Evidence map›Paper›PMID 40690313›Full record

ReviewKidney3602025

Long-Term Experience of Tolvaptan: Is Hepatotoxicity Still a Concern?

Pierre Antoine Brown, Suzy Bubolic, Annick Laplante, Thomas Jaeger, Ahsan Alam

Abstract readReview
In one paragraph

Review in Kidney360, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. Review
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

5 authors.

Pierre Antoine BrownDivision of Nephrology, Department of Medicine, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.ORCID 0000-0002-0283-4530
Suzy BubolicOtsuka Canada Pharmaceutical Inc., Saint-Laurent, Quebec, Canada.ORCID 0009-0001-5692-3416
Annick LaplanteOtsuka Canada Pharmaceutical Inc., Saint-Laurent, Quebec, Canada.ORCID 0009-0001-7987-2404
Thomas JaegerOtsuka Pharma GmbH, Frankfurt, Germany.ORCID 0009-0007-6181-4859
Ahsan AlamDivision of Nephrology, McGill University Health Centre, Montreal, Quebec, Canada.ORCID 0000-0003-1075-6963

Funding

Otsuka Canada Pharmaceutical
6 · The paper itself

Abstract

In Canada, tolvaptan (JINARC) is approved for the treatment of adults with autosomal dominant polycystic kidney disease to slow the progression of kidney enlargement and kidney function decline. Safety data from the pivotal Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes (TEMPO 3:4) study suggested the potential for increased risk of liver injury with tolvaptan, which led to the establishment of the Canadian Hepatic Safety Monitoring and Distribution Programme in 2015. This review summarizes data regarding hepatic safety from clinical trials and presents data from established risk mitigation programs and real-world evidence. Data show that frequent liver function monitoring allows timely detection of drug-induced liver injury and prompt treatment interruption. To date, this approach has led to the absence of serious liver injury or liver failure in more than 2800 patients treated with tolvaptan in Canada over the past 10 years.

Indexed as

Antidiuretic Hormone Receptor AntagonistsBenzazepinesChemical and Drug Induced Liver InjuryPolycystic Kidney, Autosomal DominantCanadaHumansLiver Function TestsTolvaptanAntidiuretic Hormone Receptor AntagonistsBenzazepinesTolvaptanADPKD

Identifiers

PMID40690313
PMCPMC12708366

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.