence yields controversial results with respect to mortality. The present study compared one-year mortality associated to treatment with tiotropium versus LABA.

Methods: A population-based cohort study using data from Italian health information systems was performed. Patients aged 45+ years, discharged with COPD diagnosis in 2006-2009 were identified. Through record linkage with drug claims, patients who received a first prescription of LABA or tiotropium within 6 months after discharge were enrolled. The main analysis was restricted to naïve users (no prior use of either LABA or tiotropium). We used 'intention to treat' (ITT) and 'as treated' (AT) approaches. We followed patients for a maximum of 12 months. Hazard ratios (HRs) were calculated by Cox regression including quintiles of propensity score. In sensitivity analysis patients receiving tiotropium + LABA combination were included in the tiotropium group.

Results: Among the 33 891 enrolees, 28% were exposed to Tio, 56% to LABA, 16% to both. Overall mean age was 74 years and the mortality rate was 122/1000 person-years (py) at the ITT analysis and 108/1000 py at the AT analysis. The adjusted HR for tiotropium only compared with LABA only was 1.06 (95%CI: 0.94-1.20) at the ITT analysis and 1.00 (95%CI: 0.93-1.08) at the AT analysis. Results were robust in sensitivity analysis.

Conclusions: In this real-world study use of tiotropium was not associated with an increased risk of one-year mortality compared with LABA. © 2016 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.

Keywords: COPD; cohort; drug treatment; mortality; pharmacoepidemiology.

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Figures

Figure 1
Figure 1
Examples of claim episode
Figure 2
Figure 2
As‐treated approach: examples for censoring because of discontinuation and switching. (a) Discontinuation. (b) Switching
Figure 3
Figure 3
(a) Selection of enrolment admission. (b) Selection of ‘new‐users’ treatment episodes
Figure 4
Figure 4
Rates and HR in sensitivity analyses, using two different study designs, adjusting for propensity score quintiles. *Sensitivity analyses compared patients with tiotropium versus LABA excluding those with prescription of ICS during follow‐up. HR adjusted for propensity score quintiles. **Sensitivity analyses compared patients with tiotropium or tiotropium + LABA versus LABA only. HR adjusted for propensity score quintiles plus variable non balanced (cardiac therapy, diuretics, betablockers, chronic respiratory disease other than COPD, ischemic heart disease, other chronic heart diseases and arrhythmia)
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References

    1. Mannino DM, Buist AS. Global burden of COPD: risk factors, prevalence, and future trends. Lancet 2007; 370(9589): 765–773 Review. - PubMed
    1. Qaseem A, Wilt TJ, Weinberger SE, et al American College of Physicians; American College of Chest Physicians; American Thoracic Society; European Respiratory Society. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med 2011; 155(3): 179–191. - PubMed
    1. O'Donnell DE, Aaron S, Bourbeau J, Hernandez P, Marciniuk D, Balter M, Ford G, Gervais A, Goldstein R, Hodder R, Maltais F, Road J, Canadian Thoracic Society. Canadian Respiratory Society Recommendations for Management of Chronic Obstructive Pulmonary Disease. Can Resp J 2003; 10(Suppl A: 11A–65A). - PubMed
    1. GOLD ‐ global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (GOLD) – updated 2013. - PubMed
    1. Chronic obstructive pulmonary disease: management of chronic obstructive pulmonary disease in adults in primary and secondary care [Internet]. National Clinical Guideline Centre (UK). London: Royal College of Physicians (UK); 2010. Jun. - PubMed

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