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.

Resumo O envelhecimento da população é um fenômeno mundial com conseqüências diretas no sistema de saúde pública. Uma das principais conseqüências do crescimento desta parcela da população é o aumento da prevalência de doenças como demência e depressão que são muito freqüentes entre os idosos. Recentemente, a relação entre fatores de risco cardiovasculares, depressão e demência foi abordada em várias investigações. Objetivos: Avaliar a relação de desempenho cognitivo e sintomas depressivos com risco cardiovascular em idosos. Métodos: 94 idosos de alto risco cardiovascular e 160 idosos saudáveis da comunidade foram avaliados num corte transversal. O Mini-Exame do Estado Mental (MEEM) e a escala de depressão geriátrica (GDS-15) foram usados para as medidas principais. O ponto de corte para presença de sintomas depressivos foi 6 na GDS. Resultados: O grupo de alto risco cardiovascular mostrou escores significativamente mais baixos no MEEM (p<0001) independente da educação, e foi significativamente associado a depressão (p<0,001). A análise de regressão logística para depressão como variável dependente, idade e grupo (idosos saudáveis da comunidade ou idosos de alto risco cardiovascular) foram mantidos na equação final. Maior idade (Razão de Chance=0,92, IC 95% 0,86-0,98) e idosos de alto risco cardiovascular (RC=2,99; IC 95% 1,36-6,59) estavam associados à presença de depressão. Conclusões: Os achados do presente estudo corroboram o desempenho cognitivo diferencial dos idosos de alto risco cardiovascular e a associação de sintomas depressivos a este grupo.

Abstract The aging of the population is a universal phenomenon with direct consequences upon the public health system. One of the main repercussions of the growth in this sector of the population is the increased prevalence of disorders such as dementia and depression which are very frequent among the elderly. The relationship between cardiovascular risk factors, dementia and depression have been addressed in many recent investigations. Objectives: To evaluate the relationship of cognitive performance and depressive symptoms with cardiovascular risk in the elderly. Methods: 94 high cardiovascular risk elderly patients and 160 healthy community elderly were evaluated cross-sectionally. The Mini Mental State Examination (MMSE) and the Geriatric Depression Scale (GDS-15) were used as the main measures. The cutoff for presence of depression was 6 on the GDS. Results: The high cardiovascular risk elderly group showed significantly lower scores on the MMSE (p<0.001) and was significantly associated to depression (p<0.001), independently of education. The logistic regression analysis for depression as the dependent variable, age and group (healthy community or high cardiovascular risk elderly) were kept in the final equation. Higher age (Odds Ratio=0.92; 95% CI 0.86-0.98) and high cardiovascular risk elderly (OR=2.99; 95% CI 1.36-6.59) were associated to depression. Conclusions: The present findings corroborate the different cognitive performance of elderly with high cardiovascular risk factors and the association of depressive symptoms with this group.