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Guideline directed statin therapy
Statins inhibit HMG-CoA reductase to reduce cholesterol synthesis and lower LDL cholesterol levels in the blood.
Statins inhibit HMG-CoA reductase to reduce cholesterol synthesis and lower LDL cholesterol levels in the blood. Used for Primary prevention of atherosclerotic cardiovascular disease in high-risk patients, Secondary prevention of cardiovascular events in patients with established coronary artery disease or other atherosclerotic disease, Hyperlipidemia and dyslipidemia management.
At a glance
| Generic name | Guideline directed statin therapy |
|---|---|
| Sponsor | Samsung Medical Center |
| Drug class | HMG-CoA reductase inhibitor (statin) |
| Target | HMG-CoA reductase |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Statins competitively inhibit the enzyme HMG-CoA reductase, which catalyzes an early rate-limiting step in cholesterol biosynthesis. This leads to decreased intracellular cholesterol, upregulation of LDL receptors on hepatocytes, and increased clearance of LDL cholesterol from circulation. Guideline-directed statin therapy refers to evidence-based dosing and intensity recommendations for statin use based on cardiovascular risk stratification.
Approved indications
- Primary prevention of atherosclerotic cardiovascular disease in high-risk patients
- Secondary prevention of cardiovascular events in patients with established coronary artery disease or other atherosclerotic disease
- Hyperlipidemia and dyslipidemia management
Common side effects
- Muscle pain or myalgia
- Elevated liver enzymes
- Myopathy or rhabdomyolysis
- New-onset diabetes
- Headache
Key clinical trials
- ASpirin Use and stAtin Strategy for Primary Prevention in Severe Coronary Calcium Score on Computed Tomography (PHASE4)
- Diabetes-Centered Evaluation of Revascularization Strategy of Functional and Imaging-CombiNEd State-of-the-Art Percutaneous Coronary Intervention or Coronary-Artery Bypass Grafting in Patients With Diabetes Mellitus and Multivessel Coronary Artery Disease (NA)
- Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques (PHASE4)
- PCSK9 inhibitoRs for Early Passivation of coRonary athEroSclerotic plaqueS in Acute Coronary Syndromes (REPRESS) (NA)
- Statins for Treatment of Primary Intracerebral Hemorrhage (NA)
- RestoratIon of Myocardial Function by PeRcutaneous cOronary interVEntion in Patients With Ischemic CardioMyoPathy (NA)
- Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With STEMI (PHASE2)
- Polypill in Acute Coronary Syndrome (PHASE2)
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 |