Amarin Announces Presentation of MARINE and ANCHOR Analyses at the American Heart Association Scientific Sessions Showing Vascepa(R) Significantly Reduced Remnant-Like Particle Cholesterol in Hypertriglyceridemic Patients
Remnant-like particle cholesterol is an important emerging risk factor for cardiovascular disease and represents the cholesterol content of a subset of triglyceride-rich lipoproteins (TRL) called remnants. In the fasting state this subset of TRLs is comprised of very low-density lipoproteins (VLDL) and intermediate-density lipoproteins (IDL), and in the non-fasting state includes these two types of lipoproteins together with chylomicron remnants.1-3 Elevated plasma TG levels are a marker of elevated remnant cholesterol and are associated with increased risk for cardiovascular disease.4-6
"As we have seen in multiple studies to date, RLP-C is a significant predictor of cardiovascular disease, and is known to be atherogenic," said
MARINE and ANCHOR were each 12-week, double-blind phase 3 studies that randomized patients to Vascepa or placebo. MARINE randomized 229 patients with TG ≥ 500 and ≤ 2000 mg/dL, while ANCHOR randomized 702 patients at high risk for cardiovascular disease with TG ≥ 200 and < 500 mg/dL despite low-density lipoprotein cholesterol (LDL-C) control while on statin therapy. In the MARINE study, stable statin therapy was permitted but not required. In the ANCHOR study, patients were required to be at high risk for cardiovascular disease as defined by the NCEP ATP III guidelines and on stable statin dose (atorvastatin, rosuvastatin, or simvastatin).
These analyses assessed the median difference in percent change from baseline to study end in RLP-C levels compared with placebo. RLP-C levels were measured with an immunoseparation assay in 218 and 252 patients in MARINE and ANCHOR, respectively. Compared with placebo, Vascepa (4 g/day) significantly reduced median RLP-C levels by 29.8% (P=0.0041) and by 25.8% (P=0.0001) in the MARINE and ANCHOR studies, respectively. Compared with placebo, Vascepa (4 g/day) significantly reduced RLP-C in statin-treated patients in the MARINE study, significantly reduced RLP-C in patients receiving moderate- to high-intensity statins in the ANCHOR study, and significantly reduced RLP-C in subgroups with higher baseline TG levels in both studies. RLP-C reductions were seen to a greater extent in subgroups with higher baseline TG levels in both studies.
About Vascepa ® (icosapent ethyl) capsules
Vascepa® (icosapent ethyl) capsules, known in scientific literature as AMR101, is a highly-pure EPA omega-3 prescription product in a 1 gram capsule.
Indications 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 and should be used 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.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Vascepa is under various stages of development for potential use in indications that have not been approved by the
Amarin Corporation Plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids.
This press release contains forward-looking statements, including statements about the potential efficacy, safety and therapeutic benefits of
Availability of other information about Amarin
Investors and others should note that we communicate with our investors and the public using our company website (www.amarincorp.com), our investor relations website (http://www.amarincorp.com/investor-splash.html), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in Amarin to review the information that we post on these channels, including our investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
1. Nordestgaard BG, Benn M, Schnohr P, Tybjærg-Hansen A. Nonfasting triglycerides and risk of myocardial infarction, ischemic heart disease, and death in men and women. JAMA. 2007;298:299-308.
2. Chapman MJ, Ginsberg HN, Amarenco P. Triglyceride-rich lipoproteins and high-density lipoprotein cholesterol in patients at high risk of cardiovascular disease: evidence and guidance for management.
3. Varbo A, Benn M, Nordestgaard BG. Remnant cholesterol as a cause of ischemic heart disease: evidence, definition, measurement, atherogenicity, high risk patients, and present and future treatment. Pharmacol Ther. 2014;141:358-67.
4. Nguyen SV, Nakamura T,
5. Nordestgaard BG, Varbo A. Triglycerides and cardiovascular disease. Lancet. 2014;384:626-35.
6. Miller M, Stone NJ, Ballantyne C, et al. Triglycerides and cardiovascular disease: a scientific statement from the
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