Important New Data on Vascepa® (Icosapent Ethyl) from the REDUCE-IT™ Trial to Be Presented Regarding Reduction in Total Ischemic Events
Multiple Scientific Presentations Scheduled for
“Amarin remains committed to generating important new information about the epidemiology and treatment of patients with residual cardiovascular risk beyond LDL-C management to advance the medical community’s understanding of relevant factors to improve patient care,” said
Data to be presented includes:
Late-Breaking Clinical Trial
- Reduction in Total Ischemic Events with Icosapent Ethyl in REDUCE-IT™.
Deepak L. Bhatt, Philippe Steg, Michael Miller, Eliot Brinton, Terry Jacobson, Steven Ketchum, Ralph Doyle, Rebecca Juliano, Lixia Jiao, Craig Granowitz, Jean Claude Tardif, John Gregson, Stuart Pocock, and Christie Ballantyne, for the REDUCE-IT Investigators
Original Presentation 409-16.
March 18, 9:00 to 9:10 am Central Time(CT) in the Main Tent (Great Hall)
Follow-up, Deep Dive II Presentation 412-16.
March 18, 1:30 to 1:35pm Central Time(CT) in Room La Nouvelle C
- Eicosapentaenoic Acid Inhibits Membrane Lipid Oxidation in a Concentration-Dependent Manner at Pharmacologic Doses In Vitro.
R. Preston Mason, and Samuel C. R. Sherratt
Presentation 1180-452 / 452.
March 16, 3:45 PM - 4:30 PM CTin Poster Hall F
- Burden of Atherosclerotic Cardiovascular Disease Risk in Persons with Elevated Triglyceride Levels According to Statin Use.
Nathan D. Wong, Wenjun Fan, Sephy Philip, Craig Granowitz, and Peter Toth
Presentation 1178-417 / 417.
March 16, 3:45 PM - 4:30 PM CTin Poster Hall F
- Long-term Statin Persistence Is Poor Among High-Risk Patients with Baseline Peripheral Artery Disease: A Real-World Administrative Claims Analysis of the Optum Research Database.
Peter P. Toth, Craig Granowitz, Michael Hull, and Sephy Philip
Presentation 1134-435 / 435.
March 16, 10:00 AM - 10:45 AM CTin Poster Hall F
- Triglycerides as a Risk Factor for Coronary Heart Disease: What Measure and What Cutoff?
Ann Marie Navar, Neha Pagidipati, Hillary Mulder, Tsion Aberra, Sephy Philip, Craig Granowitz, and Eric Peterson
Presentation 1331-414 / 414.
March 18, 9:45 AM - 10:30 AM CTin Poster Hall F
- Increased Residual Cardiovascular Risk in US Veterans and Moderately-Elevated Baseline Triglycerides and Well-Controlled LDL-C Levels on Statins.
Sarah Leatherman, Ryan Ferguson, Isabelle Weir, Cynthia Hau, Craig Granowitz, Kelly Harrington, Sephy Philip, Peter Toth, Deepak L. Bhatt, and William Boden
March 18, 1:15 PM - 1:25 PM CTin Prevention Moderated Poster Theater Poster Hall F
Amarin Investor/Analyst Conference Call
This call will commence at the time shown above and will be accessible via webcast through the investor relations section of the company’s website at www.amarincorp.com. The call can also be heard via telephone by dialing 877-407-8033. A replay of the call will be made available for a period of two weeks following the conference call. To hear a replay of the call, dial 877-481-4010 (inside
REDUCE-IT1, an 8,179-patient cardiovascular outcomes study, was completed in 2018. REDUCE-IT was a multinational cardiovascular outcomes study that evaluated the effect of prescription pure
More information on the REDUCE-IT study results can be found at www.amarincorp.com.
About Cardiovascular Disease
Worldwide, cardiovascular disease (CVD) remains the #1 killer of men and women. In
Multiple primary and secondary prevention trials have shown a significant reduction of 25% to 35% in the risk of cardiovascular events with statin therapy, leaving significant persistent residual risk despite the achievement of target LDL-C levels.4
Beyond the cardiovascular risk associated with LDL-C, genetic, epidemiologic, clinical and real-world data suggest that patients with elevated triglycerides (TG) (fats in the blood), and TG-rich lipoproteins, are at increased risk for cardiovascular disease. 5, 6, 7, 8
About VASCEPA (icosapent ethyl) Capsules
Vascepa (icosapent ethyl) capsules are a single-molecule prescription product consisting of the omega-3 acid commonly known as
Indication and Usage Based on Current FDA-Approved Label (not including REDUCE-IT results)
- Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
- The effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information for Vascepa Based on Current FDA-Approved Label (not including REDUCE-IT results) (Includes Data from Two 12-Week Studies (n=622) (MARINE and ANCHOR) of Patients with Triglycerides Values of 200 to 2000 mg/dL)
- Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components.
- In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
- Use with caution in patients with known hypersensitivity to fish and/or shellfish.
- The most common reported adverse reaction (incidence >2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no reported adverse reaction >3% and greater than placebo.
- Adverse events and product complaints may be reported by calling 1-855-VASCEPA or the
FDAat 1-800- FDA-1088.
- Patients receiving treatment with Vascepa and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
- Patients should be advised to swallow Vascepa capsules whole; not to break open, crush, dissolve, or chew Vascepa.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the
This press release contains forward-looking statements, including statements related to timing and announcements with respect to the subject clinical data. 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 patents may not be upheld in patent litigation and applications may not result in issued patents sufficient to protect the Vascepa franchise.
Availability of Other Information About Amarin
Investors and others should note that
1 Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT, Juliano RA, Jiao L, Granowitz C, Tardif JC, Ballantyne CM. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med 2019;380:11-22.
4 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.
5 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
6 Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk.
7 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.
8 Nordestgaard BG, Varbo A. Triglycerides and cardiovascular disease. Lancet. 2014;384:626–635.
Amarin Contact Information
Investor Relations and Corporate Communications
In U.S.: +1 (908) 719-1315
firstname.lastname@example.org (investor inquiries)
PR@amarincorp.com (media inquiries)
In U.S.: +1 (646) 378-2992
Source: Amarin Corporation plc