OBJECTIVES: Anemia is a common complication among chronic kidney disease patients on hemodialysis, occurring mostly due to erythropoietin deficiency. This randomized noninferiority trial sought to compare the efficacy and safety of a new epoetin formulation developed by Bio-Manguinhos, a biologics manufacturer affiliated with the Brazilian government, with those of a commercially available product currently used in Brazil (a biosimilar epoetin formulation). METHODS: The sample size needed to enable demonstration of noninferiority with a statistical power of 85% for a between-group difference in hemoglobin levels of no more than 1.5 g/dL was calculated. In total, 74 patients were randomly assigned to receive the epoetin formulation from Bio-Manguinhos (n = 36) or the biosimilar epoetin formulation (n = 38) in a double-blind fashion. The inclusion criteria were current epoetin therapy and stable hemoglobin levels for at least 3 months prior to the study. The primary and secondary outcomes were mean monthly hemoglobin levels and safety, respectively. The dose was calculated according to international criteria and adjusted monthly in both groups according to hemoglobin levels and at the assistant physicians' discretion. Iron storage was estimated at baseline and once monthly. Clinicaltrials.gov: NCT01184495. RESULTS: The study was conducted for 6 months after randomization. The mean baseline hemoglobin levels were 10.9±1.2 and 10.96±1.2 g/dL (p = 0.89) in the Bio-Manguinhos epoetin and biosimilar epoetin groups, respectively. During the study period, there was no significant change in hemoglobin levels in either group (p = 0.055, ANOVA). The epoetin from Bio-Manguinhos was slightly superior in the last 3 months of follow-up. The adverse event profiles of the two formulations were also similar. CONCLUSIONS: The epoetin formulations tested in this study are equivalent in efficacy and safety.

A Insuficiência Cardíaca Congestiva (ICC) é uma patologia com incidência crescente e que representa uma condição de grande impacto na saúde pública, com alta morbidade e mortalidade. O excesso de volume é uma complicação prevalente, presente em 80% dos pacientes atendidos com o diagnóstico de ICC. Estratégias farmacológicas e não farmacológicas no manejo terapêutico da ICC visam ao melhor manejo do volume e à redução no uso de diuréticos. A ultrafiltração extracorpórea tem evidenciado melhor controle de peso, redução nos dias de hospitalização e re-hospitalização dos pacientes com ICC. Neste artigo, relatamos dois casos atendidos no Hospital de Clínicas de Porto Alegre, relativos a pacientes com diagnóstico de ICC tratados com diálise peritoneal.

Congestive heart failure (CHF) has a growing incidence, a great impact on public health, and high morbidity and mortality. Excessive blood volume is a prevalent complication present in 80% of the patients diagnosed with CHF. Pharmacological and non-pharmacological strategies in the treatment of CHF aim to better manage blood volume and reduce the use of diuretics. Extracorporeal ultrafiltration has evidenced better weight control, and a reduction in the length of hospitalization and re-hospitalization of patients with CHF. We report the cases of 2 patients diagnosed with CHF and treated with peritoneal dialysis at Hospital de Clínicas de Porto Alegre.