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Dutasteride-Tadalafil FDC Shows Superior Symptom Reduction in BPH Phase III TrialDoes taking two prostate drugs together work better than just one for symptom relief?

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Key Takeaway
Consider FDC dutasteride/tadalafil for BPH symptom control, noting higher AE rate vs monotherapy.

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.

Imagine waking up three times a night to pee or struggling to start your stream. For men with benign prostatic hyperplasia, or an enlarged prostate, these are common frustrations. This study looked at whether taking a fixed-dose combination of dutasteride and tadalafil worked better than taking just one of these drugs. The goal was to see if the combination could calm the urge to urinate and improve flow more effectively.

After 48 weeks, the results were clear. Men taking the combination saw their symptom scores drop much faster than those on single-drug therapy. Specifically, the combination group improved by about 9.5 points on a standard symptom scale, while single-drug groups improved by only about 4 points. This means the combined approach offered a stronger boost to daily comfort and quality of life.

However, the study also found a trade-off. More men in the combination group experienced side effects compared to those on single drugs. While serious issues were rare, the higher rate of adverse events suggests that taking both drugs together comes with a higher risk of discomfort. The findings show that while the combination is more powerful, it is not without its costs.

What this means for you:
The drug combination works better for symptoms but causes more side effects than single drugs.

Study Details

Study typeRct
Sample sizen = 667
EvidenceLevel 2
PublishedApr 2026
View Original 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.
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