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Omacor + simvastatin
Omacor (omega-3 fatty acids) reduces triglycerides and supports cardiovascular health, while simvastatin lowers LDL cholesterol by inhibiting HMG-CoA reductase.
Omacor (omega-3 fatty acids) reduces triglycerides and supports cardiovascular health, while simvastatin lowers LDL cholesterol by inhibiting HMG-CoA reductase. Used for Hypertriglyceridemia in patients requiring statin therapy, Dyslipidemia with elevated triglycerides and LDL cholesterol.
At a glance
| Generic name | Omacor + simvastatin |
|---|---|
| Also known as | Omega-3-acid ethyl esters, Lovaza, Zocor |
| Sponsor | Provident Clinical Research |
| Drug class | Omega-3 fatty acid + HMG-CoA reductase inhibitor (statin) |
| Target | VLDL production pathway (Omacor); HMG-CoA reductase (simvastatin) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Omacor is a prescription-strength omega-3 polyunsaturated fatty acid (icosapent ethyl and docosahexaenoic acid) that reduces plasma triglycerides through multiple pathways including reduced hepatic VLDL production. Simvastatin is a statin that competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol and cardiovascular risk. The combination addresses multiple lipid abnormalities in dyslipidemic patients.
Approved indications
- Hypertriglyceridemia in patients requiring statin therapy
- Dyslipidemia with elevated triglycerides and LDL cholesterol
Common side effects
- Myalgia
- Elevated liver enzymes
- Gastrointestinal upset
- Rhabdomyolysis (rare)
Key clinical trials
- An Open-label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin (PHASE4)
- Women With Chest Pain and Normal Coronary Arteries Study (NA)
- Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL) (PHASE3)
- Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL (PHASE3)
- A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin (PHASE3)
- Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects (PHASE3)
- Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects (PHASE3)
- Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Omacor + simvastatin CI brief — competitive landscape report
- Omacor + simvastatin updates RSS · CI watch RSS
- Provident Clinical Research portfolio CI