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Comparator: atorvastatin
Atorvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels.
Atorvastatin 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, Reduction of risk of myocardial infarction and stroke.
At a glance
| Generic name | Comparator: atorvastatin |
|---|---|
| Also known as | Lipitor®, atorvastatin, Lipitor ® |
| Sponsor | Organon and Co |
| Drug class | HMG-CoA reductase inhibitor (statin) |
| Target | HMG-CoA reductase |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Atorvastatin competitively inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, a key enzyme in the mevalonate pathway responsible for de novo cholesterol synthesis in the liver. By reducing intracellular cholesterol levels, the drug upregulates LDL receptors on hepatocytes, increasing clearance of LDL cholesterol from the bloodstream. This leads to significant reductions in serum LDL cholesterol and triglycerides, with modest increases in HDL cholesterol.
Approved indications
- Hypercholesterolemia and dyslipidemia
- Primary and secondary prevention of cardiovascular disease
- Reduction of risk of myocardial infarction and stroke
Common side effects
- Myalgia (muscle pain)
- Elevated liver transaminases
- Headache
- Rhabdomyolysis (rare)
- Nausea
Key clinical trials
- Eze/Simva Switch Study in Diabetics (0653A-807) (PHASE3)
- An Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-804)(COMPLETED) (PHASE3)
- Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-803) (PHASE3)
- Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025) (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)
- EASEGO Study: Doubling of Atorvastatin/Simvastatin or INEGY in Patients With Hypercholesterolemia and Coronary Artery Disease(CAD)(0653A-089) (PHASE4)
- Cholesterol Lowering Level of MK0653A+Simvastatin in Patients With Hypercholesterolemia and Atherosclerotic or Coronary Vascular Disease (0653A-806)(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: atorvastatin CI brief — competitive landscape report
- Comparator: atorvastatin updates RSS · CI watch RSS
- Organon and Co portfolio CI