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Comparator: ezetimibe and simvastatin
This is a fixed-dose combination of ezetimibe (which blocks cholesterol absorption in the intestine) and simvastatin (which inhibits HMG-CoA reductase to reduce cholesterol synthesis), working synergistically to lower LDL cholesterol.
This is a fixed-dose combination of ezetimibe (which blocks cholesterol absorption in the intestine) and simvastatin (which inhibits HMG-CoA reductase to reduce cholesterol synthesis), working synergistically to lower LDL cholesterol. Used for Hypercholesterolemia and mixed dyslipidemia.
At a glance
| Generic name | Comparator: ezetimibe and simvastatin |
|---|---|
| Sponsor | Organon and Co |
| Drug class | Combination lipid-lowering agent (ezetimibe + statin) |
| Target | NPC1L1 transporter (ezetimibe) and HMG-CoA reductase (simvastatin) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
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 a statin that competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in hepatic cholesterol synthesis. Together, they provide complementary mechanisms to achieve greater LDL-C reduction than either agent alone.
Approved indications
- Hypercholesterolemia and mixed dyslipidemia
Common side effects
- Myalgia
- Elevated liver enzymes
- Headache
- Abdominal pain
- Rhabdomyolysis (rare)
Key clinical trials
- Eze/Simva Switch Study in Diabetics (0653A-807) (PHASE3)
- Study Evaluating the Efficacy and Safety of Simvastatin Alone Compared With Simvastatin Plus Ezetimibe in Type 2 Diabetic Patients (0653-021)(COMPLETED) (PHASE3)
- A Study Comparing Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Patients at Risk for Heart Disease (0653-023)(COMPLETED) (PHASE3)
- Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Drugs in Patients With Elevated Cholesterol Levels (0653A-058) (PHASE3)
- Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025) (PHASE3)
- A Study to Evaluate Ezetimibe in Korean Patients With Primary Hypercholesterolemia (0653-042) (PHASE3)
- A Multicenter Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Products in Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia (MK-0653A-077) (PHASE3)
- A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED) (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:
- Comparator: ezetimibe and simvastatin CI brief — competitive landscape report
- Comparator: ezetimibe and simvastatin updates RSS · CI watch RSS
- Organon and Co portfolio CI