James M McKenney1, Domenic Sica. 1. Virginia Commonwealth University, Richmond, Virginia, USA. jmckenney@ncrinc.net
Abstract
PURPOSE: A review of the key properties and trial results associated with prescription omega-3 fatty acids (P-O3FA) and a description of its place in the treatment of hypertriglyceridemia and coronary heart disease (CHD) risk are presented. SUMMARY: P-O3FA is made from the fish oil extracted from the fish carcass, which is put through a purification process that refines, esterifies, purifies, and concentrates the ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Each 1-g capsule provides 840 mg of EPA and DHA; the remaining 160 mg contains other omega-3 and omega-6 fatty acids, saturated fatty acids, and monounsaturated acids. When used at a daily dose of 4 g in patients with very high triglycerides (> or = 500 mg/dL), P-O3FA reduces triglycerides by an average of 45% and very-low-density-lipoprotein cholesterol by more than 50%. Changes in high-density-lipoprotein (HDL) cholesterol and non-HDL cholesterol are usually modest. P-O3FA has been tested in the GISSI-Prevenzione trial - a large, multicenter, open-label, randomized, controlled trial conducted in 11,324 patients. The results of the trial demonstrated significant reductions in all endpoints with the use of P-O3FA. CONCLUSION: P-O3FA has demonstrated an efficacy and safety in adult patients with high and very high triglycerides adjunct to diet, and the reduction in serum triglyceride levels was dependent on the baseline triglyceride levels. A large controlled clinical trial is necessary to determine if P-O3FA can be used to reduce CHD risk, either as combined with hydroxymethylglutaryl-coenzyme A reductase inhibitors or as monotherapy.
RCT Entities:
PURPOSE: A review of the key properties and trial results associated with prescription omega-3 fatty acids (P-O3FA) and a description of its place in the treatment of hypertriglyceridemia and coronary heart disease (CHD) risk are presented. SUMMARY:P-O3FA is made from the fish oil extracted from the fish carcass, which is put through a purification process that refines, esterifies, purifies, and concentrates the ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Each 1-g capsule provides 840 mg of EPA and DHA; the remaining 160 mg contains other omega-3 and omega-6 fatty acids, saturated fatty acids, and monounsaturated acids. When used at a daily dose of 4 g in patients with very high triglycerides (> or = 500 mg/dL), P-O3FA reduces triglycerides by an average of 45% and very-low-density-lipoprotein cholesterol by more than 50%. Changes in high-density-lipoprotein (HDL) cholesterol and non-HDL cholesterol are usually modest. P-O3FA has been tested in the GISSI-Prevenzione trial - a large, multicenter, open-label, randomized, controlled trial conducted in 11,324 patients. The results of the trial demonstrated significant reductions in all endpoints with the use of P-O3FA. CONCLUSION:P-O3FA has demonstrated an efficacy and safety in adult patients with high and very high triglycerides adjunct to diet, and the reduction in serum triglyceride levels was dependent on the baseline triglyceride levels. A large controlled clinical trial is necessary to determine if P-O3FA can be used to reduce CHD risk, either as combined with hydroxymethylglutaryl-coenzyme A reductase inhibitors or as monotherapy.
Authors: Robert K McNamara; I Jack Magrisso; Rylon Hofacer; Ronald Jandacek; Therese Rider; Patrick Tso; Stephen C Benoit Journal: Pharmacol Res Date: 2012-06-29 Impact factor: 7.658