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Background Statin Therapy
Background statin therapy reduces low-density lipoprotein (LDL) cholesterol by inhibiting HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis.
Background statin therapy reduces low-density lipoprotein (LDL) cholesterol by inhibiting HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis. Used for Hypercholesterolemia and cardiovascular risk reduction (used as background therapy in clinical trials).
At a glance
| Generic name | Background Statin Therapy |
|---|---|
| Sponsor | Amgen |
| Drug class | HMG-CoA reductase inhibitor (statin) |
| Target | HMG-CoA reductase |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
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 cholesterol from the bloodstream. In the context of Amgen's Phase 3 trials, background statin therapy is typically used as a control or baseline treatment to establish the additional benefit of investigational lipid-lowering agents.
Approved indications
- Hypercholesterolemia and cardiovascular risk reduction (used as background therapy in clinical trials)
Common side effects
- Muscle pain or myalgia
- Elevated liver enzymes
- Rhabdomyolysis
- Headache
- Nausea
Key clinical trials
- Further Lipid-Lowering With PCSK9 Inhibitors for Cardiovascular Outcomes in High-Risk Coronary Plaques Assessed by CT Angiography (NA)
- DNV001 Injection in Patients With Hypercholesterolemia (PHASE2)
- A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease. (PHASE4)
- Phase 2a Study to Assess CIVI 007 in Patients on a Background of Statin Therapy (PHASE2)
- Efficacy and Safety of Pitavastatin and PCSK9 Inhibitors in Liver Transplant Patients (PHASE4)
- Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support (PHASE3)
- Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed Dyslipidemia (PHASE3)
- Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia (PHASE2)
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:
- Background Statin Therapy CI brief — competitive landscape report
- Background Statin Therapy updates RSS · CI watch RSS
- Amgen portfolio CI