Amarin Sponsors Two Scientific Presentations Scheduled for National Kidney Foundation 2018 Spring Clinical Meetings
Reduced kidney function in conjunction with diabetes mellitus or ongoing inflammation, as denoted by elevated high sensitivity C-reactive protein (hsCRP) levels, in patients with persistent high triglycerides (TG) despite statin therapy are associated with increased cardiovascular disease (CVD) risk.1, 2 The data being presented report that, consistent with overall study results from the ANCHOR trial, in post hoc analyses in statin-treated patients with reduced kidney function and diabetes or elevated hsCRP, prescription pure EPA Vascepa® at 4g/day, compared to placebo, showed reductions in persistent high (200-499 mg/dL) TG and other potentially atherogenic and inflammatory markers. The clinical relevance of these data has not been determined. Amarin's REDUCE-IT trial is evaluating the potential benefit of icosapent ethyl on CV outcomes in statin-treated patients with high CV risk, including some patients with reduced kidney function and diabetes or elevated hsCRP. Further study is warranted in the millions of Americans with diabetes and kidney disease with ongoing inflammation.
Data to be presented include:
- Icosapent Ethyl Reduces Potentially Atherogenic Lipid and Inflammatory Markers in High-Risk Statin-Treated Patients With Persistent High Triglycerides, eGFR < 90 mL/min/1.73 m2, and Diabetes Mellitus
H.M. Szerlip, K. Vijay, C.M. Ballantyne, H.E. Bays, C. Granowitz, R.T. Doyle, R.A. Juliano, S. Philip
- Icosapent Ethyl Reduces Potentially Atherogenic Lipid and Inflammatory Markers in High-Risk Statin-Treated Patients With Persistent High Triglycerides, eGFR < 90 mL/min/1.73 m2, and Elevated High-Sensitivity C-Reactive Protein ≥2.0 mg/L
K. Vijay, H.M. Szerlip, C.M. Ballantyne, JR Nelson, C. Granowitz, R.T. Doyle, R.A. Juliano, S. Philip
"Amarin is excited to present some of the latest insights on the effects of icosapent ethyl, prescription pure EPA at 4g/day in patients with reduced kidney function and diabetes or ongoing inflammation," said
Amarin's clinical development program for Vascepa includes a trial known as the REDUCE-IT cardiovascular outcomes study, an 8,175-patient study commenced in 2011. REDUCE-IT is the first multinational cardiovascular outcomes study evaluating the effect of prescription pure EPA therapy, or any triglyceride lowering therapy, as an add-on to statins in patients with high cardiovascular risk who, despite stable statin therapy, have elevated triglyceride levels (150-499 mg/dL). A large portion of the male and female patients enrolled in this outcomes study are anticipated to also be diagnosed with type 2 diabetes. As reported previously, Amarin expects to announce top-line results of this important study before the end of Q3 2018. The REDUCE-IT trial is being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration.
Additional information on clinical studies of Vascepa can be found at www.clinicaltrials.gov.
About VASCEPA® (icosapent ethyl) Capsules
Vascepa® (icosapent ethyl) capsules are a single-molecule prescription product consisting of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa is not fish oil, but is derived from fish through a stringent and complex
FDA-Approved Indication and Usage
- 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
- Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components.
- 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.
- Patients receiving treatment with Vascepa and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
- In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
- Patients should be advised to swallow Vascepa capsules whole; not to break open, crush, dissolve, or chew Vascepa.
- Adverse events and product complaints may be reported by calling 1-855-VASCEPA or the
FDAat 1-800- FDA-1088.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the
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.5, 6, 7, 8
Leading clinical investigations seeking to address cardiovascular risk reduction beyond lowering LDL-C focus on interrupting the atherosclerotic process (e.g., plaque formation and instability) by beneficially affecting other lipid, lipoprotein and inflammation biomarkers and cellular functions thought to be related to atherosclerosis and cardiovascular events.
This press release contains forward-looking statements, including statements about the potential efficacy and therapeutic benefits of Vascepa, including statements about the unknown clinical relevance of the findings presented as well as statements concerning the REDUCE-IT cardiovascular outcomes study such as the anticipated inclusion of certain patient populations, related timing and announcements with respect to final outcomes and the anticipated successful completion of the REDUCE-IT study. 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 uncertainties associated generally with retrospective subset analyses, research on biomarkers thought to be relevant in the treatment of cardiovascular disease, research and development and clinical trial risk generally, including the risk that study results in modest sample sizes may not be predictive of future results in larger studies, that studied parameters may not have clinically meaningful effect and the risk that patents may not adequately protect Vascepa against competition. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the
Availability of Other Information About Amarin
Investors and others should note that Amarin communicates with its investors and the public using the company website (http://www.amarincorp.com/), the investor relations website (http://investor.amarincorp.com/), including but not limited to investor presentations and investor FAQs,
1 Palsson R, et al. Adv Chronic Kidney Dis. 2014. Gansevoort RT, et al.
2 Stuveling EM, et al. Kidney Int. 2003
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 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.
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.
Amarin Contact Information
Investor Relations and Corporate Communications
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