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SHARP: Ezetimibe plus statin reduced CV risk in patients with CKD
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Long-term cholesterol-lowering treatment with ezetimibe plus simvastatin reduced the risk for MI, stroke and surgery to open blocked arteries among patients with chronic kidney disease, according to data from the SHARP trial presented at Renal Week 2010 in Denver.
“Taking ezetimibe plus simvastatin long-term would avoid around one-quarter of MI, strokes and operations to unblock arteries, leading to their prevention in at least 250,000 people with kidney disease worldwide each year,” Colin Baigent, FFPH, FRCP, of the University of Oxford, UK, and chief investigator of the SHARP trial, said in a press release.
The double blind, placebo-controlled Study of Heart and Renal Protection (SHARP) included 9,500 patients aged 40 years and older who had CKD. One-third of the patients required dialysis, and all had lost at least 50% of their normal kidney function. Previous MI, bypass surgery and stenting were not reported in any of the patients.
Researchers randomly assigned each patient to a daily combination tablet containing ezetimibe 10 mg and simvastatin 20 mg (Vytorin; Merck/Schering Plough) or placebo. Patients were treated and followed for 5 years.
Combination treatment reduced LDL and was associated with one-sixth fewer MIs, strokes or major atherosclerotic events, which was defined as surgery to unblock arteries. Approximately one-third of patients discontinued the medication, but this was not generally due to side effects, according to the press release.
“There was no evidence of any serious adverse effects and, in particular, no support from earlier concerns that ezetimibe might cause cancer,” Martin Landray, PhD, also of the University of Oxford, and a SHARP researcher, said in a press release. “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.”
The results from SHARP are also relevant among patients with normal kidney function who are at high risk for major atherosclerotic events and are currently taking a statin, the researchers said. The combination of ezetimibe and a statin produced similar benefits to those resulting from the same LDL reduction achieved with a high-dose statin. Since the lower the cholesterol the bigger the risk reduction, these results suggest that patients who remain at high risk for major atherosclerotic events despite maximal statin therapy may benefit further from adding ezetimibe to their current statin regimen.
“SHARP now provides the first direct evidence that cholesterol-lowering is indeed effective in kidney patients, and that the benefits are substantial,” Baigent said.
For more information:
- The SHARP Collaborative Group. LB-FC6. Presented at: Renal Week 2010; Nov. 16-21, 2010; Denver.
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