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Comparator: lovastatin
Lovastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels.
Lovastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels. Used for Hypercholesterolemia, Primary prevention of coronary heart disease, Secondary prevention of coronary heart disease.
At a glance
| Generic name | Comparator: lovastatin |
|---|---|
| Sponsor | Organon and Co |
| Drug class | Statin (HMG-CoA reductase inhibitor) |
| Target | HMG-CoA reductase |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Lovastatin is a competitive inhibitor of HMG-CoA reductase, which catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. By blocking this enzyme, lovastatin decreases intracellular cholesterol production, leading to upregulation of LDL receptors on hepatocytes and increased clearance of LDL cholesterol from the bloodstream. This results in significant reductions in serum LDL and total cholesterol levels.
Approved indications
- Hypercholesterolemia
- Primary prevention of coronary heart disease
- Secondary prevention of coronary heart disease
Common side effects
- Myalgia (muscle pain)
- Elevated liver enzymes (ALT/AST)
- Headache
- Rhabdomyolysis (rare)
- Gastrointestinal disturbance
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)
- A 12 Week Study of MK0653A in Patients Who Have Been Hospitalized for a Possible Heart Problem (0653A-808) (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)
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: lovastatin CI brief — competitive landscape report
- Comparator: lovastatin updates RSS · CI watch RSS
- Organon and Co portfolio CI