An experimental, randomized, double-blind, placebo-controlled clinical trial to investigate the effect of nicardipine on cognitive function in patients with vascular dementia
Summary. Introduction and objective. Experimental and clinical data suggest that calcium channel blockers could be effective in the treatment of vascular dementia (VD). The aim of this study is to evaluate the effect of nicardipine on the progression of cognitive impairment in patients with VD. Patients and methods. We selected outpatients, of both sexes, between 55 and 80 years old, with VD. Following a placebo wash-out period (4 weeks), the patients received nicardipine 20 mg t.i.d. or placebo for one year. The primary efficacy variable was the loss of over 10% of the basal score on the Mini-Mental State Examination after one year. The time it took to reach this degree of impairment, the evolution of Pfeiffer score, the effect on functional disability, and the drug safety were also evaluated. Results. 156 patients were included, 109 completed the study, and 142 underwent intent-to-treat analysis. At the end of the study, 34.6% of patients with placebo and 21.1% with nicardipine had lost over 10% of their basal MMSE score. Favorable effects of nicardipine were found on females (40.9% vs 10.5%, p= 0.01876), patients without previous treatments (46.2% vs 13.3%, p= 0.00748) and patients with concomitant antiplatelet treatment (35.0% vs 15.9; p= 0.03836). Survival analysis showed that the patients with nicardipine took longer to lose cognitive capacities (p= 0.031; RR= 1.15-3.99). Conclusion. Nicardipine did not reduce the cognitive decline at the stated period in the total group but it significantly delayed this decline and produces better evolution in females, in patients without previous treatments, and those with antiplatelet treatment
Pacientes y métodos Se seleccionaron pacientes ambulatorios, de ambos sexos, de 55 a 80 años de edad, con DV. Tras un lavado con placebo (4 semanas), los pacientes tomaron nicardipino 20 mg/8 h o placebo durante un año. La variable de eficacia principal fue la pérdida superior al 10% de la puntuación basal del miniexamen cognoscitivo (MEC) al cabo de un año. También se valoró el tiempo transcurrido hasta alcanzar ese grado de deterioro, la escala de Pfeiffer, la repercusión funcional y la seguridad del fármaco.
Resultados Se incluyeron 156 pacientes, 109 completaron el estudio y 142 son analizados por intención de tratar. Al final del estudio, el 34,6% de pacientes con placebo y el 21,1% con nicardipino habían perdido más del 10% de su puntuación basal en el MEC. Se encontraron efectos favorables de nicardipino en mujeres (40,9% frente a 10,5%, p= 0,01876), pacientes sin tratamientos previos (46,2% frente a 13,3%, p= 0,00748) y pacientes con tratamiento concomitante antiagregante (35,0% frente a 15,9; p= 0,03836). El análisis de supervivencia demuestra que con nicardipino se tarda más en perder capacidades cognitivas (p= 0,031; RR= 1,15-3,99).
Conclusión Nicardipino retrasa la aparición del deterioro cognitivo en DV
