Efficacy and safety of orally disintegrating tamsulosin tablets in Taiwanese patients with benign prostatic hyperplasia

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Objectives: Tamsulosin is an alpha-1 adrenoceptor antagonist applied in treating lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). This study aimed to evaluate safety, efficacy and acceptance of newly formulated orally disintegrating tamsulosin tablets in Taiwanese patients with LUTS/BPH. Methods: This single center, non-comparative, observational study enrolled 45 male patients over age 50 years. All patients received 0.2mg tamsulosin orally disintegrating tablets daily and were evaluated at weeks 0, 4, 8, 12 of the 12-week treatment period. Tamsulosin efficacy was evaluated by International Prostate Symptom Score (I-PSS) with 7 questions on urinary symptoms and one disease-specific quality-of-life question, with scores ranging from 0 (no symptoms) to 35 (highly symptomatic). Maximum flow rate (ml/s), voided volume (ml), flow time (s), and mean flow rate (ml/s) were measured. Danish prostatic symptom sexual function scale rated severity and associated concerns of erection quality, ejaculatory function and pain/discomfort were also assessed. Results: Patients' mean ± SD age was 62.47±7.77 (range: 50-89) and mean ± SD I-PSS was 13.98±5.50. Statistically significant changes from baseline were found in post-test I-PSS and quality of life (both P <0.001). Mean ± SD I-PSS decreased from 14.30±9.34 to 6.73±0.88 at patients' final visit. Statistically significant increases in mean maximum flow rate and mean flow rate were found over 12-week study period (P <0.05). No adverse events were reported. No significant differences were found in pulse, SBP/DBP or sexual function. Conclusion: Orally disintegrating tamsulosin tablets demonstrate acceptable safety and efficacy for acceptance and well tolerance by Taiwanese LUTS/BPH patients.

Original languageEnglish
Pages (from-to)246-252
Number of pages7
JournalAging Male
Volume15
Issue number4
DOIs
Publication statusPublished - Dec 2012

Fingerprint

tamsulosin
Prostatic Hyperplasia
Tablets
Safety
Lower Urinary Tract Symptoms
Prostate
Quality of Life
Adrenergic Receptors
Observational Studies

Keywords

  • α1-AR antagonist
  • Benign prostatic hyperplasia
  • Efficacy
  • Oral medication
  • Safety
  • Tamsulosin

ASJC Scopus subject areas

  • Geriatrics and Gerontology

Cite this

Efficacy and safety of orally disintegrating tamsulosin tablets in Taiwanese patients with benign prostatic hyperplasia. / Lin, Ke Hsun; Lin, Yung Wei; Wen, Yu-Ching; Lee, Liang Ming.

In: Aging Male, Vol. 15, No. 4, 12.2012, p. 246-252.

Research output: Contribution to journalArticle

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abstract = "Objectives: Tamsulosin is an alpha-1 adrenoceptor antagonist applied in treating lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). This study aimed to evaluate safety, efficacy and acceptance of newly formulated orally disintegrating tamsulosin tablets in Taiwanese patients with LUTS/BPH. Methods: This single center, non-comparative, observational study enrolled 45 male patients over age 50 years. All patients received 0.2mg tamsulosin orally disintegrating tablets daily and were evaluated at weeks 0, 4, 8, 12 of the 12-week treatment period. Tamsulosin efficacy was evaluated by International Prostate Symptom Score (I-PSS) with 7 questions on urinary symptoms and one disease-specific quality-of-life question, with scores ranging from 0 (no symptoms) to 35 (highly symptomatic). Maximum flow rate (ml/s), voided volume (ml), flow time (s), and mean flow rate (ml/s) were measured. Danish prostatic symptom sexual function scale rated severity and associated concerns of erection quality, ejaculatory function and pain/discomfort were also assessed. Results: Patients' mean ± SD age was 62.47±7.77 (range: 50-89) and mean ± SD I-PSS was 13.98±5.50. Statistically significant changes from baseline were found in post-test I-PSS and quality of life (both P <0.001). Mean ± SD I-PSS decreased from 14.30±9.34 to 6.73±0.88 at patients' final visit. Statistically significant increases in mean maximum flow rate and mean flow rate were found over 12-week study period (P <0.05). No adverse events were reported. No significant differences were found in pulse, SBP/DBP or sexual function. Conclusion: Orally disintegrating tamsulosin tablets demonstrate acceptable safety and efficacy for acceptance and well tolerance by Taiwanese LUTS/BPH patients.",
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