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.
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.
authors.affiliation: *Department of Neurology, Indiana University School of Medicine, Indianapolis, IN †Department of Neurology and Psychiatry, St Louis University School of Medicine, St Louis, MO ‡Division of Neurology, Nova Southeastern University, Fort Lauderdale, FL §Novartis Pharmaceuticals Corporation, East Hanover, NJ.
authors.forename: Martin R
authors.initials: MR
authors.lastname: Farlow
authors.forename: George T
authors.initials: GT
authors.lastname: Grossberg
authors.forename: Carl H
authors.initials: CH
authors.lastname: Sadowsky
authors.forename: Xiangyi
authors.initials: X
authors.lastname: Meng
authors.forename: Drew M
authors.initials: DM
authors.lastname: Velting
mesh_terms: D000058:Accidental Falls; D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy*; D002800:Cholinesterase Inhibitors / Q000008:administration & dosage* / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D009483:Neuropsychological Tests; D011446:Prospective Studies; D000068836:Rivastigmine / Q000008:administration & dosage* / Q000627:therapeutic use; D012720:Severity of Illness Index; D057968:Transdermal Patch; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000139:chemically induced; D015431:Weight Loss
chemical_list: D002800:Cholinesterase Inhibitors; D000068836:Rivastigmine