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High intensity statin monotherapy
High-intensity statin monotherapy reduces LDL cholesterol by inhibiting HMG-CoA reductase, the rate-limiting enzyme in hepatic cholesterol synthesis.
High-intensity statin monotherapy reduces LDL cholesterol by inhibiting HMG-CoA reductase, the rate-limiting enzyme in hepatic cholesterol synthesis. Used for Primary prevention of atherosclerotic cardiovascular disease in high-risk patients, Secondary prevention following acute coronary syndrome or established coronary artery disease, Reduction of LDL cholesterol in hyperlipidemia.
At a glance
| Generic name | High intensity statin monotherapy |
|---|---|
| Sponsor | Korea University Anam Hospital |
| 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 HMG-CoA reductase, blocking the conversion of HMG-CoA to mevalonate in the cholesterol biosynthetic pathway. This leads to decreased intracellular cholesterol levels, upregulation of LDL receptors on hepatocytes, and increased clearance of LDL particles from the bloodstream. High-intensity regimens (e.g., atorvastatin 40–80 mg or rosuvastatin 20–40 mg daily) achieve ≥50% LDL reduction and are used for primary and secondary cardiovascular prevention.
Approved indications
- Primary prevention of atherosclerotic cardiovascular disease in high-risk patients
- Secondary prevention following acute coronary syndrome or established coronary artery disease
- Reduction of LDL cholesterol in hyperlipidemia
Common side effects
- Muscle myalgia or myopathy
- Elevated liver transaminases
- Headache
- Gastrointestinal upset
- Rhabdomyolysis (rare)
Key clinical trials
- Focusing on the Menopausal Transition to Improve Mid-Life Women's Health (PHASE2, PHASE3)
- Optimal Antiplatelet and Lipid Therapy in ACS With DES: OPACT Trial (NA)
- Effect of High-intensity Statin With Ezetimibe COmbination theRapy Versus High-intensity sTatin Monotherapy After Percutaneous Coronary Intervention With Drug-eluting Stents; the ESCORT Trial (NA)
- Early Statin-Ezetimibe Combination vs. Statin Monotherapy in Stroke With Atherosclerosis (PHASE2)
- Comparison of Moderate-Intensity Statin Plus Ezetimibe vs. High-Intensity Statin for Coronary Plaque Stabilization (PHASE4)
- GUIDE-CAC: Statin-Ezetimibe Without Aspirin vs. Statin Monotherapy With Aspirin in High Coronary Calcification (PHASE4)
- Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus (PHASE4)
- Ezetimibe Utilization Early After Acute Myocardial Infarction, "EzAMI Trial" (NA)
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:
- High intensity statin monotherapy CI brief — competitive landscape report
- High intensity statin monotherapy updates RSS · CI watch RSS
- Korea University Anam Hospital portfolio CI