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MK0733, 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 and dyslipidemia, Primary and secondary prevention of cardiovascular disease.
At a glance
| Generic name | MK0733, simvastatin |
|---|---|
| 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 enhanced 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 and dyslipidemia
- Primary and secondary prevention of cardiovascular disease
Common side effects
- Myalgia (muscle pain)
- Elevated liver enzymes (ALT/AST)
- Rhabdomyolysis (rare)
- Headache
- Gastrointestinal upset
Key clinical trials
- Study To Assess The Efficacy Of A Cholesterol Lowering Drug On Top Of Statins In Patients After Myocardial Infarction (MI)(0653A-150) (PHASE4)
- 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)
- To Evaluate the Lipid-Lowering Efficacy and Safety of Simvastatin 40 Mg Tablet In Patients With Hypercholesterolemia (0733-264) (PHASE4)
- A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED) (PHASE3)
- A Crossover Study to Evaluate the Efficacy of Simvastatin in Elevating HDL-C Levels in Patients With Type 2 Diabetes (0733-216)(COMPLETED) (PHASE3)
- EASEGO Study: Doubling of Atorvastatin/Simvastatin or INEGY in Patients With Hypercholesterolemia and Coronary Artery Disease(CAD)(0653A-089) (PHASE4)
- Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED) (PHASE4)
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 |