Phase 3
Completed N=8,179
A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin
Source: ClinicalTrials.gov NCT01492361 ↗Enrolled (actual)
8,179
Serious AEs
30.6%
Results posted
Apr 2022
Primary outcomePrimary: 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
◆ Published Evidence
Highly cited
3,255citations · ~465 / year
Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia.
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.
Linked Publications (5)
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Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia.
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Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT.
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REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States.
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Reduction in Revascularization With Icosapent Ethyl: Insights From REDUCE-IT Revascularization Analyses.
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REDUCE-IT INTERIM: accumulation of data across prespecified interim analyses to final results.
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 |
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
Data sourced from ClinicalTrials.gov (NCT01492361) and the linked publication. 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. Informational only — not medical advice.