[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.


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.


CONCLUSIONS
During this study, terazosin appeared to be as effective and as well tolerated as alfuzosin.
Fourcade
R O
RO
Service d'Urologie, Centre Hospitalier d'Auxerre, France.
D000317:Adrenergic alpha-Antagonists / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D000553:Ambulatory Care; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D011224:Prazosin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D011788:Quality of Life; D011799:Quinazolines / Q000627:therapeutic use*; D012720:Severity of Illness Index
D000317:Adrenergic alpha-Antagonists; D011799:Quinazolines; C041226:Terazosin; C047638:alfuzosin; D011224:Prazosin
Efficacité et tolérance de la térazosine chez des patients ambulatoires présentant une hypertrophie bénigne de la prostate: essai comparatif contre alfuzosine, randomisé, en double-aveugle. Le Groupe MG Térazosine.