Evidence map›Paper›PMID 26557135›Full record

ArticleDementia and geriatric cognitive disorders extra

A 24-Week, Randomized, Controlled Study to Evaluate the Tolerability, Safety and Efficacy of 2 Different Titration Schemes of the Rivastigmine Patch in Japanese Patients with Mild to Moderate Alzheimer's Disease.

Yu Nakamura, Christine Strohmaier, Kaoru Tamura, Naoko Kataoka, Masayuki Nakano, Shoichiro Oda, Kazuma Nishimura, Akira Homma

Abstract read
In one paragraph

Article in Dementia and geriatric cognitive disorders extra. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Yu NakamuraDepartment of Neuropsychiatry, Faculty of Medicine, Kagawa University, Kagawa, Japan.
Christine StrohmaierNovartis Pharma AG, Basel, Switzerland.
Kaoru TamuraNovartis Pharma K.K., Tokyo, Japan.
Naoko KataokaNovartis Pharma K.K., Tokyo, Japan.
Masayuki NakanoOno Pharmaceutical Co., Ltd., Osaka, Japan.
Shoichiro OdaOno Pharmaceutical Co., Ltd., Osaka, Japan.
Kazuma NishimuraOno Pharmaceutical Co., Ltd., Osaka, Japan.
Akira HommaDementia Care Research and Training Center, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo investigate whether 1-step titration of the rivastigmine patch (initiated at 5 cm(2) and titrated to 10 cm(2) after 4 weeks) is well tolerated in Japanese patients with Alzheimer's disease (AD) as compared to 3-step titration (initiated at 2.5 cm(2) and titrated by 2.5 cm(2) every 4 weeks to 10 cm(2)).

methodsA 24-week, multicenter, randomized, double-blind study was conducted in Japan between July 2012 and May 2014. Patients with mild to moderate AD aged 50-85 years were randomized 1:1 to 1-step or 3-step titration of the rivastigmine once-daily patch. The primary endpoint was the proportion of patients with adverse events leading to discontinuation.

resultsOf 216 patients randomized, 215 (1-step, n = 107; 3-step, n = 108) were included in the safety analysis. The primary endpoint outcome was 15.0% in the 1-step group and 18.5% in the 3-step group. The observed treatment difference was -3.6% (95% confidence interval: -17.0, 9.6), falling within the prespecified acceptance range.

conclusionThe tolerability of two different titration schemes was similar in Japanese patients with AD.

Indexed as

Alzheimer's diseaseCholinesterase inhibitorsJapanRandomized clinical trialRivastigmine patchTitration scheme

Identifiers

PMID26557135
PMCPMC4637522

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.