Amarin Corporation reports progress of REDUCE-IT cardiovascular outcomes study.

Amarin Corporation plc announced that its REDUCE-IT cardiovascular outcomes study involving Vascepa (icosapent ethyl) has reported and documented more than 90% of the targeted 1,612 primary major adverse cardiovascular events (MACE). The vast majority of these events have been confirmed (i.e., positively adjudicated as a patient's first on-study primary event) with some unable to be fully adjudicated per study protocol until after completion of the associated patients' final study visits.

For this first of its kind, potentially landmark, REDUCE-IT cardiovascular outcomes study, Amarin confirmed that it is on track for onset of the targeted 1,612th event to occur before the end of Q1 2018. Patients are being scheduled for final study visits commencing March 1, 2018. Amarin maintains its guidance to report top-line results from the study before the end of Q3 2018. 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 Brigham and Women's Hospital, professor of medicine, Harvard Medical School in Boston, Mass. 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 that the onset of the target final primary cardiovascular event will be reached before the end of Q1 2018, with results announced before the end of Q3 2018.