Study: Roxadustat improved cardiovascular outcomes with maintained hemoglobin levels
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Patients with anemia of CKD who receive roxadustat showed a lower level of adverse cardiovascular events when hemoglobin levels were maintained at 10 g/dL or higher, according to data presented at ASN Kidney Week.
“We have evidence that roxadustat is effective in increasing and maintaining hemoglobin levels in patients with anemia of CKD, as shown across the roxadustat clinical program,” Robert Provenzano, MD, associate professor of medicine at Wayne State University in Detroit and a primary investigator in the roxadustat global phase 3 program, said in a press release. “These new post-hoc analyses showed that for patients who were treated with roxadustat, rates of cardiovascular events were lowest in patients when their hemoglobin levels were greater than 10 g/dL.”
Investigators said data pooled from three randomized, controlled trials for non-dialysis dependent (NDD) patients and three randomized, controlled trials for dialysis-dependent (DD) patients. Overall, 2,391 patients received roxadustat in the NDD group; 1,943 patients were randomized to receive roxadustat in the DD group. Mean hemoglobin was 9.63 g/dL at baseline in the DD group, and 9.1 g/dL at baseline for patients in the NDD group.
In the DD and NDD patient population, the occurrence of major adverse cardiovascular events (MACE) and MACE+ (MACE plus heart failure or unstable angina requiring hospitalization) were lowest when achieved hemoglobin levels were at more than or equal to 11g/dL. Patients with hemoglobin less than 8 g/dL in both categories faced a higher risk of adverse events, but MACE decreased as hemoglobin increased.
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Provenzano R, et al. Paper PO-2625, Presented at: ASN Kidney Week. Oct. 22-25, 2020 (virtual meeting).
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