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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.
Clin Interv Aging. 2018; 13:235-242.CI

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.

Authors+Show Affiliations

Department of Urology.Department of Urology.Department of Urology.Department of Urology.Department of Urology. Prostate Health Laser Center, Chang Gung Memorial Hospital-Linkou, Chang Gung University, College of Medicine, Taipei, Taiwan, Republic of China.

Pub Type(s)

Clinical Trial, Phase IV
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

29445269

Citation

Yang, Pei-Shan, et al. "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." Clinical Interventions in Aging, vol. 13, 2018, pp. 235-242.
Yang PS, Chen CL, Hou CP, et al. 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. Clin Interv Aging. 2018;13:235-242.
Yang, P. S., Chen, C. L., Hou, C. P., Lin, Y. H., & Tsui, K. H. (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. Clinical Interventions in Aging, 13, 235-242. https://doi.org/10.2147/CIA.S152701
Yang PS, et al. 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. Clin Interv Aging. 2018;13:235-242. PubMed PMID: 29445269.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Yang,Pei-Shan, AU - Chen,Chien-Lun, AU - Hou,Chen-Pang, AU - Lin,Yu-Hsiang, AU - Tsui,Ke-Hung, Y1 - 2018/02/08/ PY - 2018/2/16/entrez PY - 2018/2/16/pubmed PY - 2018/7/24/medline KW - LUTS KW - neoplasms KW - outcomes KW - prostate KW - α1-adrenergic receptor SP - 235 EP - 242 JF - Clinical interventions in aging JO - Clin Interv Aging VL - 13 N2 - 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. SN - 1178-1998 UR - https://www.unboundmedicine.com/medline/citation/29445269/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_ L2 - https://dx.doi.org/10.2147/CIA.S152701 DB - PRIME DP - Unbound Medicine ER -