A 24-week, open-label extension study to investigate the long-term safety, tolerability, and efficacy of 13.3 mg/24 h rivastigmine patch in patients with severe Alzheimer disease

Martin Farlow, George T. Grossberg, Carl H. Sadowsky, Xiangyi Meng, Drew M. Velting

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

The long-term safety, tolerability, and efficacy of high-dose 13.3 mg/24 h rivastigmine patch in severe Alzheimer disease was evaluated in a 24-week, open-label extension to the double-blind ACTION study. Safety and tolerability, and efficacy on the Alzheimer's Disease Cooperative Study-Activities of Daily Living scale-Severe Impairment Version (ADCS-ADL-SIV), Severe Impairment Battery (SIB), and ADCS-Clinical Global Impression of Change (ADCS-CGIC) were assessed. Overall, 197 patients continued on 13.3 mg/24 h patch; 199 uptitrated from 4.6 mg/24 h to 13.3 mg/24 h patch. The incidence of adverse events (AEs), serious AEs and discontinuations due to AEs was similar in patients who continued on, and patients who uptitrated to, 13.3 mg/24 h patch (AEs: 57.9% and 59.8%; serious AEs: 16.2% and 16.1%; discontinuations: 11.2% and 12.1%, respectively). Larger mean changes from double-blind baseline were observed in patients uptitrated on the ADCS-ADL-SIV (-4.6; SD=8.7) and SIB (-7.0; SD=16.6), than those who continued on 13.3 mg/24 h patch (-3.9; SD=8.0 and-4.7; SD=16.8, respectively). ADCS-CGIC scores were comparable. There were no clinically relevant between-group differences in safety and tolerability. Greater decline was observed in patients with delayed uptitration to high-dose 13.3 mg/24 h patch than patients who continued on high-dose patch.

Original languageEnglish
Pages (from-to)110-116
Number of pages7
JournalAlzheimer Disease and Associated Disorders
Volume29
Issue number2
DOIs
StatePublished - Jun 9 2015

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Rivastigmine
Alzheimer Disease
Safety
Activities of Daily Living
Double-Blind Method

Keywords

  • open-label clinical trial
  • rivastigmine
  • severe Alzheimer disease
  • transdermal patch

ASJC Scopus subject areas

  • Geriatrics and Gerontology
  • Psychiatry and Mental health
  • Gerontology
  • Clinical Psychology

Cite this

A 24-week, open-label extension study to investigate the long-term safety, tolerability, and efficacy of 13.3 mg/24 h rivastigmine patch in patients with severe Alzheimer disease. / Farlow, Martin; Grossberg, George T.; Sadowsky, Carl H.; Meng, Xiangyi; Velting, Drew M.

In: Alzheimer Disease and Associated Disorders, Vol. 29, No. 2, 09.06.2015, p. 110-116.

Research output: Contribution to journalArticle

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abstract = "The long-term safety, tolerability, and efficacy of high-dose 13.3 mg/24 h rivastigmine patch in severe Alzheimer disease was evaluated in a 24-week, open-label extension to the double-blind ACTION study. Safety and tolerability, and efficacy on the Alzheimer's Disease Cooperative Study-Activities of Daily Living scale-Severe Impairment Version (ADCS-ADL-SIV), Severe Impairment Battery (SIB), and ADCS-Clinical Global Impression of Change (ADCS-CGIC) were assessed. Overall, 197 patients continued on 13.3 mg/24 h patch; 199 uptitrated from 4.6 mg/24 h to 13.3 mg/24 h patch. The incidence of adverse events (AEs), serious AEs and discontinuations due to AEs was similar in patients who continued on, and patients who uptitrated to, 13.3 mg/24 h patch (AEs: 57.9{\%} and 59.8{\%}; serious AEs: 16.2{\%} and 16.1{\%}; discontinuations: 11.2{\%} and 12.1{\%}, respectively). Larger mean changes from double-blind baseline were observed in patients uptitrated on the ADCS-ADL-SIV (-4.6; SD=8.7) and SIB (-7.0; SD=16.6), than those who continued on 13.3 mg/24 h patch (-3.9; SD=8.0 and-4.7; SD=16.8, respectively). ADCS-CGIC scores were comparable. There were no clinically relevant between-group differences in safety and tolerability. Greater decline was observed in patients with delayed uptitration to high-dose 13.3 mg/24 h patch than patients who continued on high-dose patch.",
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