ISSN: 1859 - 2872
The effects of combination therapy with 5-alpha reductase inhibitors plus alpha blockers on clinical outcomes compared with alpha blockers alone in symptomatic benign prostatic hyperplasia patients
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Abstract
Objective: To investigate whether a combination of 0.5mg avodart plus 2mg doxazosin is more effective than 2mg doxazosin alone in treatment‐naïve men with moderately symptomatic benign prostatic hyperplasia (BPH) at risk of progression. Subject and method: This was a randomized, open‐label, parallel‐group study in 100 men with an International Prostate Symptom Score (IPSS) 8 - 19, prostate volume ≥ 30mL and total serum PSA level of < 4ng/mL. Patients were randomised to 0.5mg avodart plus 2mg doxazosin (50 patients) or 2mg doxazosin alone (50 patients) and followed for 6 months. The primary endpoint was symptomatic improvement from baseline to 6 months, measured by the IPSS. Secondary outcomes included BPH clinical progression, impact on quality of life (QoL), change in prostatic volume, post-void residual volume and/or BPH‐related AUR, surgical treatment. Result: Combination therapy was found to significantly reduce the IPSS at 6 months by 4.68 points compared with 0.02 points in doxazosin alone therapy (p<0.05). With combination therapy group the risk of BPH progression was reduced by 66% compared with 34% in the doxazosin alone therapy one (p<0.05). Improvements in QoL (Question 8 of the IPSS) were significantly greater with combination therapy group compared with doxazosin alone therapy one, -1.46 điểm vs 0.14 điểm, respectively (p<0.05). Prostatic volume at month 6 was reduced by 26.3% with combination therapy but increased 0.5% with doxazosin alone therapy. Post-void residual volume at 6 months were also reduced by 50% for combination therapy but increased 40% with doxazosin alone therapy. The occurrence of BPH‐related AUR, was greater in the doxazosin alone therapy group compared with combination therapy one, 12% vs 2%, respectively. 2% patients of the doxazosin alone therapy group change in surgical treatment. Conclusion: The combination therapy with avodart plus doxazosin resulted in rapid and sustained improvements in men with moderate BPH symptoms at risk of progression with significantly greater symptom and QoL improvements and a significantly reduced risk of BPH progression compared with doxazosin alone therapy.
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References
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