الفهرس 
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Abstract
The study was approved by the commission on the Ethics of Scientific Research, Faculty of Pharmacy, Minia University. Out of 600 patients with a stable artery coronary disease who underwent treadmill stress test at the cardiology department, Minia University Hospital 90 Egyptian male and female subjects aged 40-71 years were eligible for the study.
Statins are the mainstay drugs that are widely used to lower lipid levels among patients with cardiovascular diseases. Cost-effectiveness is questionable among branded and generic market products.
The study aims to evaluate the treatments outcome and cost-effectiveness of the branded and generic rosuvastatin products available in the Egyptian market.
Patients and Methods The inclusion criteria involved patients with SCAD [low to intermediate risk zero according to treadmill duke score risk stratification] [220] who had at least moderate physical functioning, no disabling comorbidities, resting ECG changes and did not receive any lipid-lowering agents before enrolment. Informed consent was received from all the patients and they were subjected to follow-up period for 6 months. Indication for coronary angiography, history of coronary intervention or coronary bypass graft surgery, hepatic dysfunction, moderate to severe renal impairment with creatinine clearance 60 ml/min using Cockcroft-Gault formula were the exclusion criteria.
Patients were randomised (1:1:1) to either receiving the brand-name rosuvastatin or one of the two generic rosuvastatin medicines. LDL-C, total cholesterol, triglycerides, HDL-C levels and liver enzymes were tested at the enrolment and after 6 months. Average cost-effectiveness ratios for each treatment and the incremental cost-effectiveness ratio (ICER) were estimated for branded versus each generic. The output of ICER was percentage reduction in LDL-C.
Results After 6 months of statin treatment initiation, all lipid parameters were reduced significantly compared with baseline levels. There is significant difference in LDL-C reduction between the branded and generic groups (P<0.01). No significant differences were reported in triglyceride levels reduction (P=0.731) and HDL (P=0.167) among the three groups. All three statins were safe concerning liver enzymes. ICERs of the 6 months of LDL-C were 157.7 and 62 Egyptian pounds (LE).