Abstract

Our Canadian multicentre open-label study sought to evaluate, in patients with moderate/severe lower urinary symptoms (LUTS) secondary to benign prostatic hyperplasia, the effect on symptoms of 9 months of monotherapy with finasteride 5 mg following 9 months of combination treatment (finasteride with an alpha-blocker) as quantified according to the International Prostate Symptom Score (IPSS). The primary outcome measure for efficacy was the maintenance of IPSS response after cessation of the alpha-blocker. Subjects were treated with a combination of finasteride and an alpha-blocker for 9 months and then with finasteride alone for 3 or 9 months. Results showed that the IPSS scores after 3 months of monotherapy were within the criteria for equivalence to those after 9 months of combination therapy. Symptom control equivalence was also found after 9 months of monotherapy. The IPSS response rate was also similar for combination and monotherapy. The safety profile was similar and as expected with these medications. Control of LUTS associated with BPH thus appears to be maintained for at least 9 months with finasteride alone, following a 9-month course of combination therapy with finasteride and an alpha-blocker, with similar safety profiles.

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