Skin reactions at the application site of rivastigmine patch (4.6 mg/24 h, 9.5 mg/24 h or 13.3 mg/24 h): a qualitative analysis of clinical studies in patients with Alzheimer's disease.
Int J Clin Pract
; 69(5): 518-30, 2015 May.
Article
en En
| MEDLINE
| ID: mdl-25684069
ABSTRACT
BACKGROUND AND OBJECTIVES:
Rivastigmine patch is approved for the treatment of all stages of Alzheimer's disease (AD). Application site reactions may be a concern to clinicians and we used two large clinical trial databases to investigate the incidence of skin reactions in patients receiving rivastigmine patch.METHODS:
Data from a 24-week, randomised, double-blind (DB) evaluation of 13.3 vs. 4.6 mg/24 h rivastigmine patch in severe AD (ACTION) and a 72- to 96-week study comprising an initial open-label (IOL) phase followed by a 48-week randomised, DB phase (13.3 vs. 9.5 mg/24 h rivastigmine patch) in declining patients with mild-to-moderate AD (OPTIMA) were analyzed. The incidence, frequency, severity, management and predictors of application site reactions were assessed.RESULTS:
Application site reactions were mostly mild or moderate in severity and reported by similar proportions in each treatment group ( ACTION 13.3 mg/24 h, 24.5% and 4.6 mg/24 h, 24.2%; OPTIMA IOL 9.5 mg/24 h, 22.9%; DB 13.3 mg/24 h, 11.4% and 9.5 mg/24 h, 12.0%); none were rated serious. In both studies, <9% of patients required treatment for application site reactions. Application site reactions led to discontinuation of 1.7% and 2.5% of the 13.3 mg/24 h and 4.6 mg/24 h groups, respectively, in ACTION, 8.7% in OPTIMA IOL and 1.8% and 3.5% of the 13.3 mg/24 h and 9.5 mg/24 h groups, respectively, in OPTIMA DB.CONCLUSIONS:
Application site reactions were experienced by <25% of patients in both studies, with no notable effect of dose. No reactions qualified as serious and skin reactions were uncommon as a reason for study discontinuation.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Erupciones por Medicamentos
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Fármacos Neuroprotectores
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Enfermedad de Alzheimer
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Rivastigmina
Tipo de estudio:
Clinical_trials
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Incidence_studies
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Prognostic_studies
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Qualitative_research
Límite:
Aged
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Female
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Humans
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Male
Idioma:
En
Revista:
Int J Clin Pract
Asunto de la revista:
MEDICINA
Año:
2015
Tipo del documento:
Article
País de afiliación:
Estados Unidos