Rivastigmine in Alzheimer disease: efficacy over two years.
OBJECTIVE
Beyond 6 to 9 months of treatment with cholinesterase inhibitors (ChE-Is), there is a notable increase in the rate of cognitive decline in Alzheimer disease (AD) patients, and there are few longer-term studies to evaluate this finding. The authors examined whether the ChE-I rivastigmine continued to be therapeutically effective after up to 2 years of treatment in 2,010 patients with probable AD.


METHODS
The clinical course of AD patients treated with rivastigmine was compared with a prediction of their course derived by a baseline-dependent historical model of disease progression developed from data in untreated AD patients. Rivastigmine efficacy data came from four 6-month, placebo-controlled, randomized, controlled trials (RCTs) and two open-label extension studies. Cognitive performance was assessed by various clinician- and caregiver-rated measures.


RESULTS
After 2 years on rivastigmine, there was less cognitive deterioration than in historical-control subjects. These effects of rivastigmine on cognitive performance were considered clinically meaningful relative to expected global decline. Treatment-emergent adverse events were the commonly-seen side effects of ChEIs and were similar in frequency to those seen in patients assigned to shorter-term rivastigmine therapy.


CONCLUSIONS
Rivastigmine had a beneficial effect on cognitive performance for up to 2 years in patients with AD, versus no treatment or placebo treatment in historical-control subjects. Caregiver and clinician assessments indicated that the cognitive performance findings were of a magnitude relevant to global patient functioning. Rivastigmine remained safe over this 2-year treatment period.
Grossberg
George
G
St. Louis University Medical Center, MO, USA.
Irwin
Peter
P
Satlin
Andrew
A
Mesenbrink
Peter
P
Spiegel
René
R
D000368:Aged; D000544:Alzheimer Disease / Q000150:complications* / Q000188:drug therapy*; D002219:Carbamates / Q000008:administration & dosage / Q000627:therapeutic use*; D002800:Cholinesterase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D003072:Cognition Disorders / Q000175:diagnosis* / Q000209:etiology*; D004305:Dose-Response Relationship, Drug; D005500:Follow-Up Studies; D006801:Humans; D009483:Neuropsychological Tests; D048448:Phenylcarbamates; D000068836:Rivastigmine; D012720:Severity of Illness Index
D002219:Carbamates; D002800:Cholinesterase Inhibitors; D048448:Phenylcarbamates; D000068836:Rivastigmine