Vascepa® (Icosapent Ethyl) Showed Reductions in Potentially Atherogenic Lipid Parameters in Statin-Treated Women With Type 2 Diabetes and Persistent High Triglycerides
- A post-hoc analysis of the ANCHOR study further characterizing the efficacy and safety of prescription pure EPA Vascepa® (icosapent ethyl) in the subgroup of statin-treated women with persistent high triglycerides and diabetes mellitus type 2, showed that, compared with placebo, Vascepa reduced triglyceride levels and several other potentially atherogenic lipid parameters and inflammatory markers, and significantly increased blood EPA levels. The study titled, "Icosapent Ethyl in Statin-Treated Women with Persistent High Triglycerides and Diabetes Mellitus: ANCHOR Study Subanalysis," was led by
Eliot A. Brinton, MD, FAHA, FNLA.
- An in vitro mechanistic study suggesting that EPA may be a potential strategy for reducing blood vessel cell dysfunction is summarized in a published presentation, "Eicosapentaenoic Acid
Reduces Small Dense Low-Density Lipoprotein Oxidation and Human Endothelial Dysfunction in Vitro in a Manner Distinct from Docosahexaenoic Acid," by
R. Preston Mason, PhD. The data demonstrated that EPA has antioxidant properties, distinct from DHA, that preserves certain cellular functions within blood vessel cells under disease-like conditions.
"Amarin continues to invest in research into the management of lipid disorders and patients at high risk of cardiovascular disease," expressed
The ANCHOR study analysis was conducted in light of the correlation between elevated triglycerides and diabetes in women. The
As is typical with subgroup analyses, limitations of the ANCHOR data analysis include the relatively small sample size (n=146), the 12-week study length and the post-hoc study design. Nonetheless, the results show potentially valuable changes in triglyceride levels and other lipoprotein parameters and inflammatory markers with Vascepa compared with placebo. The efficacy and safety of Vascepa 4 g/day in women were consistent with the overall ANCHOR study results. Limitations of the mechanistic study data include the simplistic and hypothesis-generating nature of in vitro data.
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 (200-499 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. Amarin recently announced that the REDUCE-IT study reached the onset of approximately 80% of the target aggregate number of primary cardiovascular events and that preparations are underway for an associated pre-specified interim efficacy analysis by the independent
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
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 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 small sample sizes may not be predictive of future results in larger studies and that studied parameters may not have clinically meaningful effect. 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 we communicate with our investors and the public using our company website (www.amarincorp.com), our investor relations website (http://investor.amarincorp.com), including but not limited to investor presentations and investor FAQs,
Amarin Contact Information Investor Relations:
Elisabeth SchwartzInvestor Relations and Corporate Communications Amarin Corporation plcIn U.S.: +1 (908) 719-1315 email@example.com Lee M. Stern Trout GroupIn U.S.: +1 (646) 378-2992 firstname.lastname@example.org Media Inquiries: Ovidio Torres Finn PartnersIn U.S.: +1 (312) 329 3911 Ovidio.email@example.com
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