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INT-012 Pharmacy based dosing of darbepoetin: a randomised controlled trial in haemodialysis patients
  1. FJ van den Oever1,
  2. CFM Heetman-Meijer1,
  3. E Birnie2,
  4. YC Schrama3
  1. 1Department of Clinical Pharmacy, Sint Franciscus Gasthuis, Rotterdam
  2. 2Department of Statistics, Sint Franciscus Gasthuis, Rotterdam
  3. 3Department of Nephrology, Sint Franciscus Gasthuis, Rotterdam

Abstract

Background Renal anaemia is treated with erythropoietin analogues. For erythropoietin analogues to be most effective, adequate iron levels are required. Treatment guidelines suggest a target range for haemoglobin levels in haemodialysis patients of 6.8–7.4 mmol/l. Values above 8.1 mmol/l are associated with increased cardiovascular mortality. Previously, only 23% of all haemodialysis patients in our hospital had haemoglobin levels within this target range.

Purpose In this randomised, controlled trial, we developed a treatment algorithm for darbepoetin and intravenous iron sucrose, with the intention of improving the percentage of haemodialysis patients who were within the haemoglobin target range. Secondary endpoints were percentage of patients with haemoglobin levels above 8.1 mmol/l and percentage of patients with adequate iron levels.

Materials and methods 200 patients were randomised (n=100 for the intervention and control groups). Study duration was 13 months. Adequate iron levels were defined as transferrin saturation of at least 20% combined with serum ferritin levels between 200 and 500 µg/l. In the control group, darbepoetin and iron sucrose dosages were adjusted by the treating nephrologist as normal. In the intervention group, dosages of darbepoetin and iron sucrose were adjusted by the pharmacist, based on a treatment algorithm developed by three of the authors (FJO, CFMH and YCS). In this algorithm, previous and actual dosages of darbepoetin and iron, and serum levels of haemoglobin, transferrin saturation and ferritin were included. Statistical analysis was performed with SPSS. Median and non-parametric tests (Mann–Whitney U test) were used, as data were not distributed normally. As defined in the protocol, 15 patients were excluded from analysis due to missing data (n=6 in the intervention group, n=9 in the control group).

Results In the intervention group, 38.5% of patients had haemoglobin levels within the target range compared with 23.1% in the control group (p=0.001). Haemoglobin levels above 8.1 nmol/l were more frequent in the control group versus the intervention group (7.7 vs 0.0%, p=0.034). Adequate iron status was 21.1% in the intervention group compared with 8.3% in the control group (p=0.003).

Conclusions In haemodialysis patients, darbepoetin and iron sucrose dosing by treatment algorithm increased the percentage of patients within the target range for haemoglobin levels as well as those with adequate iron storage.

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