Amarin's REDUCE-IT Cardiovascular Outcomes Study Reaches 90% Mark for Reported Primary Events
BEDMINSTER, N.J. and DUBLIN,
"We are pleased to be nearing conclusion of this important study," commented Dr. Steven Ketchum, Amarin senior vice president, president of R&D, and chief scientific officer. "The timing of accumulated events in this study and the scheduling of final patient visits are two important steps towards learning the results of this study and understanding the extent to which Vascepa and the REDUCE-IT trial results can lead to better informed preventative care of patients at high cardiovascular risk."
Amarin is intentionally blinded to the results of the study and will remain blinded to such results until after the study is completed and the database is locked. Final patient visits will be followed by adjudication of newly reported cardiovascular events in the study, completing data entry for the greater than 33,000 patient years of study in
REDUCE-IT, and typical database quality control measures, known as cleaning. This will be followed by the database lock and final efficacy and safety analyses, including analysis of the trial's primary endpoint of first MACE events in the study, and the analyses of more than thirty pre-defined secondary and tertiary endpoints. Publication of the study design can be found at https://doi.org/10.1002/clc.22692. The lead author of this paper published in Clinical Cardiology is Deepak L. Bhatt, M.D., M.P.H., executive director of the Interventional Cardiovascular Programs at
The estimate of timing of the onset of the 1,612th MACE event is based on actual adjudicated events from inception to date in the study. The projection of the number of MACE events that will ultimately be adjudicated as a primary event (first event for the patient within the duration of the study) is also based on historical data of adjudicated events within the REDUCE-IT study. Such projections are made by independent statisticians and reviewed by Amarin and the independent steering committee for the trial, all of whom are blinded. The study was designed to provide sufficient power to detect the anticipated result, regardless of whether the final number of primary MACE is slightly more or slightly fewer than 1,612 primary MACE.
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
press release contains forward-looking statements, including statements related to the REDUCE-IT cardiovascular outcomes study including expectations for timing of last patient visits, continued event rates, results and the timing for related announcements of such events; expectations related to the sufficiency of statistical measures and protocols; expectations with respect to the successful completion of the REDUCE-IT study; and statements regarding the potential efficacy, safety and therapeutic benefits of Vascepa. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. In particular, as disclosed in its filings with the
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Amarin Contact Information
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