EFFICACY AND SAFETY OF ROSUVASTATIN COMPARED TO SIMVASTSTIN IN CORONARYARTERY DISEASE

Background: Coronary artery disease is the leading cause of morbidity and mortality worldwide. Hyperlipi- demia is a major risk factor for it. This trial was conducted to compare the efficacy and safety of rosuvastatin and simvastatin in patients with coronary artery disease.Material Methods: This study was conducted at Pharamacology Department, Gomal Medical College, D.I.Khan from May 1, 2008 to December 31, 2008. Patients with history of coronary artery disease were randomized to receive Rosuvastatin 5mg or Simvastatin 20mg for six weeks. Primary end point was number of patients achieving National Cholesterol Education Program Adult Treatment Panel (NCEP ATP III) target LDL-C 100mg/dl, while secondary end points were reduction of LDL-Cholesterol, Total Cholesterol and increase in HDL-Cholesterol and safety profile of the two drugs.Results: Eighty patients were randomized into two groups. Rosuvastatin Group consisted of 23(57.5%) males and 17(42.5%) females while Simvastatin Group 22(55%) males and 18(45%) females. Mean age was 55.35±9.7 and 55.7±8.6 years respectively. Primary end point was achieved in significantly higher number of patients in Rosuvastatin Group 30(75%) as compared to Simvastatin 17(42.5%), p=0.003. Significantly greater reduction in LDL-C from baseline occurred in Rosuvastatin group 78.2±6.14 mg/dl (44.3%) as compared to 66.8±9.9 mg/dl(37.7%) in Simvastatin, p 0.001. Total cholesterol was significantly reduced in Rosuvastatin group 98.5±8.8mg/dl (38.6%) as compared to 78.4±7.8mg/dl (30.4%) in Simvastatin, p 0.001. Increase in HDL-C was significantly greater in Rosuvastatin 4.4±0.87 mg/dl(11.5%) as compared to 2.45±0.55mg/dl(6.5%) in Simvastatin, p=0.009. Both treatments were well tolerated with no serious ad¬verse effects.Conclusion: Rosuvastatin is more efficacious in modifying lipid profile and has comparable safety and adverse event profile to Simvastatin