Last reviewed · How we verify
Simvastatin/Ezetimibe
Simvastatin inhibits cholesterol synthesis while ezetimibe blocks dietary cholesterol absorption, together reducing LDL cholesterol levels.
Simvastatin inhibits cholesterol synthesis while ezetimibe blocks dietary cholesterol absorption, together reducing LDL cholesterol levels. Used for Hypercholesterolemia and dyslipidemia, Reduction of cardiovascular risk in patients with elevated cholesterol.
At a glance
| Generic name | Simvastatin/Ezetimibe |
|---|---|
| Also known as | Simvastatin/Ezetimibe (Zetia), Vytorin |
| Sponsor | dr.Frank L.J. Visseren |
| Drug class | Statin/Ezetimibe combination |
| Target | HMG-CoA reductase; NPC1L1 transporter |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Simvastatin is an HMG-CoA reductase inhibitor that decreases endogenous cholesterol production in the liver. Ezetimibe selectively inhibits cholesterol absorption in the small intestine by blocking the Niemann-Pick C1-like 1 (NPC1L1) transporter. The combination provides complementary mechanisms to achieve greater LDL-C reduction than either agent alone.
Approved indications
- Hypercholesterolemia and dyslipidemia
- Reduction of cardiovascular risk in patients with elevated cholesterol
Common side effects
- Myalgia
- Elevated liver enzymes
- Headache
- Abdominal pain
Key clinical trials
- Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer (PHASE2)
- Early Statin-Ezetimibe Combination vs. Statin Monotherapy in Stroke With Atherosclerosis (PHASE2)
- LATAM LOWERS LDL-C (PHASE4)
- Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
- Anti-inflammatory Effects of Simvastatin (PHASE4)
- A Study to Design a Model Cohort for Analysis of Dyslipidemia (MK-0653A-204)
- A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038) (PHASE3)
- Eze/Simva Switch Study in Diabetics (0653A-807) (PHASE3)
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:
- Simvastatin/Ezetimibe CI brief — competitive landscape report
- Simvastatin/Ezetimibe updates RSS · CI watch RSS
- dr.Frank L.J. Visseren portfolio CI