Posts Tagged ‘ezetimibe’

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November 17th, 2014

IMPROVE-IT Meets Endpoint and Demonstrates Real But Modest Clinical Benefit for Ezetimibe

After all the waiting and all the controversy it turned out to be pretty simple. The IMPROVE-IT trial did what it set out to do and reached its primary endpoint. The benefit wasn’t very big or impressive but it will be enough to put to rest concerns that ezetimibe might have been an expensive placebo […]


November 12th, 2014

Newly Identified Mutations Act Like a Lifetime of Treatment with Ezetimibe

A very large genetic study published in the New England Journal of Medicine offers compelling evidence in support of a central role for LDL cholesterol in coronary heart disease. In a series of studies analyzing blood samples from nearly 100,000 people, Sekar Kathiresan and colleagues identified 15 rare mutations that block the activity of a single gene — […]


November 7th, 2014

What You Need to Know About IMPROVE-IT

The IMPROVE-IT trial will be big news when its results are finally presented on November 17 during the annual meeting of the American Heart Association. The results of the trial — underway for nearly a decade — have been long and eagerly awaited by everyone interested in cardiovascular medicine.  The trial could impact the future sales of a key Merck drug, ezetimibe; because it is […]


August 4th, 2014

Selections from Richard Lehman’s Literature Review: August 4th

This week’s topic is on the trends in use of ezetimibe after the ENHANCE trial.


May 27th, 2014

Selections from Richard Lehman’s Literature Review: May 27th

This week’s topics include mortality trends in patients with diabetes, cardiovascular remodeling in CAD and HF, and more.


January 14th, 2014

All Lots of Liptruzet In U.S. Recalled Over Packaging Defect

Merck said today that it was recalling all lots of Liptruzet, its combination of the cholesterol-lowering drugs ezetimibe and atorvastatin, in the U.S. The company said the recall was due to a packaging defect that could potentially allow air and moisture to affect the quality of the drug, although “the likelihood of the packaging defects decreasing the […]


January 3rd, 2013

Combination of Ezetimibe and Atorvastatin Back on FDA Approval Path

A combination tablet containing the cholesterol-lowering drugs ezetimibe and atorvastatin is back on the path to possible FDA approval, according to Merck, which already markets Zetia (ezetimibe) and Vytorin, the combination of ezetimibe and simvastatin. Merck has repeatedly stumbled in its efforts to gain FDA approval of the proposed new drug, which has been dubbed “Son […]


January 25th, 2012

FDA Rejects Proposed Chronic Kidney Disease Indication for Vytorin

The FDA rejected a new indication for Merck’s Vytorin and Zetia (ezetimibe plus simvastatin and ezetimibe alone) in chronic kidney disease patients. As a consolation prize, however, the agency approved a new label for Vytorin that will incorporate the results of SHARP (Study of Heart and Renal Protection), which found that the drug combination reduced the incidence […]


November 3rd, 2011

FDA Advisory Committee Recommends Approval of Vytorin for Pre-Dialysis CKD Patients

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Wednesday strongly supported the combination of ezetimibe and simvastatin (Vytorin, Merck) to prevent cardiovascular events in pre-dialysis chronic kidney disease (CKD) patients. But the panel voted against recommending Vytorin for patients with end-stage renal disease on dialysis. The votes were 16-0 in favor of the pre-dialysis […]


October 31st, 2011

FDA Gives Favorable Review to SHARP Ahead of Vytorin Advisory Panel

In preparation for Wednesday’s meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, an FDA reviewer has generally endorsed the positive interpretation of the SHARP trial of Vytorin (ezetimibe and simvastatin) in chronic kidney disease (CKD). Based on the results of SHARP (Study of Heart and Renal Protection), Merck is seeking an expansion of its […]