The incidence of muscle tissue damage during therapy with atorvastatin in patients after STEMI

Abstract

Abstract 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. Funding Acknowledgement Type of funding sources: None.