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Study spells much needed relief for kidney patients.
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. That’s the conclusion from the world’s largest ever randomised trial in kidney disease.
The Study of Heart and Renal Protection (SHARP) involved almost 9500 volunteers aged 40 or over with chronic kidney disease recruited from 380 hospitals in 18 countries.
More than 2000 were recruited from 64 sites in Australia, New Zealand, Malaysia and Thailand.
Patients included in the trial had lost at least 50 per cent of their normal kidney function, with a third of them requiring dialysis treatment. None had had a previous heart attack or needed bypass surgery or “stents” to unblock their heart arteries. Volunteers in this double-blind placebo-controlled trial 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. Study treatment and follow-up continued for an average of 5 years.
Professor Alan Cass, senior director, George Institute Renal and Metabolic Division, and the Australian National Coordinator of the SHARP study says the trail is a real breakthrough for the one-in-nine Australians over the age of 25 who have some chronic 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, which the key findings were released at the end of last year, has shown for the first time that cholesterol-lowering has similar benefits for people with kidney disease for avoiding heart attack and strokes as for people with healthy kidneys.
One major finding of the study is patients allocated to take ezetimibe plus simvastatin had one-sixth fewer heart attacks, strokes or operations to unblock arteries, with similar reductions observed in all types of patient studied.
It also found adding 10mg daily of ezetimibe to 20mg daily of simvastatin produced a large reduction in LDL (“bad”) cholesterol safely. This combination treatment may be particularly good for kidney patients, as it avoids the possibility of side-effects with high statin doses.
“People with chronic kidney disease have a very high risk of developing heart diseases or stroke. Until now, it has not been clear which treatments could reduce this risk. Consequently it is likely that the SHARP results will result in cholesterol-lowing treatment being used extensively in this large group of high-risk people,” says Cass.
“The results of the SHARP study provide much needed evidence to drive future treatment for the many Australians who suffer with chronic kidney disease. Preventing early heart attacks and strokes in this population should represent highly cost-effective therapy.
SHARP co-principal investigator, Dr Martin Landray said that SHARP provides reassuring evidence about the safety of the ezetimibe and simvastatin combination.
“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.”
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