Course of chronic kidney disease in French patients.

BACKGROUND: In 1998, a French survey showed that the referral of patients with chronic kidney disease to a nephrologist was delayed, resulting in many emergency initiations of dialysis. In 2009, the ORACLE study aimed to describe the renal course of dialysis patients from their first nephrology visit to their first dialysis session. METHODS: The ORACLE study was a multicentre retrospective study of all patients who started chronic dialysis. Data were collected at the first nephrology visit and at the first dialysis session. RESULTS: In total, 720 patients were included (69 centres). At the first nephrology visit, the mean Cockcroft-Gault (CG) indicator was 31.8 mL/min (22.7 in 1998) and 52.4% of patients (73% in 1998) had a CG <30. The mean time between the first nephrology visit and the first dialysis session was 48 months (35 months in 1998). CONCLUSION: In 2009, most patients were referred a long time before dialysis initiation, which likely allowed them to benefit from the impact of nephrology care on early outcomes when on dialysis. However, 34.2% of the dialysis sessions were still initiated under emergency conditions.

[Position statements regarding usage of biosimilars of Epoetins. Position paper of the Société de néphrologie, Société francophone de dialyse, and Société de néphrologie pédiatrique]. / Recommandations d'utilisation des biosimilaires de l'érythropoïétine (EPO). Propositions de la Société de néphrologie, de la Société francophone de dialyse et de la Société de néphrologie pédiatrique.

The European patents for epoetin alpha recently expired. Biosimilars (i.e. "a medicine which is similar to a biological medicine that has already been authorized" [EMEA 2007]) of epoetins have thus been released on the market in Europe. Because of the complexity of the processes that are required to produce medicinal products containing biotechnology-derived proteins as active substances and to characterize the physicochemical properties of these compounds, the guidelines that have been developed for generic drugs cannot be used for approval of biosimilar products. The EMEA guidelines do not answer all questions that have been raised for the development of biosimilars, and in some cases, decisions will have to be taken at a national level. This is why the Society of Nephrology (Société de néphrologie), the French-speaking Society of Dialysis (Société francophone de dialyse) and the Pediatric Society of Nephrology (Société de néphrologie pédiatrique) established guidelines for the usage of biosimilar epoetins concerning approval, identification, substitution of an innovator drug, post-marketing surveillance, extension of indication and pharmacovigilance plan.

[How to analyze and prevent the risks associated with the use of erythropoiesis stimulating agents]. / Comment analyser et prévenir les risques lors de l'administration des agents stimulant l'erythropoïès?

Erythropoiesis stimulating agents (ESAs) represent a significant cost for health care establishments, which are now subjected to new restrictions on how these agents can be dispensed, as laid down in the Decree of 24th August 2005 relating to a contract for the proper use of drugs, medical products and services. To optimize the treatment plan, ensure that these agents are used properly and satisfy the new requirements, a multidisciplinary expert group has drawn up a guide for health professionals which presents: important points specifically addressing the modalities of administration of ESAs in patients with renal disease treated by hemodialysis; a risk assessment which has helped identify preventive measures; proposals for preventive or corrective actions against medication risks or errors; an internal frame of reference for use in drawing up protocols and evaluating practices. This guide should promote a better use of ESAs once it is adopted by health care establishments, who must adapt it to their internal operations and provide suitable informational education. Training the relevant players in how to assess professional practices, together with the work of the multidisciplinary study group, are key factors that should help make this initiative a success.