G. Serment, D. Rossi, C. Reitz
Apr 1, 2000
Citations
0
Influential Citations
2
Citations
Quality indicators
Journal
Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie
Abstract
OBJECTIVES To evaluate the efficacy and to describe the modalities of use of terazosin hydrochloride dihydrate, prescribed under conditions of routine clinical practice to a vast population of patients with benign prostatic hyperplasia (BPH). MATERIAL AND METHODS 1,624 patients suffering from BPH and requiring medical treatment were included in this multicentre open clinical trial performed by 983 general practitioners. After a one-week titration phase, terazosin was administered for 4 weeks at the dosage of 5 mg per day as a single dose in the evening at bedtime. The efficacy of treatment was assessed by the variation of the IPSS score between inclusion and the end of treatment, the treatment response rate (at least 3 point reduction of the IPSS score) and the course of the quality of life score. The safety of treatment was evaluated by clinical interview and physical examination at each visit and by analysis of all adverse events occurring during the trial. RESULTS A mean 45.8% improvement of the IPSS score (corresponding to a mean decrease of 8.81 points) was demonstrated between D0 and D35 (p < 0.001). The treatment response rate was 91.8%. A mean improvement of 2.11 points (p < 0.001) of the quality of life score was obtained. Complementary subgroup analysis (moderate dysuria n = 775 and severe BPH n = 702) showed that the efficacy of treatment was independent of the initial severity of the voiding disorders. The clinical safety of treatment was considered to be good in 92.5% of cases by the investigators. The incidence of adverse events attributable to treatment and related to a fall in blood pressure was 2.6%. Less than half (20/43, i.e. 1.25% of the population) of the patients experiencing this type of adverse event had to discontinue treatment. The ease of use of treatment was considered to be good in 85.2% of cases. CONCLUSION Terazosin constitutes an effective symptomatic treatment for BPH when surgery is not indicated, whether the initial disorders are moderate or severe. The safety of treatment appears to be perfectly satisfactory, in a patient series representative of the general practice outpatient population concerned by BPH (age, state of health, concomitant treatments). The one-week progressive dose regimen allows cautious introduction of treatment and generally does not raise any problems of acceptability.