TY - JOUR T1 - Influence of patient baseline characteristics and concomitant medication on outcomes in long-term trials of COPD: Analysis of the UPLIFT® trial JF - European Respiratory Journal JO - Eur Respir J VL - 42 IS - Suppl 57 SP - P749 AU - Marc Decramer AU - Bartolome Celli AU - Norbert Metzdorf AU - Inge Leimer AU - Donald Tashkin Y1 - 2013/09/01 UR - http://erj.ersjournals.com/content/42/Suppl_57/P749.abstract N2 - Background: Several long-acting bronchodilators (BDs) were introduced recently as maintenance therapy for COPD. However, a direct comparison of the effects of these newer agents with existing therapy from long-term studies is lacking.Aims and objectives: To investigate if patient selection affects the magnitude of effects observed in clinical studies in COPD.Methods: Subgroup analysis of the UPLIFT® trial using in/exclusion criteria similar to clinical programs of other long-acting BDs (OLB), ie, exclusion of GOLD IV patients and concomitant long-acting β2-agonists. Spirometry and SGRQ: mixed-model repeated measures ANOVA with random subject effects; number of events: Poisson regression with correction for overdispersion.Results: Baseline patient characteristics are shown in the table. For UPLIFT total vs OLB subgroup, minimum, maximum improvements tiotropium versus placebo over 4 yrs were: trough FEV1, 0.09-0.10L vs 0.10-0.13L; SGRQ total score, -2.30 to -3.35 vs -2.14 to -4.14. Overall exacerbation rate (per pt-yr) in tiotropium/placebo groups differed between UPLIFT total (0.74/0.87) and OLB subgroup (0.43/0.48), rate ratios for tiotropium vs placebo were 0.86 and 0.89 respectively.View this table:Conclusion: Efficacy results in COPD placebo-controlled clinical trials are influenced by included patient population characteristics and/or allowed concomitant medication. Cross-trial efficacy comparisons should take this into account. ER -