PMID- 34506009
OWN - NLM
STAT- MEDLINE
DCOM- 20211011
LR  - 20220531
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Print)
IS  - 0741-238X (Linking)
VI  - 38
IP  - 10
DP  - 2021 Oct
TI  - Effectiveness of the 10 cm(2) Rivastigmine Patch in Taiwanese Patients with 
      Mild-to-Moderate Alzheimer's Dementia: A 48-Week Real-World Observational Study.
PG  - 5286-5301
LID - 10.1007/s12325-021-01893-6 [doi]
AB  - INTRODUCTION: The current study aimed to provide data on the effectiveness of the 
      10 cm(2) rivastigmine patch in patients with Alzheimer's disease (AD) in a 
      real-world setting in Taiwan. METHODS: This was a 48-week, single-arm, 
      open-label, observational, and post-marketing study conducted across seven 
      centers in Taiwan between May 5, 2016 and July 10, 2017. Eligible patients (aged 
      55-95 years) treated with the 10 cm(2)rivastigmine patch were enrolled based on 
      physicians' judgment and according to the Taiwan reimbursement criteria of the 
      drug. Data were prospectively collected at Week 0 (baseline), Week 24, and Week 
      48. The primary endpoint was the change in the cognitive assessment screening 
      instrument (CASI) scores at Week 48 versus baseline. The changes from baseline in 
      clinical dementia rating (CDR), mini-mental state examination (MMSE), and 
      neuropsychiatric inventory (NPI) scores were evaluated, as were treatment 
      persistence and the safety profile. RESULTS: Of the 285 eligible patients [full 
      analysis set (FAS)], 216 (75.8%) completed the study protocol while 180 (63.2%) 
      persisted on the 10 cm(2) rivastigmine patch for the full 48 weeks. At baseline, 
      89.8% of patients had a CDR score of 0.5 or 1, while the change in CDR score at 
      Week 48 was not significant. In the FAS, both the CASI and MMSE scores had 
      numerical improvement at Week 24 but declined by 2.1 and 0.4 points, 
      respectively, at Week 48 (p = 0.005 and p = 0.022). The increment in NPI scores 
      was not significant. The most common drug-related adverse events (AEs) were 
      pruritus (11.2%), nausea (3.5%), rash (3.2%), and vomiting (2.8%). CONCLUSIONS: 
      The use of the 10 cm(2) rivastigmine patch in the mild stage of AD maintained 
      cognitive function at Week 24 and neuropsychiatric function at Week 48. The 
      treatment persistency and safety profile support the clinical tolerability of the 
      rivastigmine patch in the management of mild-to-moderate AD in Taiwan.
CI  - (c) 2021. The Author(s).
FAU - Chang, Chiung-Chih
AU  - Chang CC
AD  - Department of Neurology, Institute for Translational Research in Biomedicine, 
      Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of 
      Medicine, Kaohsiung, Taiwan.
FAU - Chan, Lung
AU  - Chan L
AD  - Department of Neurology and Dementia Center, Shung Ho Hospital, School of 
      Medicine, College of Medicine, Taipei Medical University, New Taipei, Taiwan.
FAU - Chou, Hsi-Hsien
AU  - Chou HH
AD  - Department of Neurology, Chung Shan Medical University Hospital, Taichung, 
      Taiwan.
FAU - Yang, Yu-Wan
AU  - Yang YW
AD  - Department of Neurology, China Medical University Hospital, Taichung, Taiwan.
FAU - Chen, Ta-Fu
AU  - Chen TF
AD  - Department of Neurology, National Taiwan University Hospital, Taipei, Taiwan.
FAU - Chen, Ting-Bin
AU  - Chen TB
AD  - Department of Neurology, Taichung Veterans General Hospital, Taichung, Taiwan.
FAU - Chen, Chin-I
AU  - Chen CI
AD  - Department of Neurology, Wan Fang Hospital, Taipei, Taiwan.
FAU - Yang, Audrey
AU  - Yang A
AD  - Novartis (Taiwan) Co., Ltd., Taipei, Taiwan.
FAU - Hu, Chaur-Jong
AU  - Hu CJ
AUID- ORCID: 0000-0002-4900-5967
AD  - Department of Neurology and Dementia Center, Shung Ho Hospital, School of 
      Medicine, College of Medicine, Taipei Medical University, New Taipei, Taiwan. 
      chaurjongh@tmu.edu.tw.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20210910
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Cholinesterase Inhibitors)
RN  - PKI06M3IW0 (Rivastigmine)
MH  - Aged
MH  - Aged, 80 and over
MH  - *Alzheimer Disease/drug therapy
MH  - Cholinesterase Inhibitors
MH  - Cognition
MH  - Humans
MH  - Middle Aged
MH  - Rivastigmine
MH  - Treatment Outcome
PMC - PMC8478746
OTO - NOTNLM
OT  - Alzheimer's disease
OT  - Cognitive function
OT  - Rivastigmine patch
EDAT- 2021/09/11 06:00
MHDA- 2021/10/12 06:00
PMCR- 2021/09/10
CRDT- 2021/09/10 12:18
PHST- 2021/05/27 00:00 [received]
PHST- 2021/08/11 00:00 [accepted]
PHST- 2021/09/11 06:00 [pubmed]
PHST- 2021/10/12 06:00 [medline]
PHST- 2021/09/10 12:18 [entrez]
PHST- 2021/09/10 00:00 [pmc-release]
AID - 10.1007/s12325-021-01893-6 [pii]
AID - 1893 [pii]
AID - 10.1007/s12325-021-01893-6 [doi]
PST - ppublish
SO  - Adv Ther. 2021 Oct;38(10):5286-5301. doi: 10.1007/s12325-021-01893-6. Epub 2021 
      Sep 10.