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Extended-release niacin (ERN)
Extended-release niacin increases HDL cholesterol and reduces triglycerides and LDL cholesterol by modulating lipid metabolism.
Extended-release niacin increases HDL cholesterol and reduces triglycerides and LDL cholesterol by modulating lipid metabolism. Used for Dyslipidemia / hyperlipidemia (elevated triglycerides and/or low HDL cholesterol), Cardiovascular risk reduction in patients with established coronary artery disease.
At a glance
| Generic name | Extended-release niacin (ERN) |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Nicotinic acid derivative / Lipid-modifying agent |
| Target | GPR109A (hydroxycarboxylic acid receptor 2) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Niacin (vitamin B3) acts as a ligand for GPR109A and other receptors involved in lipid homeostasis, reducing hepatic VLDL production and increasing HDL-mediated reverse cholesterol transport. The extended-release formulation allows for once-daily dosing with improved tolerability compared to immediate-release formulations.
Approved indications
- Dyslipidemia / hyperlipidemia (elevated triglycerides and/or low HDL cholesterol)
- Cardiovascular risk reduction in patients with established coronary artery disease
Common side effects
- Flushing
- Pruritus
- Gastrointestinal upset (nausea, dyspepsia)
- Hyperglycemia
- Hyperuricemia / gout exacerbation
- Hepatotoxicity
Key clinical trials
- Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133) (PHASE3)
- Lipid Efficacy of the Extended Release Niacin/Laropiprant Combination in Patients With Cardiovascular Disease (PHASE4)
- Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143) (PHASE3)
- A Study to Evaluate Efficacy and Safety of Extended-Release Niacin + Laropiprant + Simvastatin in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-118) (PHASE3)
- The Impact of Tredaptive on Flow-Mediated Dilation in Cardiac Patients (PHASE4)
- Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108) (PHASE3)
- A Long-term Study of ERN/LRPT (Extended Release Niacin/Laropiprant [MK0524A]) in Patients With Dyslipidemia (0524A-102) (PHASE3)
- Short-term Effect of Extended-release Niacin on Endothelial Function. (PHASE4)
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 |