RESUMEN
We investigated the clinical efficacy and safety of administration of naftopidil at 75 mg for clinically benign hyperplasia patients who had moderate or severe urinary disturbance according to guidelines for clinical studies regarding urination disorder. Among patients with benign prostatic hyperplasia who were treated with a alpha1-adrenoceptor blocker, we administered naftopidil (75 mg/day) for 12 weeks to 85 patients in whom the global severity was evaluated as moderate or severe. This agent significantly reduced the international prostate symptom score (I-PSS) and residual urine volume, and improved the QOL index and maximum urine flow volume in comparison with the baselines. Concerning the global treatment response, a partial response or better was achieved in 83.8% of the patients. Neither blood pressure nor heart rate were changed in patients who continued to receive this therapy. Side effects included orthostatic hypotension (1 patient: discontinuation), dizziness (2 patients: discontinuation, 1 patient: continuation), and palpitation (1 patient: discontinuation). These results suggest that a once-a-day administration of naftopidil at 75 mg safely relieves urination/accumulated urine symptoms in patients with moderate or severe urination disorder related to prostatic hypertrophy.