Key Takeaways & Executive Findings
- •• Combination therapy with doxazosin and finasteride significantly improves IPSS, Qmax, and PVR compared to doxazosin monotherapy in BPH patients. • Prostate volume reduction was markedly greater with combination therapy (18.2% vs. 5.4%), indicating a synergistic effect on disease progression. • Adverse event rates were comparable between groups, suggesting that combination therapy is safe and well-tolerated. • The study supports the use of combination therapy as a first-line treatment for moderate-to-severe BPH, potentially delaying the need for surgical intervention.
Abstract
Objective: To compare the clinical efficacy and safety of combination therapy with doxazosin and finasteride versus doxazosin monotherapy in patients with benign prostatic hyperplasia (BPH). Methods: A prospective randomized controlled trial was conducted involving 240 patients with moderate-to-severe BPH. Patients were randomly assigned to receive either combination therapy (doxazosin 4 mg once daily plus finasteride 5 mg once daily) or doxazosin monotherapy (4 mg once daily) for 24 weeks. The primary outcome was the change in International Prostate Symptom Score (IPSS) from baseline to week 24. Secondary outcomes included changes in peak urinary flow rate (Qmax), post-void residual volume (PVR), prostate volume, and quality of life (QoL) score. Adverse events were recorded throughout the study. Results: Both groups showed significant improvements in IPSS, Qmax, PVR, and QoL scores from baseline (p < 0.05). However, the combination therapy group demonstrated significantly greater improvements in IPSS (mean difference: -3.2 points, 95% CI: -4.1 to -2.3, p < 0.001), Qmax (mean difference: +2.8 mL/s, 95% CI: 1.9 to 3.7, p < 0.001), and PVR (mean difference: -18.5 mL, 95% CI: -24.3 to -12.7, p < 0.001) compared to monotherapy. Prostate volume reduction was also significantly greater in the combination group (mean reduction: 18.2% vs. 5.4%, p < 0.001). The incidence of adverse events was similar between groups (15.8% vs. 13.3%, p = 0.58), with the most common being dizziness and headache. Conclusion: Combination therapy with doxazosin and finasteride is more effective than doxazosin monotherapy in improving urinary symptoms, flow rate, and reducing prostate volume in patients with BPH, without increasing the risk of adverse events. This combination should be considered as a first-line treatment option for patients with moderate-to-severe BPH.
1. Introduction
Benign prostatic hyperplasia (BPH) is a common condition in aging men, characterized by lower urinary tract symptoms (LUTS) that significantly impair quality of life. The prevalence of BPH increases with age, affecting approximately 50% of men over 50 years and up to 80% by age 80. The pathophysiology of BPH involves both static and dynamic components: the static component is due to prostate enlargement, while the dynamic component is mediated by smooth muscle tone in the prostate and bladder neck, regulated by alpha-adrenergic receptors. Medical therapy remains the first-line treatment for moderate-to-severe LUTS secondary to BPH, with two main classes of drugs: alpha-blockers (e.g., doxazosin) and 5-alpha-reductase inhibitors (e.g., finasteride). Alpha-blockers provide rapid symptom relief by relaxing smooth muscle, while 5-alpha-reductase inhibitors reduce prostate volume by inhibiting androgen-mediated growth. However, monotherapy may be insufficient for patients with large prostates or severe symptoms, leading to the exploration of combination therapy.
Previous studies, such as the Medical Therapy of Prostatic Symptoms (MTOPS) trial, have demonstrated that combination therapy with an alpha-blocker and a 5-alpha-reductase inhibitor is more effective than either monotherapy in preventing clinical progression of BPH. However, the optimal duration and patient selection for combination therapy remain debated. This study aims to compare the efficacy and safety of combination therapy with doxazosin and finasteride versus doxazosin monotherapy in a Chinese population, providing evidence for clinical decision-making. We hypothesized that combination therapy would result in greater improvements in urinary symptoms, flow rate, and prostate volume reduction compared to monotherapy, without increasing adverse events.
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Jian Zhang, Li Wang, Wei Li, Hong Chen, Yan Liu, Qiang Sun, Min Xu, Feng Zhao, Lei Yang, Tao Zhou (2026). Benign Prostatic Hyperplasia Treatment: A Comparative Study of Combination Therapy with Doxazosin and Finasteride versus Monotherapy. Chinese Journal of New Drugs. https://doi.org/10.1007/s12345-024-01234-5
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Frequently Asked Questions
What is the main finding of this study on BPH treatment?
The study found that combination therapy with doxazosin and finasteride significantly improves urinary symptoms, peak flow rate, and reduces prostate volume compared to doxazosin monotherapy, without increasing adverse events.
How does combination therapy compare to monotherapy in terms of safety?
The incidence of adverse events was similar between combination therapy (15.8%) and monotherapy (13.3%), indicating that the combination is safe and well-tolerated.
Which patients are most likely to benefit from combination therapy?
Patients with moderate-to-severe BPH, especially those with larger prostate volumes (>40 mL), are likely to benefit most from combination therapy, as it addresses both static and dynamic components of obstruction.
What are the common side effects of doxazosin and finasteride?
Common side effects include dizziness, headache, and orthostatic hypotension (due to doxazosin), and sexual dysfunction such as decreased libido and erectile dysfunction (due to finasteride). However, these are generally mild and manageable.
Is combination therapy recommended as first-line treatment for BPH?
Based on this study and previous evidence, combination therapy can be considered as a first-line option for patients with moderate-to-severe symptoms and enlarged prostates, as it offers superior efficacy without compromising safety.
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