title: Long-term response to galantamine in relation to short-term efficacy data: pooled analysis in patients with mild to moderate Alzheimer's disease.
abstract: BACKGROUND
  This analysis aimed to identify an operational, clinically relevant definition of response achieved in short-term clinical trials to support the identification of patients with Alzheimer's disease (AD) who would benefit most from long-term galantamine therapy.
  
  
  METHODS
  Data were analyzed from 6 randomized placebo-controlled trials of up to 6 months' duration, which included patients with mild to moderate AD receiving maintenance doses of galantamine 16-24 mg/day, and from 12 open-label extensions (galantamine 24 mg/day maintenance therapy). Assessments included changes from baseline in the 11-item AD Assessment Scale-Cognitive subscale (ADAS-Cog 11).
  
  
  RESULTS
  Pooled analysis of the 5-6 month trial data showed that at the trial endpoint (2-5 months after reaching maintenance doses), the proportions of galantamine- (n=1,173) versus placebo-treated patients (n=801) with probable AD categorized according to "improved", "stable" or "non-rapid decline" criteria, were 45.8% versus 27.2%, 59.5% versus 37.1%, and 87.6% versus 69.7%, respectively (observed cases analysis), whilst changes in ADAS-Cog 11 scores versus baseline were -4.9, -4.7 and -2.9 points, respectively, for "improved", "stable" and "non-rapid decline" galantamine-treated patients (-1.5 points for galantamine recipients overall). "Improved" or "stable" galantamine-treated patients displayed mean improvement in ADAS-Cog 11 scores over baseline until 18 months after starting treatment, and attenuated deterioration thereafter; for galantamine-treated patients exhibiting "non-rapid decline", mean ADAS-Cog 11 score returned to baseline after approximately 12 months.
  
  
  CONCLUSIONS
  Patients who demonstrate improvement, stability, or limited cognitive decline 2-5 months after reaching maintenance doses of galantamine are more likely to experience continued benefit from long-term galantamine therapy.
authors.affiliation: Johnson & Johnson Pharmaceutical Services, 30 Turnhoutseweg, 2340 Beerse, Belgium. skavanag@its.jnj.com
authors.forename: S
authors.initials: S
authors.lastname: Kavanagh
authors.forename: I
authors.initials: I
authors.lastname: Howe
authors.forename: H R
authors.initials: HR
authors.lastname: Brashear
authors.forename: D
authors.initials: D
authors.lastname: Wang
authors.forename: B
authors.initials: B
authors.lastname: van Baelen
authors.forename: M
authors.initials: M
authors.lastname: Todd
authors.forename: S
authors.initials: S
authors.lastname: Schwalen
mesh_terms: D000544:Alzheimer Disease / Q000188:drug therapy*; D002800:Cholinesterase Inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D005702:Galantamine / Q000627:therapeutic use*; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D002800:Cholinesterase Inhibitors; D005702:Galantamine