Background In 2012, due to a problem in manufacturing continuous erythropoietin receptor activator (CERA), the Spanish Health System issued an alert recommending not starting new treatments with this drug and replacing it by other erythropoiesis-stimulating agents (ESA) in patients already on treatment.
Purpose To assess the dose and efficacy of the ESA that replaced CERA after it became unavailable.
Materials and methods A longitudinal retrospective study was conducted in patients treated with CERA when it became unavailable. The follow-up period was 4 months. We recorded the type and dose of ESA that replaced CERA and compared them with the equivalent agents recommended in summary of product characteristics (SPC). Effectiveness was judged by haemoglobin levels (Hb) at 4 months of follow-up. Other variables collected: Hb, transferrin saturation index (TSI), ferritin, albumin, C-reactive protein (CRP) and parathyroid hormone (PTH).
Results 187 patients were included (58.8% female, aged 67.7 [17.2] years old). CERA was replaced by epoetin β in 52.4% of cases (previous monthly dose CERA: 94.6 [59.2] mcg), darbepoetin α in 39.6% (previous monthly dose CERA: 82.4 [56.9] mcg) and ESA prescription was discontinued in 8.0% (previous monthly dose CERA: 78.0 [60.6] mcg). No differences were found between these groups in TSI, ferritin, albumin, CRP or PTH. At the time of inclusion, Hb was 11.6 (1.5) g/dl and after 4 months it was 11.7(1.6) g/dl. Mean monthly doses of epoetin β was 18389.2(16018.3) IU and darbepoetin α 98.8(78.5) mcg were similar to those recommended by SPC (<32000 IU epoetin β and <160 mcg, respectively). At the end of the follow-up, the ESA dose was retained in 68.8% of patients, reduced in 5.8%, increased in 2.9% and was replaced by another different ESA in 8.7%.
Conclusions Epoetin β and darbepoetin α were similarly effective compared to CERA. Doses were according to those recommended in SPC and most of them did not need to be adjusted.
No conflict of interest.
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