{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T10:55:17Z","timestamp":1792839317629,"version":"4.5.0"},"reference-count":27,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2017,3,29]],"date-time":"2017-03-29T00:00:00Z","timestamp":1490745600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Ikaria Therapeutics LLC\/a Mallinckrodt Company"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2017,6]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The goal of hepatorenal syndrome type 1 (<jats:styled-content style=\"fixed-case\">HRS<\/jats:styled-content>\u20101) treatment is to improve renal function. Terlipressin, a synthetic vasopressin analogue, is a systemic vasoconstrictor used for the treatment of <jats:styled-content style=\"fixed-case\">HRS<\/jats:styled-content>\u20101, where it is available.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To compare the efficacy of terlipressin plus albumin vs. placebo plus albumin in patients with <jats:styled-content style=\"fixed-case\">HRS<\/jats:styled-content>\u20101.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Pooled patient\u2010level data from two large phase 3, randomised, placebo\u2010controlled studies were analysed for <jats:styled-content style=\"fixed-case\">HRS<\/jats:styled-content> reversal [serum creatinine (<jats:styled-content style=\"fixed-case\">SC<\/jats:styled-content>r) value \u2264133\u00a0\u03bcmol\/L], 90\u2010day survival, need for renal replacement therapy and predictors of <jats:styled-content style=\"fixed-case\">HRS<\/jats:styled-content> reversal. Patients received intravenous terlipressin 1\u20132\u00a0mg every 6\u00a0hours plus albumin or placebo plus albumin up to 14\u00a0days.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The pooled analysis comprised 308 patients (terlipressin: <jats:italic>n\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>153; placebo: <jats:italic>n\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>155). <jats:styled-content style=\"fixed-case\">HRS<\/jats:styled-content> reversal was significantly more frequent with terlipressin vs. placebo (27% vs. 14%; <jats:italic>P\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>0.004). Terlipressin was associated with a more significant improvement in renal function from baseline until end of treatment, with a mean between\u2010group difference in <jats:styled-content style=\"fixed-case\">SC<\/jats:styled-content>r concentration of \u221253.0\u00a0\u03bcmol\/L (<jats:italic>P\u00a0<\/jats:italic>&lt;<jats:italic>\u00a0<\/jats:italic>0.0001). Lower <jats:styled-content style=\"fixed-case\">SC<\/jats:styled-content>r, lower mean arterial pressure and lower total bilirubin and absence of known precipitating factors for <jats:styled-content style=\"fixed-case\">HRS<\/jats:styled-content> were independent predictors of <jats:styled-content style=\"fixed-case\">HRS<\/jats:styled-content> reversal and longer survival in terlipressin\u2010treated patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Terlipressin plus albumin resulted in a significantly higher rate of <jats:styled-content style=\"fixed-case\">HRS<\/jats:styled-content> reversal vs. albumin alone in patients with <jats:styled-content style=\"fixed-case\">HRS<\/jats:styled-content>\u20101. Terlipressin treatment is associated with improved renal function. (ClinicalTrials.gov identifier: <jats:styled-content style=\"fixed-case\">OT<\/jats:styled-content>\u20100401, <jats:styled-content style=\"fixed-case\">NCT<\/jats:styled-content>00089570; <jats:styled-content style=\"fixed-case\">REVERSE<\/jats:styled-content>,<jats:styled-content style=\"fixed-case\"> NCT<\/jats:styled-content>01143246).<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.14052","type":"journal-article","created":{"date-parts":[[2017,3,30]],"date-time":"2017-03-30T01:56:43Z","timestamp":1490839003000},"page":"1390-1402","source":"Crossref","is-referenced-by-count":91,"title":["Reversal of hepatorenal syndrome type 1 with terlipressin plus albumin vs. placebo plus albumin in a pooled analysis of the <scp>OT<\/scp>\u20100401 and <scp>REVERSE<\/scp> randomised clinical studies"],"prefix":"10.1111","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8682-5748","authenticated-orcid":false,"given":"A. J.","family":"Sanyal","sequence":"first","affiliation":[{"name":"Department of Medicine Virginia Commonwealth University Richmond VA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T. D.","family":"Boyer","sequence":"additional","affiliation":[{"name":"Department of Medicine University of Arizona Tucson AZ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R. T.","family":"Frederick","sequence":"additional","affiliation":[{"name":"Department of Transplantation California Pacific Medical Center San Francisco CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F.","family":"Wong","sequence":"additional","affiliation":[{"name":"Department of Medicine University of Toronto Toronto ON Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Rossaro","sequence":"additional","affiliation":[{"name":"University of California Davis Sacramento CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V.","family":"Araya","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Central Bucks Specialists, Ltd. Doylestown PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H. E.","family":"Vargas","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Mayo Clinic Arizona Phoenix AZ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K. R.","family":"Reddy","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Department of Medicine University of Pennsylvania Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S. C.","family":"Pappas","sequence":"additional","affiliation":[{"name":"Orphan Therapeutics Lebanon NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Teuber","sequence":"additional","affiliation":[{"name":"Orphan Therapeutics Lebanon NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Escalante","sequence":"additional","affiliation":[{"name":"Ikaria Therapeutics LLC\/a Mallinckrodt Company Hampton NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Jamil","sequence":"additional","affiliation":[{"name":"Ikaria Therapeutics LLC\/a Mallinckrodt Company Hampton NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,3,29]]},"reference":[{"key":"e_1_2_7_2_1","first-page":"1310","article-title":"Diagnosis, prevention and treatment of hepatorenal syndrome in cirrhosis","volume":"56","author":"Salerno F","year":"2007","journal-title":"Gut"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrgastro.2012.96"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2011.12.032"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.20687"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/lt.24049"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1097\/00007890-199502150-00010"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1053\/jhep.2002.33160"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/lt.21951"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-6143.2006.01526.x"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2010.05.004"},{"key":"e_1_2_7_12_1","first-page":"39","article-title":"A randomized, placebo\u2010controlled, double\u2010blind study to confirm the reversal of hepatorenal syndrome type 1 with terlipressin: the REVERSE trial design","volume":"4","author":"Boyer TD","year":"2012","journal-title":"Open Access J Clin Trials"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1440-1746.2003.02934.x"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.21907"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2008.02.024"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10620-007-9919-9"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.02.026"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.23286"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1440-1746.2009.06132.x"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2008.02.014"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.510230122"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10620-013-2899-z"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2010.11.020"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2013.12.032"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2008.01828.x"},{"key":"e_1_2_7_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.23283"},{"key":"e_1_2_7_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2011.03.012"},{"key":"e_1_2_7_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2012.01.012"}],"container-title":["Alimentary Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fapt.14052","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/apt.14052","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,23]],"date-time":"2023-09-23T13:34:02Z","timestamp":1695476042000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/apt.14052"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,3,29]]},"references-count":27,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2017,6]]}},"alternative-id":["10.1111\/apt.14052"],"URL":"https:\/\/doi.org\/10.1111\/apt.14052","archive":["Portico"],"relation":{},"ISSN":["0269-2813","1365-2036"],"issn-type":[{"value":"0269-2813","type":"print"},{"value":"1365-2036","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,3,29]]}}}