[Efficiency and tolerance of terazosine in ambulatory patients with benign prostatic hypertrophy: comparative randomized and double-blind trial versus alfuzosin. The MG Terazosine Group].

OBJECTIVE: To compare, in general practice, the efficacy and safety of terazosin (5 mg per day in single dose) versus alfuzosin (7.5 mg per day in 3 doses) in patients with symptomatic benign prostatic hyperplasia (BPH) treated for 16 weeks.
MATERIAL AND METHODS: Thirteen investigators included patients over the age of 50 years presenting with BPH with an International Prostate Symptom Score (IPSS) greater than 12 and a post-voiding residual volume less than 300 ml. After a one-week observation period, these patients were randomized to receive either terazosin or alfuzosin for 16 weeks (112 days) under double-blind conditions. The primary endpoint was the percentage reduction of the IPSS score at 3 weeks and 16 weeks; the secondary endpoint was the IPSS quality of life score. Safety was evaluated by recording adverse events and monitoring blood pressure.
RESULTS: Seventy four patients were included: 39 in the terazosin group, 35 in the alfuzosin group. The 2 groups were not significantly different before treatment. Improvement of the IPSS score was similar in the 2 treatment groups (p = 0.97 at 3 weeks, and p = 0.29 at 16 weeks), as was the improvement of the quality of life score (p = 0.47 at 3 weeks and p = 0.71 at 16 weeks). Treatment was considered to be "effective or very effective" in 31 patients (86%) in the terazosin group, and in 28 patients (82%) in the alfuzosin group. The IPSS score was greater than or equal to 12 before treatment for all patients included in the study. Twenty-five patients had a score < 12 at 3 weeks versus 56 at 16 weeks (p = 0.0001). Seven patients had a quality of life score less than 2 before treatment, versus 38 at 3 weeks, and 56 at 16 weeks (p = 0.0001). No significant difference was observed between the 2 groups in terms of the number of adverse events reported, or the course of blood pressure and prostate specific antigen. No patient dropped out of the study because of treatment-related adverse events. Two deaths were observed in the terazosin group (2 patients aged 86 and 93 years), but any relation to treatment was excluded.
CONCLUSION: During this study, terazosin appeared to be as effective and as well tolerated as alfuzosin.

RCT Entities:   Population Interventions Outcomes