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Ezetimibe + Atorvastatin
This combination reduces cholesterol by blocking intestinal cholesterol absorption (ezetimibe) and inhibiting HMG-CoA reductase to decrease hepatic cholesterol synthesis (atorvastatin).
This combination reduces cholesterol by blocking intestinal cholesterol absorption (ezetimibe) and inhibiting HMG-CoA reductase to decrease hepatic cholesterol synthesis (atorvastatin). Used for Hypercholesterolemia and mixed dyslipidemia, Cardiovascular risk reduction in patients requiring LDL-C lowering.
At a glance
| Generic name | Ezetimibe + Atorvastatin |
|---|---|
| Also known as | SCH 58235, Zetia, Lipitor |
| Sponsor | Organon and Co |
| Drug class | Cholesterol absorption inhibitor + HMG-CoA reductase inhibitor (statin combination) |
| Target | NPC1L1 (ezetimibe); HMG-CoA reductase (atorvastatin) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Ezetimibe selectively inhibits Niemann-Pick C1-like 1 (NPC1L1) protein in the intestinal brush border, reducing dietary and biliary cholesterol absorption. Atorvastatin is an HMG-CoA reductase inhibitor (statin) that blocks the rate-limiting enzyme in hepatic cholesterol synthesis. Together, they provide complementary mechanisms to lower LDL cholesterol and reduce cardiovascular risk.
Approved indications
- Hypercholesterolemia and mixed dyslipidemia
- Cardiovascular risk reduction in patients requiring LDL-C lowering
Common side effects
- Myalgia (muscle pain)
- Elevated liver enzymes
- Headache
- Diarrhea
- Rhabdomyolysis (rare)
Key clinical trials
- A Prospective, Open, Observational Study to Confirm the Lipid-lowering Effect, Changes in Glucose Metabolism, and Safety After 6 Months of Administration of Atostazet to Hypercholesterolemic Patients 65 Years of Age or Older
- 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)
- A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
- Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorvastatin (PHASE1)
- A Study Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Atorvastatin (PHASE1)
- Intensive Lipid-lowering for Plaque and Major Adverse Cardiovascular Events in Low to Intermediate 10-year ASCVD Risk Population (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:
- Ezetimibe + Atorvastatin CI brief — competitive landscape report
- Ezetimibe + Atorvastatin updates RSS · CI watch RSS
- Organon and Co portfolio CI