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Statin plus fenofibrate
This combination reduces cholesterol and triglycerides through dual lipid-lowering pathways: statins inhibit HMG-CoA reductase to lower LDL cholesterol, while fenofibrate activates PPAR-alpha to reduce triglycerides and raise HDL cholesterol.
This combination reduces cholesterol and triglycerides through dual lipid-lowering pathways: statins inhibit HMG-CoA reductase to lower LDL cholesterol, while fenofibrate activates PPAR-alpha to reduce triglycerides and raise HDL cholesterol. Used for Dyslipidemia with elevated LDL cholesterol and triglycerides, Cardiovascular risk reduction in patients with mixed dyslipidemia.
At a glance
| Generic name | Statin plus fenofibrate |
|---|---|
| Sponsor | University of Ioannina |
| Drug class | Combination lipid-lowering agent (statin + fibrate) |
| Target | HMG-CoA reductase (statin component); PPAR-alpha (fenofibrate component) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Statins competitively inhibit HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels. Fenofibrate is a fibric acid derivative that activates peroxisome proliferator-activated receptor alpha (PPAR-alpha), which upregulates lipoprotein lipase and reduces hepatic triglyceride production. The combination addresses multiple dyslipidemia patterns, particularly in patients with elevated triglycerides and low HDL cholesterol alongside elevated LDL cholesterol.
Approved indications
- Dyslipidemia with elevated LDL cholesterol and triglycerides
- Cardiovascular risk reduction in patients with mixed dyslipidemia
Common side effects
- Myalgia or muscle pain
- Elevated liver enzymes
- Rhabdomyolysis (rare)
- Gastrointestinal disturbance
Key clinical trials
- Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
- Efficacy and Safety of Pitavastatin and PCSK9 Inhibitors in Liver Transplant Patients (PHASE4)
- To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM (NA)
- 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)
- Retrospective Survey Evaluating the Effectiveness and Safety of Dual Inhibition Lipid-lowering in the Treatment of Dyslipidemia (Study P05171)(COMPLETED)
- Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic Syndrome (TRISTAN)
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 plus fenofibrate CI brief — competitive landscape report
- Statin plus fenofibrate updates RSS · CI watch RSS
- University of Ioannina portfolio CI