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Original Research

Three-year outcome analysis of alpha 1-blocker naftopidil for patients with benign prostatic hyperplasia in a prospective multicenter study in Japan

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Pages 1309-1316 | Published online: 22 Jul 2016
 

Abstract

Purpose

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.

Patients and 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.

Conclusion

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.

Acknowledgments

The authors thank members of the Hokkaido Urological Disorders Conference for their assistance: Doctor Satoshi Takahashi and Doctor Ryuichi Kato of Sapporo Medical University, Doctor Koichi Takeda and Doctor Nobukazu Suzuki of Teine Urological Clinic, Doctor Toshikazu Nitta of Sanjukai Hospital, Doctor Masahiro Nishimura of Motomachi Urology, Doctor Naoto Mikuma of Bethel Urology Clinic, Doctor Masanori Matsukawa of Takikawa Municipal Hospital, Doctor Yoshinori Tanaka of Hokkaido Prefectural Esashi Hospital, and Doctor Masamichi Sasai of Yawaragi Hinyokika. A part of this paper was presented at the AUA Annual Meeting 2014 as a poster presentation. The poster’s abstract was published in J Urol. 191(4):e671, supplement (hyperlinks: http://www.jurology.com/article/S0022-5347(14)02107-7/abstract and https://www.auanet.org/university/abstract_detail.cfm?id=PD23-12&meetingID=14ORL).

Author contributions

All authors contributed toward data analysis, drafting and critically revising the paper and agree to be accountable for all aspects of the work.

Disclosure

Naoya Masumori has received advisor fee and lecture fee from Astellas Pharma. Naoya Masumori has also received lecture fees from Nippon Shinyaku, Asahi Kasei, and GSK. Taiji Tsukamoto, Akihiko Shibuya, Noriomi Miyao, Yasuharu Kunishima, and Akihiko Iwasawa declare that they have no conflicts of interest in this work.