VASCEPA® (icosapent ethyl) CV Outcomes Trial Results
Free handout provided by Amarin Pharma, Inc.
The effects of VASCEPA® (icosapent ethyl) on the prevention of cardiovascular events was evaluated in a multi-center, double-blind, randomized, placebo-controlled, event-driven trial (REDUCE-IT) in 8,179 adult patients at LDL-C goal, with established cardiovascular disease (CVD) or at high risk for CVD, and hypertriglyceridemia (fasting TG ≥135 and <500 mg/dL).
REDUCE-IT results were first presented as a late-breaker on November 10, 2018 in Chicago, Illinois and concurrently published online. See the publication at www.NEJM.org(www.nejm.org).
FDA has not reviewed and opined on a supplemental new drug application related to REDUCE-IT. FDA has thus not reviewed the information herein or determined whether to approve VASCEPA for use to reduce the risk of major adverse cardiovascular events in the REDUCE-IT patient population. This information is intended to ensure Amarin meets its continuing obligation to update healthcare professionals regarding off-label use of VASCEPA to assure that its communications remain truthful and non-misleading, consistent with the federal court approved settlement under Amarin Pharma, Inc. et al. v. United States Food and Drug Administration et al., 119 F.Supp.3d 196, 236 (S.D.N.Y. 2015).
FDA-Approved Indication and Limitations of Use for VASCEPA
- VASCEPA® (icosapent ethyl) is indicated as an adjunct to diet to reduce TG levels in adult patients with severe (>500 mg/dL) hypertriglyceridemia
- In patients with severe hypertriglyceridemia, the effect of VASCEPA on cardiovascular mortality or morbidity or on the risk of pancreatitis has not been determined
Important Safety Information for VASCEPA from FDA-Approved Label Data from Two 12-Week Studies (MARINE and ANCHOR) of Patients with TG Values of 200 to 2000 mg/dL (n=622 on VASCEPA, n=309 on placebo)
- 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% VASCEPA, 1.0% placebo)
- Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 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
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