CardioExchange Archive

November 7th, 2014

What You Need to Know About IMPROVE-IT

Larry Husten, PHD

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 […]

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May 3rd, 2013

FDA Approves Combination of Ezetimibe and Atorvastatin

Larry Husten, PHD

The FDA has approved a new combination drug from Merck for lowering cholesterol. The drug, which will carry the brand name of Liptruzet, is a combination of two previously approved cholesterol-lowering drugs, ezetimibe and atorvastatin. Merck said the new drug (pronounced “LIP-true-zett”) would be commercially available starting next week. Liptruzet will be available as a once-daily […]

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January 3rd, 2013

Combination of Ezetimibe and Atorvastatin Back on FDA Approval Path

Larry Husten, PHD

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 […]

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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 8th, 2011

SHARP Results Published in Lancet

Larry Husten, PHD

The main results of SHARP (Study of Heart and Renal Protection) have now been published in the Lancet, following their preliminary presentation last November at the American Society of Nephrology meeting. The results are also posted online on the trial’s website. In brief, SHARP randomized 9270 patients with chronic kidney disease (CKD) — one-third of whom were on […]

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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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November 20th, 2010

SHARP Shows Benefit for Vytorin in Chronic Kidney Disease

Larry Husten, PHD

The long-awaited SHARP study has turned up positive results for Vytorin (ezetimibe and simvastatin) in a population of patients with chronic kidney disease. Results of SHARP (Study of Heart and Renal Protection) were presented on Saturday at the American Society of Nephrology meeting in Denver and were scheduled to be posted online on the trial’s website. SHARP compared […]

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