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Comparator: statins
Statins inhibit HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels.
Statins inhibit 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 | Comparator: statins |
|---|---|
| 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
Statins competitively block HMG-CoA reductase, which catalyzes the conversion of HMG-CoA to mevalonate in the cholesterol biosynthetic pathway. This leads to decreased hepatic cholesterol production, upregulation of LDL receptors on hepatocytes, and enhanced clearance of LDL from the bloodstream. The net effect is a reduction in circulating LDL cholesterol and associated cardiovascular risk.
Approved indications
- Hypercholesterolemia and dyslipidemia
- Primary and secondary prevention of cardiovascular disease
Common side effects
- Muscle pain or myalgia
- Elevated liver enzymes (ALT/AST)
- Rhabdomyolysis
- Headache
- Gastrointestinal upset
Key clinical trials
- Chaigui Longmu Ejiao Paste for Ischemic Heart Disease (PHASE2)
- ISCHEMIA-EXTEND (Extended Follow-up)
- DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction (PHASE3)
- Protocol for Improvement of Therapy With Warfarin (PHASE3)
- Study of an Approved Drug With a Statin (a Medication That Lowers Cholesterol Levels) as Compared to Statin Therapy Alone in Patients With High Cholesterol (0653-040) (PHASE3)
- A 12 Week Study of MK0653A in Patients Who Have Been Hospitalized for a Possible Heart Problem (0653A-808) (PHASE3)
- EASEGO Study: Doubling of Atorvastatin/Simvastatin or INEGY in Patients With Hypercholesterolemia and Coronary Artery Disease(CAD)(0653A-089) (PHASE4)
- Vytorin Treating Uncontrolled Lipids (VyTUL) Study (0653A-122) (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 |