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Abstract
Background:
The purpose of this analysis was to quantify haemoglobin (Hb) variability in patients receiving haemodialysis (HD) and erythropoiesis-stimulating agent (ESA) treatment from data independently collected in two different geographical settings
Study design, settings and patients:
Two studies retrospectively reviewed patients undergoing HD and stable ESA treatment at centres in Australia and the UK (56 and 154 patients, respectively). Monthly Hb values were obtained over a 12-month period. The frequency, duration, amplitude and direction of Hb fluctuations (Hb outside the range 11–12 g/dl in the Australian data-set and 11–12.5 g/dl in the UK data-set) were evaluated.
Results:
The overall mean Hb level was 11.27 and 11.71 g/dl in the Australian and UK data-set, respectively. All patients experienced ≥1 Hb fluctuation and 68–73% had ≥3 fluctuations over the study period. Upward and downward Hb fluctuations occurred with similar frequency and were of similar amplitude. Fluctuations of more extreme amplitude (high amplitude fluctuations) were more common than fluctuations of lesser amplitude. The total duration of time spent outside the Hb range (mean ± standard deviation) was 8.6 ± 2.5 and 7.4 ± 2.5 months in the Australian and UK data-set, respectively. The total duration with Hb <11 g/dl was 3.7 ± 3.0 and 3.7 ± 2.7 months, respectively. Most patients (95%) required ESA dose adjustment; the median number of dose adjustments per patient was 2 (range 0–5).
Conclusions:
Despite the study limitations of retrospectivity and its cross-sectional nature, the reported observations that Hb fluctuations outside target ranges occur frequently in patients on HD receiving ESAs are clearly confirmed and were strikingly similar in the two different geographical locations.
Transparency
Declaration of funding
Roche Pharmaceuticals provided funding support for data analysis and manuscript preparation.
Declaration of financial/other relationships
A.R. has disclosed that she has no significant relationships with or financial interests in any commercial companies related to this study or article. R.G.W. has disclosed that he is or has been a member on advisory boards for Janssen-Cilag, Amgen and Roche. He has been involved in numerous international clinical trials with these companies and has also received research grants from those companies. He has also disclosed that he received travel support to international and national meetings from these companies. I.C.M. has disclosed that he has received research grants, honoraria from and is a scientific advisor for Amgen, Ortho Biotech, Affymax and Roche.
Some peer reviewers receive honoraria from CMRO for their review work. The peer reviewers of this paper have disclosed that they have no relevant financial relationships.
Acknowledgement
The authors acknowledge the assistance of dialysis staff at both institutions in helping to collect data for the preparation of this manuscript.