Drug intelligence / Profile preview

simvastatin + fenofibrate

Development stage
Unknown
Lead developer
Abbott
Modality
Small Molecules
Administration
Oral
01

Overview

**simvastatin + fenofibrate** is a fixed-dose oral combination of two lipid-modifying agents: simvastatin, a statin that inhibits HMG-CoA reductase and lowers LDL cholesterol and overall cardiovascular risk, and fenofibrate, a peroxisome proliferator-activated receptor alpha (PPARα) agonist that lowers triglycerides and increases HDL cholesterol. The combination is primarily indicated for the treatment of mixed dyslipidemia in high cardiovascular risk patients whose lipid levels are not adequately controlled with simvastatin alone. Its mechanism involves synergistic modulation of lipid metabolism pathways, leading to improved control of LDL cholesterol, triglycerides, and HDL cholesterol. The combination, unlike statin plus gemfibrozil, is not associated with a clinically relevant increase in simvastatin plasma concentrations. Clinical trials (e.g., ACCORD, SAFARI) demonstrate significant improvements in triglyceride and HDL levels and confirm safety, with the risk of serious adverse events such as myopathy only minimally increased compared to statin alone.

Brand names
Cholib
Other names
fenofibrate/simvastatinfixed-dose simvastatin/fenofibrate combination
02

Targets

PPARA (Peroxisome proliferator-activated receptor alpha)HMGCR (3-hydroxy-3-methylglutaryl-coenzyme A reductase)

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