New Drug Promising for Lowering Cholesterol

In a phase III study, an investigational cholesterol absorption inhibitor called ezetimibe reduced low-density lipoprotein (LDL) by 18% and total cholesterol (TC) by 12%. Significant reductions were seen within the first two weeks and maintained throughout the study. The findings were reported at the European Atherosclerosis Society Meeting, in Glasgow (Scotland).

The patients in the study were defined as having primary hypercholesterolemia, with baseline LDL of 130-250 mg/dl and triglycerides of less than or equal to 350 mg/dl. A separate study that combined ezetimibe with a statin (fluvastatin) provided additional reductions compared to either drug alone. After 14 days on the combination, LDL levels were reduced by 32%. Another study that combined ezetimibe with fenofibrate, a fibric-acid derivative, reduced LDL levels after 14 days by 36.3%.

The new drug is under joint development by Merck & Co. (Whitehouse Station, NJ, USA) and Schering-Plough Corp. (Kenilworth, NJ, USA). The safety profile for ezetimibe was found to be similar to placebo. No clinically significant changes or trends in clinical laboratory tests, including those assessing muscle and liver function, were observed, and no significant effects on fat-soluble vitamins were found. "The significant reductions in LDL seen in this study suggest that ezetimibe may offer a new approach to helping patients achieve their LDL target,” said R. H. Knopp, M.D., who presented the study results as lead investigator.






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