Retrospective, observational, cohort study to assess the persistence and adherence to Duodart vs concomitant therapy of alpha blocker (AB) plus 5-alphareductase inhibitor (5-ARI) in German BPH-patients

Trial description: The combination therapy of AB+5-ARI is recommended for subjects with lower urinary tract symptoms due to benign prostate hyperplasia (BPH) at increased risk for progression. DUODART is a fixed dose combination (FDC ) of dutasteride (5-ARI)/tamsulosin (AB). DUODART may offer more convenience to subjects as well as improve persistence and adherence. However, the levels of DUODART persistence and adherence in the real world have not been compared to the concomitant therapy of any AB plus any 5-ARI so far, and it is unclear if these theoretical advantages may hold true in reality. Hence, this retrospective study is designed to assess the treatment persistence and adherence of men subjects who received AB+5ARI combination therapy when prescribed as DUODART, compared with prescriptions of separate combination drugs (concomitant therapy). The results of this study may make physicians aware of differences in persistence and adherence of their subjects to different therapy regimens (FDC versus concomitant therapy) and help them to take the right decision in order to maximize subject’s benefits from treatment. Male subjects who received combination therapy with DUODART or AB+5-ARI between 01/07/2011 and 31/12/2016 will be eligible for this analysis. Subjects will be followed-up for 12-54 months after index date. Index date is the first prescription of a 5-ARI/AB combination therapy, either as DUODART or as concomitant therapy. DUODART™ is a registered trademark of the GlaxoSmithKline group of companies.