Die Notwendigkeit zur Revision des Hämoglobingrenzwerts in der deutschen Qualitätssicherungs-Richtlinie Dialyse

Zusammenfassung

Die Qualitätssicherungs-Richtlinie Dialyse (QSD-RL) schreibt vor, dass in einer Dialyseeinrichtung < 15 % aller im Quartal behandelten Patienten einen Hämoglobin (Hb)-Wert < 10 g/dl haben soll. Dieser Hb-Grenzwert lässt sich bei ca. 90 % der Dialysepatienten nur durch Gabe von Erythropoese-stimulierenden Arzneimitteln (ESA) erreichen. Es stellt sich jedoch die Frage, ob dieser Hb-Grenzwert noch dem aktuellen Kenntnisstand entspricht. Aufgrund von vier randomisiert-kontrollierten Studien, wobei insbesondere die TREAT-Studie hervorzuheben ist, und drei Metaanalysen ist es evident, dass bei chronischer Niereninsuffizienz (CKD) ein ESA-induzierter Hb-Anstieg keinen Überlebensvorteil bewirkt, sondern sogar Nachteile verursachen kann, wobei insbesondere das erhöhte kardio- und zerebrovaskuläre sowie malignomassoziierte Risiko zu beachten ist. Vor diesem Hintergrund haben 2011 die US-amerikanische Food and Drug Administration (FDA), der deutsche Gemeinsame Bundesausschuss mit einer Änderung der Arzneimittel-Richtlinie (AM-RL) und der Leitlinienentwurf von KDIGO (Kidney Disease: Improving Global Outcomes) sehr restriktive Empfehlungen zum Einsatz von ESA bei CKD formuliert, wonach der in der QSD-RL vorgeschriebene Hb-Grenzwert von 10 g/dl obsolet und deshalb eine zeitnahe Revision der QSD-RL geboten erscheint. Hierzu bieten sich zwei Alternativen an: Entweder wird der bisherige Hb-Grenzwert ersatzlos gestrichen und eine individualisierte Therapie der renalen Anämie praktiziert („Individualisierung“) oder statt des bisherigen Hb-Grenzwert von 10 g/dl gilt zukünftig ein Grenzwert von 9 g/dl (modifizierte „Standardisierung“).

Abstract

The German Quality Assurance Directive for Dialysis (QSD-RL) stipulates that no more than 15 % of all patients treated in a dialysis unit in any quarter may have a hemoglobin (Hb) value lower than 10 g/dl. For approximately 90 % of dialysis patients, this Hb threshold value can be simply achieved by administering erythropoiesis-stimulating agents (ESA). However, the question is raised as to wether this Hb threshold accords with the current state of knowledge. It is now evident from four randomized controlled trials (above all the TREAT study) and three meta-analyses that an ESA-induced increase in Hb does not produce any significant survival benefit in cases of chronic kidney disease (CKD), but may actually be detrimental. Critical attention must be focused in this regard on the higher risk of cardiovascular and cerebrovascular events, as well as malignoma-associated risks. In 2011, in response to these findings, the American Food and Drug Administration (FDA), the Drug Directive (AM-RL) of the German Federal Joint Committee and KDIGO (Kidney Disease: Improving Global Outcomes) amended guidelines for the treatment of renal anemia. Very restrictive recommendations were made regarding the use of ESA in CKD, according to which the Hb threshold value of 10 g/dl stipulated in the Quality Assurance Directive is now obsolete, thus necessitating prompt revision of the Directive. Two alternatives are available in this regard: either the 10 g/dl Hb threshold value applicable hitherto is withdrawn without replacement, and individualized treatment of renal anemia is practised (“individualization”) instead, or a threshold value of 9 g/dl (modified “standardization”) is applied in future.

Schlüsselwörter

chronische Niereninsuffizienz - renale Anämie - Erythropoetin - Hämoglobin-Grenzwert - Dialyserichtlinie

Keywords

chronic kidney disease - renal anemia - erythropoietin - hemoglobin threshold value - dialysis directive

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