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Clinical Trial
. 2018 Feb 8:13:235-242.
doi: 10.2147/CIA.S152701. eCollection 2018.

An open-label, prospective interventional study of the tolerability and efficacy of 0.4 mg oral tamsulosin oral controlled absorption system in men with lower urinary tract symptoms associated with benign prostatic hyperplasia who are unsatisfied with treatment with 0.2 mg tamsulosin

Pei-Shan Yang  1 , Chien-Lun Chen  1 , Chen-Pang Hou  1 , Yu-Hsiang Lin  1 , Ke-Hung Tsui  1   2
Affiliations
Clinical Trial

An open-label, prospective interventional study of the tolerability and efficacy of 0.4 mg oral tamsulosin oral controlled absorption system in men with lower urinary tract symptoms associated with benign prostatic hyperplasia who are unsatisfied with treatment with 0.2 mg tamsulosin

Pei-Shan Yang et al. Clin Interv Aging. .

Abstract

Purpose: The aim of this study was to investigate the efficacy and tolerability of switching from 0.2 mg tamsulosin to 0.4 mg tamsulosin oral controlled absorption system (OCAS) over a 12-week period in Taiwanese men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

Patients and methods: Taiwanese male patients who were dissatisfied with treatment with 0.2 mg tamsulosin were enrolled in this clinical study and switched to 0.4 mg tamsulosin OCAS. Efficacy was assessed over a 12-week period by an International Prostate Symptom Score (IPSS) questionnaire and analysis of urinary flow by uroflowmetry.

Results: A statistically significant improvement was observed in total IPSS scores from baseline (14.94±7.41, moderate) to 12 weeks (7.36±5.77, mild) in 81 patients who were switched from 0.2 to 0.4 mg tamsulosin OCAS (P<0.001). The IPSS subscores for storage, voiding, nocturia, and quality of life (QOL) were also significantly improved over the 12-week period. Uroflowmetry analysis demonstrated significantly increased maximum flow rate, average flow rate, and mean voided volume from baseline to the end of the 12-week period. The 0.4 mg tamsulosin OCAS dose was well tolerated, with only mild dizziness (five patients) and headache (two patients) as the most frequent adverse events. No clinically significant reduction was observed in blood pressure or vital signs.

Conclusion: Treatment with 0.4 mg tamsulosin OCAS in Taiwanese men with LUTS associated with BPH who were dissatisfied with 0.2 mg tamsulosin significantly improved IPSS scores, urinary flow, and QOL and was well tolerated, suggesting that this should be the recommended dose offered to Taiwanese male patients.

Keywords: LUTS; neoplasms; outcomes; prostate; α1-adrenergic receptor.

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Conflict of interest statement

Disclosure C-LC, C-PH, Y-HL, and K-HT received investigator fees from Astellas Taiwan Pharma, Inc., for conducting the study. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Analysis of IPSS total scores in patients with LUTS associated with BPH who were switched from 0.2 to 0.4 mg tamsulosin OCAS. Notes: Analysis of primary efficacy was determined by assessing change from baseline in total IPSS (scores from seven questions based on urinary symptoms) to 12 weeks after initiating treatment with 0.4 mg tamsulosin OCAS. Significant reductions in mean IPSS total scores from baseline were observed at Week 4, Week 8, and Week 12 after 0.4 mg tamsulosin OCAS treatment (P<0.001). *Statistically significant (P<0.001) change from baseline values determined by paired t-test. Abbreviations: BPH, benign prostatic hyperplasia; IPSS, International Prostate Symptom Score; LUTS, lower urinary tract symptoms; OCAS, oral controlled absorption system.
Figure 2
Figure 2
Analysis of urine efficacy assessments in patients with LUTS associated with BPH who were switched from 0.2 to 0.4 mg tamsulosin OCAS. Notes: Analysis of urine efficacy was determined by assessing change from baseline in total IPSS (scores from seven questions based on urinary symptoms), up to 12 weeks after initiating treatment with 0.4 mg tamsulosin OCAS. Significant reductions in mean IPSS from baseline were observed at Week 4, Week 8, and Week 12 after 0.4 mg tamsulosin OCAS treatment for (A) IPSS storage, (B) IPSS voiding, (C) IPSS nocturia, and (D) IPSSQOL. *Statistically significant (P<0.05) change from baseline values determined by paired t-test. Abbreviations: BPH, benign prostatic hyperplasia; IPSS, International Prostate Symptom Score; IPSSQOL, IPSS – quality of life; LUTS, lower urinary tract symptoms; OCAS, oral controlled absorption system.
Figure 3
Figure 3
Analysis of satisfaction (VAS) in patients with LUTS associated with BPH who were switched from 0.2 to 0.4 mg tamsulosin OCAS. Notes: Analysis of patients’ feeling of satisfaction was determined by using the VAS at baseline and up to 12 weeks after initiating treatment with 0.4 mg tamsulosin OCAS. Significant increases in VAS scores were observed up to Week 12 after 0.4 mg tamsulosin OCAS treatment. *Statistically significant (P<0.05) change from baseline values determined by paired t-test. Abbreviations: BPH, benign prostatic hyperplasia; LUTS, lower urinary tract symptoms; OCAS, oral controlled absorption system; VAS, visual analog scale.
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References

    1. Lee C, Kozlowski JM, Grayhack JT. Intrinsic and extrinsic factors controlling benign prostatic growth. Prostate. 1997;31(2):131–138. - PubMed
    1. Garraway WM, Collins GN, Lee RJ. High prevalence of benign prostatic hypertrophy in the community. Lancet. 1991;338(8765):469–471. - PubMed
    1. Barkin J. Benign prostatic hyperplasia and lower urinary tract symptoms: evidence and approaches for best case management. Can J Urol. 2011;18(Suppl):14–19. - PubMed
    1. van Koeveringe GA, Vahabi B, Andersson KE, Kirschner-Herrmans R, Oelke M. Detrusor underactivity: a plea for new approaches to a common bladder dysfunction. Neurourol Urodyn. 2011;30(5):723–728. - PubMed
    1. Oelke M, Baard J, Wijkstra H, de la Rosette JJ, Jonas U, Hofner K. Age and bladder outlet obstruction are independently associated with detrusor overactivity in patients with benign prostatic hyperplasia. Eur Urol. 2008;54(2):419–426. - PubMed

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