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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\n            \u003Cp id=\u0022p-1\u0022\u003EThis article presents initial data from A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin [REVERSE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01143246\u0026amp;atom=%2Fspmdc%2F14%2F48%2F17.2.atom\u0022\u003ENCT01143246\u003C\/a\u003E], the largest trial to date in type 1 hepatorenal syndrome using terlipressin.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EHepatorenal Syndrome\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHepatology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ELiver Conditions\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EHepatorenal Syndrome\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHepatology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ELiver Conditions\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHepatology\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EThomas D. Boyer, MD, University of Arizona, Tucson, Arizona, USA, presented initial data from A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin [REVERSE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01143246\u0026amp;atom=%2Fspmdc%2F14%2F48%2F17.2.atom\u0022\u003ENCT01143246\u003C\/a\u003E], the largest trial to date in type 1 hepatorenal syndrome (HRS-1) using terlipressin. The results demonstrated that terlipressin plus albumin treatment improved renal function in patients with HRS-1 when compared with albumin alone.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EAccording to Dr Boyer, HRS-1 involves the development of renal failure in patients with liver cirrhosis due to a sequence of events beginning with portal hypertension and development of a hyperdynamic circulation, leading to splanchnic and systemic vasodilation, and ultimately renal vasoconstriction.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003ETerlipressin is an arginine vasopressor (V1) receptor agonist that causes splanchnic and systemic vasoconstriction, redistributing blood to the arterial circulation, thereby improving renal perfusion. Albumin also augments this effect by helping to maintain the enhanced arterial blood volume.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe REVERSE trial was a randomized, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy of terlipressin plus albumin for the treatment of HRS-1.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe primary end point was confirmed HRS reversal (CHRSR), defined as the number of patients with 2 serum creatinine values \u2264 1.5 mg\/dL at least 48 hours apart while on treatment. Secondary end points included HRS reversal (1 serum creatinine value \u2264 1.5 mg\/dL) and change in renal function as assessed by changes in serum creatinine.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EPatients with HRS-1 were randomized 1:1 to treatment with terlipressin plus albumin (n = 93) or placebo (albumin alone; n = 95).\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EThe primary end point of CHRSR was not met in the trial (19.6% vs 13.1%; \u003Cem\u003EP\u003C\/em\u003E = .221). However, with respect to secondary end points, there was significant improvement in renal function in patients in the terlipressin group, with greater mean decreases in serum creatinine from baseline through the end of the study (1.2 vs 0.6 mg\/dL; \u003Cem\u003EP\u003C\/em\u003E = .0004). This corresponded to a significant increase in glomerular filtration rate with terlipressin (18.4 vs 11.7 mL\/min\/1.73 m\u003Csup\u003E2\u003C\/sup\u003E; \u003Cem\u003EP\u003C\/em\u003E = .0001; \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E).\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/48\/17.2\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Improvement in Renal Function in the REVERSE Trial\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-2061006379\u0022 data-figure-caption=\u0022Improvement in Renal Function in the REVERSE Trial\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/48\/17.2\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/48\/17.2\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/48\/17.2\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/15571\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\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-9\u0022 class=\u0022first-child\u0022\u003EImprovement in Renal Function in the REVERSE Trial\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003ESCr, serum creatinine; GFR, glomerular filtration rate; SE, standard error; MDRD, modification of diet in renal disease.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced with permission from TD Boyer, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-10\u0022\u003EImprovements in serum creatinine were also found to correlate with patient survival at 90 days (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001).\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EThere was no significant difference in HRS reversal between the groups (23.7% vs 15.2%; \u003Cem\u003EP\u003C\/em\u003E = .130).\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003EThe need for renal replacement therapy (RRT) was similar between the 2 groups. Among patients with CHRSR, none in the terlipressin group required RRT by 90 days, compared with about 25% of those who received placebo. The response to terlipressin may therefore be more durable, Dr Boyer suggested.\u003C\/p\u003E\u003Cp id=\u0022p-13\u0022\u003EOverall survival was similar in both groups, with approximately half of the patients (56 vs 53) remaining alive at 90 days.\u003C\/p\u003E\u003Cp id=\u0022p-14\u0022\u003EThe incidence of adverse events (AEs) was consistent with those reported in previous trials using terlipressin. Additionally, as expected with the use of a vasoactive drug, significantly more patients in the terlipressin group required treatment discontinuation because of AEs (20.4% vs 6.3%; \u003Cem\u003EP\u003C\/em\u003E = .008).\u003C\/p\u003E\u003Cp id=\u0022p-15\u0022\u003EDr Boyer concluded that terlipressin treatment has a favorable benefit-risk profile in HRS-1, and, compared with placebo, is associated with significant improvement in renal function that also correlates with improved survival.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\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\/14\/48\/17.2.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_figures.js?nzofi1\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_openurl.js?nzofi1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}