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Topline results from the REDUCE-IT trial, currently exploring the potential cardiac benefits of&nbsp;icosapent&nbsp;ethyl ( Vascepa, Amarin) for use in statin-controlled patients with elevated triglycerides,&nbsp;has met its primary efficacy and safety endpoints, according to a press release from its manufacturer, Amarin.&nbsp;The researchers for the REDUCE-IT study enrolled patients with LDL-C levels between 41 and 100 mg/dL who were taking statins and presented with cardiovascular risk factors such as elevated triglycerides (between 150 and 499 mg/dL) and either established cardiovascular disease or diabetes mellitus and at least one other cardiovascular risk factor. Patients were randomized&nbsp;1:1 and&nbsp;assigned to receive a stable statin plus&nbsp;Vascepa&nbsp;4 g/day or stable statin plus placebo.&nbsp;The&nbsp;study included a total of 8,179 patients. The primary study endpoint was a composite&nbsp;of major&nbsp;adverse cardiac events (MACE), including&nbsp;cardiovascular&nbsp;death, nonfatal myocardial infarction, nonfatal stroke, coronary&nbsp;revascularization, or unstable angina&nbsp;requiring&nbsp;hospitalization.&nbsp;According to the&nbsp;preliminary&nbsp;study&nbsp;results reported&nbsp;by the manufacturer, the study met its primary efficacy endpoint, with an approximately 25% reduction in relative risk for MACE reported for the intent-to-treat population (P&lt;0.001). Efficacy was demonstrated across the secondary endpoints&nbsp;as&nbsp;well. In addition, the study also met its primary safety endpoint; the drug was well-tolerated, with similar adverse event rates&nbsp;reported&nbsp;between study groups.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&ldquo;I look forward to the publication of these detailed REDUCE-IT results in a major peer-reviewed journal and to presenting them at the AHA in November,&rdquo; stated Deepak L. Bhatt, MD, MPH, Professor of Medicine at Harvard Medical School, Executive Director of Interventional Cardiovascular Programs at the Heart and Vascular Center at Brigham and Women&rsquo;s Hospital, and the Principal Investigator and Steering Committee Chair for REDUCE-IT, said in a press release.&nbsp;The study has been accepted for presentation as a late-breaking clinical trial, and complete results will be reported at the American Heart Association 2018 Scientific Sessions in Chicago on November 10.&nbsp;&nbsp;Source:<a href="https://investor.amarincorp.com/news-releases/news-release-details/reduce-ittm-cardiovascular-outcomes-study-vascepar-icosapent"> Amarin Press Release </a>

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Topline results from the REDUCE-IT trial, currently exploring the potential cardiac benefits of icosapent ethyl ( Vascepa, Amarin) for use in statin-controlled patients with ...

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