title: Three-year outcome analysis of alpha 1-blocker naftopidil for patients with benign prostatic hyperplasia in a prospective multicenter study in Japan.
abstract: OBJECTIVE
  Our aim was to prospectively analyze the 3-year outcomes of naftopidil treatment for patients with benign prostatic hyperplasia (BPH), including those who dropped out during follow-up and had retreatment for BPH after termination of the drug within 3 years.
  
  
  METHODS
  Naftopidil, 50 mg/d or 75 mg/d, was given to 117 patients having BPH aged 50 years and older who had international prostate symptom scores (IPSS) ≥8. They were prospectively followed for 3 years with periodic evaluation. If naftopidil was terminated, the reason was determined. For patients with termination, an outcome survey was done to evaluate the status of retreatment for BPH at 3 years.
  
  
  RESULTS
  Twenty-five patients (21.4%) continued the same medication for 3 years. The total IPSS, quality of life index, BPH problem index, and maximum flow rate were significantly improved during 3 years. Treatment failure defined as symptomatic progression (an increase in the IPSS of ≥4 points compared to the baseline value), development of acute urinary retention, conversion to other α1-blockers, add-on of a 5α-reductase inhibitor, or conversion to surgery was observed in 41 patients (35.0%). In the univariate analysis, age, prostate volume, and serum prostate-specific antigen were predictors of treatment failure. Of the 50 patients who discontinued naftopidil during the follow-up, only 13 (26%) patients reported that they needed retreatment with α1-blockers and/or surgery within 3 years.
  
  
  CONCLUSIONS
  Long-term efficacy of naftopidil was observed, although older age, increased prostate volume, and elevated prostate-specific antigen at baseline were highly likely to result in treatment failure. Even after termination for various reasons, only a small portion of the patients needed retreatment for BPH within 3 years.
authors.affiliation: Department of Urology, Sapporo Medical University School of Medicine, Sapporo.
authors.forename: Naoya
authors.initials: N
authors.lastname: Masumori
authors.affiliation: Department of Urology, Sapporo Medical University School of Medicine, Sapporo.
authors.forename: Taiji
authors.initials: T
authors.lastname: Tsukamoto
authors.affiliation: Kaguraoka Urological Clinic, Asahikawa.
authors.forename: Akihiko
authors.initials: A
authors.lastname: Shibuya
authors.affiliation: Division of Urology, Muroran City General Hospital, Muroran.
authors.forename: Noriomi
authors.initials: N
authors.lastname: Miyao
authors.affiliation: Hokkaido Social Work Association Obihiro Hospital, Obihiro.
authors.forename: Yasuharu
authors.initials: Y
authors.lastname: Kunishima
authors.affiliation: Iwasawa Clinic, Sapporo, Japan.
authors.forename: Akihiko
authors.initials: A
authors.lastname: Iwasawa
keywords: alpha 1-blocker; benign prostatic hyperplasia; long-term outcome; naftopidil; retreatment; treatment failure