Evaluation of OM3-PL/FFA Pharmacokinetics After Single and Multiple Oral Doses in Healthy Volunteers.

Purpose: The US Food and Drug Administration has approved several omega-3 (OM3)-containing prescription drugs for the treatment of severe hypertriglyceridemia (HTG). However, there is still a need to develop formulations with high bioavailability irrespective of the fat content and time of the meal. OM3-phospholipid (PL)/free fatty acid (FFA) is an investigational drug for the treatment of severe HTG containing naturally derived krill oil mixture of OM3, mainly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as PL esters and as FFA.

A Single-dose, Comparative Bioavailability Study of a Formulation containing OM3 as Phospholipid and Free Fatty Acid to an Ethyl Ester Formulation in the Fasting and Fed States.

Purpose: Formulations of ω (OM)-3 with adequate bioavailability in the low-fat fed state are advantageous in patients with severe hypertriglyceridemia (HTG), as these patients are advised to adhere to a low-fat diet. The OM3-containing prescription drugs approved by the US Food and Drug administration (FDA) provide OM3 in either ethyl ester (EE) or free fatty acid (FFA) forms. The OM3 FFA form and formulations with micelle-forming ability have shown improved bioavailability versus the EE form.

4-Hydroxyisoleucine: a plant-derived treatment for metabolic syndrome.

The plant fenugreek has been used for centuries as a treatment for diabetes. This article presents evidence that the major isomer of 4-hydroxyisoleucine, an atypical branched-chain amino acid derived from fenugreek, is responsible for the effects of this plant on glucose and lipid metabolism. 4-Hydroxyisoleucine was demonstrated to stimulate glucose-dependent insulin secretion by a direct effect on pancreatic islets.

A comparison of pravastatin and gemfibrozil in the treatment of dyslipoproteinemia in patients with non-insulin-dependent diabetes mellitus.

The effects of pravastatin (pravachol) compared with gemfibrozil on cholesterol-rich and trigylceride-rich lipoproteins were evaluated in this multi-centered trial. Following an 8-12 week prerandomization phase, 136 patients with NIDDM and hypercholesterolemia were randomized to receive either pravastatin 40 mg or gemfibrozil 1200 mg daily for 16 weeks. The reduction of total cholesterol (TC), betaquant LDL and LDL cholesterol (LDL-C) was significantly greater in patients treated with pravastatin than with gemfibrozil.