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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Fenofibrate; Simvastatin

Criteria

Inclusion Criteria:

1. Age ≥ 18 years.

2. Chronic hemodialysis patients with 3 dialysis sessions per week.

3. Lipid profile:

1. Total Cholesterol ≥ 200 mg/dl or LDL ≥ 130 mg/dl.

2. Triglycerides ≥ 150 mg/dl.

Exclusion Criteria:

1. Previous intolerance to fibrates or statins.

2. Use of any fibrates or statins within 6 months prior to study.

3. Hypothyroidism.

4. Active liver disease [unexplained persistent increase in liver enzymes (ALT & AST > 2x ULN)].

5. Uncontrolled hypertension.

6. History of MI or coronary bypass surgery in last 3 months.

7. Muscle toxicity (Phosphocreatine kinase (CPK) > 2x ULN).

8. Gall bladder disease.

9. Use of any immunosuppressant or steroid.