Pharmacovigilance of NeuroEPO in subjects included in clinical trials.

Introduction: NeuroEPO is a variant of recombinant human erythropoietin with low sialic acid content, formulated for intranasal administration. Objective: to evaluate the safety of NeuroEPO, during its use in subjects included in clinical trials developed in Cuba, during the years 2013 -2020. Materials and methods: a retrospective study was conducted, based on the safety data of 356 subjects included in five completed clinical trials (25 healthy volunteers, 34 patients with diagnosis of Spinocerebellar Ataxia type 2, 127 with diagnosis of Parkinson's disease and 170 with clinical diagnosis of mild-moderate Alzheimer's disease). carried out. Events were classified according to severity, intensity, drug attitude, outcome and causality. Results: 137 (38.48 %) patients with AEs were reported, distributed in 63 types with a frequency of 162 events. Of these, 18 (28.6 %) types with a frequency of 44 (27.2 %) were related to the study drug. All were classified non-serious, mild intensity and 41 (93.2 %) with reversible outcome. Conclusions: Treatment with NeuroEPO by intranasal route was safe.

Autorentext

Autore: Daymys Estévez IglesiasTutor: Dr.C. Leslie Pérez RuizDr.C. Ivón González Blanco Consulente: Dr.C Carmen Elena Viada González