title: Safety and tolerability of donepezil in mild cognitive impairment: open-label extension study.
abstract: Following a 48-week, double-blind, randomized, placebo-controlled trial of donepezil in 821 patients with amnestic mild cognitive impairment (aMCI), safety and tolerability of donepezil (10 mg) were further evaluated in a 28-week extension study. Of 499 participants who completed the double-blind phase, 145 enrolled in the open-label study. Adverse events (AEs) were recorded throughout. Overall, 57.4% of participants in the donepezil/donepezil group and 62.3% in the placebo/donepezil group experienced an AE, with the most frequent treatment-emergent AEs being diarrhea, muscle spasms, insomnia, and nausea. Most were mild to moderate in severity and were more common in the first several weeks after treatment initiation. More participants in the placebo/donepezil group (22.1%) discontinued donepezil due to an AE compared with the donepezil/donepezil group (10.3%). These findings support the safety of donepezil in patients with aMCI. When compared with other studies, however, the data suggest that patients with Alzheimer's tolerate donepezil better than patients with MCI.
authors: Alzheimer's Disease and Memory Disorders Center, Baylor College of Medicine, 6550 Fannin, Houston, TX 77030, USA. rdoody@bcm.tmc.edu
authors: Rachelle S
authors: RS
authors: Doody
authors: Steven
authors: S
authors: Ferris
authors: Stephen
authors: S
authors: Salloway
authors: Yijun Sun
authors: Robert
authors: R
authors: Goldman
authors: Yikang Xu
authors: Jeff
authors: J
authors: Gao
authors: Anita K
authors: AK
authors: Murthy
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000647:Amnesia / Q000188:drug therapy* / Q000523:psychology; D002800:Cholinesterase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D003072:Cognition Disorders / Q000188:drug therapy* / Q000523:psychology; D003967:Diarrhea / Q000139:chemically induced; D000077265:Donepezil; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007189:Indans / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009483:Neuropsychological Tests; D010880:Piperidines / Q000008:administration & dosage / Q000009:adverse effects*; D011569:Psychiatric Status Rating Scales; D012720:Severity of Illness Index; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced; D013035:Spasm / Q000139:chemically induced; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002800:Cholinesterase Inhibitors; D007189:Indans; D010880:Piperidines; D000077265:Donepezil