PD23-12 LONG-TERM EFFICACY AND SAFETY OF ALPHA 1-BLOCKER NAFTOPIDIL FOR PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA: 3-YEAR OUTCOME ANALYSIS OF A PROSPECTIVE MULTICENTER STUDY.

Abstract

METHODS: This prospective study was conducted in 155 men 49-86 years of age who visited our hospital and opted for medical treatment consisting of BPH with dutasteride. Fifty treated with dutasteride 0.5 mg daily for at least 6 months and who had persistent OAB symptoms (OAB Symptom Score (OABSS) 5) were enrolled. These patients were treated for the OAB symptoms with either solifenacin 5 mg/day or mirabegron 50 mg/day for 12 weeks (N1⁄425 in each) and evaluated by the International Prostate Symptom Score (IPSS) and OABSS just before and 4 and 12 weeks after solifenacin or mirabegron treatment. Postvoided residual urine volume (PVR) and the incidence of adverse events were also evaluated. RESULTS: Mean values of prostate volume, PVR, IPSS, and OABSS just before administration of solifenacin or mirabegron were 39.0 ml, 53.2 ml, and 17.6, 8.1, respectively, and these parameters were not significantly different between the two groups. The changes of IPSS and OABSSwere -2.0 and -2.0 at 4 weeks and -3.1 and -2.7 at 12 weeks after solifenacin treatment, respectively, which were significantly lower than those just before the administration. Four patients treatedwith solifenacin could not continue due to adverse events; 3 caseshaddysuria and1 case hadblurred vision.Thechangesof IPSSandOABSSwere -3.3 and -1.7 at 4 weeks and -3.0 and -2.5 at 12 weeks after mirabegron treatment, respectively, which were significantly lower than those just before the administration. All patients continued the mirabegron treatment. The incidence of minor adverse events was 12 and 7 cases in solifenacin and mirabegron treatment, respectively. Two and no patients had more than 100 ml PVR after solifenacin and mirabegron treatment, respectively. CONCLUSIONS: Solifenacin and mirabegron are effective in BPH patients treated with dutasteride but having OAB symptoms.