Effect of atorvastatin on muscle symptoms in coronary heart disease patients with self-perceived statin muscle side effects: a randomized, double-blinded crossover trial.
Placebo-controlled
Atorvastatin
Coronary heart disease
Crossover trial
Statin-associated muscle symptoms
Journal
European heart journal. Cardiovascular pharmacotherapy
ISSN: 2055-6845
Titre abrégé: Eur Heart J Cardiovasc Pharmacother
Pays: England
ID NLM: 101669491
Informations de publication
Date de publication:
03 11 2021
03 11 2021
Historique:
received:
22
04
2020
revised:
29
04
2020
accepted:
24
06
2020
pubmed:
2
7
2020
medline:
31
3
2022
entrez:
2
7
2020
Statut:
ppublish
Résumé
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. 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). 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.
Identifiants
pubmed: 32609361
pii: 5865858
doi: 10.1093/ehjcvp/pvaa076
pmc: PMC8566260
doi:
Substances chimiques
Hydroxymethylglutaryl-CoA Reductase Inhibitors
0
Atorvastatin
A0JWA85V8F
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
507-516Informations de copyright
© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.
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