Anaemia management with C.E.R.A. in routine clinical practice: OCEANE (Cohorte Mircera patients non-dialyses), a national, multicenter, longitudinal, observational prospective study, in patients with chronic kidney disease not on dialysis.

OBJECTIVE: The aim of this study was to describe the management of anaemia with a continuous erythropoietin receptor activator (C.E.R.A., methoxy polyethylene glycol epoetin-ß), in patients with chronic kidney disease (CKD) not on dialysis, naïve or non-naïve to treatment with erythropoiesis-stimulating agents (ESAs) at inclusion. DESIGN: National, multicentre, longitudinal, observational prospective study. SETTING: 133 nephrologists practicing in France selected patients during their routine follow-up visits. The study was non-interventional. PARTICIPANTS: They were adult CKD patients not on dialysis or kidney transplant patients, naïve or not to ESA treatment: 524 patients not on dialysis (48% ESA-naïve) and 92 kidney transplant patients (24% ESA-naïve) were included and followed up every 3 months during 1 year. OUTCOME MEASURES: The two main endpoints were the percentage of patients who achieved target haemoglobin (Hb) levels as per European Medicines Agency guidelines (10-12 g/dl) around 6 months of treatment and modalities of treatment. RESULTS: Approximately one in two patients had an Hb level within 10-12 g/dl at baseline, and around 6 and 12 months of treatment. Ninety per cent of ESA-naïve patients achieved at least +1 g/dl increase over baseline Hb levels or had Hb within 10-12 g/dl around 6 and 12 months. The Hb level remained at approximately 11.5 g/dl during the 12 months of follow-up. Around 6 months: almost all patients were receiving a once-monthly subcutaneous dose of C.E.R.A. (patients not on dialysis: 95±54 µg; kidney transplant patients: 121±70 µg); approximately half the patients did not require a change in C.E.R.A. dose. Adverse effects related to C.E.R.A. were observed in less than 5% of patients and led to modification or discontinuation of treatment in 2%. CONCLUSIONS: The efficacy and safety of C.E.R.A. in CKD patients not on dialysis, with or without kidney transplantation, were confirmed in routine clinical practice.

[Is the management of anemia in hemodialysis patients improving in France? Results of the DiaNE study]. / La prise en charge de l'anémie du patient hémodialysé en France s'améliore-t-elle? Résultats de l'étude DiaNE.

French and international clinical practice guidelines recommend a minimum hemoglobin level of 11 g/dl in patients with chronic kidney disease. Previous studies implemented between 1996 and 2003 showed that only 35 to 55% the patients reach this target. Dialysis NeoRecormon Epidemiology (DiaNE) is a one-year French multicentric observational study designed to follow a cohort of 1200 patients with ESRD treated with epoetin beta to assess the management of anemia in routine nephrologic practice. From December 2003 to September 2004, 1241 hemodialysis patients were recruited by 229 centers. At baseline, 64.4% of patients had hemoglobin levels greater than 11 g/dl. The proportion of patients with hemoglobin levels greater than 11 g/dl at the end of the study was 71.6%. These results could be partly explained by iron deficiency: 46% of patients had a serum ferritin between 200 and 500 microg/l and about one third of patients had a transferrin-iron saturation percentage greater or equal to 30% at baseline and at the end of the study. Epoetin beta was administrated by subcutaneous route in 65.5% of patients with similar efficacy and with less mean doses than intravenous route (114.6+/-81.5 IU/kg versus 146.5+/-124.3 IU/kg at the end of the study). In conclusion, the management of anemia in hemodialysis patients is not optimal but is slightly better than the management observed between 1996 and 2003. Iron and inflammatory status should be taken into account to improve the efficacy of anemia therapy using erythropoietin-stimulating agents.

[Methodology and quality control in EPIGRAM, a pharmacoepidemiological study of obesity in general practice]. / EPIGRAM, etude pharmacoépidémiologique de l'obésité: méthodologie et critères de qualité.

The EPIGRAM pharmacoepidemiological study was conducted in general practitioners prescribing orlistat (Xenical) in order to describe, under real clinical conditions, the management of obese or overweight patients. A 1-year follow-up of a patient cohort treated with orlistat was also conducted. Quality criteria specific to the study were defined to ensure the scientific validity of the results; these criteria mainly involved the following items: independent scientific committee, sampling investigator's recruitment, study organisation and quality control of the collected data. On-site control visits of a sample of 13% of participating GPs revealed that 75% of the controlled data were documented in a source file of which 85% were consistent with the source data. Only 1% of the 130 000 controlled data (data were controlled only on visits for which information was available) gave rise to correction requests. Of the patients treated with orlistat on inclusion, 17% were lost to follow-up by their GP and 25% were contacted directly at the end of the study.