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Titolo Latest US KDOQI Anaemia Guidelines update?what are the implications for Europe?
Autore I.C. Macdougall, K.-U. Eckardt, F. Locatelli
Referenza Nephrol Dial Transplant 2007; 22 (10): 2738-2742
Contenuto Extract At the time of writing, the European Agency for the Evaluation of Medicinal Products (EMEA) has provided no guidance or recommendation, none of the Summaries of Product Characteristics have been altered and, waiting for a KDIGO initiative, the European Best Practice Guidelines have not been updated. The EMEA is indeed looking closely at the implications of CHOIR and CREATE, and is expected to announce their opinions and recommendations within the next couple of months. In the meantime, several clear messages have recently emerged from the fog surrounding the issue of target haemoglobin in CKD patients. According to Hippocrates, a physician\\\'s first responsibility is to ?do no harm?. The evidence base for CKD anaemia management now suggests that aiming for haemoglobin targets >13.0 g/dl in patients receiving ESAs runs the risk of causing harm. Generally aiming for a haemoglobin of 11-12 g/dl would seem to provide the best compromise, in terms of gaining benefit and minimizing the risks of using ESAs, recognizing that this target range is very narrow and there will be a Gaussian distribution of Hb values actually achieved by the patients. It still leaves us with the two ?woolly? areas on either side of this haemoglobin range: do patients with haemoglobin levels of 10-11 g/dl really fare less well than those whose haemoglobin is >11 g/dl? Secondly, although deliberately targeting haemoglobin levels >13 g/dl may increase the likelihood of causing harm, there is no evidence to suggest that transient fluctuations into this haemoglobin range should cause either the nephrologist or the patient any concern. One must be mindful that the adverse data from CHOIR were generated from a group of patients who were deliberately targeting a haemoglobin of 13.5 g/dl and using very large doses of epoetin alfa to overcome patient hyporesponsiveness. This situation is likely to differ from that of a patient who is targeted to a haemoglobin between 11 and 12 g/dl, but who occasionally (through normal biological variability) develops a haemoglobin of 12-13 g/dl or above. Although it is noteworthy that the mean haemoglobin concentration in the higher Hb arm in CHOIR was 12.6 g/dl, this does not imply that targeting patients into this range confers harm. Since many observational studies have in fact shown that patient outcome improves with higher Hb levels, it is possible that the concept of a single optimal target Hb for all patients is not correct and that both EPO resistance (the amount of ESA needed to increase the Hb concentration by 1 g/dl) as well as the absolute ESA dose required to achieve a certain Hb level are also important for anaemia management.
Data 30.10.2007
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