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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\u003Cp id=\u0022p-1\u0022\u003EThe serotonin 5-hydroxytryptamine receptor antagonist ramosetron reduces symptoms significantly more than placebo in women with diarrhea-predominant irritable bowel syndrome. Ramosetron is effective in women at half the dose required to reduce symptoms in men and has a manageable side effect profile.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Eramosetron\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eirritable bowel syndrome with diarrhea\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eserotonin 5-hydroxytryptamine receptor antagonist\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ewomen\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Equality of life\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Egastroenterology clinical trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eirritable bowel syndrome\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENCT01736423\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\u003Cp id=\u0022p-2\u0022\u003EControlling symptoms in irritable bowel syndrome with diarrhea (IBS-D) can be challenging. Studies have suggested a role for serotonin 5-hydroxytryptamine (5-HT\u003Csub\u003E3\u003C\/sub\u003E) receptors and antagonists in the gastrointestinal tract in the pathogenesis of IBS-D. In one study, ramosetron, a 5-HT\u003Csub\u003E3\u003C\/sub\u003E antagonist, significantly improved stool consistency when compared with placebo in Japanese men (\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.001) [Fukudo S et al. \u003Cem\u003EClin Gastroenterol Hepatol\u003C\/em\u003E. 2014]. Of note, ramosetron is not FDA approved.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EShin Fukudo, MD, PhD, Tohoku University Graduate School of Medicine, Sendai, Japan, presented the results of a double-blind placebo-controlled phase 3 trial designed to determine the effects of ramosetron vs placebo in women with IBS-D and to assess adverse events (AEs) [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01736423\u0026amp;atom=%2Fspmdc%2F15%2F14%2F14.2.atom\u0022\u003ENCT01736423\u003C\/a\u003E]. Women with IBS-D were randomly assigned to oral ramosetron 2.5 \u00b5g (n\u2005=\u2005292) or placebo (n\u2005=\u2005284) once a day before breakfast for 12 weeks. Co\u2013primary end points included responder rates assessed by global improvement of irritable bowel syndrome symptoms and the Bristol Stool Scale. Secondary end points included abdominal pain or discomfort, abnormal bowel habit, stool frequency, and Japanese version of IBS-Quality of Life (IBS-QOL-J).\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThere were no significant differences between groups in baseline characteristics, including mean age (41 years), duration of disease (156 months), and symptoms. The co\u2013primary end point results are shown in \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E.\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/16783\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/16783\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16783\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \u003Cp id=\u0022p-5\u0022 class=\u0022first-child\u0022\u003ECo\u2013primary End Point Results: Global Improvement\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-8\u0022\u003ERamosetron rapidly improved symptoms, with significant relief occurring by week 2. Stool consistency improved significantly with ramosetron treatment vs placebo at monthly assessments throughout the trial (\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.001). At the last point, 40.8% of the ramosetron group vs 24.3% of the placebo group showed significant improvement in stool consistency (\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.001). By day 2, patients in the ramosetron group showed an improved Bristol Stool Scale (\u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.018 vs placebo). In addition, ramosetron significantly reduced daily stool frequency (\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.001). At study end, ramosetron also significantly improved abdominal pain and discomfort vs placebo (51.4% vs 37.7%; \u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.001) and abnormal bowel habits during the study (50.3% vs 31.0%; \u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.001). Ramosetron significantly improved some measures of IBS-QOL at study end, including overall quality of life, dysphoria, and food avoidance (\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.01 for all), as well as interference with activity (\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.001).\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003ERamosetron was associated with significantly more AEs than placebo, including gastrointestinal disorders (\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.001); however, there were no differences between treatment groups in infections and infestations. No ischemic colitis was observed, but the number of patients in the study may be too small to see this AE.\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003ETo conclude, ramosetron is effective in women with IBS-D at a dose half of that indicated for men, for reasons that are currently unclear. Improvements in IBS-QOL exceeded the minimal clinically important difference, further supporting ramosetron as therapeutic option for women as well as men.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 SAGE Publications\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/15\/14\/14.2.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzlhj1\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nzlhj1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}