Abstract
There is not much published literature on the use of rivastigmine patch in a "routine" clinical setting.
Objectives:
In this naturalistic longitudinal observational study we sought to evaluate the safety, tolerability and efficacy of the rivastigmine patch in patients with early and late onset moderate Alzheimer's disease in a routine clinical setting.
Methods:
Out of all routine clinical referrals, the first 30 patients with diagnosis of moderate Alzheimer's dementia who were started on rivastigmine patch were included in the study. Rivastigmine patch dose was titrated from 4.6 to 9.5 mg/ 24 hours as appropriate. The primary outcome measure was safety and tolerability, measured by the incidence of adverse events and discontinuation due to any reason. The secondary outcome measure was to examine improvement on global, functional and behavioral domains as demonstrated by the MMSE (Mini Mental State Examination) score, BADLS (Bristol Activities of Daily Living Skills) score, patient and carer feedback and clinical judgment.
Results:
Adverse events were reported in 20% of patients and 10% of total patients needed discontinuation of treatment. Improvement on global, functional and behavioral domains was observed in two thirds of patients whereas one third showed a relative decline. The most common side effect was skin irritation or erythema.
Conclusions:
The rivastigmine transdermal patch may provide a treatment option for those patients who require a change in their current oral cholinesterase inhibitor therapy due to safety or tolerability concerns.
Key words:
rivastigmine; transdermal patch; observational study; longitudinal study; Alzheimer's dementia; clinical settings
Resumo
Não há muita publicação na literatura sobre o uso do adesivo de rivastigmina na prática clínica.
Objetivos:
Em um estudo observacional longitudinal naturalístico nós tentamos avaliar a segurança, tolerabilidade e eficácia do adesivo transdérmico de rivastigmina em pacientes com doença de Alzheimer moderada de início precoce e tardio.
Métodos:
Os primeiros 30 pacientes ambulatoriais com DA moderada de clínicas de referência que iniciaram o uso de adesivo de rivastigmina foram incluídos no estudo. A dose foi escalonada de 4,6 a 9,5 mg/24 hs quando apropriado. As medidas de desfecho primário foram a segurança e tolerabilidade medidas pela incidência de eventos adversos e descontinuação por alguma razão. A medida de desfecho secundário foi a melhora global, funcional e comportamental, demonstrada pelos escores do Mini-Exame do Estado Mental (MEEM), escores na escala de Atividade de Vida Diária de Bristol, retorno do paciente e cuidador e julgamento clínico.
Resultados:
Eventos adversos foram reportados em 20% dos pacientes e 10% deles descontinuaram o tratamento. Melhora em domínios global, funcional e comportamental foi observada em dois terços dos pacientes, enquanto que, no terço restante um declínio relativo foi observado. O efeito colateral mais comum foi irritação ou eritema de pele.
Conclusões:
O adesivo transdérmico de rivastigmina pode ser uma opção terapêutica para aqueles pacientes que requeiram mudança na sua terapia oral com inibidor da colinesterase devido à sua segurança e tolerabilidade.
Palavras-chave:
rivastigmina; adesivo transdérmico; estudo longitudinal; doença de Alzheimer; clínica
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Full text available only in PDF format.
References
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- Cummings J, Wimblad B. A Rivastigmine patch for the treatment of Alzheimer's disease and Parkinson's disease dementia Expert Rev Neurother 2007;7:1457-1463.
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- The ICD 10 International classification of mental and behavioural disorders; 10th edition; World Health Organisation; Geneva.
- NICE Guidance - Technology Appraisal 111- Alzheimer disease (National Institute of Clinical Excellence- UK).
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- Winblad B, Kawata AK, Beusterien KM, et al. Caregiver preference for Rivastigmine patch relative to capsules for the treatment of probable Alzheimer's disease. Int J Geriatr Psychiatry 2007;22:485-491.
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- Sadowsky CH, Dengiz A, Olin JT, Koumaras B, Meng X, Brannan S; US38 study group. Switching from donepezil tablets to rivastigmine trans-dermal patch on Alzheimer's disease. Am J Alzhemers Dis Other Demen 2009;24:267-275.
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Publication Dates
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Publication in this collection
Jul-Sep 2010
History
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Received
29 Apr 2010 -
Accepted
04 Aug 2010
