Anaemia management in dialysis patients in Switzerland "AIMS"

The prevalence of chronic kidney disease (CKD) is increasing all over the world. In the US, out of over 400,000 were end-stage renal disease (ESRD) patients in 2002, more than 90,000 were new ESRD patients. In most European countries, the incidence of ESRD increased over the last decade at an annual rate of 6-8%. End-stage renal disease is in more than 90% of the patients associated with anaemia. Untreated anaemia impairs the patients’ quality of life and may be associated with the development of cardiovascular complications and reduce long-term survival. Earlier, treatment options of renal anaemia were essentially restricted to blood transfusions. The introduction of the recombinant human erythropoietin (rHuEPO, epoetin, EPO) more than ten years ago revolutionized the anaemia management. The correction of anaemia improved the prognosis of dialysis patients in terms of quality of life, cardiovascular morbidity and mortality.
Based on evidence and clinical experience, the treatment of renal anaemia slightly changed over the last decade and clinical practice varied across Europe. Therefore, the European Renal Association/European Dialysis and Transplantation Association (ERA-EDTA) developed together with European nephrologists guidelines for the treatment of renal anaemia. The European Best Practice Guidelines (EBPG) for the management of anaemia in patients with chronic renal failure was issued in 1999 with the aim to standardize anaemia management, to provide evidence-based recommendations and to improve patient care. However, more important than the publication of guidelines is their implementation in everyday clinical practice.
The present survey, AnaemIa Management in dialysis patients in Switzerland, called “AIMS” was the first survey performed in Switzerland assessing current anaemia ma-nagement in dialysis patients after the edition of the EBPG. The objectives of the survey were to assess the quality of anaemia management with epoetin beta achieved in Swiss dialysis centres and to compare it with current guidelines. Likewise, the efficacy and safety of the 1x weekly administration of epoetin beta was examined. Anaemia mana-gement in respect of the patients’ clinical condition was investigated in comparison to the recommendations of the guidelines. Furthermore, it was assessed whether physicians individualize anaemia management according to the patients’ clinical condition. In order to meet these objectives, no randomized clinical trial was necessary. Therefore, a practice based, open-intervention survey was performed, since no specific interference in treat-ment strategies was requested. Surveys of non-interventional design and with less rigid inclusion criteria may allow higher external validity of the study results. The survey was initiated in June 2002 and patient recruitment lasted until December 2003 with an observation period of 12 months. A representative patient population of 368 dialysis patients of 28 Swiss dialysis centres were included in this survey, with 340 patients from 26 centres being eligible. Of these, six-months results were presented.
The aim of this survey was to assess current anaemia management with epoetin beta in dialysis patients for 12 months. Therefore, epoetin beta therapy and efficacy parameters were requested to be documented monthly. At patient registration (baseline), aetiology of chronic renal failure, concomitant diseases, selected dialysis treatment modalities, dry weight and laboratory parameter, such as haemoglobin, serum ferritin, transferrin satura-tion and serum creatinine were registered. Laboratory parameters were documented if performed in the course of the clinical routine.
The main characteristics of the included patients were as follow: mean age was 64 ± 15 years and 95% of the patients were treated by haemodialysis. Most common diagnoses of end-stage renal disease were glomerulonephritis (23%), diabetic nephropathy (21%), hypertension and vascular causes (21%), and polycystic kidney disease (8%). Most pre-valent baseline co-morbidities in this survey were cardiac-related. Hypertension occurred in 61% of the patients, coronary artery disease in 26% and heart failure in 17%. Diabetes was reported in 27% of the patients.
In the first analysis, the quality of anaemia control achieved with epoetin beta in dialysis patients in Switzerland was assessed. Six months results demonstrated a high standard of anaemia management in the participating dialysis centres. Mean haemoglobin concentra-tion was 11.8 ± 1.4 g/dl at baseline and 11.8 ± 1.4 g/dl at month 6 and remained stable over the total observation period. 74% and at 76% of the patients achieved haemoglobin concentration of ≥11 g/dl at baseline and month 6 (overall 79%), respectively. Mean weekly epoetin dose administered was 143 ± 108 IU/kg/week at baseline and 155 ± 126 IU/kg/week at month 6. The findings of “AIMS” suggest that anaemia management improved over the last five years towards higher haemoglobin concentrations in dialysis patients compared to the results in the “ESAM” survey.
In the second analysis, anaemia management of dialysis patients in Swiss dialysis centres was compared to the recommendations of the EBPG. Further, physicians’ targets for anaemia treatment were assessed in respect of the guidelines and of the achieved values. Anaemia management in dialysis patients in Switzerland corresponded for the majority of the patients to the European guidelines and was well controlled. Physicians’ target for haemoglobin concentrations tended towards 12 g/dl, 60% of the participating centres aimed at partial normalization (Hb ≥12 g/dl) and 23% at full normalization (Hb ≥13 g/dl) of haemoglobin conentration in dialysis patients. The physicians’ target haemoglobin level was achieved in only 48% of the patients compared to 79% achieving 11 g/dl, since physicians’ goals were ambitious with a trend towards normalized haemoglobin concen-trations. In contrast to the recommendation, 90% of the patients received epoetin beta already at therapy initiation as a 1x weekly dosing regimen and 65% of all patients with intravenous epoetin administration received epoetin beta as a 1x weekly dosing scheme, even though there is lack of evidence to support 1x weekly dosing of intravenous epoetin in haemodialysis patients. These findings demonstrate that clinical practice diverges partially from the recommended guidelines.
In the third analysis the efficacy and safety of two dosing schedules of epoetin beta in dialysis patients were compared. The 1x weekly subcutaneous administration of epoetin beta in stable chronic kidney disease patients was approved in 2001 by the European Authority and, therefore, one of the objectives of the survey was to elaborate the relevance of the 1x weekly administration in Swiss dialysis centres. 61% (n=207) of the patients received epoetin beta 1x weekly for all six months and 39% (n=133) received it 2-3x weekly. Baseline parameters of both groups were comparable with the exception of age and baseline dose of epoetin beta. The 1x weekly administration of epoetin beta appeared to be as effective as the 2-3x weekly administration in maintaining haemoglobin concentration. These data show that in a large proportion of dialysis patients anaemia can be effectively managed with a 1x weekly administration of epoetin beta, reducing thus the work-load for medical staff.
In the fourth analysis, the prevalence of diagnosis and co-morbidities and the impact of co-morbidities on anaemia treatment were assessed in dialysis patients in Switzerland. The prevalence of the most common diagnosis and co-morbidities of Swiss dialysis
patients corresponded to those of the ERA-EDTA registry and of the USRDS registry, respectively. The influence of the underlying disease on haemoglobin and epoetin dose was investigated. In the univariate and multivariate analysis, diabetes and heart failure showed to have a significant influence on patients’ haemoglobin concentration. Mean haemoglobin was highest in patients with COPD (chronic obstructive pulmonary disease) and lowest in cancer patients. The majority of the dialysis centres aimed at identical target haemoglobin concentrations for all dialysis patients, irrespective of the co-mor-bidities or the physical condition. Only 40% of all dialysis centres said to individualize anaemia treatment.
The present survey provided evidence about the quality of anaemia management in Swiss dialysis patients for the first time after the publication of the EBPG in 1998. The findings of “AIMS” demonstrate that a high quality of anaemia control in dialysis patients in Switzerland was achieved. Target haemoglobin concentrations in Switzerland tended towards 12 g/dl and higher, reflecting the ongoing discussion about the optimal target haemoglobin level in dialysis patients which has not been defined yet. Anaemia treatment in Swiss dialysis centres was in adherence to current guidelines and was tailored to the patients’ health in approximately one third of all participating dialysis centres. In order to improve patient care, registry database and quality assessement tools have been in-creasingly used in many clinical disciplines. Up to now, no registry database has been established for renal patients in Switzerland. The increasing age of dialysis patients and the number of associated co-morbidities make the management of these patients more complex. Quality assessement tools are becoming more and more essential in order to im-prove patient care and therapy on an individual base. The present survey represents a simplified tool to perform quality assessments of anaemia management in chronic kidney disease patients in each dialysis centre and may build the basis for the national registry database.