Clinical Efficacy of α1-Adrenargic Receptor Antagonist Naftopidil 75 mg/day in Patients with Benign Prostatic Hyperplasia.

Abstract

The clinical efficacy and safety of 75 mg/day of naftopidil, an α1-adrenargic receptor antagonist, was assessed in patients with benign prostatic hyperplasia (BPH). A total of 28 patients (mean age, 71.1 years; range, 46-86 years) with BPH were studied. Inclusion criteria were: (i) International Prostate Symptom Score (IPSS) ≥8; and (ii) quality of life (QOL) index ≥3. IPSS, QOL index, Overactive Bladder Symptom Score (OABSS), and bladder diary (urinary frequency in daytime and nighttime, frequency of urinary incontinence and urgency) were evaluated before and 4 weeks after treatment with naftopidil at 75 mg/day. Total IPSS and QOL index were significantly decreased after treatment. Total OABSS tended to decrease after treatment, with significant improvements in the "urgency" parameter. From the bladder diary, urinary frequency in daytime and nighttime and frequency of urgency were significantly decreased after treatment. Total IPSS and QOL index in patients with previous treatment were significantly improved after treatment, with significant improvements in the "incomplete emptying,""poor flow" and "nocturia" parameters of IPSS. One case with a mild adverse effect of dizziness was encountered. These results suggest that administration of naftopidil at 75 mg/day was safe and effective for patients with BPH, regardless of the presence of previous treatment. This study indicates the feasibility of naftopidil at 75 mg/day as a first-line treatment for men with BPH, or a second-line treatment in cases with symptoms of incomplete emptying, poor flow and nocturia.