PMID- 12714795
OWN - NLM
STAT- MEDLINE
DCOM- 20031110
LR  - 20181130
IS  - 1420-8008 (Print)
IS  - 1420-8008 (Linking)
VI  - 16
IP  - 1
DP  - 2003
TI  - A large, community-based, open-label trial of donepezil in the treatment of 
      Alzheimer's disease.
PG  - 15-24
AB  - This phase III trial was conducted to evaluate the safety and efficacy of 
      donepezil in Alzheimer's disease (AD) patients with a greater range of comorbid 
      conditions and concomitant medication use than those previously evaluated in 
      placebo-controlled studies. Patients (n = 1,035) with mild to moderate probable 
      or possible AD were enrolled from 255 sites in the USA; 894 (86%) completed the 
      trial. Mean age was 74.9 years (+/- 7.8); baseline standardized Mini-Mental State 
      Examination (sMMSE) score was 19.77 (+/- 5.4). Nearly all patients had at least 1 
      prior or comorbid medical condition (97%) or were taking at least 1 concomitant 
      medication (93%). Safety assessments included recording treatment-emergent 
      adverse events (AEs). To confirm comparability with past studies, efficacy was 
      measured using the sMMSE. Over the 12-week study period, the mean sMMSE score 
      increased by 1.54 points over baseline (p < 0.0001) in donepezil-treated 
      patients. Most AEs (64%) were mild, and the occurrence of cholinergic-induced AEs 
      was significantly lower after a dose increase at 4 weeks than that seen with a 
      dose increase after 1 week in previous trials. Risk ratios for gastrointestinal 
      side effects were not significantly increased by the use of aspirin or 
      nonsteroidal anti-inflammatory drugs. Risk ratios for bradycardia were not 
      significantly increased by the use of beta-blockers, nondihydropyridine calcium 
      channel blockers or digoxin. Therefore, donepezil improved cognition, as measured 
      by the sMMSE, and was well tolerated despite high concomitant medication use and 
      extensive comorbidity. These results highlight donepezil as a safe and effective 
      treatment for AD patients typically seen by community-based physicians.
CI  - Copyright 2003 S. Karger AG, Basel
FAU - Relkin, Norman R
AU  - Relkin NR
AD  - Department of Neurology and Neuroscience, Weill Medical College of Cornell 
      University, 428 East 72nd Street, Suite 500, New York, N.Y. 10021, USA. 
      nrelkin@mail.med.cornell.edu
FAU - Reichman, William E
AU  - Reichman WE
FAU - Orazem, John
AU  - Orazem J
FAU - McRae, Thomas
AU  - McRae T
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - Switzerland
TA  - Dement Geriatr Cogn Disord
JT  - Dementia and geriatric cognitive disorders
JID - 9705200
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Antidepressive Agents)
RN  - 0 (Cholinesterase Inhibitors)
RN  - 0 (Indans)
RN  - 0 (Piperidines)
RN  - 0 (Vitamins)
RN  - 8SSC91326P (Donepezil)
RN  - R16CO5Y76E (Aspirin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Alzheimer Disease/*drug therapy/epidemiology
MH  - Anti-Inflammatory Agents, Non-Steroidal/administration & dosage
MH  - Antidepressive Agents/administration & dosage
MH  - Aspirin/administration & dosage
MH  - Cholinesterase Inhibitors/*administration & dosage/*adverse effects
MH  - Comorbidity
MH  - Donepezil
MH  - Female
MH  - Gastrointestinal Diseases/chemically induced/epidemiology
MH  - Humans
MH  - Indans/*administration & dosage/*adverse effects
MH  - Male
MH  - Middle Aged
MH  - Piperidines/*administration & dosage/*adverse effects
MH  - Risk Assessment
MH  - Vitamins/administration & dosage
EDAT- 2003/04/26 05:00
MHDA- 2003/11/11 05:00
CRDT- 2003/04/26 05:00
PHST- 2002/10/16 00:00 [received]
PHST- 2003/04/26 05:00 [pubmed]
PHST- 2003/11/11 05:00 [medline]
PHST- 2003/04/26 05:00 [entrez]
AID - 69988 [pii]
AID - 10.1159/000069988 [doi]
PST - ppublish
SO  - Dement Geriatr Cogn Disord. 2003;16(1):15-24. doi: 10.1159/000069988.