SUSTAINED-RELEASE ALFUZOSIN, FINASTERIDE AND THE COMBINATION OF BOTH IN THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA

Objectives: To assess the additive benefit of combining an al-blocker and a Sa-reductase inhibitor. Methods: This European, randomized, doub le-blind, multicenter trial involved 1.051 patients with lower urinary tract symptoms related to benign prostatic hyperplasia. Patients rece ived sustained release (SR) alfuzosin (n = 358), a selective alpha(1)- blocker given at a dose of 5 mg twice daily without dose titration; fi nasteride (n = 344), 5 mg once daily, or both drugs (n = 349), for 6 m onths. Primary efficacy criteria were symptomatic improvement (Interna tional Prostate Symptom Score: I-PSS) and maximum flow rate (Q(max)). Safety was assessed by monitoring adverse events. Results: Symptomatic improvement was significantly higher from the Ist month of treatment with SR alfuzosin, alone or in combination; mean changes in I-PSS vers us baseline at end-point were -6.3 and -6.1, respectively, compared wi th -5.2 with finasteride alone (SR alfuzosin vs. finasteride, p = 0.01 ; combination vs. finasteride, p = 0.03). The percentages of patients with a decrease in I-PSS of at least 50% were 43, 42 and 33% for SR al fuzosin, the combination and finasteride, respectively (SR alfuzosin v s. finasteride, p = 0.008; combination vs. finasteride, p = 0.009). In the overall population, increases in Q(max) were greater with SR alfu zosin and the combination, compared with finasteride alone after 1 mon th of therapy, but changes at end-point were similar in the three trea tment groups. In those 47% of patients likely to be obstructed (baseli ne Q(max) <10 ml/s), however, mean increases in Q(max) were significan tly higher with SR alfuzosin, alone or in combination, whatever the vi sit. Finasteride, alone or in combination, significantly impaired sexu al function. The incidence of postural symptoms was low and similar in the three treatment groups. Conclusion: In this 6-month trial, SR alf uzosin was more effective than finasteride, with no additional benefit in combining both drugs.