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

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

Welcome to the SHARP trial / 欢迎浏览心肾保护研究(SHARP)网站 / ยินดีต้อนรับสู่ SHARP / SHARP -க்கு நல்வருகை

The world’s largest trial investigating the benefits of cholesterol lowering in kidney patients.

Decorative image: Kidney x-ray image

Video: Professor Colin Baigent discusses the SHARP Results

Summary of Main SHARP Findings

Taking the combination of simvastatin and ezetimibe long-term reduced the risk of heart attacks, strokes and operations to open blocked arteries by about one quarter in people with chronic kidney disease, irrespective of the severity of their disease.

This combination treatment reduced risk safely, and may be particularly good for kidney patients as it avoids the possibility of side-effects with high statin doses.

There was no support for previous concerns with ezetimibe about possible adverse effects on cancer, and no evidence of an increased risk of muscle or liver problems.

SHARP Post-Trial Follow-up

The main SHARP trial finished in 2010, but an additional project known as SHARP Post-Trial Follow-Up (SHARP PTFU) is currently underway. This involves ~ 5-6 years’ extended follow-up of SHARP participants in several countries. This project will assess whether, in the longer-term: (i) the beneficial effects in reducing the risk of heart attacks, strokes and operations to open blocked arteries seen in SHARP persist; (ii) any hazardous effects (such as cancer) emerge; and (iii) there is any longer-term protective effect on the kidneys. Results for SHARP PTFU are anticipated in 2018.

Project comparing SHARP outcomes with UK registry data

During the SHARP trial, participants were regularly followed up in study clinics, with events such as hospitalisations being recorded. Those events which were of particular interest to the study (known as ‘study outcomes’) such as heart attacks and strokes were reviewed by study doctors. This process is known as clinical adjudication, and is seen as the ‘gold standard’ for assessment of study outcomes. However, it is very resource intensive and expensive, and substantially increases the cost of doing research, and so we are exploring whether healthcare information routinely collected in the UK through national registries is as complete and as reliable as adjudicated outcomes. If this is able to be demonstrated, it could greatly simplify future trial design, and hence benefit patients and the public.

We will investigate this by obtaining routinely collected data from NHS Digital which will include hospital admission data, cancer and mortality data which we will compare with the clinical follow up data. Follow the link below for further information and how you can withdraw from this part of the research should you wish to.

Information for SHARP UK trial participants regarding use of registry data


Comments from the Principal Investigators

Professor Colin Baigent

“This is excellent news for patients who have kidney disease. It was already known that cholesterol-lowering could reduce the risk of heart attacks, strokes and the need for surgery to unblock arteries in people with normal kidney function. But, this trial now shows that cholesterol-lowering has similar effects in people with chronic kidney disease. Taking simvastatin plus ezetimibe long-term would avoid around one quarter of heart attacks, strokes and operations to unblock arteries, leading to their prevention in at least 250,000 people with kidney disease worldwide each year.”

Professor Martin Landray

“In SHARP there was no evidence of any serious adverse effects and, in particular, no support for earlier concerns that ezetimibe might cause cancer. SHARP shows clearly that the large cholesterol reduction produced with this treatment is safe, and provides similar benefits to those seen in people with normal kidney function.”