Amarin Corp Plc (AMRN)

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Reduce-it had both Primary and Secondary patients, 70% were primary.


Study
REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl—Intervention Trial)


Design
Phase IIIb, multicenter, double-blind, placebo-controlled, randomized trial with parallel assignment



Inclusion Criteria
General Criteria
• ≥45 years with established CVD (Secondary Prevention Cohort) OR
≥50 years with diabetes mellitus and ≥1 additional risk factor for CVD (Primary Prevention Cohort)
• Fasting triglyceride levels ≥135 mg/dL and <500 mg/dL
• LDL-C >40 mg/dL and ≤100 mg/dL
• On stable statin therapy (with or without ezetimibe) for ≥4 weeks
Secondary Prevention Cohort (≥45 years with ≥1 of the following):
• Documented CAD (≥1 of the following):
o Documented multivessel CAD (≥50% stenosis in ≥2 major arteries, with or without revascularization) o Documented prior MI
o Hospitalization for high risk NSTE-ACS
• Documented cerebrovascular or carotid disease (≥1 of the following): o Prior ischemic stroke
o Symptomatic carotid artery disease with ≥50% carotid arterial stenosis o Asymptomatic carotid artery disease with ≥70% carotid arterial stenosis o History of carotid revascularization
• Documented PAD (≥1 of the following):
o Ankle-brachial index <0.9 with symptoms of intermittent claudication or o History of aortoiliac or peripheral arterial intervention
Primary Prevention Cohort (≥50 years with diabetes mellitus and ≥1 of the following additional risk factors for CVD):
• Men ≥55 years and women ≥65 years
• Cigarette smoker within three months
• Hypertension (SBP ≥140 mm Hg OR DBP ≥90 mm Hg)
• HDL-C ≤40 mg/dL for men or ≤50 mg/dL for women
• hsCRP >3 mg/L
• Renal dysfunction
• Retinopathy
• Micro- or macroalbuminuria
• Ankle-brachial index <0.9 without symptoms of intermittent claudication


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