Clinical and economic outcomes associated with use of fluticasone propionate 250 mcg and salmeterol 50 mcg combination versus tiotropium as initial maintenance treatment for chronic obstructive pulmonary disease in a managed care setting

Trial description: Several studies have directly compared the clinical and economic outcomes of fluticasone propionate 250 mcg and salmeterol 50 mcg combination (FSC) vs tiotropium (TIO) for the treatment of Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study was to provide an updated cost comparison of these maintenance medications in the treatment of COPD. Specifically, the purpose of the study was to examine and quantify health care resource use and costs with initiating FSC or TIO as maintenance treatments. The primary objective of this study is to compare COPD-related costs (total, medical, prescription) in subjects initiating maintenance treatment with FSC versus TIO. The null hypothesis is that no significant difference will be observed between the two treatments. The secondary objectives are to compare components of COPD-related medical costs in subjects initiating maintenance treatment with FSC versus TIO and to compare the rate and number of COPD-related exacerbations after initiation of FSC versus TIO as maintenance treatment in subjects with COPD. The study design is a retrospective, observational matched cohort study.The Truven Health MarketScan Commercial Claims and Encounters Database (Commercial) and Medicare Supplemental and Coordination of Benefits Database (Medicare) will be used for this study. The Commercial database includes over 40 million individuals, and represents the medical experience of insured employees and their dependents for active employees, early retirees, COBRA continuees, and their dependents insured by employer-sponsored plans (ie, non-Medicare eligibles). The Medicare database contains claims data for approximately 3.1 million Medicare-eligible retirees with employer-sponsored Medicare Supplemental plans. Beneficiaries in the MarketScan Medicare database have drug coverage; therefore, drug data are available and provide additional valuable information. Both databases include detailed cost, use, and outcomes data for healthcare services performed as inpatient and outpatient services and prescription drug claims, as well as information on subject enrollment.