The prescription omega-3 utilized in this study is made by Pronova, a
"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
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
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.
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.
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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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