Evidence map›Paper›PMID 41129080›Full record

ArticleTherapeutic innovation & regulatory science2026

Risk of Venous Thromboembolism with Pemafibrate in Dyslipidemia: A Nationwide, Retrospective, Cohort Study Using a Japanese Claims Database.

Kenichiro Ikeda, Mika Tada, Shun Nakano, Takuma Tsushio, Yoshinari Watanabe, Sara Minamikawa, Chieko Ishiguro, Kenji Yokoyama, Kenji Fujisawa, Masaya Tanahashi and 2 more

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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

12 authors.

Kenichiro IkedaMedical Affairs Department, Kowa Company Ltd., Tokyo, Japan. kikeda@kowapharma.com.
Mika TadaMedical Affairs Department, Kowa Company Ltd., Tokyo, Japan.
Shun NakanoPharmacovigilance Department, Kowa Company Ltd., Tokyo, Japan.
Takuma TsushioClinical Data Science Department, Kowa Company Ltd., Tokyo, Japan.
Yoshinari WatanabeClinical Data Science Department, Kowa Company Ltd., Tokyo, Japan.
Sara MinamikawaMedical Affairs Department, Kowa Company Ltd., Tokyo, Japan.
Chieko IshiguroLaboratory of Clinical Epidemiology, Department of Data Science, Center for Clinical Sciences, Japan Institute for Health Security, Tokyo, Japan.
Kenji YokoyamaDepartment of Hematology and Oncology, Tokai University Hachioji Hospital, Tokyo, Japan.
Kenji FujisawaClinical Data Science Department, Kowa Company Ltd., Tokyo, Japan.
Masaya TanahashiClinical Data Science Department, Kowa Company Ltd., Tokyo, Japan.
Hideki SuganamiClinical Data Science Department, Kowa Company Ltd., Tokyo, Japan.
Atsushi KasanoMedical Affairs Department, Kowa Company Ltd., Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe study aimed to assess whether pemafibrate, a selective peroxisome proliferator-activated receptor α modulator, increases the risk of venous thromboembolism (VTE) in real-world clinical practice in Japan.

methodsIn this retrospective cohort study, we utilized a claims database with data from December 2017 to July 2023. The exposed group consisted of patients with dyslipidemia using pemafibrate, while the control group included patients not using fibrate drugs. Each exposed patient was randomly matched with five control patients at a 1:5 ratio using time-matching. The primary endpoint was the number of days until the first occurrence of VTE, which was defined using ICD-10 codes and anticoagulant prescription records. We used a Cox proportional hazards model with standardized mortality ratio weight (SMRW) to estimate the adjusted hazard ratio (HR) and 95% confidence interval (CI) for the exposed group relative to the control group.

resultsThe study included 23,195 patients in the exposed group and 115,975 in the control group. In the full analysis population, 46.6% of patients were women, with a median age of 70.0 years and a median BMI of 23.6. VTE occurred in 1.2% (286/23,195) of the exposed group and 2.0% (2297/115,975) of the control group, with an incidence rate of 0.95 and 1.33 per 100 person-years, respectively. There was no significant increase in the risk of VTE in the exposed group (HR, 0.925; 95%CI, 0.809-1.058).

conclusionsWe found no increase in VTE risk associated with pemafibrate in clinical practice in Japan.

Indexed as

ButyratesDyslipidemiasVenous ThromboembolismAdultAgedBenzoxazolesDatabases, FactualEast Asian PeopleFemaleHumansJapanMaleMiddle AgedProportional Hazards ModelsRetrospective StudiesRisk FactorsBenzoxazolesButyrates(R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acidClaims databaseDyslipidemiaJapanPemafibrateSelective peroxisome proliferator-activated receptor α modulatorVenous thromboembolism

Identifiers

PMID41129080
PMCPMC12753562

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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.