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Press Release: Vascepa® (icosapent ethyl) 26% Reduction in Key Secondary Composite Endpoint of Cardiovascular Death, Heart Attacks and Stroke Demonstrated in REDUCE-IT™ Supports 25% Overall Reduction in Five-Point Major Adverse Cardiovascular Event Prim


Landmark Cardiovascular Risk Reduction Benefits Demonstrated in REDUCE-IT Are Largest of Any Major Cardiovascular Outcomes Study of a Drug Intended to Address Residual Cardiovascular Risk Remaining After Cholesterol ManagementCardiovascular Death Reduced by 20%
Fatal or Nonfatal Heart Attacks Reduced by 31%
Fatal or Nonfatal Stroke Reduced by 28%
Urgent or Emergent Coronary Revascularization Reduced by 35%
Hospitalization for Unstable Angina Reduced by 32%
Number Needed to Treat for Primary Composite Endpoint: 21Patient Years of Study Support Favorable Benefit/Risk Profile in REDUCE-ITAffordably Priced Vascepa Positions Amarin with Potential to Help Millions of PatientsConference Call Scheduled for Today, Saturday, November 10, 2018 at 7:15 pm CT/8:15 pm ETCHICAGO, Nov. 10, 2018 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) announced today the primary results from the Vascepa® (icosapent ethyl) cardiovascular (CV) outcomes trial, REDUCE-IT™, following presentation of the late-breaking clinical trial results at the 2018 Scientific Sessions of the American Heart Association (AHA) in Chicago, Illinois.  REDUCE-IT primary results confirmed 25% relative risk reduction (RRR) for the topline primary endpoint result with multiple robust demonstrations of efficacy, including 20% reduction in cardiovascular death.Cardiovascular benefits appeared not to be influenced significantly by triglyceride (TG) levels at baseline (135 mg/dL to 499 mg/dL baseline range) or as achieved at one year, suggesting mechanisms at work with use of Vascepa that are independent of triglyceride reduction. Results were robust across multiple subgroups, including in patients with and without diabetes at baseline. REDUCE-IT study results were simultaneously published in The New England Journal of Medicine and are available at nejm.org/doi/full/10.1056/NEJMoa1812792.  REDUCE-IT was a global study of 8,179 statin-treated adults with elevated CV risk. Many patients with well-managed LDL-C remain at high risk for cardiovascular events. No therapy is currently approved to treat the residual risk in REDUCE-IT patients and no other therapy has demonstrated a 25% risk reducti...


Posted: 2018-11-10 20:00:00

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