Clinical evaluation of urapidil (Ebrantil®), an α1-adrenergic blocker, on micturition disturbance due to benign prostatic hyperplasia (BPH), with estimate criteria for efficacy of treatment in BPH

The subjects comprised 50 patients with benign prostatic hyperplasia (BPH) which could be treated with conservative therapy. They were given urapidil (Ebrantil®) in doses ranging from 30 mg/day to 60 mg/day for 4 weeks. The physicians in charge evaluated the effects of this drug therapy and 'estimate criteria for efficacy of treatment in BPH' was used to make an objective evaluation of the drug effects. The rates of improvement in subjective symptoms were 78.0% (39/50) according to the results of evaluation by the treating physicians and 64.3% (27/42) according to the results of evaluation by the criteria. Four irritative symptoms and three obstructive symptoms were selected from I-PSS in order to compare the transition of these symptoms. The results of this comparative study demonstrated that these two groups of symptoms were improved to similar levels. QOL scores were recorded before and after urapidil administration. Compared with the pre-treatment scores, the post-treatment scores recorded two and four weeks later showed a significant decrease. The rate of improvement calculated according to the results of QOL scoring was 67.5% (27/40). The rates of improvement in objective symptoms were 72.0% (36/50) according to the results of evaluation by the treating physicians and 46.5% (20/43) according to the results of evaluation by the criteria. The effective rates by severity were 76.0% (38/50) according to the results of global improvement rating by the treating physicians and 63.2% (24/38) according to the results of global utility rating by the criteria. No significant differences were recognized between these results. Although four patients complained of adverse effects such as vertigo, light-headedness and fatigue, no abnormal fluctuations in laboratory results were recognized. The measurement results of blood pressure and heart rate showed no significant changes. 'Estimate criteria for efficacy of treatment in BPH' has never been used to evaluate α1-adrenergic blockers. Further widespread use of the criteria is expected and this will allow doctors to select the optimum therapy for each patient by evaluating various drugs and therapeutic techniques using the criteria.