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Todd A. Lee, PharmD, PhD; Caitlyn Wilke, MS; Min Joo, MD, MPH; Kevin T. Stroupe, PhD; Jerry A. Krishnan, MD, PhD; Glen T. Schumock, PharmD, MBA; A. Simon Pickard, PhD

Arch Intern Med. 2009;169(15):1403-1410.

Background  To date, there is mixed evidence on the safety and effectiveness of tiotropium. Our objective was to evaluate the comparative effectiveness of regimens containing tiotropium bromide vs other medication regimens for chronic obstructive pulmonary disease (COPD) in real-world clinical settings.

Methods  We conducted a cohort study on 2 separate cohorts with a diagnosis of COPD in the Veterans Affairs health care system. Patients with a diagnosis of COPD prescribed tiotropium and patients in a historic cohort prior to the introduction of tiotropium were selected for comparison using propensity scores, with the base case including scores from 0.1 to 0.4. Outcomes identified during follow-up were all-cause mortality, COPD exacerbations, and COPD hospitalizations. Exposure to COPD medication regimens was defined in a time-varying manner and Cox proportional hazards regression were used to evaluate outcomes.

Results  For 42 090 patients in the base case, the regimen of tiotropium + inhaled corticosteroids (ICS) + long-acting β-agonists (LABA) was associated with 40% reduced risk of death (hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.45-0.79) compared with ICS + LABA. This combination was associated with reduced rates of COPD exacerbations (HR, 0.84; 95% CI, 0.73-0.97) and COPD hospitalizations (HR, 0.78; 95% CI, 0.62-0.98). Tiotropium in combination with 2 other medications was associated with increased risk of mortality, exacerbations, and hospitalizations.

Conclusions  When used with ICS and LABA, tiotropium use was associated with a decreased risk of mortality compared with treatment with ICS and LABA. However, this result was not consistent in other medication regimens that included tiotropium.

Author Affiliations: Center for Management of Complex Chronic Care, Edward Hines Jr VA Hospital, Hines, Illinois (Drs Lee, Joo, Stroupe, and Pickard); Center for Pharmacoeconomic Research and Department of Pharmacy Practice, College of Pharmacy (Drs Lee, Schumock, and Pickard and Ms Wilke), and Section of Pulmonary, Critical Care and Sleep Medicine, College of Medicine (Dr Joo), University of Illinois at Chicago; Institute for Healthcare Studies and Division of General Internal Medicine, Northwestern University Feinberg School of Medicine, Chicago (Dr Stroupe); and Section of Pulmonary and Critical Care Medicine, Departments of Medicine and Health Studies (Dr Krishnan), University of Chicago, Chicago.

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