Amarin Schedules Webcast Discussion of Primary REDUCE-IT™ Trial Results Following Presentation at 2018 Scientific Sessions of American Heart Association
Webcast to Commence at
- Presentation of REDUCE-IT clinical trial results:
Saturday, Nov. 10, 2018at 2:18 p.m. Central Time(CT) / 3:18 p.m. Eastern Time(ET) Amarininvestor/analyst conference call to discuss REDUCE-IT results: Saturday, Nov. 10, 2018at 7:15 p.m. CT/ 8:15 p.m. ET
- Continuing medical education programs with REDUCE-IT on the agenda (the curriculum of which is developed independently of
Amarin): Sunday, Nov. 11, 2018at 6:30 p.m. CT/ 7:30 p.m. ETand Monday, Nov. 12, 2018at 6:00 a.m. CT/ 7:00 a.m. ET
Presentation of REDUCE-IT Clinical Results
Presentation of REDUCE-IT primary clinical trial results is classified by the AHA as late-breaking clinical trial results and listed as Main Event 1 for timeframe described above. A link to the notice of this presentation is provided at:
The AHA makes available a live stream and archived webcast of the REDUCE-IT primary clinical trial results presentation at:
In connection with the presentation of such results,
Presentation of the REDUCE-IT clinical trial results is scheduled immediately following presentation and discussion of results from a clinical trial known as VITAL. VITAL is an NIH-funded trial of vitamin D3 and 1 gram of an omega-3 mixture (prescription Lovaza) for the primary prevention of cancer and cardiovascular disease in a nationwide
Amarin Investor/Analyst Conference Call
This call will commence at the time shown above. The webcast will be accessible 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
Investors and analysts who are attending AHA and who wish to attend this meeting in person should inform
Continuing Medical Education Programs
Two live independently conducted continuing education programs for healthcare professionals are scheduled during AHA with discussion of REDUCE-IT results known to be part of their curriculum. Space in these CME programs is limited. Information regarding these CME programs is available via the websites of the organizers of the programs. Accessibility to such programs via webcast live or on an enduring basis is being evaluated by the organizers. The organizers are Medtelligence and
The REDUCE-IT cardiovascular outcomes study commenced in 2011, enrolled and followed 8,179 randomized patients, and was conducted based on a special protocol assessment agreement with
REDUCE-IT is the first global cardiovascular outcomes study to prospectively evaluate the effect of Vascepa, or any therapy, in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated TGs between 150-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other CV risk factor (primary prevention cohort). The design of the REDUCE-IT cardiovascular outcomes study was published in
The REDUCE-IT hypothesis tested whether additional cardiovascular risk reduction beyond LDL-C controlled with statin therapy could be achieved in high risk patients with the putative cardioprotective effects of Vascepa 4 grams/day. Independent of REDUCE-IT,
About Cardiovascular Disease
Worldwide, cardiovascular disease (CVD) remains the #1 killer of men and women. In
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.9, 10, 11, 12
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 expectations regarding scientific presentation. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. In addition,
Availability of Other Information About Amarin
Investors and others should note that
1 Bhatt DL, Steg PG, Brinton EA, Jacobson TA, Miller M, Tardif J-C, Ketchum SB, Doyle RT Jr,
2 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.
3 Borow KM, Nelson JR, Mason RP. Biologic plausibility, cellular effects, and molecular mechanisms of eicosapentaenoic acid (
4 Nelson JR, Wani O, May HT, et al. Potential benefits of eicosapentaenoic acid on atherosclerotic plaques. Vascul Pharmacol. 2017;91:1–9.
5 Mason RP, Dawoud H, Jacob RF, et al. Eicosapentaenoic acid improves endothelial function and nitric oxide bioavailability in a manner that is enhanced in combination with a statin. Biomed Pharmacother. 2018;103:1231-1237.
6 Takamura M, Kurokawa K, Ootsuji H, et al. Long-term administration of eicosapentaenoic acid improves post-myocardial infarction cardiac remodeling in mice by regulating macrophage polarization.
9 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
10 Toth PP, Granowitz C, Hull M, et al. High triglycerides increase cardiovascular events, medical costs, and resource utilization in a real-world analysis of statin-treated patients with high cardiovascular risk and well-controlled low-density lipoprotein cholesterol [abstract]. Circulation. 2017;136(suppl 1):A15187.
11 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.
12 Nordestgaard BG, Varbo A. Triglycerides and cardiovascular disease. Lancet. 2014; 384: 626–635.
Amarin Contact Information
Investor Relations and Corporate Communications
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In U.S.: +1 (646) 378-2992
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Source: Amarin Corporation plc