Thesis (M.Sc.) - Cairo University - Faculty of Pharmacy - Department of Pharmaceutics

Background: Cardiovascular disease (CVD) is considered the main cause of morbidity and mortality among hemodialysis (HD) patients. The pathogenesis of accelerated atherosclerosis and CVD among these patients is multifactorial and primarily mediated by dyslipidemia, oxidative stress and inflammation. Both statins and fibrates have beneficial effects in treating dyslipidemia via their effect on the lipid profile, oxidative stress and inflammation. Objective: This study aims to compare the efficacy and safety of an intermittent low dose fenofibrate versus simvastatin in chronic hemodialysis patients together with evaluation of their compliance. Our screening panel included lipid profile, inflammatory markers and oxidative stress markers. Setting: Sixty chronic hemodialysis patients were recruited from Kasr Al-Aini center for kidney disease and dialysis, King Fahd dialysis unit, the dialysis unit in the New Kasr Al Aini Teaching hospital, Cairo University teaching hospitals and the two dialysis units present in Ahmed Maher Teaching hospital, Cairo, Egypt. Methods: This was a multicenter, prospective, randomized, parallel study. Serum levels of total cholesterol (TC) and triglycerides (TGs) were screened for all patients (402 patients) available in the study centers. Sixty eligible patients were randomly assigned to receive either fenofibrate 100 mg (group 1, n = 30) or simvastatin 20 mg (group 2, n = 30) three times/week after their dialysis session for 16 weeks. The safety and efficacy of drugs on lipid profile, oxidized low density lipoprotein (ox-LDL), glutathione peroxidase (GSH-Px) and C-reactive protein (CRP) were compared before and after 16-week treatment. Results: After 16 weeks, within group comparison revealed significant decrease in serum ox-LDL by 17% and 13% and significant increase in GSH-Px by 32.01% and 35.4% in fenofibrate and simvastatin groups (P < 0.05), respectively. Changes in serum CRP levels before and after treatment were not significant in both groups (P > 0.05). However, simvastatin group showed significantly lower CRP level than fenofibrate at the end of the study (P < 0.05). The median reduction in TC, TGs and low density lipoprotein-cholesterol LDL-C was 25.79% the study

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