{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,20]],"date-time":"2026-02-20T06:43:13Z","timestamp":1771569793561,"version":"3.50.1"},"reference-count":14,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2013,11,5]],"date-time":"2013-11-05T00:00:00Z","timestamp":1383609600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Otsuka america pharma"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2014,3]]},"abstract":"<jats:sec><jats:title>BACKGROUND<\/jats:title><jats:p>The rate of hyponatremia is higher in hospitalized cancer patients than in hospitalized patients without cancer and is associated with poor clinical outcomes. The availability of V<jats:sub>2<\/jats:sub> receptor antagonists has been a major breakthrough in the management of hyponatremia, but its efficacy and safety in treating hyponatremia in patients with cancer is not known.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p>Adult patients with cancer who were admitted to The University of Texas MD Anderson Cancer Center with nonhypovolemic hyponatremia (125\u2010130 mmol\/L) were randomized to receive either tolvaptan or placebo in a double\u2010blind, placebo\u2010controlled, adaptive, randomized trial. Both groups received the standard of care for hyponatremia, except that patients were allowed to drink to thirst.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>A preplanned Data Safety Monitoring Board analysis of 30 of 48 randomized patients who completed the study revealed that the primary endpoint of hyponatremia correction was met by 16 of 17 patients who received tolvaptan and by 1 of 13 patients who received placebo (94% vs 8%; <jats:italic>P<\/jats:italic>\u2009&lt;\u2009.001), which met the study stopping rule for superiority. The secondary endpoints between the tolvaptan and placebo groups (mean\u2009\u00b1\u2009standard deviation) for length of stay (21\u2009\u00b1\u200915 days vs 26\u2009\u00b1\u200915 days, respectively) and change in the Mini\u2010Mental State Examination score (\u22120.35\u2009\u00b1\u20091.66 vs 0.31\u2009\u00b1\u20092.42, respectively) were not significantly different. No overcorrection of serum sodium (&gt;12 mmol\/L per day) was noted in the tolvaptan group, and the main adverse events noted were dry mouth, polydipsia, and polyuria, leading to 13% study withdrawal.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS<\/jats:title><jats:p>Although tolvaptan was effective for correcting hyponatremia in patients with cancer, studies with a larger sample size will be required to confirm the current findings, including the outcomes of secondary endpoints. <jats:bold><jats:italic>Cancer<\/jats:italic> 2014;120:744\u2013751<\/jats:bold>. \u00a9 <jats:italic>2013 American Cancer Society<\/jats:italic>.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.28468","type":"journal-article","created":{"date-parts":[[2013,11,5]],"date-time":"2013-11-05T15:48:47Z","timestamp":1383666527000},"page":"744-751","source":"Crossref","is-referenced-by-count":38,"title":["Tolvaptan in hospitalized cancer patients with hyponatremia: A double\u2010blind, randomized, placebo\u2010controlled clinical trial on efficacy and safety"],"prefix":"10.1002","volume":"120","author":[{"given":"Abdulla K.","family":"Salahudeen","sequence":"first","affiliation":[{"name":"Nephrology Section Department of General Internal Medicine The University of Texas MD Anderson Cancer Center Houston Texas"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Najeeba","family":"Ali","sequence":"additional","affiliation":[{"name":"Nephrology Section Department of General Internal Medicine The University of Texas MD Anderson Cancer Center Houston Texas"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marina","family":"George","sequence":"additional","affiliation":[{"name":"Hospitalist Section Department of General Internal Medicine The University of Texas MD Anderson Cancer Center Houston Texas"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amit","family":"Lahoti","sequence":"additional","affiliation":[{"name":"Nephrology Section Department of General Internal Medicine The University of Texas MD Anderson Cancer Center Houston Texas"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shana","family":"Palla","sequence":"additional","affiliation":[{"name":"Department of Biostatistics The University of Texas MD Anderson Cancer Center Houston Texas"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,11,5]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/ki.1986.134"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.semnephrol.2009.03.004"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2011.08.029"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjmed.2006.05.007"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200005253422107"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa065181"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2005-2287"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrd1927"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/00000421-198212000-00014"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/0022-3956(75)90026-6"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.acn.2004.11.004"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1080\/01621459.1996.10476908"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.1995.tb05796.x"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1205511"}],"container-title":["Cancer"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fcncr.28468","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/acsjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cncr.28468","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,12]],"date-time":"2025-10-12T12:09:20Z","timestamp":1760270960000},"score":1,"resource":{"primary":{"URL":"https:\/\/acsjournals.onlinelibrary.wiley.com\/doi\/10.1002\/cncr.28468"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2013,11,5]]},"references-count":14,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2014,3]]}},"alternative-id":["10.1002\/cncr.28468"],"URL":"https:\/\/doi.org\/10.1002\/cncr.28468","archive":["Portico"],"relation":{},"ISSN":["0008-543X","1097-0142"],"issn-type":[{"value":"0008-543X","type":"print"},{"value":"1097-0142","type":"electronic"}],"subject":[],"published":{"date-parts":[[2013,11,5]]}}}