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statin + ezetimibe
Statin inhibits cholesterol synthesis while ezetimibe blocks dietary cholesterol absorption, together reducing LDL cholesterol levels.
Statin inhibits cholesterol synthesis while ezetimibe blocks dietary cholesterol absorption, together reducing LDL cholesterol levels. Used for Hypercholesterolemia and dyslipidemia, Cardiovascular disease prevention in patients requiring additional LDL-C lowering.
At a glance
| Generic name | statin + ezetimibe |
|---|---|
| Also known as | Anticholesterol drug |
| Sponsor | University of Roma La Sapienza |
| Drug class | Lipid-lowering agent combination (statin + cholesterol absorption inhibitor) |
| Target | HMG-CoA reductase; NPC1L1 transporter |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Statins competitively inhibit HMG-CoA reductase, the rate-limiting enzyme in hepatic cholesterol synthesis. Ezetimibe selectively inhibits the Niemann-Pick C1-like 1 (NPC1L1) transporter in the intestinal brush border, preventing dietary and biliary cholesterol absorption. The combination provides complementary mechanisms to achieve greater LDL-C reduction than either agent alone.
Approved indications
- Hypercholesterolemia and dyslipidemia
- Cardiovascular disease prevention in patients requiring additional LDL-C lowering
Common side effects
- Myalgia
- Elevated liver enzymes
- Gastrointestinal disturbance
- Headache
Key clinical trials
- A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events (PHASE3)
- Cholesterol Disruption in Combination With the Standard of Care in Patients With Advanced Pancreatic Adenocarcinoma (EARLY_PHASE1)
- Moderate-intensity Statin vs. Individualized LDL-C Target-based Therapy in Older Adults With Type 2 Diabetes (iTARGET-Elderly Study) (NA)
- Assessing the Impact of Intensification of Lipid Lowering Therapy With Guidelines-based Evinacumab Administration on Coronary Plaque Volumes Measured by Coronary Computed Tomography Angiography (CCTA) in Patients With Homozygous Familial Hypercholesterolemia (HoFH)
- Efficacy and Safety of Pitavastatin/Ezetimibe After Switching From Statin Monotherapy to Pitavastatin/Ezetimibe in Patients With Hypercholesterolemia
- triPle Oral thERapy With Bempedoic Acid vs uSual Care in Early Lipid Management of Patients With acUte coronAry synDromE (PHASE3)
- Optimal Antiplatelet and Lipid Therapy in ACS With DES: OPACT Trial (NA)
- Evolocumab in Patients With Multivessel Coronary Disease After Acute Myocardial Infarction: A Target Trial Emulation
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:
- statin + ezetimibe CI brief — competitive landscape report
- statin + ezetimibe updates RSS · CI watch RSS
- University of Roma La Sapienza portfolio CI