ArticleDrugs - real world outcomes2025
Trends in Reports of Statin-Associated Immune-Mediated Necrotizing Myopathy Using the Japanese Adverse Drug Event Report Database.
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.
What it found
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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.
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.
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Who cites it
4 citing papers in PubMed.
- Statin-Associated Muscle Symptoms and Myotoxicity: A Clinically Oriented Narrative Review with a Practical Prevention, Evaluation, and Management Algorithm.Medicina (Kaunas, Lithuania) · 2026Review
- Article
- Article
- Effectiveness of proprotein convertase subtilisin/kexin type 9 inhibitors in managing hypercholesterolemia post-statin-associated immune-mediated necrotizing myopathy: report of five cases and literature review.Rheumatology international · 2025Review
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
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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 Socratic graph.