Amarin announces presentation of latest clinical research evaluating VASCEPA
Amarin supported new data, presented at ESC Congress 2020, the annual meeting of the European Society of Cardiology (ESC), held from August 29 - September 1, adding to the growing body of knowledge on VASCEPA (icosapent ethyl) in patients at risk for major adverse cardiovascular events. Data presented include:
- In key data from the EVAPORATE study presented at the ESC Congress 2020 by Matthew Budoff, M.D., The Lundquist Institute, VASCEPA demonstrated significant, 17% regression of low attenuation plaque (LAP) volume on multidetector computed tomography (MDCT) compared with placebo over 18 months.
- There were significant differences between icosapent ethyl and placebo at study end for secondary endpoints of other types of plaque volume changes, including and sequentially total, total non-calcified, fibrofatty, and fibrous plaque volumes. All of these forms of coronary plaque regressed in the icosapent ethyl group and progressed in the placebo group. The only secondary endpoint which did not achieve a significant difference between groups in multivariable modeling was dense calcium .
- The presentation "REDUCE-IT: Accumulation of Data Across Prespecified Interim Analyses to Final Results", presented on behalf of all authors by Brian Olshansky, M.D., University of Iowa, was the first presentation of results from the pre-specified interim analyses for the landmark REDUCE-IT cardiovascular outcomes study.
- An independent, unblinded Data and Safety Monitoring Committee performed interim analyses of data during the REDUCE-IT cardiovascular outcomes study at approx. 60% and 80% (2.9 and 3.7 years of median primary endpoint follow-up, respectively), with a final analysis at 4.9 years median follow-up. Highly statistically significant outcomes were achieved for both primary and key secondary composite endpoints at the first interim, persisted at the second interim, and fully evolved at the final analysis. Consistent, statistically significant outcome measures demonstrating the robust and early benefit of icosapent ethyl were evident for the primary composite endpoint starting at 21 months, and for the key secondary composite endpoint at 25 months.
- VASCEPA demonstrated significantly greater benefits in total (first and subsequent) cardiovascular events vs. placebo across studied baseline statin types and prespecified baseline levels of triglycerides, LDL-C, and hsCRP and in patients with or without low HDL-C and elevated triglycerides at baseline.
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