Key result
Complete anemia correction with epoetin beta in 603 stage 3-4 CKD patients showed no cardiovascular advantage over partial correction in preliminary CREATE analyses.
RCT (n=603)
Open-label
Parallel-group
Yes
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Randomized trial reveals that complete anemia correction provides no cardiovascular advantage in chronic kidney disease, suggesting early normalization does not prevent cardiac events.
Anemia has received increasing attention as an independent cardiovascular risk factor in patients with chronic kidney disease (CKD); a number of studies have highlighted its clear relationship with CKD mortality, because its impact on cardiac function leads to the development of left ventricular hypertrophy. However, despite the association between higher hemoglobin levels and better outcomes, a number of clinical studies have failed to demonstrate that fully correcting anemia has a positive effect on morbidity and mortality in patients with CKD. The Cardiovascular Reduction Early Anemia Treatment Epoetin beta (CREATE) study was designed from the hypothesis that, as anemia develops early in the course of CKD and nearly at the same time as cardiovascular disease, its earlier correction may provide better protection against the development of cardiovascular abnormalities. This randomized, multicenter, open-label, parallel-group trial involved 603 patients who had moderate anemia (hemoglobin 11 to 12.5 g/dl) and stage 3 to 4 CKD (estimated GFR 15 to 35 ml/min) and were randomly assigned to attain complete or partial anemia correction. The final results are due to be published within a few months, but the preliminary analyses do not show that complete anemia correction leads to any cardiovascular advantage, although the cardiovascular event rate was half that expected, possibly as a result of patient selection, trial effect, and improved medical care. The baseline findings also indicated that the burden of cardiovascular disease already is very high even in relatively early stages of CKD.
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Locatelli et al. (2006) conducted an RCT in Moderate anemia and stage 3 to 4 chronic kidney disease (n=603). Complete anemia correction with Epoetin beta vs. Partial anemia correction was evaluated on Cardiovascular events. Complete anemia correction with epoetin beta in 603 stage 3-4 CKD patients showed no cardiovascular advantage over partial correction in preliminary CREATE analyses.
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