Key result
Achieving a hemoglobin level of ≥11 g/dL at 3 months with darbepoetin alfa was associated with a lower risk of composite renal endpoints (HR 0.731) compared to <11 g/dL, without increasing cardiovascular adverse events.
Why the study?
Does long-term use of darbepoetin alfa improve renal outcomes and maintain safety in Japanese non-dialysis chronic kidney disease patients with renal anemia?
Observational (n=5,547)
Yes
Does long-term use of darbepoetin alfa improve renal outcomes and maintain safety in Japanese non-dialysis chronic kidney disease patients with renal anemia?
Hazard Ratio: 0.731 (95% CI 0.604–0.884)
Absolute Event Rate: 39.5% vs 44.8%
p-value: p=0.0013
In Japanese non-dialysis CKD patients, long-term darbepoetin alfa was safe, and achieving Hb ≥ 11 g/dL at 3 months was associated with improved renal survival without increasing cardiovascular risk.
May support Hb ≥11 g/dL targets with darbepoetin for renal benefit in CKD; hypothesis-generating and requires RCT confirmation before practice change.
BACKGROUND: This post-marketing surveillance (PMS) study evaluated the safety and effectiveness of long-term darbepoetin alfa (darbepoetin) for the treatment of renal anemia in Japanese non-dialysis chronic kidney disease patients. METHODS: Patients were treated with darbepoetin and followed up for 3 years. Adverse events (AEs), adverse drug reactions (ADRs), hemoglobin (Hb) levels, and renal function were assessed. Patients were stratified by Hb level at the time of occurrence of cardiovascular-related AEs. Statistical analyses were performed to explore factors affecting the occurrence of AEs, cardiovascular-related AEs, and composite renal endpoints. RESULTS: In the safety analysis set (5547 patients), AEs and ADRs occurred in 44.4 and 7.1% of patients, respectively. Cardiovascular-related AEs were observed in 12.6% of the overall population. The proportion of patients who presented cardiovascular-related AEs was lower among those with a higher Hb level at the time of occurrence. In the effectiveness analysis set (5024 patients), mean Hb levels remained between 10.0 and 10.6 g/dL (Weeks 4-156). Three months after darbepoetin administration, patients with Hb ≥ 11 g/dL presented fewer composite renal endpoints than those with Hb < 11 g/dL (p = 0.0013), and the cumulative proportion of renal survival was higher in those with Hb ≥ 11 g/dL vs. Hb < 11 g/dL (p < 0.0001). CONCLUSIONS: This PMS study showed the safety and effectiveness of long-term use of darbepoetin in a large number of patients. Patients with Hb ≥ 11 g/dL presented fewer composite renal endpoints than those with Hb < 11 g/dL, without an increase in the incidence of cardiovascular-related AEs.
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Tanaka et al. (2018) conducted an observational in Renal anemia in non-dialysis chronic kidney disease (n=5,547). Darbepoetin alfa (Hb ≥ 11 g/dL) vs. Hb < 11 g/dL was evaluated on Composite renal endpoints (50% reduction in eGFR, initiation of dialysis, or kidney transplantation) (HR 0.731, 95% CI 0.604-0.884, p=0.0013). Achieving a hemoglobin level of ≥11 g/dL at 3 months with darbepoetin alfa was associated with a lower risk of composite renal endpoints (HR 0.731) compared to <11 g/dL, without increasing cardiovascular adverse events.
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