Evidence map›Paper›PMID 39890736›Full record

ArticleDrugs - real world outcomes2025

Trends in Reports of Statin-Associated Immune-Mediated Necrotizing Myopathy Using the Japanese Adverse Drug Event Report Database.

Akina Takami, Gen Terashima, Takumi Tajima, Koki Yamashita, Ataru Igarashi

Abstract read
In one paragraph

Article in Drugs - real world outcomes, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. 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.

Akina TakamiDepartment of Health Policy and Public Health, Graduate School of Pharmaceutical Sciences, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. mariechanmail@g.ecc.u-tokyo.ac.jp.ORCID http://orcid.org/0009-0004-3289-822X
Gen TerashimaJMDC, Inc., Tokyo, Japan.ORCID http://orcid.org/0000-0002-6804-5585
Takumi TajimaJMDC, Inc., Tokyo, Japan.ORCID http://orcid.org/0009-0007-9633-5831
Koki YamashitaMaxwell International, Inc., Chiba, Japan.ORCID http://orcid.org/0009-0005-3187-0900
Ataru IgarashiDepartment of Health Policy and Public Health, Graduate School of Pharmaceutical Sciences, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.ORCID http://orcid.org/0000-0001-6307-6916

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn October 2016, precautions of the package inserts for ethical drugs containing statins were revised for immune-mediated necrotizing myopathy (IMNM).

objectiveOur objective was to assess the trend in statin-associated IMNM reported before and after the release of the revised precautions in Japan.

methodsWe investigated the number of case reports and estimated annual incidence rate of statin-associated IMNM using the Japanese Adverse Drug Event Report and Japan Medical Data Center (JMDC) databases, respectively. To identify IMNM case reports, we used the preferred term "immune-mediated myositis" (MedDRA version 27.1).

resultsWe identified 172 statin-associated IMNMs in 145 case reports of patients between 1 April 2004 and 31 March 2023. The most common suspected statin administered to the patients was rosuvastatin (34.3%), followed by pitavastatin (25.0%) and atorvastatin (22.1%). No statin-associated IMNM was reported in patients who were treated with combination agents containing statins. The number of reported statin-associated IMNMs increased from 3 in 2015 to a peak of 51 in 2019, after which it was 22 (2020), 17 (2021), and 21 (2022) in the following years. The estimated annual incidence rate did not differ with statins, it rarely exceeded 5 per 1,000,000 patients.

conclusionsThere was an increasing trend in the number of statin-associated IMNM after the revised precautions of package inserts for statins were released.

Identifiers

PMID39890736
PMCPMC11829879

What Socratic holds

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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 Socratic graph.