PMID- 30953330 OWN - NLM STAT- MEDLINE DCOM- 20200518 LR - 20200518 IS - 1865-8652 (Electronic) IS - 0741-238X (Linking) VI - 36 IP - 6 DP - 2019 Jun TI - A 48-Week, Multicenter, Open-Label, Observational Study Evaluating Oral Rivastigmine in Patients with Mild-to-Moderate Alzheimer's Disease in Taiwan. PG - 1455-1464 LID - 10.1007/s12325-019-00939-0 [doi] AB - INTRODUCTION: Rivastigmine is a cholinesterase inhibitor, approved for the treatment of mild-to-moderate dementia of Alzheimer's type. This study assessed the short- and long-term effectiveness and safety of rivastigmine in patients with mild-to-moderate Alzheimer's disease (AD) in a real-world clinical setting in Taiwan. METHODS: This was a 48-week, single-arm, open-label, prospective, observational, post-marketing surveillance, multicenter study. The primary outcomes were change from baseline to week 48 in the Mini-Mental State Examination (MMSE) and Clinical Dementia Rating (CDR) scores. One-year persistence to treatment, effect on activities of daily living, and incidence of adverse events (AEs) were also assessed. RESULTS: Overall, 151 patients were enrolled in the study, of which 91 (60.26%) completed this study. At the end of the study, the mean rivastigmine dose received by the patients was 6.59 mg/day. At week 48, the changes in mean [standard deviation (SD)] MMSE and CDR scores in the intent-to-treat (ITT) population from baseline were - 1.00 (3.8; p = 0.0344) and 0.07 (0.29; p = 0.0403), respectively. The most frequently reported AEs by preferred term were dizziness (12.58%) and nausea (9.27%). No new or unexpected AEs were observed, and 30 (20.13%) patients in the ITT population were on rivastigmine therapy for 1 year without treatment discontinuation. CONCLUSION: Despite the low 1-year persistence rate, rivastigmine showed a stabilizing effect on declining cognition in patients with mild-to-moderate AD in a real-world scenario. Rivastigmine is well tolerated at 6.0-9.0 mg/day with no unexpected safety concerns. FUNDING: Novartis Co. Ltd., Taipei, Taiwan. FAU - Chang, Chiung-Chih AU - Chang CC AD - Department of Neurology, Cognition and Aging Center, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kao-hsiung, Taiwan. FAU - Peng, Giia-Sheun AU - Peng GS AD - Taipei Veterans General Hospital Hsinchu Branch, Hsinchu County, Taiwan. FAU - Lai, Te-Jen AU - Lai TJ AD - Institute of Medicine and Department of Psychiatry, Chung Shan Medical University Hospital, Taichung, Taiwan. FAU - Li, Chien-Hsun AU - Li CH AD - Department of Neurology, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan. FAU - Liu, Ching-Kuan AU - Liu CK AD - Department of Neurology, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan. ckliu@kmu.edu.tw. AD - Department of Neurology, School of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan. ckliu@kmu.edu.tw. AD - Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan. ckliu@kmu.edu.tw. LA - eng SI - figshare/10.6084/m9.figshare.7868804 PT - Journal Article PT - Multicenter Study PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20190405 PL - United States TA - Adv Ther JT - Advances in therapy JID - 8611864 RN - 0 (Cholinesterase Inhibitors) RN - PKI06M3IW0 (Rivastigmine) MH - Administration, Oral MH - Aged MH - Aged, 80 and over MH - Alzheimer Disease/*drug therapy/epidemiology MH - Cholinesterase Inhibitors/administration & dosage/*therapeutic use MH - Dose-Response Relationship, Drug MH - Female MH - Humans MH - Male MH - Middle Aged MH - Prospective Studies MH - Research Design MH - Rivastigmine/administration & dosage/*therapeutic use MH - Taiwan/epidemiology MH - Treatment Outcome OTO - NOTNLM OT - Alzheimer's disease OT - Cognition OT - Dementia OT - Neurology OT - Rivastigmine OT - Treatment persistence EDAT- 2019/04/07 06:00 MHDA- 2020/05/19 06:00 CRDT- 2019/04/07 06:00 PHST- 2017/10/09 00:00 [received] PHST- 2019/04/07 06:00 [pubmed] PHST- 2020/05/19 06:00 [medline] PHST- 2019/04/07 06:00 [entrez] AID - 10.1007/s12325-019-00939-0 [pii] AID - 10.1007/s12325-019-00939-0 [doi] PST - ppublish SO - Adv Ther. 2019 Jun;36(6):1455-1464. doi: 10.1007/s12325-019-00939-0. Epub 2019 Apr 5.