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

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 40mg/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<0.001), 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 <70mg/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 40mg dose of rosuvastatin, initiated early and continued for 12 weeks, was effective in terms of reducing LDL cholesterol and was well tolerated.