Evidence mapPaperPMID 32609361Full record

Trial reportEuropean heart journal. Cardiovascular pharmacotherapy2021

Effect of atorvastatin on muscle symptoms in coronary heart disease patients with self-perceived statin muscle side effects: a randomized, double-blinded crossover trial.

Oscar Kristiansen, Nils Tore Vethe, Kari Peersen, Morten Wang Fagerland, Elise Sverre, Elena Prunés Jensen, Morten Lindberg, Erik Gjertsen, Lars Gullestad, Joep Perk and 5 more

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in European heart journal. Cardiovascular pharmacotherapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
3.5field-weighted citation impact, top 7% of its field
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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.

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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

15 authors at 6 institutions in 2 countries.

Oscar KristiansenDepartment of Medicine, Drammen Hospital, Vestre Viken Hospital Trust, Dronninggata 28, Drammen 3004, Norway.ORCID 0000-0002-4539-0239
Nils Tore VetheDepartment of Pharmacology, Oslo University Hospital, Sognsvannsveien 20, Oslo 0372, Norway.ORCID 0000-0003-2649-4769
Kari PeersenDepartment of Cardiology, Vestfold Hospital Trust, Halfdan Wilhelmsens alle 17, Tønsberg 3103, Norway.
Morten Wang FagerlandOslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Domus Medica, Gaustad, Sognsvannsveien 9, Oslo 0372, Norway.ORCID 0000-0003-4535-5043
Elise SverreDepartment of Medicine, Drammen Hospital, Vestre Viken Hospital Trust, Dronninggata 28, Drammen 3004, Norway.ORCID 0000-0002-1519-9759
Elena Prunés JensenDepartment of Laboratory Medicine, Vestre Viken Hospital Trust, Dronninggata 28, Drammen 3004, Norway.
Morten LindbergCentral Laboratory, Vestfold Hospital Trust, Halfdan Wilhelmsens alle 17, Tønsberg 3103, Norway.ORCID 0000-0002-5568-7810
Erik GjertsenDepartment of Medicine, Drammen Hospital, Vestre Viken Hospital Trust, Dronninggata 28, Drammen 3004, Norway.ORCID 0000-0001-6388-581X
Lars GullestadDepartment of Cardiology, Oslo University Hospital Rikshospitalet, Sognsvannsveien 20, 0372, Oslo, Norway.
Joep PerkDepartment of Cardiology, Public Health Department, Linnaeus University, Kalmar 391 82, Sweden.
Toril DammenDepartment of Behavioural Sciences in Medicine, Faculty of Medicine, University of Oslo, Domus Medica, Sognsvannsveien 9, Oslo 0372, Norway.
Stein BerganDepartment of Pharmacology, Oslo University Hospital, Sognsvannsveien 20, Oslo 0372, Norway.ORCID 0000-0002-3199-2722
Einar HusebyeDepartment of Medicine, Drammen Hospital, Vestre Viken Hospital Trust, Dronninggata 28, Drammen 3004, Norway.
Jan Erik OtterstadDepartment of Cardiology, Vestfold Hospital Trust, Halfdan Wilhelmsens alle 17, Tønsberg 3103, Norway.
John MunkhaugenDepartment of Medicine, Drammen Hospital, Vestre Viken Hospital Trust, Dronninggata 28, Drammen 3004, Norway.
Oslo University Hospital · NOUniversity of Oslo · NOSykehuset i Vestfold · NODrammen Hospital · NOLinnaeus University · SEVestre Viken Hospital Trust · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo estimate the effect of atorvastatin on muscle symptom intensity in coronary heart disease (CHD) patients with self-perceived statin-associated muscle symptoms (SAMS) and to determine the relationship to blood levels of atorvastatin and/or metabolites. METHODS AND

resultsA randomized multi-centre trial consecutively identified 982 patients with previous or ongoing atorvastatin treatment after a CHD event. Of these, 97 (9.9%) reported SAMS and 77 were randomized to 7-week double-blinded treatment with atorvastatin 40 mg/day and placebo in a crossover design. The primary outcome was the individual mean difference in muscle symptom intensity between the treatment periods, measured by visual-analogue scale (VAS) scores. Atorvastatin did not affect the intensity of muscle symptoms among 71 patients who completed the trial. Mean VAS difference (statin-placebo) was 0.31 (95% CI: -0.24 to 0.86). The proportion with more muscle symptoms during placebo than atorvastatin was 17% (n = 12), 55% (n = 39) had the same muscle symptom intensity during both treatment periods whereas 28% (n = 20) had more symptoms during atorvastatin than placebo (confirmed SAMS). There were no differences in clinical or pharmacogenetic characteristics between these groups. The levels of atorvastatin and/or metabolites did not correlate to muscle symptom intensity among patients with confirmed SAMS (Spearman's rho ≤0.40, for all variables).

conclusionRe-challenge with high-intensity atorvastatin did not affect the intensity of muscle symptoms in CHD patients with self-perceived SAMS during previous atorvastatin therapy. There was no relationship between muscle symptoms and the systemic exposure to atorvastatin and/or its metabolites. The findings encourage an informed discussion to elucidate other causes of muscle complaints and continued statin use.

Indexed as

Coronary DiseaseHydroxymethylglutaryl-CoA Reductase InhibitorsAtorvastatinCross-Over StudiesDouble-Blind MethodHumansMusclesAtorvastatinHydroxymethylglutaryl-CoA Reductase InhibitorsAtorvastatinCoronary heart diseaseCrossover trialPlacebo-controlledStatin-associated muscle symptoms

Identifiers

PMID32609361
PMCPMC8566260
OpenAlexW3038367706

What Socratic holds

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LicenceCC BY-NC
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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 Socratic graph.