Comparative Efficacy and Safety Profile of 5 Mg Rosuvastatin versus 10 Mg Rosuvastatin in Patients with Ischemic Heart Disease

Objectives: To compare the efficacy and clinical profile of 5 mg rosuvastatin versus 10 mg rosuvastatin in improving the management of patients with IHD. Material and Methods: This study was jointly conducted by Department of Pharmacology, Khyber Medical College, and Cardiology Department of Khyber Teaching Hospital from January 2011 to August 2011. The patients presenting to coronary care unit and cardiology OPD were randomized into a two groups; Group A and Group B each comprising 50 patients. Group A recieved 5 mg of rosuvastatin and Group B received 10 mg of resovuastatin for three months. National cholesterol Education programme adult treat panel III (NCEP ATP III) guideline for LDL-C was chosen as the primary objective while assessing the safety profile and toxicity was considered the secondary end point. A rise in HDL-C was also anticipated. Results: Thirty-four (68%) patients in group A and 41 (82%) patients in group B were male. All the patients were resident of Peshawar. Their mean ages were 51.4 ± 7.6 and 49.35 ± 5.65 years respectively in group A and B. The LDL-C dropped to NCEP ATP III value of < 100 mg% in 3 (26%) patients in group A compared to 4 (88%) in group B P < 0.0004. LDL-C levels after the 3 month treatment showed a mean reduction of 66.2 ± 3.8 and 84.1 ± 4.3 in group A and B respectively implying 39.02% and 48.38 % reduction with a P value < 0.0001. The reduction to total cholesterol (TLC) was 31.69% (mean 83.2 ± 7.5) and 41.28% (mean 107.0 ± 3.3) in the respective groups with a P value of < 0.0001. The significant value for triglycerids was a P < 0.04 for group B while the HDL-C improvement was 0.0006 in group B (receiving 10 mg rosuvastatin). The reported increased in the incidence of myalgia and muscle weakness was statistically insignificant P < 0.06. Conclusion: Rosuvastatin; clinically proven antilipidemic agent for the management of IHD has a better efficacy with almost identical adverse effects in 10 mg doses as compared with 5 mg doses and this satisfies the NCEPATP III guidelines.