Dutasteride-Tadalafil FDC Shows Superior Symptom Reduction in BPH Phase III Trial
A 48-week, phase III randomized trial enrolled 667 patients with benign prostatic hyperplasia (BPH), with 619 analyzed for efficacy and 655 for safety. The study compared a fixed-dose combination (FDC) of dutasteride 0.5 mg/tadalafil 5 mg against dutasteride 0.5 mg monotherapy and tadalafil 5 mg monotherapy. The primary outcome was change in total International Prostate Symptom Score (IPSS) from baseline to Week 48.
The FDC demonstrated superior efficacy for the primary outcome. At 48 weeks, the mean change in total IPSS was -9.49 for the FDC, compared to -4.40 for dutasteride monotherapy and -4.24 for tadalafil monotherapy. The least squares mean differences were -5.09 (95% CI -6.13 to -4.50) and -5.29 (95% CI -6.30 to -4.27) versus the respective monotherapies, both with P < 0.001. The FDC group also showed the most pronounced improvement in quality of life, though specific data were not reported. For erectile function, the FDC improved the IIEF-EF total score by a least squares mean difference of 4.03 (95% CI 2.35 to 5.71; P < 0.05) compared to dutasteride monotherapy. Improvements in maximum urinary flow rate and post-void residual volume were seen in all groups but were not statistically significant between them.
Safety analysis showed adverse events occurred in 32.88% of patients on the FDC, compared to 21.20% on dutasteride and 26.48% on tadalafil monotherapy. Few serious adverse events were observed, and the overall safety profile was deemed acceptable. Key limitations include the lack of reported data on discontinuation rates, funding sources, and conflicts of interest. The study did not report on the clinical significance of the IPSS improvement or long-term outcomes beyond 48 weeks. For practice, this evidence suggests the FDC may offer enhanced symptom control for BPH, but the higher rate of adverse events necessitates a balanced consideration of benefits and risks for individual patients.
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