Evidence map›Paper›PMID 16453090›Full record

ArticleCardiovascular drugs and therapy2005

Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients--the PRIMO study.

Eric Bruckert, Gilles Hayem, Sylvie Dejager, Caroline Yau, Bernard Bégaud

2 registry-linked trialsAbstract read
PubMed Publisher
In one paragraph

Article in Cardiovascular drugs and therapy, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 413 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
413citing papers in PubMed, 14 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.

NCT04826354 phase4completedstarted 2021, after this paper: background citation

Effects of High-dose StAtin Versus Low-dose Statin Plus Ezetimibe on Statin-Associated Muscle Symptoms & on Reaching Target LDL-C Levels Among Elderly Patients With Atherosclerotic Cardiovascular Disease

Ran2021Enrolled582Registered outcomes11Posted comparisons0ConditionsAtheroscleroses, CoronaryArmsRosuvastatin, rosuvastatin and ezetimibe
PMID 30423391PMID 28249067PMID 30403574PMID 28007331PMID 28304224PMID 26039521PMID 28444290PMID 22686958PMID 29020411PMID 30580575PMID 23183941PMID 16214597other papers from this trial
Open the trial in the graph
NCT00990834 nawithdrawnnot on this mapstarted 2009, after this paper: background citation

Muscle Characteristics Associated With Statin Therapy

TypeinterventionalSponsorScripps HealthRan2009 to 2011Enrolled0ConditionsHydroxymethylglutaryl-CoA Reductase Inhibitors, MyopathyArmssimvastatin
3 · Its place in the literature

Who cites it

413 citing papers in PubMed, 14 syntheses or guidelines pooled it.

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  6. Prevalence of statin intolerance: a meta-analysis.European heart journal · 2022 · on this map
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  7. Association Between Vitamin D Supplementation and Statin-Associated Muscle Symptoms: A Systematic Review.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2022
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  10. Cerivastatin for lowering lipids.The Cochrane database of systematic reviews · 2020 · on this map
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  12. A comprehensive review and meta-analysis of risk factors for statin-induced myopathy.European journal of clinical pharmacology · 2018 · on this map
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353 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Eric BruckertDepartment of Endocrinology, Hôpital de la Pitié-Salpétrière, Assistance Publique-Hôpitaux de Paris 83 Bd de L'Hôpital, 75 013, Paris, France. eric.bruckert@psl.ap-hop-paris.fr
Gilles Hayem
Sylvie Dejager
Caroline Yau
Bernard Bégaud

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo characterize the risk factors, rate of occurrence, onset, nature and impact of mild to moderate muscular symptoms with high-dosage HMG-CoA reductase inhibitor (statin) therapy in general practice.

methodsThe Prédiction du Risque Musculaire en Observationnel (Prediction of Muscular Risk in Observational conditions, PRIMO) survey was an observational study of muscular symptoms in an unselected population of 7924 hyperlipidemic patients receiving high-dosage statin therapy in a usual care, outpatient setting in France. Information on patient demographics, treatment history and muscular symptoms was obtained by questionnaires.

resultsMultivariate analysis revealed the strongest predictors for muscular symptoms to be a personal history of muscle pain during lipid-lowering therapy (odds ratio, OR, 10.12, 95% CI 8.23-12.45; P < 0.0001), unexplained cramps (OR 4.14; 95% CI 3.46-4.95; P < 0.0001) and a history of creatine kinase (CK) elevation (OR 2.04; 95% CI 1.55-2.68; P < 0.0001). Overall, muscular symptoms were reported by 832 patients (10.5%), with a median time of onset of 1 month following initiation of statin therapy. Muscular pain prevented even moderate exertion during everyday activities in 315 patients (38%), while 31 (4%) were confined to bed or unable to work. Fluvastatin XL was associated with the lowest rate of muscular symptoms (5.1%) among individual statins.

conclusionPRIMO demonstrated that mild to moderate muscular symptoms with high-dosage statin therapy may be more common and exert a greater impact on everyday lives than previously thought. Knowledge of the risk factors for muscular symptoms will allow identification and improved management of high-risk patients. The risk of muscular symptoms with fluvastatin XL treatment may be lower than with high dosages of other statins.

Indexed as

AgedAlcohol DrinkingDose-Response Relationship, DrugFemaleFranceHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHyperlipidemiasMaleMiddle AgedMultivariate AnalysisMusculoskeletal DiseasesOutpatientsPainPredictive Value of TestsRisk FactorsHydroxymethylglutaryl-CoA Reductase Inhibitors

Identifiers

PMID16453090

What OpenQuestion holds

Texttitle and abstract
Read underepoch 390

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 OpenQuestion graph.