Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis

A Double Blind Comparison of Omacor and Placebo as Secondary Prevention Against Cardiovascular Events in Patients Undergoing Chronic Hemodialysis

The aim of this investigator initated study is to examine the effect of OMACOR (Omega-3-acid ethyl ester 90) on the incidence of cardiovascular events and mortality in patients undergoing chronic hemodialysis, who has previously experienced a cardiovascular event.

Patients with renal failure have a high incidence of cardiovascular disease and increased premature mortality. Omega-3 polyunsaturated fatty acids from fish are known to have cardioprotective effects in subects with normal renal function. The aim of present study is to examine the effect of OMACOR (Omega-3-acid ethyl ester 90) on the incidence of cardiovascular events and mortality in patients undergoing chronic hemodialysis, who has previously experienced a cardiovascular event.

Design: A prospective, randomised, placebo controlled study. 2 year treatment period.

Inclusion Criteria:

• Males and females above 18 years of age

• Patients having been treated with chronic hemodialysis for at least 6 months

• Patients with documented cardiovascular disease, at least one of the following

  1. Angina pectoris
  2. Previous Acute myocardial infarction
  3. Previous PTCA/CABG or demonstated atheroclerosis after coronary angio
  4. Previous Transitory Cerebral Ischemia
  5. Previous Apoplexia Cerebri
  6. Symptoms of peripheral vascular disease

• Written informed consent

Exclusion Criteria:

• Active malignant disease, except basal cell carcinoma or spinocellular carcinoma
• Patients undergoing peritoneal dialysis
• Any condition associated with a risk of poor compliance, as judged by investigator
• Pregnant or breastfeeding
• Participation in other clinical studies involving treatment with drugs.