SHARP by Colin Baigent

SHARP results

The Study of Heart and Renal Protection (SHARP) concluded that around a quarter of all heart attacks, strokes, and operations to open blocked arteries could be avoided in people with chronic kidney disease by using the combination of ezetimibe and simvastatin to lower blood cholesterol levels.

The SHARP study involved almost 9,500 volunteers aged 40 or over with chronic kidney disease recruited from 380 hospitals in 18 countries. Volunteers were randomly allocated to take either cholesterol-lowering therapy with a tablet containing ezetimibe 10mg daily and simvastatin 20mg daily, or matching dummy "placebo" tablets for an average of 5 years.

Summary of major findings

  • Taking the combination of ezetimibe and simvastatin 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

Colin Baigent: Lowering cholesterol in chronic kidney disease

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

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 ezetimibe plus simvastatin 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.

Dr 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.