Randomized Comparative Efficacy and Safety Study of Intermittent Simvastatin and Fenofibrate in Hemodialysis

Overview

Sixty chronic hemodialysis patients were randomly assigned to receive fenofibrate 100 mg (group 1, n = 30) or simvastatin 20 mg (group 2, n = 30) three times/week after their dialysis session. The safety and efficacy of drugs on lipid profile, oxidized low density lipoproteins (ox-LDL), glutathione peroxidase (GSH-Px) and C-reactive protein (CRP) were compared before and after 16-week treatment.

This is a prospective randomized open label parallel study. The selected patients will be randomly allocated to one of two groups * Group I (30 patients): Patients receiving fenofibrate (100 mg) taken on dialysis days after the dialysis session (three times per week). * Group II (30 patients): Patients receiving simvastatin (20 mg) taken on dialysis days after the dialysis session (3 times per week). A careful history of all patients including demographic characteristics, physical examination, chief complaint, past medical history, drug history, familial history, social history, disease(s). Monitoring Parameters: For efficacy, the following parameters are measured: 1. Lipid profile (total cholesterol, HDL, TG and LDL from Friedwald formula \[10\] {LDL-C= TC-\[HDL + TG\\5\]). (measured at baseline and every month for 4 months) 2. C-reactive protein (CRP). (measured at baseline and after 4 months) 3. Oxidative stress markers: oxidized LDL and human glutathione peroxidase (measured at baseline and after 4 months). For safety: (measured at baseline and every month for 4 months) 1. Observe for signs \& symptoms of muscle toxicity and measure phosphocreatine kinase (CPK). 2. Liver function tests: ALT, AST, ALP \& albumin. 3. Urea \& serum creatinine. (to monitor renal function) 4. Hemoglobin 5. Other measurements: Body mass index (BMI), Blood Pressure, electrolytes (Sodium,potassium, calcium, phosphorous) and assess patient compliance by tablet counting. Statistical analysis will be used to compare the effects of simvastatin and fenofibrate on lipid profile, inflammatory marker (CRP) and oxidative stress markers (oxidized LDL and glutathione peroxidase). In addition, comparing their safety on renal and hepatic functions, phosphocreatine kinase, blood pressure and blood glucose level.

Conditions

Interventions

Eligibility

Outcomes