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New Data Shows Lovaza Improves Multiple Lipid Parameters in Patients...



Results from a new study showed that 4 grams per day dose of LOVAZA's174; (omega-3-acid ethyl esters) plus atorvastatin significantly reduced non-high-density-lipoprotein cholesterol (non-HDL-C) in adult patients. Data also showed that treatment with LOVAZA plus atorvastatin resulted in a significantly greater decrease in triglyceride levels when compared to a higher dose of atorvastatin alone. The safety findings of this study were consistent with previous studies with LOVAZA both as monotherapy and in combination with statins. These findings were presented Tuesday, November 11, 2008 at the 2008 American Heart Association'ss Annual Scientific Sessions in New Orleans, LA.



Non-HDL-C, measured as total cholesterol minus high-density-lipoprotein (HDL), is a secondary treatment target for patients with mixed dyslipidemia and high triglyceride levels. According to the National Cholesterol Education Program'ss Adult Treatment Panel III, if triglycerides remain high (e200 mg/dL) after LDL-C treatment (such as statin therapy), treating non-HDL-C levels by increasing the dose of statins or adding another medication should be considered.



About the Study


The trial was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 16 week study to assess the effects of LOVAZA when co-administered with escalating doses of atorvastatin in 245 patients with baseline non-HDL-C's38;gt;160 mg/dL and TG 250-599 mg/dL versus atorvastatin alone.



After a four-week diet lead-in, dyslipidemic subjects 18-79 years of age received LOVAZA (4g/d) or placebo plus atorvastatin (10, 20 and 40 mg/d at weeks 1-8, weeks 9-12 and weeks 13-16, respectively). The primary endpoint was the difference between groups in non-HDL-C at week eight. Secondary endpoints included changes in a variety of other lipid parameters. Data showed that treatment with LOVAZA resulted in significant reduction in non-HDL-C levels and improvement in secondary end points when co-administered with each of the atorvastatin doses studied.



About LOVAZA


LOVAZA is made from all natural fish oil, 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 (e 500 mg/dL) in adults.



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 and contains a highly purified blend of EPA and DHA which are active ingredients in omega-3 fatty acids. Like cholesterol, triglycerides are fats (lipids) that, in balanced and moderate amounts, perform significant and important functions in the human body. However, when triglyceride 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 at http://www.LOVAZA.com.



GlaxoSmithKline - one of the world'ss 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.



Enquiries:        


        


UK Media enquiries:


Philip Thomson    (020) 8047 5502


Claire Brough    (020) 8047 5502


Alice Hunt    (020) 8047 5502


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US Media enquiries:    


Rob Perry     (215) 751 7583


Mary Anne Rhyne    (919) 483 2839


Sarah Alspach    (215) 751 7709


        


European Analyst/Investor enquiries:    


David Mawdsley    (020) 8047 5564


Sally Ferguson    (020) 8047 5543


Gary Davies    (020) 8047 5503


        


US Analyst/ Investor enquiries:    


Tom Curry (215) 751 5419


        


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 s operations are described under 'sRisk Factors's in the 'sBusiness Review's in the company's s Annual Report on Form 20-F for 2007.



Registered in England 's38; Wales:


No. 3888792






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