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Effectiveness of the 10 cm2 Rivastigmine Patch in Taiwanese Patients with Mild-to-Moderate Alzheimer's Dementia: A 48-Week Real-World Observational Study
Chang Chiung-Chih, Chan Lung, Chou Hsi-Hsien, Yang Yu-Wan, Chen Ta-Fu, Chen Ting-Bin, Chen Chin-I, Yang Audrey et al.. Advances in therapy, 2021-09-11
Topic: Risk, prevention and care in population studies
Plain-language summary
The current study aimed to provide data on the effectiveness of the 10 cm2 rivastigmine patch in patients with Alzheimer's disease (AD) in a real-world setting in Taiwan. 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 cm2rivastigmine 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. Of the 285 eligible patients [full analysis set (FAS)], 216 (75.8%) completed the study protocol while 180 (63.2%) persisted on the 10 cm2 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%). The use of the 10 cm2 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.
What this study adds
Evidence grade: Low
This is a trial. In this 48-week real-world study, the 10 cm2 rivastigmine patch showed numerical cognitive improvement at Week 24 but CASI and MMSE scores declined by Week 48, and the change in CDR score was not significant. Reported effect size: 75.8%; 63.2%; 89.8%.
Taken from this record’s own fields, not from reading the paper. The grade is assigned from the abstract’s wording; what that means.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Chiung-Chih, C., Lung, C., Hsi-Hsien, C., Yu-Wan, Y., Ta-Fu, C., Ting-Bin, C., et al. (2021). Effectiveness of the 10 cm2 Rivastigmine Patch in Taiwanese Patients with Mild-to-Moderate Alzheimer's Dementia: A 48-Week Real-World Observational Study. Advances in therapy. https://doi.org/10.1007/s12325-021-01893-6
Vancouver
Chiung-Chih C, Lung C, Hsi-Hsien C, Yu-Wan Y, Ta-Fu C, Ting-Bin C, et al. Effectiveness of the 10 cm2 Rivastigmine Patch in Taiwanese Patients with Mild-to-Moderate Alzheimer's Dementia: A 48-Week Real-World Observational Study. Advances in therapy. 2021. doi:10.1007/s12325-021-01893-6. PMID: 34506009.
BibTeX
@article{chiungchih2021-34506009,
author = {Chiung-Chih, Chang and Lung, Chan and Hsi-Hsien, Chou and Yu-Wan, Yang and Ta-Fu, Chen and Ting-Bin, Chen and Chin-I, Chen and Audrey, Yang and others},
title = {{Effectiveness of the 10 cm2 Rivastigmine Patch in Taiwanese Patients with Mild-to-Moderate Alzheimer's Dementia: A 48-Week Real-World Observational Study}},
journal = {Advances in therapy},
year = {2021},
doi = {10.1007/s12325-021-01893-6},
pmid = {34506009},
url = {https://doi.org/10.1007/s12325-021-01893-6}
}
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record's author list ends in “et al.”, so not every author is named. Check the citation against the original before you use it.
Key findings
- The primary endpoint was the change in the cognitive assessment screening instrument (CASI) scores at Week 48 versus baseline.
- 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.
- The increment in NPI scores was not significant.
Why it matters
In this 48-week real-world study, the 10 cm2 rivastigmine patch showed numerical cognitive improvement at Week 24 but CASI and MMSE scores declined by Week 48, and the change in CDR score was not significant. It reports on an existing symptomatic drug in a single-arm, open-label study, not a cure or prevention.
Study details
- Study designopen-label trial
- Effect size75.8%; 63.2%; 89.8%
- Evidence strengthLow
How this study scored 34/100
Published in a peer-reviewed journal. Scored zero for study design, sample size, studied in people and randomized / blinded because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Advances in therapy) |
| Journal's citation record | 1 / 4 | Advances in Therapy: journal h-index 114 (OpenAlex, 2026-10-29) |
| Study design | 0 / 12 | Design recorded as “open-label trial”, which our rubric does not rank (not stated in the record — scored 0) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 3 / 5 | 2021 — within 6 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| Randomized / blinded | 0 / 2 | No randomization or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | 1 / 7 | Cited 4 times (OpenAlex, 2026-10-17) |
| Citations per year | 0 / 5 | 0.6 citations a year over 7 year(s) since 2021 |
| Impact for its field and year | 1 / 6 | Cited 0.2× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 0 / 6 | No other study in this library cites it |
| Still being cited | 1 / 4 | Cited 4 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 2 / 4 | Last-listed author Chaur‐Jong Hu: h-index 48 (OpenAlex, whole career) |
| Institution's track record | 0 / 3 | National Taiwan University Hospital: institution h-index 509 (OpenAlex) |
| Multicenter collaboration | 3 / 3 | OpenAlex lists 11 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 34506009) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 34 / 100 | — |
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