PMID- 12626851 OWN - NLM STAT- MEDLINE DCOM- 20030707 LR - 20181130 IS - 1420-8008 (Print) IS - 1420-8008 (Linking) VI - 15 IP - 4 DP - 2003 TI - An observational clinical study of the efficacy and tolerability of donepezil in the treatment of Alzheimer's disease. PG - 189-98 AB - An open-label, observational Post-Marketing Surveillance (PMS) study was undertaken in Germany to examine the efficacy and tolerability of donepezil in routine clinical practice. Alzheimer's disease (AD) patients were treated with donepezil (5 or 10 mg once daily) and observed for a period of approximately 3 months. Study assessments included the Mini-Mental State Examination (MMSE), the Nurses' Observation Scale for Geriatric Patients (NOSGER), and adverse events (AEs). A total of 2,092 patients (mean age 73.0 years; mean +/- SD MMSE score 17.8 +/- 5.8) were included in the efficacy assessments. MMSE and NOSGER scores showed statistically significant improvements in the total patient population and in the subpopulations with severe AD or AD with concomitant Parkinsonian symptoms (ADPS cohort). AEs were reported in a total of 12% of patients and were mostly due to peripheral cholinergic effects. In this observational PMS study, donepezil was shown to be an effective and well-tolerated therapy in the overall patient population, in patients with severe AD, and in the ADPS cohort. CI - Copyright 2003 S. Karger AG, Basel FAU - Hager, Klaus AU - Hager K AD - Department of Geriatrics, Henrietten Hospital, Hannover, Germany. Geriatrie.Hannover@t-online.de FAU - Calabrese, Pasquale AU - Calabrese P FAU - Frolich, Lutz AU - Frolich L FAU - Gobel, Claus AU - Gobel C FAU - Berger, Frank M AU - Berger FM LA - eng PT - Comparative Study PT - Journal Article PL - Switzerland TA - Dement Geriatr Cogn Disord JT - Dementia and geriatric cognitive disorders JID - 9705200 RN - 0 (Cholinesterase Inhibitors) RN - 0 (Indans) RN - 0 (Piperidines) RN - 8SSC91326P (Donepezil) SB - IM MH - Activities of Daily Living MH - Adult MH - Aged MH - Aged, 80 and over MH - Alzheimer Disease/complications/*drug therapy MH - Cholinesterase Inhibitors/adverse effects/*therapeutic use MH - Clinical Trials as Topic MH - Cohort Studies MH - Donepezil MH - Female MH - Humans MH - Indans/adverse effects/*therapeutic use MH - Male MH - Middle Aged MH - Parkinsonian Disorders/complications MH - Piperidines/adverse effects/*therapeutic use MH - *Product Surveillance, Postmarketing MH - Prospective Studies MH - Psychiatric Status Rating Scales MH - Severity of Illness Index MH - Treatment Outcome EDAT- 2003/03/11 04:00 MHDA- 2003/07/08 05:00 CRDT- 2003/03/11 04:00 PHST- 2002/09/28 00:00 [accepted] PHST- 2003/03/11 04:00 [pubmed] PHST- 2003/07/08 05:00 [medline] PHST- 2003/03/11 04:00 [entrez] AID - 68786 [pii] AID - 10.1159/000068786 [doi] PST - ppublish SO - Dement Geriatr Cogn Disord. 2003;15(4):189-98. doi: 10.1159/000068786.