Evidence map›Paper›PMID 41455853›Full record

ArticleTherapeutic innovation & regulatory science2026

Safety Comparison of Risk of Liver Dysfunction between Generic and Brand Statin Drugs Marketed in Japan: A Cohort Study Using MID-NET®.

Hotaka Maruyama, Yuki Kinoshita, Takashi Ando, Jun Okui, Maki Komamine, Kazuhiro Kajiyama, Naoya Horiuchi, Yoshiaki Uyama

Abstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

8 authors.

Hotaka Maruyama *Office of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Yuki Kinoshita *Office of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Takashi Ando *Office of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Jun OkuiOffice of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Maki KomamineOffice of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Kazuhiro KajiyamaOffice of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Naoya HoriuchiOffice of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Yoshiaki UyamaOffice of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan. uyama-yoshiaki@pmda.go.jp.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To verify safety profiles of generic statins in a real-world setting, the risk of liver dysfunction as a common adverse event was compared between generic and brand drugs. A new user cohort design was employed in which patients prescribed one of six statins (atorvastatin, simvastatin, pitavastatin, pravastatin, fluvastatin, or rosuvastatin) in Japan between January 1, 2014 and March 31, 2022 were identified in the MID-NET

Indexed as

Chemical and Drug Induced Liver InjuryDrugs, GenericHydroxymethylglutaryl-CoA Reductase InhibitorsAdultAgedAtorvastatinCohort StudiesFemaleHumansJapanMaleMiddle AgedAtorvastatinDrugs, GenericHydroxymethylglutaryl-CoA Reductase InhibitorsDatabase StudyGeneric drugsHigh dimensional propensity scoreLiver dysfunctionPharmacoepidemiologyStatin

Identifiers

PMID41455853
PMCPMC12945947

What Socratic holds

Textmetadata
LicenceCC BY
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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 Socratic graph.