June 19th, 2012
Is Chronic Kidney Disease a CHD Risk Equivalent?
Larry Husten, PHD
A study published in the Lancet provides new data about whether chronic kidney disease (CKD) should, like diabetes, be considered a coronary heart disease (CHD) risk equivalent. Marcello Tonelli and colleagues analyzed data from a population of 1.25 million people in Alberta, Canada. During a median follow-up of 4 years, 11,340 people were admitted to the hospital […]
May 29th, 2012
More Evidence Against Tight Glycemic Control
Steven Coca, DO, MS
Along with tight blood pressure control and RAAS blockade, most nephrologists recommend tight glycemic control (i.e., HbA1C < 7) for patients with type 2 diabetes, with the goals of reducing incident CKD or CKD progression. Data from observational studies has shown that tight glycemic control is associated with less albuminuria. Thus, conventional wisdom has been […]
March 19th, 2012
Questions Raised About Antiplatelet Therapy in Chronic Kidney Disease
Larry Husten, PHD
Many people develop chronic kidney disease (CKD) as they grow older, and many people with CKD take antiplatelet agents to prevent cardiovascular events. However, the efficacy of antiplatelet therapy in CKD has not been examined, despite the fact that people with CKD are more likely to die from nonatherosclerotic conditions and are more likely to […]
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 […]
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 […]
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 […]
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 […]
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 […]
April 12th, 2011
Two Studies Try to Improve Risk Prediction for Kidney Disease Progression
Larry Husten, PHD
Two papers presented at the World Congress of Nephrology and simultaneously published online in JAMA raise hope for better tools to calculate the risk for developing kidney failure, but the techniques are not yet ready for clinical use, according to an accompanying editorial. In the first study, Carmen Peralta and colleagues evaluated a triple-marker strategy combining […]
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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