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Fixed combination simvastatin/ezetimibe
This combination reduces cholesterol by blocking its synthesis in the liver (simvastatin) and inhibiting its absorption in the intestines (ezetimibe).
This combination reduces cholesterol by blocking its synthesis in the liver (simvastatin) and inhibiting its absorption in the intestines (ezetimibe). Used for Hypercholesterolemia and mixed dyslipidemia, Reduction of cardiovascular risk in patients requiring additional LDL-C lowering.
At a glance
| Generic name | Fixed combination simvastatin/ezetimibe |
|---|---|
| Sponsor | Novartis |
| Drug class | Statin/cholesterol absorption inhibitor combination |
| Target | HMG-CoA reductase (simvastatin); Niemann-Pick C1-like 1 protein (ezetimibe) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Simvastatin is an HMG-CoA reductase inhibitor that decreases hepatic cholesterol production, while ezetimibe selectively inhibits cholesterol absorption at the intestinal brush border. Together, they provide complementary lipid-lowering effects, reducing both endogenous and dietary cholesterol levels more effectively than either agent alone.
Approved indications
- Hypercholesterolemia and mixed dyslipidemia
- Reduction of cardiovascular risk in patients requiring additional LDL-C lowering
Common side effects
- Myalgia
- Elevated liver enzymes
- Headache
- Gastrointestinal disturbance
- Rhabdomyolysis (rare)
Key clinical trials
- Early Statin-Ezetimibe Combination vs. Statin Monotherapy in Stroke With Atherosclerosis (PHASE2)
- A Study to Design a Model Cohort for Analysis of Dyslipidemia (MK-0653A-204)
- Clinical Study to Evaluate Adherence Improvement Fixed-dose Combination of Olostar Tab. in Patients With Hypertension and Dyslipidemia (PHASE4)
- Efficacy of Fluvastatin and Fenofibrate in Comparison to Simvastatin and Ezetimibe in Patients With Metabolic Syndrome (PHASE4)
- Efficiency of Rosuvastatin Versus the Fixed Combination of Ezetimibe/Simvastatin in Outpatients
- A Clinical Trial Comparing Torcetrapib/Atorvastatin to Ezetimibe/Simvastatin In Subjects With A Cholesterol Disorder. (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 |