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New Data Shows Prescription Omega-3 Acid Ethyl Esters Reduced the Incidence of Death in Heart Failure Patients
Date:9/4/2008

-Data Published in 'The Lancet' and Presented at ESC Congress-

PHILADELPHIA, Sept. 4 /PRNewswire/ -- Results from a new international study, the GISSI Heart Failure (GISSI-HF) study, showed that 1 g/d dose of omega-3 acid ethyl esters reduced all cause mortality and hospital admissions for cardiovascular reasons in patients with chronic heart failure. These findings are published in this week's online version of 'The Lancet' and were presented at the European Cardiovascular Society (ESC) Congress 2008 in Munich, Germany on Sunday, August 31, 2008.

The prescription omega-3 utilized in this study is made by Pronova, a Norway based marine pharmaceutical company. GSK has the rights to market Pronova's omega-3 formulation in the United States. In the U.S., this product is marketed as LOVAZA(R) and is FDA approved, in addition to diet, to treat adult patients with triglycerides greater than or equal to 500 mg/dL only. LOVAZA is the only FDA approved omega-3 medicine in the U.S., but is not indicated for the treatment of heart failure.

"The GISSI Heart Failure Project offers new insights into the potential benefits of prescription omega-3s in heart failure and should not be generalized to over the counter dietary supplements," said Jai Patel, Vice President GSK Global Cardiovascular Clinical Development. "To date, there have not been trials comparing the effects and benefits of different formulations of omega-3s. The potency and purity of omega-3 dietary supplements may not be consistent. The FDA does not review dietary supplements for efficacy or safety and they are not approved to treat any disease," he continued.

Results from the GISSI HF-study showed that long term treatment with prescription omega-3 acid ethyl esters was effective in reducing both all cause mortality and admissions to the hospital for cardiovascular reasons. Treatment with prescription omega-3 acid ethyl esters resulted in a nine percent relative risk reduction in
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SOURCE GlaxoSmithKline
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