Objective: 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).
Methods: 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: 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.
Conclusion: 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.