Clinical Efficacy and Safety of Naftopidil Treatment for Patients with Benign Prostatic Hyperplasia and Hypertension: A Prospective, Open-Label Study

PURPOSE To investigate the efficacy and safety of naftopidil for benign prostatic hyperplasia (BPH) patients, mainly focusing on changes in blood pressure (BP). MATERIALS AND METHODS Of a total of 118 patients, 90 normotensive (NT) and 28 hypertensive (HT) patients were randomly assigned to be treated with naftopidil 50 mg or 75 mg for 12 weeks, once-daily. Safety and efficacy were assessed by analyzing changes from baseline in systolic/diastolic BP and total International Prostate Symptom Score (IPSS) at 4 and 12 weeks. Adverse events (AEs), obstructive/irritative subscores, quality of life (QoL) score, maximum urinary flow rate (Qmax), and benefit, satisfaction with treatment, and willingness to continue treatment (BSW) questionnaire were also analyzed. RESULTS Naftopidil treatment decreased mean systolic BP by 18.7 mm Hg for the HT 50 mg group (p<0.001) and by 18.3 mm Hg for the HT 75 mg group (p<0.001) and mean diastolic BP by 17.5 mm Hg for the HT 50 mg group (p<0.001) and by 14.7 mm Hg for the HT 75 mg group (p=0.022). In the NT groups (both naftopidil 50 mg and 75 mg), naftopidil elicited no significant changes in BP from baseline values. After 12 weeks, naftopidil 50 and 75 mg groups showed significant improvements in IPSS scores (total, obstructive/irritative subscores, QoL score) and Qmax from baseline. AEs were reported in 7.8% (50 mg group) and 2.9% (75 mg group) of patients. In both the 50 mg and 75 mg groups, >86% of all patients agreed to continue their current medications. CONCLUSION Our results suggest that naftopidil treatment in BPH patients with hypertension allows for optimal management of BP within the normal range.