Vascepa® (Icosapent Ethyl) Showed Reductions in Potentially Atherogenic Lipid and Inflammatory Markers in Statin-Treated Patients with Reduced Kidney Function and Persistent High Triglycerides
The poster titled "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" showed that, consistent with overall ANCHOR study results, compared with placebo, icosapent ethyl (IPE) 4g/day significantly decreased the primary endpoint of triglycerides (TG) (−19.7%; P < 0.0001) and other lipids without increasing LDL-C. Apolipoproteins and markers of oxidation and inflammation were significantly improved. This poster was authored by:
The poster titled "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" showed that, consistent with overall ANCHOR study results, in statin-treated patients with reduced kidney function and elevated high-sensitivity C-reactive protein (hsCRP) with persistent high TG, IPE 4g/day reduced TG and other potentially atherogenic and inflammatory markers without raising low-density cholesterol vs. placebo. This poster was authored by:
Both posters reported data from post hoc analyses in statin-treated patients with reduced kidney function and diabetes or elevated hsCRP with persistent high (200-499 mg/dL) TG. In these patients, prescription pure EPA Vascepa® at 4g/day, compared to placebo, showed reductions in TG and other potentially atherogenic lipid and inflammatory markers.
"More research is needed in elucidating future CV risk in patients with reduced kidney function and high triglycerides despite statin therapy," said Harold M. Szerlip, MD. "The REDUCE-IT trial will enroll some patients with characteristics presented in these posters to determine if intervention with high dose, prescription pure EPA will reduce CV events in statin-treated patients with persistent hypertriglyceridemia. I look forward to learning the results of this important study."
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. 3, 4, 5, 6
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 and EPA, including implications about the potential clinical importance of the findings presented as well as statements concerning the REDUCE-IT cardiovascular outcomes study. These statements are not promises or guarantees related to the potential for favorable outcomes from the ongoing REDUCE-IT cardiovascular outcomes trial. As disclosed in 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,
3 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
4 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.
5 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.
6 Nordestgaard BG, Varbo A. Triglycerides and cardiovascular disease.
Amarin Contact Information
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