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fluvastatin, ezetimibe
This combination reduces LDL cholesterol through dual inhibition of cholesterol synthesis and intestinal absorption.
This combination reduces LDL cholesterol through dual inhibition of cholesterol synthesis and intestinal absorption. Used for Hypercholesterolemia and mixed dyslipidemia.
At a glance
| Generic name | fluvastatin, ezetimibe |
|---|---|
| Sponsor | Novartis |
| Drug class | Statin + ezetimibe combination |
| Target | HMG-CoA reductase; NPC1L1 |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Fluvastatin is an HMG-CoA reductase inhibitor that blocks hepatic cholesterol synthesis, while ezetimibe inhibits Niemann-Pick C1-like 1 (NPC1L1) protein to reduce intestinal cholesterol absorption. Together, they provide complementary mechanisms to lower LDL cholesterol levels more effectively than either agent alone.
Approved indications
- Hypercholesterolemia and mixed dyslipidemia
Common side effects
- Myalgia
- Elevated liver transaminases
- Headache
- Gastrointestinal disturbance
Key clinical trials
- LATAM LOWERS LDL-C (PHASE4)
- A 12 Week Study of MK0653A in Patients Who Have Been Hospitalized for a Possible Heart Problem (0653A-808) (PHASE3)
- An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (PHASE3)
- Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL) (PHASE3)
- Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL (PHASE3)
- A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin (PHASE3)
- Observational Study of Approaches to Lipid-Lowering Therapy in Russian Patients With Coronary Heart Disease <<Treat to Goal>> (Study P05464)
- An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia (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 |