CardioExchange Archive

January 25th, 2012

FDA Rejects Proposed Chronic Kidney Disease Indication for Vytorin

Larry Husten, PHD

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 […]

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November 3rd, 2011

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

Larry Husten, PHD

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 […]

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October 31st, 2011

FDA Gives Favorable Review to SHARP Ahead of Vytorin Advisory Panel

Larry Husten, PHD

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 […]

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June 12th, 2011

CardioExchange Panel: Ezetimibe + Simvastatin for Chronic Kidney Disease — What’s the Point of SHARP?

CardioExchange Editors, Staff

Last week saw the publication of the SHARP trial (Study of Heart and Renal Protection) in which some 9,200 patients with chronic kidney disease (CKD) were randomized to  either placebo or the combination of simvastatin and ezetimibe. CardioExchange put questions about these data to a panel of experts. Whose views do you agree with? What points did […]

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November 22nd, 2010

SHARP: A Tale of Two Press Releases

Larry Husten, PHD

Two press releases were issued about the SHARP trial : one from Merck, the much-maligned and criticized manufacturer of Vytorin (the combination of ezetimibe and simvastatin), and one from the group running the trial, the highly-respected Clinical Trials Service Unit (CTSU) at Oxford. Here’s the surprise: compared to the Oxford press release, the Merck release is a paragon, […]

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