"Working to improve the health of kidney patients world-wide"

UKCRN ID 2542, NCT00125593, EudraCT 2004-001156-37, ISRCTN 54137607

FDA Approval Information

25th January 2012

You can also download the FDA Approval Press Release as a PDF (72 KB).

(If you don't already have Adobe Reader you can download it from the Adobe website).

Decorative image: Kidney x-ray image

FDA approval: Change to drug label provides evidence for using cholesterol-lowering treatment routinely in kidney disease patients

In parallel with the publication of the main SHARP results in the Lancet, the study results have been submitted to a variety of healthcare regulatory agencies around world. Following an extensive review of the data, the United States Food and Drug Administration (FDA) convened a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee in Washington DC on 2nd November 2011 to discuss the study results and their implications for clinical practice. The Advisory Committee included eminent clinicians and statisticians, and also patient and consumer representatives. Full details of this meeting can be found on the FDA website.

SHARP principal investigator Professor Colin Baigent presented the study rationale, design and results, and the SHARP Steering Committee Chairman Professor Sir Rory Collins spoke about the public health implications of the study results. You can download the slides presented by CTSU. Presentations were also made by Merck & Co., the manufacturers of ezetimibe plus simvastatin, and the FDA Clinical Reviewer. At the end of the day-long open meeting, the Advisory Committee voted 16 to 0 in favour of approving the use of ezetimibe 10mg plus simvastatin 20mg in patients with pre-dialysis kidney disease, but after much discussion did not endorse its use in dialysis patients.

Following this meeting, FDA approval was given for revised wording of the combination simvastatin plus ezetimibe tablet (proprietary name “Vytorin”) drug label so to include the SHARP results. This provides compelling evidence for using this cholesterol-lowering treatment in patients with chronic kidney disease. You can download the corresponding CTSU Press Release. Chronic kidney disease affects about 30 million people in the USA (and many more worldwide), and it is associated with a very high risk of cardiovascular disease. SHARP enrolled a wide range of people with kidney disease. Its results indicate that the use of Vytorin would typically reduce a patient’s risk of a heart attack, stroke, revascularization or coronary (“heart”) death by about one quarter. No other treatment has been shown in a randomized trial to provide protection against cardiovascular disease in patients with kidney disease. The FDA’s approval of new labelling for Vytorin is therefore an important step forward in the care of such patients.

The Advisory Committee had high praise for the SHARP study with comments including:

  • “A well run and organised study that went to lots of effort to get good data on the target group. The results are truly robust.”

  • “A wonderful addition to the care of CKD patients. It is going to change care.”

  • “An important study, it was extremely well designed.”

  • “The way in which this study has been conducted and communicated is of tremendous value. This is an exceptionally well-designed and well done study.”

  • “This is an amazing day. You have a study that is independent, transparent, hypothesis-driven and achieved its end points.”

These comments are testimony to the hard work of all the participants and staff involved with SHARP around the world. The Advisory Committee’s endorsement of the study results and the use of ezetimibe 10mg plus simvastatin 20mg in patients with CKD is an important step towards improving the health of kidney patients world-wide.

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