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Comparator: simvastatin
Simvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels.
Simvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels. Used for Hypercholesterolemia, Primary prevention of cardiovascular disease, Secondary prevention of cardiovascular events in patients with established coronary heart disease.
At a glance
| Generic name | Comparator: simvastatin |
|---|---|
| Also known as | Zocor®, MK0733 |
| Sponsor | Organon and Co |
| Drug class | HMG-CoA reductase inhibitor (statin) |
| Target | HMG-CoA reductase |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Simvastatin is a statin that competitively inhibits HMG-CoA reductase, blocking the conversion of HMG-CoA to mevalonate in the cholesterol biosynthetic pathway. This leads to decreased intracellular cholesterol production, upregulation of LDL receptors on hepatocytes, and increased clearance of LDL cholesterol from the bloodstream. The net result is a significant reduction in serum LDL cholesterol and triglycerides, with modest increases in HDL cholesterol.
Approved indications
- Hypercholesterolemia
- Primary prevention of cardiovascular disease
- Secondary prevention of cardiovascular events in patients with established coronary heart disease
Common side effects
- Myalgia (muscle pain)
- Elevated liver enzymes (ALT/AST)
- Headache
- Rhabdomyolysis (rare)
- Nausea
Key clinical trials
- Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival (NA)
- 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)
- Effectiveness of Two Approved Drugs in Lowering High Cholesterol (0733-224) (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)
- Aggrastat to Zocor (AtoZ) - the Use of Two Approved Drugs to Treat Patients Who Have Experienced Chest Pain or a Heart Attack (0733-180) (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: simvastatin CI brief — competitive landscape report
- Comparator: simvastatin updates RSS · CI watch RSS
- Organon and Co portfolio CI