Efficacy and safety of the intensive dose of rosuvastatin 40 mg/day in patients with acute coronary syndrome and at high risk of cardiovascular disease-ROSUVEES-2

摘要

Background: Randomized clinical trials have established the benefits of statin therapy in acute coronary syndromes (ACS) via their pleiotropic effects.Aim of the study: This was a 12-week, open-label, multicenter, postmarketing observational study evaluating the efficacy and safety of rosuvastatin 40 mg/day in very high-risk or high-risk Indian patients according to NCEP ATP III guidelines.Methodology: One hundred and sixty two patients (age: 30 to 69 years) with evidence of coronary artery disease, hospitalized with chest pain with/without electrocardiogram changes and with non-ST segment elevation ACS and ST segment elevation ACS who received optimal reperfusion therapy were enrolled. The primary endpoint was the percent change from baseline in low-density lipoprotein cholesterol (LDL-C) levels at 6 and 12 weeks of treatment. Other lipid parameters, high sensitive C-reactive protein (hsCRP), glycosylated hemoglobin, and clinical biochemical parameters were also assessed. Results: At 12 weeks, intensive therapy with rosuvastatin 40 mg/day significantly reduced LDL-C (p< 0.001), total cholesterol (TC) (p <. 0.001), triglyceride (p<0.01), TC/high density lipoprotein cholesterol (HDL-C) ratio (p < 0.001), non-HDL-C (p < 0.001), LDL-C/HDL-C ratio (p < 0.O01), and hsCRP (p = 0.034) in very high-risk and high-risk patients with ACS. Overall, 54.5% (61/112) patients achieved LDL-C goal of <70 mg/dL However, the change in HDL-C and very low density lipoprotein cholesterol (VLDL-C) were not significant. Few adverse events including myalgia were reported during the study. Conclusion: Results of this study showed that 40 mg dose of rosuvastatin, initiated early and continued for 12 weeks, was effective in terms of reducing LDL cholesterol and was well tolerated.