Combined therapy with dutasteride and tadalafil vs dutasteride or tadalafil monotherapy in benign prostatic hyperplasia: a randomised phase III trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: OBJECTIVES: To evaluate the efficacy and safety of a fixed-dose combination (FDC) of dutasteride and tadalafil vs monotherapy in patients with benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: This phase III trial enrolled 667 patients. After screening and washout, eligible patients were stratified by the baseline International Prostate Symptom Score (IPSS) and randomised (1:1:1) to receive FDC dutasteride 0.5 mg/tadalafil 5 mg (FDC 0.5/5 mg), dutasteride 0.5 mg, or tadalafil 5 mg for 48 weeks. The primary endpoint was the change in total IPSS from baseline to Week 48. Efficacy and safety were assessed at 4, 12, 24, 36, and 48 weeks. RESULTS: In total, 619 patients were analysed for efficacy. The least squares (LS) mean (standard error [se]) change in total IPSS at 48 weeks from baseline was -9.49 (0.37) for the FDC 0.5/5 mg group vs -4.40 (0.37) for dutasteride 0.5 mg group (LS mean difference [LSMD] -5.09, 95% confidence interval [CI] -6.13 to -4.50; P < 0.001), and -9.53 (0.36) for the FDC 0.5/5 mg group vs -4.24 (0.37) for tadalafil 5 mg group (LSMD -5.29, 95% CI -6.30 to -4.27; P < 0.001). The FDC 0.5/5 mg group demonstrated the most pronounced improvement in quality of life. Although the maximum urinary flow rate and post-void residual volume improved in all groups, differences were not statistically significant. In the comparison between the FDC 0.5/5 mg and dutasteride 0.5 mg groups, the LSMD (95% CI) of change from baseline to Week 48 in the international index of erectile function - erectile function (IIEF - EF) total score was 4.03 (2.35 to -5.71) (P < 0.05). Among the 655 patients analysed for safety, treatment-emergent adverse events occurred in 32.88% (FDC 0.5/5 mg) vs 21.20% (dutasteride 0.5 mg) and 26.48% (tadalafil 5 mg), with few serious adverse events observed. CONCLUSIONS: The FDC 0.5/5 mg demonstrated superior efficacy, and an acceptable safety profile compared with dutasteride and tadalafil monotherapies in patients with BPH.
Source: British Journal of Urology
DOI: 10.1111/bju.70163
Authors: Seung Wook Lee, Seung Hwan Lee, Jae Heon Kim, Joon Hwa Noh, Jun Ho Lee, U‐Syn Ha, Cheol Young Oh, Taek Won Kang, Kyung Seop Lee, Sangchul Lee, Deok Hyun Han, Jun Hyun Han, Sang Hoon Song, Hyun Jun Park, Byung Ha Chung, Gyeong Eun Min, In Gab Jeong, Kyung Hyun Moon, Won Tae Kim, Ji Youl Lee, Choung‐Soo Kim
Institutions: Seoul National University, Yonsei University, Seoul National University Bundang Hospital, Hanyang University Guri Hospital, Yonsei University Health System, Soonchunhyang University, Kwangju Christian Hospital, Eulji University, The Catholic University of Korea Seoul St. Mary's Hospital, Eulji University Nowon Eulji Medical Center, Catholic University of Korea, Hallym University, Hallym University Sacred Heart Hospital, Chonnam National University, Keimyung University Daegu Dongsan Hospital, Keimyung University Dongsan Hospital, Keimyung University, Samsung Medical Center, Hallym University Dongtan Sacred Heart Hospital, Asan Medical Center, University of Ulsan, Pusan National University, Gangnam Severance Hospital, Kyung Hee University, Kyung Hee University Hospital at Gangdong, Ulsan University Hospital, Chungbuk National University, Chungbuk National University Hospital, Ewha Womans University, Ewha Womans University Mokdong Hospital
Language: English
Subfield: Urology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,770
OpenAlex ID: W7128494452