Modalities of use of terazosin in routine medical practice in outpatients with obstructive and irritative voiding disorders.

Objectives: To evaluate the efficacy and to describe the modalities of use of terazosin hydrochloride dihydrate, prescribed under conditions of routin e clinical practice to a vast population of patients with benign prostatic hyperplasia (BPH). Material and Methods: 1,624 patients suffering from BPH and requiring medic al treatment were included in this multicentre open clinical trial performe d 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 dos e 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) ten d the course of the quality of life score. The safety of treatment was eval uated by clinical interview and physical examination at each visit and by a nalysis of all adverse events occurring during the trial Results: A mean 45.8% improvement of the IPSS score (corresponding to a mea n decrease of 8.81 points) was demonstrated between DO and D35 (p<0.001). T he 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 an alysis (moderate dysuria n = 775 and severe BPH n = 702) showed that the ef ficacy 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 case s by the investigators. The incidence of adverse events attributable to tre atment 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 o f adverse event had to discontinue treatment. The ease of use of treatment was considered to be goad in 85.2% of cases. Conclusion: Terazosin constitutes an effective symptomatic treatment for BP H 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 populat ion concerned by BPH (age, state of health, concomitant treatments). The on e-week progressive dose regimen allows cautious introduction of treatment a nd generally does not mise any problems of acceptability.