Omega-3-based treatment lowers triglycerides without increasing LDL cholesterol
MedWire News: An omega-3 fatty acid agent, AMR101, reduces triglyceride levels in patients with very high triglycerides, without significantly increasing their low-density lipoprotein (LDL) cholesterol levels, report US researchers.
The group explains that AMR101 is a partially synthetic omega-3 fatty acid-based drug that contains more than 96% of the omega-3 eicosapentaenoic acid (EPA) ethyl ester and no docosahexaenoic acid (DHA).
Many triglyceride-lowering therapies, such as fibrates and fish oil agents, contain a mixture of EPA and DHA, but, when administered to patients with very high triglyceride levels (≥500 mg/dl [5.65 mmol/l]), often substantially increase LDL cholesterol levels.
"The treatment guidelines suggest LDL cholesterol is the primary lipid treatment target to reduce atherosclerotic coronary heart disease risk," say the researchers. "Thus, an increase in LDL cholesterol levels when treating hypertriglyceridemic patients could complicate achievement of the LDL cholesterol treatment goals."
Harold Bays (Louisville Metabolic and Atherosclerosis Research Center, Kentucky) and colleagues investigated the efficacy of AMR101 in reducing triglyceride levels and other lipid parameters in patients with very high triglyceride levels.
A total of 229 patients were randomly assigned to receive AMR101 4 g per day (n=77), AMR101 2 g per day (n=76), or placebo (n=76) for 12 weeks.
The team reports that the median triglyceride level for the whole cohort was 679.5 mg/dl (7.68 mmol/l) at baseline, with 39% of individuals having a level of more than 750 mg/dl (8.48 mmol/l).
Treatment with AMR101 2 g and 4 g per day reduced the placebo-corrected median triglyceride levels by a significant 19.7% and 33.1%, respectively.
AMR101 4 g per day also reduced the placebo-corrected median levels of non-high-density lipoprotein (nonHDL) cholesterol, lipoprotein-associated phospholipase A2, very-low-density lipoprotein-triglycerides, and apolipoprotein B, by a significant 17.7%, 13.6%, 25.8%, and 8.5%, respectively, while AMR101 2 g per day significantly reduced nonHDL cholesterol levels by 8.1%.
"Importantly, neither dose significantly increased the LDL cholesterol levels," write the authors in The American Journal of Cardiology.
In a subgroup analysis of patients with triglyceride levels above 750 mg/dl at baseline, the researchers found that daily treatment with 2 or 4 g of AMR101 resulted in a significant 32.9% or 45.4% respective reduction in the median placebo-adjusted triglyceride levels.
Bays et al conclude: "The results of the present study have demonstrated that in patients with very high triglyceride levels, AMR101 is the first nonstatin triglyceride-lowering therapy to reduce triglyceride levels without significantly increasing the LDL cholesterol levels."
MedWire (www.medwire-news.md) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2011
By Nikki Withers