title: Evaluating high-dose rivastigmine patch in severe Alzheimer's disease: analyses with concomitant memantine usage as a factor.
abstract: BACKGROUND
  ACTION, a 24-week, prospective, randomized, parallel-group, double-blind study in patients with severe Alzheimer's disease (AD), demonstrated significant efficacy of 13.3 mg/24 h versus 4.6 mg/24 h rivastigmine patch on the Severe Impairment Battery (SIB) and Alzheimer's Disease Cooperative Study-Activities of Daily Living scale-Severe Impairment Version (ADCS-ADL-SIV). Overall, 61% of the study population received at least 1 dose of concomitant memantine, regardless of dose or duration. This retrospective analysis investigated the effects of concomitant memantine on the efficacy, safety and tolerability of 13.3 mg/24 h versus 4.6 mg/24 h rivastigmine patch.
  
  
  METHODS
  Patients were stratified according to whether or not they received at least one dose of concomitant memantine during the double-blind phase. Changes from baseline on the SIB and ADCS-ADL-SIV were compared using analysis of covariance (ANCOVA) with treatment, pooled center, memantine usage and treatment-by-memantine as factors, and baseline as a covariate. Safety and tolerability were assessed.
  
  
  RESULTS
  Memantine-treated patients were younger than those not receiving memantine (mean 75.9 and 78.8 years, respectively), with a lower screening Mini-Mental State Examination (8.6 and 9.2, respectively). ANCOVA confirmed there was no significant interaction (p>0.1) between study treatment and memantine use on the SIB or ADCS-ADL-SIV. The incidence of adverse events was: 71.4%, 13.3 mg/24 h patch with memantine; 79.7%, 13.3 mg/24 h patch alone; 74.7%, 4.6 mg/24 h patch with memantine; and 71.1%, 4.6 mg/24 h patch alone.
  
  
  CONCLUSIONS
  These data suggest benefit of 13.3 mg/24 h versus 4.6 mg/24 h rivastigmine patch, regardless of concomitant memantine use. The incidence of adverse events with highdose patch was similar in memantine-treated patients and those not receiving memantine.
authors.forename: George T
authors.initials: GT
authors.lastname: Grossberg
authors.forename: Martin R
authors.initials: MR
authors.lastname: Farlow
authors.forename: Xiangyi
authors.initials: X
authors.lastname: Meng
authors.affiliation: Department of Neurology and Psychiatry, St Louis University School of Medicine, 1438 South Grand Boulevard, St Louis, MO 63104, USA. grossbgt@slu.edu.
authors.forename: Drew M
authors.initials: DM
authors.lastname: Velting
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy* / Q000523:psychology; D000704:Analysis of Variance; D016022:Case-Control Studies; D015259:Dopamine Agents / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008559:Memantine / Q000627:therapeutic use*; D018696:Neuroprotective Agents / Q000008:administration & dosage*; D048448:Phenylcarbamates / Q000008:administration & dosage*; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D000068836:Rivastigmine; D057968:Transdermal Patch; D016896:Treatment Outcome
chemical_list: D015259:Dopamine Agents; D018696:Neuroprotective Agents; D048448:Phenylcarbamates; D000068836:Rivastigmine; D008559:Memantine