Evidence map›Paper›PMID 39953249›Full record

Observational studyClinical and experimental nephrology2025

Safety and efficacy of tolvaptan in real‑world Japanese patients with autosomal dominant polycystic kidney disease: final results of SLOW‑PKD surveillance.

Toshio Mochizuki, Satoru Muto, Kyoko Suzue, Satoshi Komaniwa, Toshiki Tanaka, Yasuhiko Fukuta, Yuko Yamashige

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in Clinical and experimental nephrology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02847624 (Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD in Japan), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT02847624 completednot on this map

Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD in Japan

TypeobservationalSponsorOtsuka Pharmaceutical Co., Ltd.Ran2014 to 2022Enrolled1,802ConditionsPolycystic Kidney, Autosomal DominantArmstolvaptan
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Novel Roles of GPCRs in the Renal Collecting Duct.Physiology (Bethesda, Md.) · 2026
    Review
  2. Review
  3. Article
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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

7 authors.

Toshio MochizukiDepartment of Nephrology, Tokyo Women's Medical University, 8-1 Kawada-Cho, Shinjuku-Ku, Tokyo, 162-8666, Japan.
Satoru MutoDepartment of Urology, Graduate School of Medicine, Juntendo University, Tokyo, Japan.
Kyoko SuzueDepartment of Pharmacovigilance, Otsuka Pharmaceutical Co., Ltd, 3-2-27 Otedori, Chuo-Ku, Osaka, 540-0021, Japan.
Satoshi KomaniwaDepartment of Pharmacovigilance, Otsuka Pharmaceutical Co., Ltd, 3-2-27 Otedori, Chuo-Ku, Osaka, 540-0021, Japan. Komaniwa.Satoshi@otsuka.jp.ORCID http://orcid.org/0009-0003-3296-8139
Toshiki TanakaDepartment of Medical Affairs, Otsuka Pharmaceutical Co., Ltd, 2-16-4 Konan, Minato-Ku, Tokyo, 108-8241, Japan.
Yasuhiko FukutaDepartment of Pharmacovigilance, Otsuka Pharmaceutical Co., Ltd, 3-2-27 Otedori, Chuo-Ku, Osaka, 540-0021, Japan.
Yuko YamashigeDepartment of Pharmacovigilance, Otsuka Pharmaceutical Co., Ltd, 3-2-27 Otedori, Chuo-Ku, Osaka, 540-0021, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTolvaptan, a vasopressin type 2 receptor antagonist, has been used to treat autosomal dominant polycystic kidney disease in Japan since 2014.

methodsThis long-term, real-world, post-marketing surveillance (PMS) was conducted in Japan from March 2014 to March 2022. Safety was assessed based on adverse drug reactions (ADRs). For efficacy, changes in the slope of total kidney volume (TKV) and estimated glomerular filtration rate (eGFR) were assessed before and during the administration of tolvaptan.

resultsA total of 1676 patients were enrolled, with mean TKV (n = 1000) of 2149 ± 1339 mL and eGFR (n = 1641) of 44.4 ± 21.7 mL/min/1.73 m

conclusionThere were no major problems with the safety of tolvaptan treatment, and efficacy in limiting TKV increase in this PMS was comparable to the previous, pivotal randomized control trials. Trial registration ClinicalTrials.gov; NCT02847624.

Indexed as

Antidiuretic Hormone Receptor AntagonistsPolycystic Kidney, Autosomal DominantTolvaptanAdultAgedFemaleGlomerular Filtration RateHumansJapanKidneyMaleMiddle AgedProduct Surveillance, PostmarketingTime FactorsTreatment OutcomeYoung AdultAntidiuretic Hormone Receptor AntagonistsTolvaptanAutosomal dominant polycystic kidney diseaseGlomerular filtration ratePost-marketing surveySafety profileTolvaptanTotal kidney volume

Identifiers

PMID39953249
PMCPMC12125073

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Registered trials

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.