Real-world evidence based study on dutasteride+tamsulosin (DUT-TAM) in South Korea

Trial description: Fixed-dose combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg therapy has not been approved yet by local regulatory authorities in South Korea. Nevertheless, in real-world practice, clinicians in South Korea may prescribe free combination (i.e., concomitant administration) therapy of dutasteride 0.5 mg plus tamsulosin 0.4 mg for the treatment of symptomatic Benign Prostatic Hyperplasia (BPH). The purpose of this study is to 1) assess the frequency and duration of free combination dutasteride 0.5 mg plus tamsulosin 0.4 mg therapy use among participants with BPH in South Korea, and 2) evaluate the safety profile of free combination dutasteride 0.5 mg plus tamsulosin 0.4 mg therapy compared to dutasteride 0.5 mg monotherapy and to tamsulosin 0.4 mg monotherapy. Evidence generated from this study will supplement GSK’s regulatory submission package application for Duodart in South Korea. The study will use claims data from the South Korean Health Insurance Review and Assessment Service-National Patient Sample (HIRA-NPS). The study will include all participants with medical claims for BPH who met the eligibility criteria and were identifiable from the HIRA-NPS database between 1-Jan-2012 to 31-Dec-2017.