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…

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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…

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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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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…

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A new analysis of TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) is raising questions about the use of target-based strategies for the treatment of anemia in people with chronic kidney disease. (Last year, the main TREAT results showed that treatment with darbepoetin alfa was not beneficial – and was associated with an increase in the…

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The African-American Study of Kidney Disease and Hypertension (AASK) investigated the role of intensive blood-pressure control in slowing the progression of chronic kidney disease in black patients. In the previously reported results of the randomized portion of AASK, intensive BP control had no effect on the progression of CKD. Now the AASK Collaborative Research Group reports the…

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