Abstract

Abstract Background and Aims Among patients with CKD, prevalence of anaemia increases with CKD severity,1 and is accompanied by elevated risk of hospitalisation and mortality.2 Treatment options include iron therapy and ESAs; international guidelines recommend initiating ESA therapy when haemoglobin (Hb) declines <10 g/dL, and to monitor Hb and iron status every 3 months during ESA treatment.3 This study aimed to describe the routine clinical management of patients with NDD-CKD and anaemia following ESA initiation, in Germany, Spain and the UK. Method This was a non-interventional, retrospective cohort study of adults with NDD-CKD stages 3b–5 (as defined in KDIGO 2012 guidelines)1 diagnosed with anaemia (Hb <13.0 g/dL [males] or <12.0 g/dL [females]), who began ESA treatment 01 Jan 2015–31 Dec 2015 inclusive. Data for ≤24 months after ESA initiation were extracted from medical records: patient characteristics; anaemia diagnosis and treatment (including iron and ESA use); Hb, serum ferritin and transferrin saturation (TSAT) measurements; and CKD-related outcomes. Patients were excluded if they had been diagnosed with end-stage kidney disease at baseline, or previously received a kidney transplant or dialysis. Results In total, 848 patient records (Germany, 211; Spain, 430; UK, 207) were included. Average age was 66 years (Table). Most patients were white and almost half had >2 comorbidities. Prior to ESA initiation, at least half of all patients in each country received either oral or intravenous (IV) iron therapy. The average (mean ± SD) number of months between anaemia diagnosis and initiation of ESA therapy was 8.4 ± 19.2. Hb levels were recorded at ESA initiation for almost all (91.3%) patients and averaged 9.8 ± 1.0 g/dL for the total cohort; this initial Hb level was similar between countries (Table). Mean ± SD estimated glomerular filtration rate (eGFR) at ESA initiation was 28.0 ± 10.4 ml/min/1.73m2. Across countries, 72–88% of patients received ESAs at home. The mean ± SD duration of therapy (at the time of data collection) was 41.2 ± 18.2 months, and the median weekly dose of short-acting and long-acting ESAs was 3238 IU and 20 μg, respectively. During their initial course of therapy, three-quarters of patients had either an increase or decrease in ESA dose. Less than 10% of patients switched ESAs, while approximately one-third discontinued within 2 years of initiation. At 3 and 6 months post-ESA initiation, only 64.7% of the sample had a documented Hb measurement despite continuing ESA treatment; this proportion was further reduced to 60.0% by 12 months after initiation. The Hb target was maintained by 88.7%, 74.6% and 49.4% of patients at 3, 6 and 12 months, respectively. Mean ferritin levels were 167.3 ng/mL at initiation and 198.7 ng/mL at 12 months (among the 85% and 48% of the sample, respectively, with recorded data). Mean TSAT was 22.1% at initiation and 25.6% at 12 months (among the 67% and 38%, respectively, with recorded data). Approximately three-quarters of patients (77.3%) received iron therapy concomitantly with ESA treatment; in the UK, most of these received IV iron, while in Germany and Spain, a majority received oral iron (Table). Blood transfusions were more common in Spain (24.2%) than in Germany (5.1%) or the UK (8.4%). Approximately one-fifth of patients required dialysis. Conclusion Initiation of ESAs to treat anaemia among patients with NDD-CKD in Germany, Spain and the UK follows current guidelines. However, recommendations to regularly monitor Hb were not routinely followed or were poorly documented. As most patients with NDD-CKD anaemia were treated at home, oral therapies may be of benefit to these patients

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