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The CREATE trial investigates the impact of early anemia correction on cardiovascular risk among patients with chronic kidney disease (CKD) who are not yet on renal replacement therapy. In a multicenter study involving 600 patients, those receiving immediate anemia treatment with epoetin beta at Hb levels around 11 g/dL showed a reduction in cardiovascular mortality compared to those treated later. The findings indicate that early intervention can significantly lower risks associated with left ventricular hypertrophy and related complications.
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The CREATE Trial Cardiovascular risk Reduction by Early Anemia Treatment with Epoetin beta (CREATE) trial References Eckardt KU. The CREATE trial: building the evidence. Nephrol Dial transplant. 2001;16(Suppl.2):16–18. Locatelli F, et al. Anemia and cardiovascular risk: the lesson for CREATE.J Am Soc Nephrol. 2006;17:S262–S266.
Background Renal anemia is an independent risk factor for the development of left ventricular hypertrophy (LVH). Hence early initiation of anemia therapy might prove to be a better way to reduce cardiac morbidity and mortality in renal disease.
Aim To investigate the effect of early anemia correction on the reduction of cardiovascular risk in patients not yet on renal replacement therapy.
Method Study design: It was an open, randomized, parallel group and multicenter study. Study population: A total of 600 patients with creatinine clearance (CrCl) around 15–35 ml/min and Hb level around 11–12 g/dL were included in this trial. Treatment regimen: The patients were divided into 2 groups where in group A received immediate anemia correction with epoetin beta therapy when their Hb levels were around 11 g/dL, while group B received therapy with epoetin beta when their Hb level was <10.5 g/dL. End point: Death due to myocardial infarction or stroke was the primary end point in this trial while death due to recurrent ischemia with ECG changes.
Result There was a high prevalence of hypertension seen in the patients. Preliminary data showed that 64% had abnormal ECG findings; almost half of the population had increased left ventricular (LV) mass, 15% patients showed normal LV mass but presented concentric remodeling. Mortality was less than the need for dialysis, which contradicts the epidemiologic data concerning the CKD population as a whole.
Conclusion Thus, the early anemia correction will reduce cardiovascular risk in patients yet on renal replacement therapy. There is a progressive increase in the frequency of LVH at more severe CKD stages. The study shows immediate or early anemia correction will reduce cardiovascular risk in patients who are yet on renal replacement therapy.