Evidence map›Paper›PMID 25689936›Full record

Trial reportJournal of gastroenterology2015

Can serum albumin level affect the pharmacological action of tolvaptan in patients with liver cirrhosis? A post hoc analysis of previous clinical trials in Japan.

Isao Sakaida, Koji Nakajima, Kiwamu Okita, Masatsugu Hori, Tohru Izumi, Masaya Sakurai, Yoshiyuki Shibasaki, Sayaka Tachikawa, Hidetsugu Tsubouchi, Hiromi Oka and 1 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of gastroenterology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
5.0field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

  1. Interventions for chronic non-hypovolaemic hypotonic hyponatraemia.The Cochrane database of systematic reviews · 2018
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  4. Importance of early use of tolvaptan in hyponatremic acutely decompensated heart failure patients, a retrospective study.The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

Isao SakaidaDepartment of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Minami Kogushi 1-1-1, Ube, Yamaguchi, 755-8505, Japan. sakaida@yamaguchi-u.ac.jp.
Koji NakajimaDepartment of Medical Affairs, Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan. nakajimak@otsuka.jp.
Kiwamu OkitaShunan Memorial Hospital, Kudamatsu, Yamaguchi, Japan.
Masatsugu HoriOsaka Medical Center for Cancer and Cardiovascular Diseases President Emeritus, Osaka, Japan.
Tohru IzumiKitasato University, Sagamihara, Kanagawa, Japan.
Masaya SakuraiDepartment of Medical Affairs, Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan.
Yoshiyuki ShibasakiDepartment of Medical Affairs, Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan.
Sayaka TachikawaDepartment of Medical Affairs, Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan.
Hidetsugu TsubouchiDepartment of Medical Affairs, Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan.
Hiromi OkaDepartment of Medical Affairs, Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan.
Hiroyuki KobayashiDepartment of Medical Affairs, Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan.
Otsuka (Japan) · JPKitasato University Hospital · JPOsaka Medical Center for Cancer and Cardiovascular Diseases · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with hypoalbuminemia often fail to respond to increased doses of loop diuretics. We therefore performed a post hoc analysis to investigate the pharmacological action of tolvaptan and whether it is dependent on the serum albumin level.

methodsThis analysis was based on four previous clinical trials of tolvaptan in patients with liver cirrhosis who exhibited insufficient response to conventional diuretics. We analyzed the correlation between the change in the initial 24-h cumulative urine volume from baseline and the serum albumin level at baseline, and assessed potential predictive factors of response to tolvaptan.

resultsThe correlation coefficient was 0.029 in the placebo group and -0.112 in the 7.5 mg tolvaptan group of patients with liver cirrhosis. Administration of tolvaptan provoked a stable response regardless of the serum albumin level. Tolvaptan use was identified as a significant predictor of pharmacological action, and was shown to change the initial urine volume by 885 mL (P < 0.0001) in liver cirrhosis patients.

conclusionsIn this post hoc analysis, tolvaptan increased the initial urine volume from baseline regardless of serum albumin levels. Use of tolvaptan as an add-on therapy to loop diuretics can be considered an optimal therapeutic option in patients with insufficient response to loop diuretics.

Indexed as

AgedAntidiuretic Hormone Receptor AntagonistsBenzazepinesFemaleHumansHyponatremiaJapanLiver CirrhosisMaleRisk AssessmentSerum AlbuminSurvival RateTolvaptanAntidiuretic Hormone Receptor AntagonistsBenzazepinesSerum AlbuminTolvaptanAlbuminDiureticsInitial urine volumeLiver cirrhosisTolvaptan

Identifiers

PMID25689936
PMCPMC4592499
OpenAlexW2094789155

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.