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Efficacy of Low-Dose Tamsulosin on Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia

A Nonblind Multicentre Korean Study

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Abstract

Objective

To evaluate the efficacy and tolerability of tamsulosin 0.2mg once daily in Korean patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH), who were treated for up to 1 year.

Materials and methods

Of the 211 patients from six urology outpatient centres who participated in this investigation, 146 patients were evaluable. Tamsulosin 0.2 mg/day was administered orally in a nonblind design for a 1-year period. The primary efficacy parameters were improvement in the total, obstructive and irritative International Prostate Symptom Score (IPSS), measured at baseline and at weeks 12, 24, 36 and 52, and in the maximal urinary flow rate (Qmax) measured at baseline and at weeks 24 and 52. The secondary efficacy parameters were a decrease of ≥30% in IPSS, and an increase in Qmax of ≥30% from baseline. Changes in parameters between baseline and 52 weeks were assessed using Student’s paired t-test.

Results

Statistically significant, gradual improvements in all efficacy parameters were observed over the 1-year period. Tamsulosin 0.2 mg/day resulted in a mean reduction of 41.1% in total IPSS (p < 0.001) and a mean increase of 4.56 mL/sec in Qmax at 52 weeks (p < 0.001). Tamsulosin was well tolerated; adverse events occurred in 6.2% of patients and there were no withdrawals as a result of adverse events. There were no significant changes in blood pressure or pulse rate during the study.

Conclusions

One-year treatment with tamsulosin 0.2 mg/day in Korean patients with suspected BPH was well tolerated and effective in improving LUTS and urinary flow. The effect on symptoms was apparent after 12 weeks of treatment, and symptom improvement was observed for up to 1 year.

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Acknowledgements

This study was supported by a grant from Yamanouchi Pharmaceutical Co. Ltd. The authors have provided no information on sources of funding or on conflicts of interest directly relevant to the content of this review/study.

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Authors and Affiliations

  1. Department of Urology, Keimyung University School of Medicine, Daegu, Korea

    Choal Hee Park & Hyuk Soo Chang

  2. Department of Urology, Chonnam National University Medical School, Gwangju, Korea

    Bong Ryul Oh

  3. Department of Urology, Dankook University College of Medicine, Cheonan, Korea

    Hyung Jee Kim

  4. Department of Urology, Chungnam National University College of Medicine, Taejon, Korea

    Chong Koo Sul

  5. Department of Urology, Kyungpook National University College of Medicine, Daegu, Korea

    Sung Kwang Chung

  6. Department of Urology, Dong-A University College of Medicine, 3-ga Dongdaesin-dong, Seo-gu, Busan, 1, Korea

    Se Il Jung

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  1. Choal Hee Park
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  2. Hyuk Soo Chang
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  3. Bong Ryul Oh
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  4. Hyung Jee Kim
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  5. Chong Koo Sul
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  7. Se Il Jung
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Correspondence to Se Il Jung.

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Park, C.H., Chang, H.S., Oh, B.R. et al. Efficacy of Low-Dose Tamsulosin on Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia. Clin. Drug Investig. 24, 41–47 (2004). https://doi.org/10.2165/00044011-200424010-00005

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  • DOI: https://doi.org/10.2165/00044011-200424010-00005

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