Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients JELIS : a randomised open-label, blinded endpoint analysis. Author information: 1 Kobe University, Kobe, Japan. Comment in Lancet. Nat Clin Pract Cardiovasc Med. Evid Based Med. We aimed to test the hypothesis that long-term use of eicosapentaenoic acid EPA is effective for prevention of major coronary events in hypercholesterolaemic patients in Japan who consume a large amount of fish.
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Worldwide, cardiovascular disease CVD remains the 1 killer of men and women. Vascepa is not fish oil, but is derived from fish through a stringent and complex FDA -regulated manufacturing process designed to effectively eliminate impurities and isolate and protect the single molecule active ingredient.
The effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined. Patients receiving treatment with Vascepa and other drugs affecting coagulation e. Patients should be advised to swallow Vascepa capsules whole; not to break open, crush, dissolve, or chew Vascepa. Nothing in this press release should be construed as promoting the use of Vascepa in any indication that has not been approved by the FDA.
Important Cautionary Information About Topline Results Existing and prospective investors are cautioned not to place undue reliance on topline results. As with any topline cardiovascular outcomes study result, further REDUCE-IT data assessment and data release will yield additional useful information to inform greater understanding of the study outcome.
Forward-Looking Statements This press release contains forward-looking statements, including expectations regarding planned publication, scientific presentation, regulatory review and related timing thereof; expectations that REDUCE-IT results could lead to a new treatment paradigm in the patient population studied; plans for sales force, international and insurance coverage expansion. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties.
Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated generally with research and development, clinical trials and related regulatory approvals; the risk that sales may not meet expectations and related cost may increase beyond expectations; the risk that patents may not be upheld in patent litigation and applications may not result in issued patents sufficient to protect the Vascepa franchise.
A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin.
JELIS STUDY PDF
N Engl J Med. The median follow-up duration was 58 months 4. Analysis was by intention-to-treat. The primary, secondary, and tertiary adjudicated endpoint analyses were validated by the data monitoring committee independent statistician. Offer good through December 31, Overall adverse event rates were similar across treatment groups. About Amarin jeliis Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia [published online ahead of print November 10, ].
Omega-3-Fettsäuren (EPA, DHA)
Japan EPA Lipid Intervention Study - JELIS