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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 mortality, compared with the placebo group. The study also demonstrated that patients in the omega-3 acid ethyl esters group had an eight percent relative risk reduction in death or hospital admissions for cardiovascular reasons compared to the placebo group.

GSK acquired the rights to LOVAZA early this year when it completed an acquisition of Reliant Pharmaceuticals Inc. Since then, GSK has committed significant resources to better educate U.S. doctors and patients on LOVAZA's role in treating very high triglycerides.

About The GISSI-HF Trial

The GISSI Heart Failure Project is a multicenter, randomized, double blind, placebo controlled study from 357 cardiology and internal medicine centers in Italy that evaluated patients with symptomatic heart failure. Patients 18 years and older with clinical evidence of heart failure of any cause classified according to the European Society of Cardiology guidelines as New York Heart Association class II-IV were randomized to receive 1g daily omega-3 acid ethyl esters (3,494 patients) or placebo (3,481 patients). Median age of study participants was 67 years and 42 percent of participants were older than 70 years. At study admission, patients were already on optimal therapy for heart failure e.g. 94 percent of patients were on ACE Inhibitors / ARBs, 65 percent on beta blockers and 39 percent on spironolactone. Co-primary endpoints were time to death, and time to death or admission to hospital for cardiovascular reasons.

Patients were followed for a median of 3.9 years. Results from the study showed that long term treatment with omega-3 acid ethyl esters resulted in a nine percent relative risk reduction in all cause mortality; 955 patients in the omega-3 acid ethyl esters group (27%) died, compared with 1014 (29%) in the placebo group. The study also demonstrated that patients in the omega-3 acid ethyl esters group had an eight percent relative risk reduction in death or hospital admissions for cardiovascular reasons; 1,981 patients (57%) in the omega-3 acid ethyl esters group died or were admitted to the hospital for cardiovascular reasons compared to 2,053 patients (59%) in the placebo group. The rate of treatment discontinuation due to adverse reactions was the same in both groups. The most commonly reported adverse event was gastrointestinal disturbance and the rate of occurrence (3%) was similar in both groups.

About LOVAZA

LOVAZA is made from nature, and is the first and only U.S. Food and Drug Administration (FDA) approved omega-3 medicine. Along with a healthy diet, LOVAZA is approved to reduce very high triglycerides (greater than or equal to 500 mg/dL) in adults. LOVAZA has been shown to help reduce triglyceride levels by 45%. Treatment with LOVAZA also resulted in an increase in LDL-C by a median of 45%, from a median baseline of 89 mg/dL to 109 mg/dL at end of therapy.

Omega-3 fatty acids are a type of polyunsaturated fatty acids, also known as essential fatty acids, which are vital to human health. LOVAZA is derived from all-natural fish oils. Like cholesterol, triglycerides are fats (lipids) that, in balanced and moderate amounts, perform significant and important functions in the human body. However, when triglycerides levels are too high, they may cause some health problems.

Important safety information for LOVAZA (omega-3-acid ethyl esters)

LOVAZA, along with diet, helps to lower very high triglyceride levels.

If you are allergic to fish, you should not take LOVAZA.

Talk to your doctor about any medications you are taking, especially those that may increase your risk of bleeding.

Possible side effects include burping, infection, flu-like symptoms, and upset stomach.

For more information about LOVAZA, please see the Patient Information or full Prescribing Information.

GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2007.

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SOURCE GlaxoSmithKline
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