The U.S. Food and Drug Administration (FDA) has approved omega-3 acid ethyl esters (Omacor®) for the treatment of hypertriglyceridemia.
The product is the first of its class to be approved by the FDA and contains highly concentrated ethyl esters of eicosapentanoic acid and docosahexaenoic acid. According to a company news release, the proprietary manufacturing process eliminates heavy metals and other environmental pollutants commonly detected in many omega-3 products.
The approval was based on the results of two placebo-controlled trials showing that 4 g per day of omega-3 acid ethyl esters reduced median triglyceride levels by 44.9% in 84 adult patients with triglyceride levels greater than 500 mg/dL (median, 792 mg/dL).
While median very low density lipoprotein (LDL) and non–high density lipoprotein cholesterol levels likewise decreased (41.7% and 13.8%, respectively) compared with baseline, median LDL cholesterol levels increased by 44.5%. Patients should be monitored to ensure that LDL cholesterol levels do not increase excessively.
The product has been approved for use in Europe and Asia, where it is marketed by Pronova Biocare AS in conjunction with Pfizer, SPA, Sigma Tau, Solvay, and AstraZeneca.
C-Peptide Replacement Prevents Painful Diabetic Neuropathy
Findings from a new study suggest that C-peptide replacement may be a useful treatment for painful diabetic neuropathy that occurs under insulin-deficient conditions. Using a rat model of type 1 diabetes, Dr. Anders A. F. Sima and colleagues, from Wayne State University in Detroit, show that although it has no effect on hyperglycemia, C-peptide replacement prevents progressive thermal hyperalgesia and C-fiber loss.
Ann Neurol 2004;56:827-835