Effect of atorvastatin on muscle symptoms in coronary heart disease patients with self-perceived statin muscle side effects: a randomized, double-blinded crossover trial
Open accessAbstract
AIMS: To 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 RESULTS: A 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). CONCLUSION: Re-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.
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23 studies were included for data extraction, with 9 RCTs analyzed quantitatively.
“23 studies were included for data extraction [20–26,35–50], with 9 RCTs analyzed quantitatively.”
New evidence on the management of SAMS has become available from randomized controlled trials and observational data.
“New evidence on the management of SAMS have since become available both from randomized control trials (RCTs) and from observational data [20–26].”
Nine trials assessed statin against placebo.
“nine trials assessed statin against placebo [20–26,43]”
13 RCTs conducted between 2006-2023 were included, of which five were parallel, five crossover, and three n-of-1.
“We included 13 RCTs conducted between 2006–2023, of which five were parallel RCTs [40,46–49], five were crossover RCTs [20,21,23,26,43] and three were n-of-1 RCTs [22,24,25] (S4 File, Table 1).”
8 out of 13 RCTs were judged at low risk of bias.
“We judged 8 [20,22,23,25,26,40,48,49] out of 13 RCTs at low risk of bias (S2 File).”
Two trials used high-intensity statins.
“two trials used high-intensity statins [23,47]”
Most trials used a mean difference in pain intensity between statin and comparator group.
“most trials [22,23,25,40,49] used a mean difference in pain intensity between statin and comparator group”
In earlier studies, SAMS were assessed through incidence of SAMS and later quantified with the VAS.
“In earlier studies, SAMS were assessed through incidence of SAMS [17,43,46–48] and later quantified with the VAS (visual analogue scale) [22,23,25,40,49].”
Many studies implemented wash-out periods or a threshold time for SAMS occurrence, which presents a difficulty for cross-over designs and particularly n-of-1 trials.
“Although many studies implemented wash-out periods [23] or a threshold time for SAMS occurrence [22,49], this presents a difficulty for cross-over designs and particularly n-of-1 trials.”
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- Authors
- Kristiansen, O., Vethe, N. T., Peersen, K., Wang Fagerland, M., Sverre, E., Prunés Jensen, E., Lindberg, M., Gjertsen, E., Gullestad, L., Perk, J., Dammen, T., Bergan, S., Husebye, E., Otterstad, J. E., & Munkhaugen, J.
- Affiliations
- University of Oslo (NO)
- Oslo University Hospital (NO)
- Sykehuset i Vestfold (NO)
- Oslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Domus Medica, Gaustad, Sognsvannsveien 9, Oslo 0372, Norway
- Department of Laboratory Medicine, Vestre Viken Hospital Trust, Dronninggata 28, Drammen 3004, Norway
- Drammen Hospital (NO)
- Linnaeus University (SE)
- Corresponding author
- Kristiansen, Oscar
- ORCID
- Venue
- European Heart Journal - Cardiovascular Pharmacotherapy
- Publisher
- Oxford University Press (OUP)
- Published
- 2020-07-01
- Volume
- 7
- Issue
- 6
- Pages
- 507-516
- ISSN
- 2055-6837 (ISSN-L)
- 2055-6845
- PMC
- PMC8566260
- OpenAlex
- W3038367706
- Cited by
- 27
- References
- 41
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 6 · 2023: 5 · 2022: 6 · 2021: 6
- FWCI
- 3.88
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- European Heart Journal - Cardiovascular Pharmacotherapy (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- NORA - Norwegian Open Research Archives (submittedVersion, cc-by-nc)
- Funders
- The South-Eastern Norway Regional Health Authority (2019079)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
- Keywords
- atorvastatin, statin-associated muscle symptoms, statin-induced myopathy, coronary artery disease, statin rechallenge, pharmacokinetics, systemic exposure, placebo-controlled crossover trial
- MeSH terms
- Atorvastatin, Coronary Disease, Double-Blind Method, Humans, Muscles, Cross-Over Studies, Hydroxymethylglutaryl-CoA Reductase Inhibitors
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