Comparison of the cholesterol-lowering effects and toxicity of D-003 and lovastatin in normocholesterolaemic rabbits.

Background: D-003 is a mixture of long-chain aliphatic primary acids isolated from sugar-cane wax and having cholesterol-lowering effects and a safety profile that have been proven in animals and in previous clinical studies in healthy volunteers. Lovastatin, the first member of the statin class, is an effective and well tolerated cholesterol-lowering drug. Some lovastatin-related adverse effects have been reported, and preclinical assessment has shown that the rabbit is the most sensitive species to lovastatin toxicity.

Six-month toxicity study of oral administration of D-003 in Sprague Dawley rats.

Background: D-003 is a mixture of high molecular weight aliphatic primary acids purified from sugarcane wax (Saccharum officinarum) having cholesterol-lowering and antiplatelet effects.

Aim: This study was undertaken to investigate the toxicity induced by long-term oral administration of D-003 for 6 months to Sprague Dawley rats of both sexes.

Methods: Rats were randomly divided into four groups (20 rats of each sex/group): a control group.