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 Tsui1,2 1Department of Urology, 2Prostate Health Laser Center, Chang Gung Memorial Hospital-Linkou, Chang Gung University, College of Medicine, Taipei, Taiwan, Republic of China Purpose: The aim of this study was to investiga...
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Dove Medical Press
2018
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oai:doaj.org-article:dc03241ded0c4ad8b9ee6f6f0f1755212021-12-02T05:00:25ZAn 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 tamsulosin1178-1998https://doaj.org/article/dc03241ded0c4ad8b9ee6f6f0f1755212018-02-01T00:00:00Zhttps://www.dovepress.com/an-open-label-prospective-interventional-study-of-the-tolerability-and-peer-reviewed-article-CIAhttps://doaj.org/toc/1178-1998Pei-Shan Yang,1 Chien-Lun Chen,1 Chen-Pang Hou,1 Yu-Hsiang Lin,1 Ke-Hung Tsui1,2 1Department of Urology, 2Prostate Health Laser Center, Chang Gung Memorial Hospital-Linkou, Chang Gung University, College of Medicine, Taipei, Taiwan, Republic of China 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: prostate, neoplasms, α1-adrenergic receptor, LUTS, outcomesYang PSChen CLHou CPLin YHTsui KHDove Medical Pressarticleprostateneoplasmsα1-adrenergic receptorLUTSoutcomesGeriatricsRC952-954.6ENClinical Interventions in Aging, Vol Volume 13, Pp 235-242 (2018) |
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prostate neoplasms α1-adrenergic receptor LUTS outcomes Geriatrics RC952-954.6 |
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prostate neoplasms α1-adrenergic receptor LUTS outcomes Geriatrics RC952-954.6 Yang PS Chen CL Hou CP Lin YH Tsui KH 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 |
| description |
Pei-Shan Yang,1 Chien-Lun Chen,1 Chen-Pang Hou,1 Yu-Hsiang Lin,1 Ke-Hung Tsui1,2 1Department of Urology, 2Prostate Health Laser Center, Chang Gung Memorial Hospital-Linkou, Chang Gung University, College of Medicine, Taipei, Taiwan, Republic of China 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: prostate, neoplasms, α1-adrenergic receptor, LUTS, outcomes |
| format |
article |
| author |
Yang PS Chen CL Hou CP Lin YH Tsui KH |
| author_facet |
Yang PS Chen CL Hou CP Lin YH Tsui KH |
| author_sort |
Yang PS |
| title |
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 |
| title_short |
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 |
| title_full |
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 |
| title_fullStr |
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 |
| title_full_unstemmed |
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 |
| title_sort |
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 |
| publisher |
Dove Medical Press |
| publishDate |
2018 |
| url |
https://doaj.org/article/dc03241ded0c4ad8b9ee6f6f0f175521 |
| work_keys_str_mv |
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1718400859621031936 |