FDA reconfirm efficacy of cholesterol-lowering drugs

The U.S. FDA reaffirmed its stance that high level of LDL or “bad cholesterol,” is key risk factor for heart diseases such as heart attack, stroke etc, and reduction in LDL cholesterol lowers the risk of these diseases.

The agency was reviewing of data from ENHANCE, a trial, which was comparing Zocor (HMG-CoA reductase inhibitor), a drug inhibit the production of cholesterol in the liver, in combination to Vytorin with Zetia (ezemtimibe), which limits the cholesterol absorption.

Preliminary results from ENHANCE had shown that there was no considerable difference in the thickness of the walls of the blood vessels of the neck. Though, the LDL cholesterol reduction, in patients with Vytorin compared to Zocor was significant.

FDA, after the completion of ENHANCE trial has completed its review. After two years of continues treatment, no significant difference was seen in the thickness of carotid artery between Vytorin and Zocor patients. However, the levels of bad cholesterol decreased by 56% in the Vytorin group and 39% reduction occur in the Zocor group.

The ENHANCE trial was unable to change FDA’s position on the advantages of lowering LDL cholesterol level. According to the best available data, patients should keep on using Vytorin for the reduction of LDL cholesterol. If they have any queries about Vytorin, Zetia or the ENHANCE trial, consult to your doctor.

FDA reconfirm efficacy of cholesterol-lowering drugs
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