Statin ezetimibe fails to reduce CKD mortality
Lipid-lowering therapy with simvastatin and ezetimibe reduces major atherosclerotic events and is well tolerated in patients with chronic kidney disease (CKD), according to results of the Study of Heart and Renal Protection (SHARP), published online in last week (9 June 2011).
But a failure to lower cardiac or all-cause mortality is being attributed to the fact that atheromatous coronary disease is responsible for only a minority of cardiovascular deaths in CKD patients — a finding reinforced by SHARP.
Patients with CKD (3,023 on dialysis and 6,247 not) with no known history of myocardial infarction or coronary revascularisation were randomised to simvastatin 20mg ezetimibe 10mg daily versus matching placebo. During a median 4.9 years follow-up, treatment with simvastatin and ezetimibe resulted in a 17 per cent proportional reduction in the primary endpoint of major atherosclerotic events compared with placebo (11.3 per cent vs 13.4 per cent, rate ratio [RR] 0.83, 95 per cent confidence interval 0.74–0.94; log-rank P=0.0021), but this was largely made up of a reduction in coronary revascularisation.
There was no significant difference between the proportion of patients allocated to simvastatin ezetimibe who had a non-fatal myocardial infarction or died from coronary heart disease compared with placebo (P=0.37).
Three previous studies of statin treatment in CKD patients failed to show any significant effect on cardiovascular endpoints, and the SHARP authors say that this may have been because they had a smaller number and proportion of vascular events in their primary outcomes, which were related to atherosclerosis.
An accompanying suggests that clinicians now considering statin monotherapy in their CKD patients can gain support from SHARP data, which shows that the overall potency and safety of simvastatin ezetimibe was similar to that of atorvastatin 20mg daily, rosuvastatin 10mg daily and fluvastatin 40–80mg daily in the earlier CKD studies.
Reena Popat, acting principal pharmacist for renal and urology services at Barts and The London NHS Trust, commented: "Based on the available evidence, I believe there is unlikely to be an active move to put patients on ezetimibe simvastatin yet and, of course, the costs of ezetimibe need to be considered in light of the growing number of patients with CKD."
Citation: Electronicjuice URI: 11078919
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