Evidence map›Paper›PMID 27074553›Full record

ArticleBritish journal of clinical pharmacology2016

Muscle rupture associated with statin use.

Corine Ekhart, Loek de Jong, Liana Gross-Martirosyan, Florence van Hunsel

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In one paragraph

Article in British journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 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.

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

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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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

4 authors.

Corine EkhartNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Loek de JongNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Liana Gross-MartirosyanDutch Medicines Evaluation Board Agency, Utrecht, The Netherlands.
Florence van HunselNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimStatins are used in the treatment of hyperlipidaemia. They are among the most commonly prescribed drugs worldwide. Statins have been linked to musculoskeletal adverse drug reactions. However muscle rupture has not been discussed as an adverse drug reaction to statins so far. The aim of this article is to give an overview of cases of muscle rupture associated with the use of statins.

methodWe analyzed the cases of muscle rupture associated with the use of statins that were collected by the Netherlands Pharmacovigilance Centre Lareb complemented with the review of cases from the EudraVigilance database.

resultsFifteen cases of muscle rupture associated with statin use have been identified in the database of the Netherlands Pharmacovigilance Centre. Overall, there was a plausible temporal association of events in most cases. In addition, the EudraVigilance database contained 165 reports of muscle rupture reported in patients using statins. Muscle rupture was disproportionally associated with statin use in both databases. The reporting odds ratio was 23.4 (95% CI 11.9, 46.0) and 14.6 (95% CI 12.3, 17.2), respectively.

conclusionData from spontaneous reporting systems suggest that use of statins is associated with muscle rupture. Physicians and patients should be aware that this can occur.

Indexed as

AdultAdverse Drug Reaction Reporting SystemsAgedFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMiddle AgedMuscle, SkeletalMuscular DiseasesNetherlandsPharmacovigilanceRuptureHydroxymethylglutaryl-CoA Reductase Inhibitorsadverse drug reactionmuscle rupturestatins

Identifiers

PMID27074553
PMCPMC4972163

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Registered trials

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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.