Alleine dies Meldung müsste Vascepa Zweistellig machen, unglaublich gute Wirkung:
VASCEPA® (Icosapent Ethyl) Found in Prespecified and Post Hoc Analyses to Significantly Reduce Stroke in At-Risk Patients in Analyses of Landmark REDUCE-IT® Study Presented at International Stroke Conference 2021
Amarin Corporation plc
Wed, March 17, 2021, 4:30 PM
28% and 32% significant reductions in first and total strokes, respectively, demonstrated with VASCEPA compared to placebo, as well as reductions in first and total ischemic strokes each by 36%, without increasing hemorrhagic stroke, in statin-treated patients with elevated cardiovascular risk
Consistent reductions in overall stroke and in ischemic stroke observed across multiple subgroups
Administration of pure icosapent ethyl, VASCEPA, represents a novel clinical approach to stroke reduction
REDUCE-IT® STROKE abstract receives prestigious Paul Dudley White International Scholar Award to recognize the authors with the highest ranked abstract from the United States at the International Stroke Conference 2021
DUBLIN, Ireland and BRIDGEWATER, N.J., March 17, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced the presentation of REDUCE-IT® STROKE at the International Stroke Conference 2021, being held virtually from March 17 – March 19, 2021, adding to the growing body of knowledge on the clinical impact of VASCEPA® (icosapent ethyl). These new analyses supported by Amarin were presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s Hospital, Harvard Medical School, Boston, MA.
“The REDUCE-IT STROKE analyses provide important data supporting a new approach to prevent strokes using icosapent ethyl in appropriate patients,” commented Dr. Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital, Professor of Medicine at Harvard Medical School, and principal investigator of REDUCE-IT. “The findings of benefit in at-risk patients include significant reductions in overall strokes and in ischemic strokes. Importantly, with respect to safety, we did not observe any significant increase in hemorrhagic stroke. These results further strengthen the case for pure eicosapentaenoic acid (EPA) in the form of prescription icosapent ethyl as a key intervention beyond statins for stroke prevention in studied patients.”
The REDUCE-IT STROKE analyses examined stroke rates across the enrolled patient population (n=8179). Enrolled patients were required to be treated with statins and other conventional therapies, and all patients had either established cardiovascular disease or diabetes and had other cardiovascular risk factors such as elevated triglyceride levels. Event rates for time to first fatal or nonfatal stroke were 2.4% for VASCEPA vs. 3.3% for placebo for a relative risk reduction (RRR) of 28% (p=0.01). Ischemic stroke time to first event rates were 2.0% for VASCEPA vs. 3.0% for placebo for a RRR of 36% (p=0.002). Hemorrhagic stroke occurred at low rates with no significant difference for VASCEPA vs. placebo (0.3% vs 0.2%; p=0.55).
Stroke is a major and often debilitating cardiovascular event significantly impacting not only patients and their loved ones, but also the healthcare system. Patients with elevated triglycerides despite statin therapy have increased risk for stroke-related events. Each year in the United States, about 795,000 people experience a new or recurrent stroke. Approximately 610,000 of these are first strokes, and 185,000 are recurrent strokes, or approximately 1 stroke every 40 seconds.1 The latest statistical update from the American Heart Association (AHA) shows that in the United States, the annual cost of stroke is $49.8 Billion.2
“Strokes significantly impact the healthcare system, driving substantial immediate and long-term costs,” said Steven Ketchum, Ph.D., senior vice president and president, research & development and chief scientific officer, Amarin. “The subgroup data presented at ISC 2021 provide new insight into the unique potential benefits of VASCEPA administration on alleviating the societal burden of strokes.”
The REDUCE-IT STROKE abstract received the prestigious Paul Dudley White International Scholar Award, recognizing the authors with the highest ranked abstract across the United States at the International Stroke Conference 2021. The esteemed Paul Dudley White Award is named in honor of one of Boston’s most revered cardiologists, Dr. Paul Dudley White, who was a founding father of the American Heart Association and an early leader in preventive cardiology.
REDUCE-IT was designed and powered for the primary composite endpoint, of which stroke was one of five prespecified components; it was not powered for subgroup analysis. Stroke was a prespecified secondary endpoint within the testing hierarchy; ischemic stroke was a prespecified tertiary endpoint; stroke subgroup analyses were post hoc. No information was collected on stroke related disability, such as Rankin scores.
Brigham and Women’s Hospital receives research funding from Amarin for Dr. Bhatt’s work as the REDUCE-IT study Chair.
Additional information on ISC 2021 can be found here.
Amarin is a rapidly growing, innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our scientific research foundation to our focus on clinical trials, and now our commercial expansion, we are evolving and growing. In 2009, Amarin had fewer than twenty employees. Today, with offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, and Zug in Switzerland, Amarin has approximately 1,000 employees and commercial partners and suppliers around the world. We are committed to rethinking cardiovascular risk through the advancement of scientific understanding of the impact on society of significant residual risk that exists beyond traditional therapies, such as statins for cholesterol management.
About Cardiovascular Risk
The number of deaths in the United States attributed to cardiovascular disease continues to rise. There are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds), in the United States. Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. Cardiovascular disease results in 859,000 deaths per year in the United States.1 In aggregate, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, one every 13 seconds in the United States alone.
Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.3 Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.4,5,6