Evidence map›Paper›PMID 39638563›Full record

ArticleBMJ open diabetes research & care2024

Sex-differences in reporting of statin-associated diabetes mellitus to the US Food and Drug Administration.

David P Kao, James L Martin, Christina L Aquilante, Elise L Shalowitz, Katarina Leyba, Elizabeth Kudron, Jane E B Reusch, Judith G Regensteiner

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open diabetes research & care, 2024. 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
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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

8 authors.

David P KaoColorado Center for Personalized Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA david.kao@ucdenver.edu.ORCID 0000-0002-2832-9348
James L MartinColorado Center for Personalized Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Christina L AquilanteColorado Center for Personalized Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Elise L ShalowitzColorado Center for Personalized Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Katarina LeybaDepartment of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Elizabeth KudronColorado Center for Personalized Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Jane E B ReuschLudeman Family Center for Women's Health Research, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.ORCID 0000-0001-8620-1003
Judith G RegensteinerLudeman Family Center for Women's Health Research, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDiabetes mellitus (DM) is increasingly recognized as a possible consequence of statin therapy. Secondary analysis of randomized clinical trials and limited observational cohort analyses have suggested that women may be more likely than men to experience statin-associated DM. No analyses of real-world drug safety data addressing this question have been published. RESEARCH DESIGN AND

methodsThis was a retrospective pharmacovigilance analysis of spontaneously reported adverse drug events (ADEs) submitted to the Food and Drug Administration Adverse Event Reporting System between January 1997 through December 2023. We analyzed cases that mentioned atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin in aggregate as well as cases reporting atorvastatin, pravastatin, rosuvastatin, simvastatin individually. DM events were identified using the Medical Dictionary for Regulatory Activities. We used the proportional reporting ratio to identify increased rates of statin-associated DM events in women and men compared with all other medications, and the reporting OR to compare reporting rates in women versus men.

resultsA total of 18,294,814 ADEs were reported during the study period. Among statin-associated ADEs, 14,874/519,209 (2.9%) reports mentioned DM in women compared with 7,411/489,453 (1.5%) in men, which were both significantly higher than background (0.6%). Statins were the primary-suspected or secondary-suspected cause of the ADE significantly more often in women than men (60 vs 30%), and reporting rates were disproportionately higher in women than in men for all statins. (reporting OR 1.9 (95% CI 1.9 to 2.0)). The largest difference in reporting of statin-associated DM between women and women was observed with atorvastatin.

conclusionsAnalysis of post-marketing spontaneous ADE reports demonstrated a higher reporting rate of DM-associated with statin use compared with other medications with a significantly higher reporting rate in women compared with men. Future studies should consider mechanisms of statin-associated DM moderated by sex.

Indexed as

Adverse Drug Reaction Reporting SystemsDiabetes MellitusHydroxymethylglutaryl-CoA Reductase InhibitorsUnited States Food and Drug AdministrationAdultAgedFemaleFollow-Up StudiesHumansMaleMiddle AgedPharmacovigilanceRetrospective StudiesSex FactorsUnited StatesHydroxymethylglutaryl-CoA Reductase InhibitorsDrug-Related Side Effects and Adverse ReactionsHypercholesterolemiaMedical Informatics ComputingWomen's Health

Identifiers

PMID39638563
PMCPMC11624814

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

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.