Free combination of dutasteride plus tamsulosin for the treatment of benign prostatic hyperplasia in South Korea: analysis of drug utilization and adverse events using the National Health Insurance Review and Assessment Service database

• DOI: 10.1186/s12894-021-00941-1
• Publication Date: 2021-12-21T11:03:50Z
• Authors: Zrinka Lulic; Hwancheol Son; Sang-Bae Yoo; Marianne Cunnington; Pratiksha Kapse; Diane Miller; Vanessa Cortes; Suna Park; Rachel H. Bhak; Mei Sheng Duh
• Keywords: Dutasteride; Tamsulosin; Combination therapy

Abstract Objective To assess the use and safety of free combination therapy (dutasteride tamsulosin), dutasteride monotherapy, or tamsulosin monotherapy in patients with benign prostatic hyperplasia (BPH). Methods This non-interventional retrospective cohort study used claims data from Korea Health Insurance Review Assessment-National Patient Sample database. Patients BPH ≥ 40 years age receiving 0.5 mg 0.4 daily) mg, daily dose between 2012 2017 were included. The frequency, duration treatment risk any adverse event (AE) serious AE (SAE) was compared for versus each using non-inferiority testing. Results Of 14,755 eligible patients, 1529 (10.4%) received therapy, 6660 (45.1%) 6566 (44.5%) monotherapy. proportion treated exceeded pre-specified 3% threshold ‘frequent’ use. Safety results indicated a similar SAE irrespective group. adjusted relative over observation period comparing 1.07 (95% confidence interval [CI] 1.03, 1.12), 0.98 CI 0.95, 1.02) demonstrating non-inferiority. 0.66, 1.74) 0.90 0.56, 1.45), respectively. Although did not statistically demonstrate based on margins, 95% ratio estimates included null lower limit below indicating no meaningful differences groups. Absolute risks low. Conclusion Combination is frequently real-world practice South demonstrates profile to either