One quarter of all heart attacks, strokes, and surgical operations to open blocked arteries could be avoided if people with chronic kidney disease could lower their cholesterol levels. This can be done by administering a combination of ezetimibe and simvastatin to lower cholesterol levels in the blood. That’s the conclusion from the world’s largest-ever randomized trial with kidney disease patients.
The key findings were released on Saturday, November 20th, at the American Society of Nephrology, the trial’s principal investigator Professor Colin Baigent said: “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, irrespective of the severity of their illness,” said Proffesor Baigent.
“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,” he concluded.
The Study of Heart and Renal Protection (SHARP) involved almost 9,500 volunteers aged 40 or over with chronic kidney disease. They were recruited from 380 hospitals in 18 countries.
Patients in the trial had lost at least half of their normal kidney function, with a third of them requiring dialysis treatment. None had experienced a previous heart attack or needed bypass surgery or “stents” to unblock their heart arteries.
SHARP was designed, conducted and analysed independently of all funding sources by the Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU) of Oxford University, with guidance by an independent Steering Committee that included many of the world’s leading kidney specialists.
The study was supported by Merck & Co., (which is known as MSD outside the US and Canada) who also supplied the study treatments, with additional support from the Australian National Health and Medical Research Council (NHMRC), the British Heart Foundation (BHF) and the UK Medical Research Council (MRC).
Planning began in the mid-1990s, with two pilot studies followed by a main study that started in 2003 and ended in September of this year.
Summary of major findings:
- The patients allocated to take ezetimibe plus simvastatin had one-sixth fewer heart attacks, strokes or operations to unblock arteries (“major atherosclerotic events”), with similar reductions observed in all types of patient studied.
- During this long trial, the proportion of patients who stopped takingÂ their allocated treatment was about one third, but this was notÂ generally due to side-effects and was the same for both real and dummyÂ treatments. If taken without interruption, however, ezetimibe plusÂ simvastatin could have even larger effects than were seen in SHARP,Â potentially reducing risk by about one quarter.
- Adding 10mg daily of ezetimibe to 20mg daily of simvastatin produced aÂ large reduction in LDL (“bad”) cholesterol safely. This combinationÂ treatment may be particularly good for kidney patients, as it avoidsÂ the possibility of side-effects with high statin doses.
- There was no support for previous concerns with ezetimibe aboutÂ possible adverse effects on cancer, and no evidence of an increasedÂ risk of muscle or liver problems.
For more info, visit www.sharpinfo.org
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