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Ezetimibe + Simvastatin
Ezetimibe and simvastatin work together to lower cholesterol by blocking intestinal cholesterol absorption and inhibiting hepatic cholesterol synthesis.
Ezetimibe and simvastatin work together to lower cholesterol by blocking intestinal cholesterol absorption and inhibiting hepatic cholesterol synthesis. Used for Hypercholesterolemia and mixed dyslipidemia, Cardiovascular risk reduction in patients requiring additional LDL-C lowering.
At a glance
| Generic name | Ezetimibe + Simvastatin |
|---|---|
| Also known as | SCH 58235, Vytorin®, MK653A, MK0653A, Zetia |
| Sponsor | Organon and Co |
| Drug class | Combination lipid-lowering agent (ezetimibe + statin) |
| Target | NPC1L1 transporter (ezetimibe); HMG-CoA reductase (simvastatin) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Ezetimibe selectively inhibits the Niemann-Pick C1-like 1 (NPC1L1) transporter in the intestinal brush border, reducing dietary and biliary cholesterol absorption. Simvastatin is an HMG-CoA reductase inhibitor that blocks the rate-limiting enzyme in hepatic cholesterol synthesis. Together, they provide complementary mechanisms to reduce LDL cholesterol levels more effectively than either agent alone.
Approved indications
- Hypercholesterolemia and mixed dyslipidemia
- Cardiovascular risk reduction in patients requiring additional LDL-C lowering
Common side effects
- Myalgia
- Elevated liver transaminases
- Headache
- Abdominal pain
- Rhabdomyolysis (rare)
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:
- Ezetimibe + Simvastatin CI brief — competitive landscape report
- Ezetimibe + Simvastatin updates RSS · CI watch RSS
- Organon and Co portfolio CI