Evidence map›Paper›PMID 15922693›Full record

ArticleThe American journal of medicine2005

Evaluation of cases of severe statin-related transaminitis within a large health maintenance organization.

Evguenia C Charles, Kari L Olson, Brian G Sandhoff, David L McClure, John A Merenich

Registry-linked trialAbstract read
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In one paragraph

Article in The American journal of medicine, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05613400 (The Effect of Simvastatin on Bone Density in Postmenopausal Women With Type 2 Diabetes), which is not on this map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
–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.

NCT05613400 phase4unknown statusstarted 2022, after this paper: background citation

The Effect of Simvastatin on Bone Density in Postmenopausal Women With Type 2 Diabetes: a Double-blind, Randomized Active-comparator (Ezetimibe) Controlled Clinical Trial

Ran2022Enrolled240Registered outcomes7Posted comparisons0ConditionsDiabetes Mellitus, Type 2ArmsEzetimibe 10mg, Simvastatin 10mg
Open the trial in the graph
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Article
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  7. Article
  8. First Iranian guidelines for the diagnosis, management, and treatment of hyperlipidemia in adults.Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences · 2024
    Article
  9. HMG-CoA Reductase Inhibitors for Traumatic Brain Injury.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2023
    Review
  10. [Statin-related drug-induced liver injury].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2023
    Article
  11. A Modern Approach to Dyslipidemia.Endocrine reviews · 2022
    Article
  12. Article
  13. Drug-induced liver injury: Do we know everything?World journal of hepatology · 2017
    Review
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  16. Article
  17. Article
  18. 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

5 authors.

Evguenia C CharlesClinical Pharmacy Cardiac Risk Service, Kaiser Permanente of Colorado, Denver, Colorado, USA.
Kari L Olson
Brian G Sandhoff
David L McClure
John A Merenich

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo describe the rate, potential causes, symptoms, time to onset, and time to resolution of severe transaminitis associated with increased 3-hydroxy-3-methylglutaryl coenzyme reductase inhibitor ("statin") usage in a large group model health maintenance organization. SUBJECTS AND

methodsHealth plan members 18 years of age and older, not receiving chemotherapy, who had received at least 1 statin prescription between January 1, 1997, and December 31, 2001 were eligible. All eligible patients with an alanine aminotransferase greater than 10 times the upper limit of normal at any time during the study period were identified using computerized laboratory records. Medical records were subsequently reviewed in order to determine whether the elevation was attributable to statin therapy.

resultsAlanine aminotransferase had never been measured in 2334 of 25334 (9%) of eligible patients. In the remaining 23000 patients, 62 (0.3%) were identified with an alanine aminotransferase greater than 10 times the upper limit of normal during the 5-year study period. Of these, 17 (0.1% of 23000 patients) had severe transaminitis deemed directly attributable to statin use. All except 4 of these 17 cases were associated with drug interactions. In 16 cases, transaminitis resolved upon statin discontinuation.

conclusionsIn the observed study sample, statin-related severe transaminitis occurred infrequently. These findings support less frequent liver enzyme monitoring for most patients on statins. Continued monitoring remains warranted for patients on concomitant medications or those with comorbid conditions.

Indexed as

AdultAgedAged, 80 and overAlanine TransaminaseColoradoComorbidityDrug InteractionsFemaleHealth Maintenance OrganizationsHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMiddle AgedRetrospective StudiesAlanine TransaminaseHydroxymethylglutaryl-CoA Reductase Inhibitors

Identifiers

What Socratic holds

Textmetadata
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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.