Objective To study the incidence of side effects from muscle tissue during therapy with atorvastatin at various doses in patients with acute ST-segment elevation myocardial infarction (STEMI) during 48 weeks of follow-up. Methods The study included 115 STEMI patients aged 30 to 65 years (mean age 51.7±9.5 years). Patients were randomized to atorvastatin treatment groups. Group 1 included 59 people who took atorvastatin 80 mg / day; group 2 - 56 patients who received moderate doses of atorvastatin. The compared persons were matched by age, sex, and anthropometric data. Initially on the 7–9th days, after 24 and 48 weeks of follow-up, the CPK-MB serum level was analyzed. Muscle damage was assessed after 5–6, 24, 48 weeks of follow-up according to the development of the following symptoms: pain, fatigue, muscle weakness, decreased physical activity - on a 10-point scale. Results The CPK-MB level in the 1st group initialy was 701.5 [95% CI 391; 1012] U / L, after 24 weeks - 162.8 [95% CI 130.2; 195.4] U / L (p<0.001), after 48 weeks - 205.6 [95% CI 134.8; 276.4] U / L (p<0.001). In group 2, the dynamics of CPK-MB: on days 7–9 - 522.7 [95% CI 115.8; 755.1 U / L, after 24 weeks - 141.4 [95% CI 122.6; 160.3] U / L (p=0.0004), after 48 weeks - 150.5 [95% CI 123.9; 177.1] U / L (p=0.0003). A detailed analysis in four patients of the 1st group revealed an increase in CPK-MB >4 upper limit of normal (ULN) after 48 weeks of follow-up (6.8%). Moreover, symptoms of muscle damage against the background of pathological CPK-MB values were observed only in two people (3.4%). In patients of the 2nd group after 24–48 weeks of therapy with atorvastatin, there was no increase in CPK-MB >4 ULN. In addition, there were no cases of drug withdrawal in any of the groups due to an increase in CPK-MB>10 ULN. Clinical symptoms of muscle damage after 5–6th, 24th and/or 48th weeks of follow-up were diagnosed in the 1st group in 41 patients (69.5%), in the 2nd group - in 31 people (55%) (p=0.11). Conclusion In STEMI patients on the background of 48-week therapy with atorvastatin, no serious adverse effects on the muscle tissue were revealed, which testifies in favor of the safety of high-dose statin therapy. The incidence of myalgia did not depend on the dose of the drug. FUNDunding Acknowledgement Type of funding sources: None.
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