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
dc.contributor.author | Farlow, Martin R. | |
dc.contributor.author | Grossberg, George T. | |
dc.contributor.author | Sadowsky, Carl H. | |
dc.contributor.author | Meng, Xiangyi | |
dc.contributor.author | Velting, Drew M. | |
dc.contributor.department | Department of Neurology, IU School of Medicine | en_US |
dc.date.accessioned | 2015-12-10T17:38:37Z | |
dc.date.available | 2015-12-10T17:38:37Z | |
dc.date.issued | 2015-04 | |
dc.description.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. | en_US |
dc.eprint.version | Author's manuscript | en_US |
dc.identifier.citation | Farlow, M. R., Grossberg, G. T., Sadowsky, C. H., Meng, X., & Velting, D. M. (2014). 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. Alzheimer Disease & Associated Disorders, 1. http://doi.org/10.1097/WAD.0000000000000073 | en_US |
dc.identifier.uri | https://hdl.handle.net/1805/7679 | |
dc.language.iso | en_US | en_US |
dc.publisher | Lippincott Williams & Wilkins | en_US |
dc.relation.isversionof | 10.1097/WAD.0000000000000073 | en_US |
dc.relation.journal | Alzheimer Disease & Associated Disorders | en_US |
dc.rights | Publisher Policy | en_US |
dc.source | Author | en_US |
dc.subject | severe Alzheimer's disease | en_US |
dc.subject | rivastigmine | en_US |
dc.subject | transdermal patch | en_US |
dc.title | 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 | en_US |
dc.type | Article | en_US |