Phase 3 N=8,179 Randomized Triple-blind Prevention

A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin

Cardiovascular Diseases

Bottom Line

View on ClinicalTrials.gov: NCT01492361 ↗

Enrolled (actual)

8,179

Serious AEs

30.6%

Results posted

Apr 2022

Primary outcome: Primary: Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization. — 705; 901 Participants — p=0.00000001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: AMR101 (Drug); Placebo (Drug); Statin therapy (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Amarin Pharma Inc.
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.	705; 901	0.00000001 sig
SECONDARY Composite of CV Death, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.	459; 606	0.0000006 sig
SECONDARY Composite of CV Death or Nonfatal MI (Including Silent MI).	392; 507	<0.0001 sig
SECONDARY Fatal or Nonfatal MI (Including Silent MI).	250; 355	<0.0001 sig
SECONDARY Non-elective Coronary Revascularization Represented as the Composite of Emergent or Urgent Classifications.	216; 321	<0.0001 sig
SECONDARY CV Death.	174; 213	0.0315 sig
SECONDARY Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.	108; 157	0.0018 sig
SECONDARY Fatal or Nonfatal Stroke.	98; 134	0.0129 sig
SECONDARY Total Mortality, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.	549; 690	<0.0001 sig
SECONDARY Total Mortality.	274; 310	0.0915

Summary

AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) developed by Amarin Pharma Inc. for the treatment of cardiovascular disease in statin-treated patients with hypertriglyceridemia. The purpose of this study was to evaluate whether this drug, combined with a statin therapy, will be superior to the statin therapy alone, when used as a prevention in reducing long-term cardiovascular events in high-risk patients with mixed dyslipidemia.

Eligibility Criteria

Inclusion Criteria

Men and non-pregnant or sterile women ages 45 and older
Hypertriglyceridemia
On statin therapy for at least four weeks
Either having established cardiovascular disease or at high risk for cardiovascular disease

Exclusion Criteria

Severe heart failure
Any life-threatening disease other than cardiovascular disease
Active severe liver disease
Hemoglobin A1c >10.0%
Poorly controlled hypertension
Planned coronary intervention (such as stent placement or heart bypass) or any non-cardiac major surgical procedure
Known familial lipoprotein lipase deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III)
Known hypersensitivity to the study product, fish and/or shellfish, or placebo
History of acute or chronic pancreatitis
Patients are excluded if using the following medications:
PCSK9 inhibitors
niacin >200 mg/day or fibrates;
any omega-3 fatty acid medications ;
dietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil, krill oil, or algal oil);
bile acid sequestrants

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01492361). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.