A post hoc pooled analysis of exacerbations among US participants in randomized controlled trials of tiotropium

作者:Anzueto Antonio*; Niewoehner Dennis E; Leimer Inge; Ruehmkorf Fee; Celli Bartolome R; Decramer Marc; Tashkin Donald P
来源:Respiratory Medicine, 2013, 107(12): 1912-1922.
DOI:10.1016/j.rmed.2013.07.020

摘要

Background: Exacerbations are a defining outcome of chronic obstructive pulmonary disease (COPD). We evaluated the effect of tiotropium on COPD exacerbations and related hospitalizations among patients from the USA enrolled in clinical trials. %26lt;br%26gt;Methods: Data were pooled from six randomized, double-blind, placebo-controlled trials (6 to %26gt;= 12 months%26apos; duration) of tiotropium in patients with COPD. Exacerbations were defined retrospectively as an increase in or new onset of %26gt;1 respiratory symptom lasting for %26gt;= 3 days and requiring treatment with systemic corticosteroids and/or antibiotics. Time to first exacerbation or hospitalization and exacerbation rates were analyzed at 6 months, and at 1 year for studies %26gt;= 1 year. %26lt;br%26gt;Results: In total, 4355 patients (tiotropium, 2268, placebo, 2087; mean age 66.5 years; forced expiratory volume in 1 s [FEV1] 1.03 L [35.5% predicted]) were analyzed at 6 months and 2455 at 1 year (tiotropium 1317, placebo 1138; mean age 65.5 years; FEV1, 1.03 L [37.0% predicted]). Tiotropium delayed time to first exacerbation or first hospitalized exacerbation at 6 months (hazard ratios [HRs], 0.80, 0.65, respectively; p %26lt; 0.001 vs placebo) and 1 year (HRs, 0.73 and 0.55; p %26lt; 0.001 vs placebo) and reduced exacerbation rates and hospitalization rates (6 months: HRs, 0.79, 0.64; 1 year: HRs, 0.78, 0.56, respectively; all p %26lt; 0.01 vs placebo). Tiotropium significantly reduced exacerbations, irrespective of inhaled corticosteroid use at baseline. Tiotropium was not associated with an increased risk of cardiac-related events. %26lt;br%26gt;Conclusions: Tiotropium significantly reduced the risk and rates of exacerbations and hospitalizations among US patients with COPD.

  • 出版日期2013-12