A meta-analysis of GFR slope as a surrogate endpoint for kidney failure

Glomerular filtration rate (GFR) decline is causally associated with kidney failure and is a candidate surrogate endpoint for clinical trials of chronic kidney disease (CKD) progression. Analyses across a diverse spectrum of interventions and populations is required for acceptance of GFR decline as an endpoint. In an analysis of individual participant data, for each of 66 studies (total of 186,312 participants), we estimated treatment effects on the total GFR slope, computed from baseline to 3 years, and chronic slope, starting at 3 months after randomization, and on the clinical endpoint (doubling of serum creatinine, GFR < 15 ml min−1 per 1.73 m2 or kidney failure with replacement therapy). We used a Bayesian mixed-effects meta-regression model to relate treatment effects on GFR slope with those on the clinical endpoint across all studies and by disease groups (diabetes, glomerular diseases, CKD or cardiovascular diseases). Treatment effects on the clinical endpoint were strongly associated with treatment effects on total slope (median coefficient of determination (R2) = 0.97 (95% Bayesian credible interval (BCI) 0.82–1.00)) and moderately associated with those on chronic slope (R2 = 0.55 (95% BCI 0.25–0.77)). There was no evidence of heterogeneity across disease. Our results support the use of total slope as a primary endpoint for clinical trials of CKD progression

Utilização de eritropoetina por pacientes incidentes em hemodiálise no Sistema Único de Saúde, Brasil, 2002-2003 Erythropoietin use by incident hemodialysis patients in the Brazilian Unified National Health System, 2002-2003

Este estudo visa a descrever o perfil demográfico e epidemiológico de pacientes incidentes em hemodiálise, que utilizaram eritropoetina em 2002 e 2003, no Brasil, e identificar fatores associados ao uso desse medicamento. Foram analisados dados demográficos, clínicos e relacionados à unidade de diálise de 32.136 pacientes, identificados por pareamento determinístico-probabilístico de dados do subsistema de autorização de procedimentos de alto custo e do Sistema de Informações sobre Mortalidade. Um modelo de regressão de Poisson foi usado para identificar fatores associados ao uso de eritropoetina. Sexo masculino; idade inferior a 65 anos; nefropatia diabética; fístula arteriovenosa ao iniciar hemodiálise e residir em outras Unidades Federativas diferentes do Mato Grosso foram fatores associados ao uso de eritropoetina. A política de atenção ao doente renal, a alocação de recursos para estados e municípios e o manejo da anemia, segundo o perfil farmacoterapêutico dos pacientes, devem ser revistos, a fim de reduzir as iniquidades observadas na utilização da eritropoetina.<br>This study aimed to describe the demographic and epidemiological profile of Brazilian patients entering hemodialysis from 2002 to 2003 and identify predictors of erythropoietin use. The study analyzed demographic and clinical characteristics and dialysis facility-related variables from 32,136 patients identified by deterministic-probabilistic matching in the database of authorizations for high-cost procedures and the Mortality Information System. Poisson regression was used to identify predictors of erythropoietin use. Male gender, age < 65 years, diabetic renal failure, arteriovenous fistula at the beginning of hemodialysis, and living in States of Brazil other than Mato Grosso were predictors of erythropoietin use. The policy of care for chronic kidney disease, resource allocation for States and municipalities, and anemia management according to the patient's drug therapy profile need to be revised in order to reduce observed inequities in erythropoietin use