{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T14:29:22Z","timestamp":1787754562383,"version":"build-2784847793"},"reference-count":14,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2015,4,17]],"date-time":"2015-04-17T00:00:00Z","timestamp":1429228800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"published-print":{"date-parts":[[2015,5]]},"abstract":"\n Objective<\/jats:title>\n \n To evaluate efficacy and safety of silodosin in a pooled analysis of individual patient data from three registrational randomised controlled trials (\n RCTs<\/jats:styled-content>\n ) comparing silodosin and placebo in patients with lower urinary tract symptoms (\n LUTS<\/jats:styled-content>\n ).\n <\/jats:p>\n <\/jats:sec>\n \n Patients and Methods<\/jats:title>\n \n A pooled analysis of 1494 patients from three 12\u2010week, multicentre, double\u2010blind, placebo\u2010controlled phase\n III RCTs<\/jats:styled-content>\n was performed. Efficacy and safety data were assessed across patients with different baseline characteristics.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Silodosin was significantly more effective than placebo in improving all International\n P<\/jats:styled-content>\n rostate\n S<\/jats:styled-content>\n ymptom\n S<\/jats:styled-content>\n core (\n IPSS<\/jats:styled-content>\n )\u2010related parameters, and maximum urinary flow rate (\n Q<\/jats:styled-content>\n max<\/jats:sub>\n ) regardless of patients age (\n P<\/jats:italic>\n < 0.041). Comparing the efficacy of silodosin in the different age groups, there were no differences for all the\n IPSS<\/jats:styled-content>\n \u2010related parameters, whereas\n Q<\/jats:styled-content>\n max<\/jats:sub>\n improvement was slightly higher in patients aged <65 years (\n P<\/jats:italic>\n = 0.009). Silodosin was significantly more effective than placebo in reducing all\n IPSS<\/jats:styled-content>\n \u2010related parameters regardless of baseline\n IPSS<\/jats:styled-content>\n (\n P<\/jats:italic>\n \u2264 0.001). Similarly, silodosin was more effective than placebo in improving\n IPSS<\/jats:styled-content>\n \u2010related parameters regardless of baseline\n Q<\/jats:styled-content>\n max<\/jats:sub>\n (\n P<\/jats:italic>\n \u2264 0.02). Silodosin was associated with significantly higher adverse event (\n AE<\/jats:styled-content>\n ) rates, compared with placebo, in all patient subgroups, with retrograde ejaculation being the most common. Prevalence of dizziness, orthostatic hypotension, and discontinuation rate was similar with silodosin and placebo in most patient subgroups.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n We analysed the efficacy and safety of silodosin in several patient subgroups, showing that silodosin was more effective than placebo in improving all\n IPSS<\/jats:styled-content>\n \u2010related parameters in all patient subgroups, whereas\n AEs<\/jats:styled-content>\n were similar. Notably, cardiovascular\n AEs<\/jats:styled-content>\n were not higher in patients taking antihypertensive drugs or with mild renal function impairment. Discontinuation rates due to\n AEs<\/jats:styled-content>\n were lower in elderly patients.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/bju.12906","type":"journal-article","created":{"date-parts":[[2014,8,18]],"date-time":"2014-08-18T03:13:10Z","timestamp":1408331590000},"page":"802-814","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Individual patient data from registrational trials of silodosin in the treatment of non\u2010neurogenic male lower urinary tract symptoms (\n LUTS<\/scp>\n ) associated with benign prostatic hyperplasia (\n BPH<\/scp>\n ): subgroup analyses of efficacy and safety data"],"prefix":"10.1111","volume":"115","author":[{"given":"Giacomo","family":"Novara","sequence":"first","affiliation":[{"name":"Department of Oncological, Surgical, and Gastroenterological Sciences Urology Clinic University of Padua Padua Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher R.","family":"Chapple","sequence":"additional","affiliation":[{"name":"Department of Urology Royal Hallamshire Hospital Sheffield UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Montorsi","sequence":"additional","affiliation":[{"name":"Department of Urology Vita\u2010Salute University San Raffaele Hospital Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2015,4,17]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1464-410X.2003.04369.x"},{"key":"e_1_2_6_3_1","unstructured":"OelkeM BachmannA DescazeaudAet\u2009al.EAU guidelines on the treatment of non\u2010neurogenic male LUTS. Available at:http:\/\/www.uroweb.org\/gls\/pdf\/12_Male_LUTS.pdf. 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