• Oscar Kristiansen, Nils Tore Vethe, Kari Peersen, Morten Wang Fagerland, Elise Sverre, Elena Prunés Jensen, Morten Lindberg, Erik Gjertsen, Lars Gullestad, Joep Perk, Toril Dammen, Stein Bergan, Einar Husebye, Jan Erik Otterstad, and John Munkhaugen.
• Department of Medicine, Drammen Hospital, Vestre Viken Hospital Trust, Dronninggata 28, Drammen, Norway.
• Eur Heart J Cardiovasc Pharmacother. 2020 Jul 1.

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-center 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-weeks 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 -0.24-0.86). 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 (Spearmans 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.© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.

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