Evaluation of the convenience of changing the rivastigmine administration route in patients with Alzheimer disease

Blesa González, R.; Boada Rovira, M.; Martínez Parra, C.; Gil-Saladié, D.; Almagro, C.A.; Gobartt Vázquez, A.L.

doi:10.1016/S2173-5808(11)70057-8

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Abstract

Introduction

Rivastigmine transdermal patches for the treatment of Alzheimer's disease (AD) have potential benefits compared to capsules because of their sustained absorption through the skin, good local tolerability and reduction of gastrointestinal problems.

Purpose

To assess gastrointestinal and skin tolerability and the need for optimal dose titration of rivastigmine transdermal patches in Alzheimer's disease patients previously treated with oral rivastigmine.

Patients and methods

A multicenter, randomized, open-label study including patients with mild to moderate AD (DSM-IV) previously treated with rivastigmine capsules (6–12mg/day) was conducted. Patients were randomized to: continue with capsules for 3 months (n=49) or switch to rivastigmine patch without titration (9.5mg/day for 3 months; n=48), or switch to rivastigmine patch with titration (4.6mg/day for 1 month followed by 9.5mg/day for 2 months, n=43).

Results

Incidence of gastrointestinal adverse events was 6.1% in the group treated orally and 4.2% in the group treated with non-titrated patches (P=.908). Skin tolerability was good (n=15, 16.7%) without any serious adverse events registered. Patch treatment was considered very easy to use by 72% of patients compared with 30% in the group with oral treatment (P=.0005). 60% of patients were satisfied with the patch, while only 14% were satisfied with capsules (P<.0001).

Conclusions

Rivastigmine patches have a tolerability profile similar to that shown by capsules, but are associated with greater patient satisfaction.

Keywords:

Alzheimer's disease

Rivastigmine

Treatment

Tolerability

Satisfaction

Administration route

Resumen

Introducción

Los parches transdérmicos de rivastigmina para el tratamiento de la enfermedad de Alzheimer presentan posibles beneficios respecto a las cápsulas por su absorción sostenida a través de la piel, buena tolerabilidad local y reducción de problemas gastrointestinales.

Objetivo

Evaluar la tolerabilidad gastrointestinal y cutánea y la necesidad de titulación para obtener dosis óptimas de rivastigmina transdérmica en pacientes con Alzheimer previamente tratados oralmente.

Pacientes y métodos

Se llevó a cabo un estudio multicéntrico, aleatorizado y abierto que incluyó a 142 pacientes con Alzheimer de leve a moderado y previamente tratados con rivastigmina oral (6–12mg/día). La muestra fue aleatorizada a: continuar con tratamiento oral durante 3 meses (n=49); cambio al parche sin titulación (9,5mg/día durante 3 meses, n=47) o cambio al parche con titulación (4,6mg/día por 1 mes seguido de 9,5mg/día por 2 meses, n=43).

Resultados

La incidencia de efectos adversos gastrointestinales fue del 6,1% en el grupo tratado oralmente y del 4,2% en el grupo tratado con parche sin titulación (p=0,908). La tolerabilidad cutánea fue buena (n=15, 16,7%), sin observarse acontecimientos adversos graves. El tratamiento con parche fue considerado muy fácil de utilizar por el 72% de pacientes en comparación con el 30% con tratamiento oral (p=0,0005). El 60% se mostraron satisfechos con el parche, mientras que únicamente un 14% se declaró satisfecho con las cápsulas (p<0,0001).

Conclusiones

Los parches de rivastigmina presentan un perfil de tolerabilidad similar a las cápsulas y se asocian con una mayor satisfacción de los pacientes.

Palabras clave:

Enfermedad de Alzheimer

Rivastigmina

Tratamiento

Tolerabilidad

Satisfacción

Vía de administración

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