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Efficacy of 13.3?mg/24?h versus 4.6?mg/24?h rivastigmine patch on activities of daily living in severe Alzheimer's disease.

ABSTRACT: OBJECTIVE:Investigate efficacy of 13.3?mg/24?h rivastigmine patch in patients with severe Alzheimer's disease on Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale-Severe Impairment Version items and domains. METHODS:Retrospective analysis of the 24-week, randomized, double-blind ACTivities of daily living and cognitION (ACTION) study, using factor analysis to establish "best fit" for Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale-Severe Impairment Version items into domains. Treatment differences (13.3 vs 4.6?mg/24?h patch) on items and domains were assessed. RESULTS:Overall, 632 patients provided Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale-Severe Impairment Version data. Factor analysis yielded four domains. The 13.3 versus 4.6?mg/24?h patch demonstrated significantly greater efficacy on "Daily function" (p?=?0.038), supported by greatest effect sizes on items within this domain, and trend toward greater efficacy on "Communication" (p?=?0.052). No significant between-group differences were observed on "Independence" (p?=?0.600) or "Environment" (p?=?0.261). CONCLUSION:The 13.3?mg/24?h patch was superior to 4.6?mg/24?h patch on "Daily function" in severe Alzheimer's disease.

SUBMITTER: Micca JL

PROVIDER: S-EPMC4607239 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Efficacy of 13.3 mg/24 h versus 4.6 mg/24 h rivastigmine patch on activities of daily living in severe Alzheimer's disease.

Micca Joseph L JL Galvin James E JE Velting Drew M DM Meng Xiangyi X

SAGE open medicine 20141201

<h4>Objective</h4>Investigate efficacy of 13.3 mg/24 h rivastigmine patch in patients with severe Alzheimer's disease on Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale-Severe Impairment Version items and domains.<h4>Methods</h4>Retrospective analysis of the 24-week, randomized, double-blind ACTivities of daily living and cognitION (ACTION) study, using factor analysis to establish "best fit" for Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale-Severe ...[more]

PMID: 26770753

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Project description:IntroductionOPtimizing Transdermal Exelon In Mild-to-moderate Alzheimer's disease (OPTIMA) was a randomized, double-blind comparison of 13.3 mg/24 h versus 9.5 mg/24 h rivastigmine patch in patients with mild-to-moderate Alzheimer's disease who declined despite open-label treatment with 9.5 mg/24 h patch. Over 48 weeks of double-blind treatment, high-dose patch produced greater functional and cognitive benefits compared with 9.5 mg/24 h patch.MethodsUsing OPTIMA data, a post-hoc responder analysis was performed to firstly, compare the proportion of patients demonstrating improvement or absence of decline with 13.3 mg/24 h versus 9.5 mg/24 h patch; and secondly, identify predictors of improvement or absence of decline. 'Improvers' were patients who improved on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) by ≥4 points from baseline, and did not decline on the instrumental domain of the Alzheimer's Disease Cooperative Study-Activities of Daily Living scale (ADCS-IADL). 'Non-decliners' were patients who did not decline on either scale.ResultsOverall, 265 patients randomized to 13.3 mg/24 h and 271 to 9.5 mg/24 h patch met the criteria for inclusion in the intention-to-treat population and were included in the analyses. Significantly more patients were 'improvers' with 13.3 mg/24 h compared with 9.5 mg/24 h patch at Weeks 24 (44 (16.6%) versus 19 (7.0%); P < 0.001) and 48 (21 (7.9%) versus 10 (3.7%); P = 0.023). A significantly greater proportion of patients were 'non-decliners' with 13.3 mg/24 h compared with 9.5 mg/24 h patch at Week 24 (71 (26.8%) versus 44 (16.2%); P = 0.002). At Week 48, there was a trend in favor of 13.3 mg/24 h patch. Functional and cognitive assessment scores at double-blind baseline did not consistently predict effects at Weeks 24 or 48.ConclusionMore patients with mild-to-moderate Alzheimer's disease who are titrated to 13.3 mg/24 h rivastigmine patch at time of decline are 'improvers' or 'non-decliners' i.e. show responses on cognition and activities of daily living compared with patients remaining on 9.5 mg/24 h patch.Trial registrationClinicaltrials.gov identifier: NCT00506415; registered July 20, 2007.

Dataset Information

Efficacy of 13.3?mg/24?h versus 4.6?mg/24?h rivastigmine patch on activities of daily living in severe Alzheimer's disease.

Publications

Efficacy of 13.3 mg/24 h versus 4.6 mg/24 h rivastigmine patch on activities of daily living in severe Alzheimer's disease.

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