Efficacy, Safety, and Tolerability of Switching from Oral Cholinesterase Inhibitors to Rivastigmine Transdermal Patch with 1-Step Titration in Patients with Mild to Moderate Alzheimer's Disease: A 24-Week, Open-Label, Multicenter Study in Japan.

Autor:	Ueda K; Novartis Pharma K.K., Tokyo, Japan., Katayama S; Katayama Medical Clinic, Okayama, Japan., Arai T; Faculty of Medicine, University of Tsukuba, Ibaraki, Japan., Furuta N; Yokufukai Hospital, Tokyo, Japan., Ikebe S; Ikebe Clinic, Shizuoka, Japan., Ishida Y; Takeda General Hospital, Fukushima, Japan., Kanaya K; Hachioji Medical Center, Geriatric Medicine, Tokyo Medical University, Tokyo, Japan., Ouma S; Department of Neurology, Fukuoka University, Fukuoka, Japan., Sakurai H; Department of Geriatric Medicine, Tokyo Medical University, Tokyo, Japan., Sugitani M; Sagamihara Kyodo Hospital, Kanagawa, Japan., Takahashi M; Department of Neurology, Osaka Red Cross Hospital, Osaka, Japan., Tanaka T; Department of Psychiatry, Osaka University Graduate School of Medicine, Osaka, Japan., Tsuno N; Department of Neuropsychiatry, Kagawa University School of Medicine, Kagawa, Japan., Wakutani Y; Department of Neurology, Kurashiki Heisei Hospital, Okayama, Japan., Shekhawat A; Novartis Healthcare Pvt. Ltd., Data Sciences, SSP, PLS, Hyderabad, India., Das Gupta A; Novartis Healthcare Pvt. Ltd., Data Sciences, SSP, PLS, Hyderabad, India., Kiyose K; Novartis Pharma K.K., Tokyo, Japan., Toriyama K; Novartis Pharma K.K., Tokyo, Japan., Nakamura Y; Department of Neuropsychiatry, Kagawa University School of Medicine, Kagawa, Japan.
Jazyk:	angličtina
Zdroj:	Dementia and geriatric cognitive disorders extra [Dement Geriatr Cogn Dis Extra] 2019 Aug 15; Vol. 9 (2), pp. 302-318. Date of Electronic Publication: 2019 Aug 15 (Print Publication: 2019).
DOI:	10.1159/000501364
Abstrakt:	Background: Few studies have investigated treatment options for patients with Alzheimer's disease (AD) showing a poor response to oral cholinesterase inhibitors (ChEIs) in Japan. Objective: To investigate the efficacy and safety of switching from oral ChEIs to rivastigmine transdermal patch in patients with AD. Methods: In this multicenter, open-label, phase IV study in outpatient clinics in Japan, patients with mild-moderate AD who had a poor response to or experienced difficulty in continuing donepezil or galantamine were switched to rivastigmine transdermal patch (5 cm 2 ; loaded dose 9 mg, delivery rate 4.6 mg/24 h) with a 1-step titration in week 4 (10 cm 2 ; loaded dose 18 mg, delivery rate 9.5 mg/24 h), which was continued for 4 weeks in the titration period and 16 weeks in a maintenance period. The primary endpoint was the change in Mini-Mental State Examination (MMSE) total score from baseline to week 24. Results: A total of 118 patients were enrolled and switched to rivastigmine, of which 102 completed the 24-week study. The MMSE total score was essentially unchanged during the study, with a least-square mean change (SD) of -0.35 (2.64) at week 24 ( p = 0.1750). Exploratory analysis with a mixed-effect model comparing changes in MMSE between the pre- and post-switch periods suggested that switching to rivastigmine prevented a worsening of MMSE. Application site skin reactions/irritations occurred in 30.5% of patients overall, in 22.0% in the 8-week titration period, and in 10.2% in the 16-week maintenance period. Conclusion: Within-class switching from an oral ChEI to rivastigmine transdermal patch might be an efficacious and tolerable option for AD patients showing a poor or limited response to a prior oral ChEI. Competing Interests: This study was funded by Novartis Pharma K.K. Kengo Ueda, Kazuki Kiyose, and Kazuhiro Toriyama are full-time employees of Novartis Pharma K.K. Ankita Shekhawat and Ayan Das Gupta are full-time employees of Novartis Healthcare Pvt. Ltd. In the past year, Sadao Katayama has received speaking fees from Novartis Pharma K.K., and research fees including payment for clinical trials from Eli Lilly Japan K.K., Biogen Japan Ltd., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., and Boehringer Ingelheim Japan. Tetsuaki Arai has received speaking fees from Eisai Co., Ltd. and Daiichi Sankyo Co., Ltd. Nobuo Furuta has received speaking fees from Janssen Pharmaceutical K.K. Makio Takahashi has received lecture fees from Eisai Co., Ltd., Ono Pharmaceutical Co., Ltd., Janssen Pharmaceutical K.K. and Novartis Pharma K.K. Toshihisa Tanaka has received fees for research from Biogen Japan Ltd., MSD K.K., Shionogi & Co., Ltd., and speaking fees from Ono Pharmaceutical Co., Ltd., Eisai Co., Ltd., and Meiji Seika Pharma Co., Ltd. Yu Nakamura has received speaking fees from Daiichi Sankyo Co., Ltd., Ono Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Eisai Co., Ltd., Novartis Pharma K.K., Eli Lilly Japan K.K., MSD K.K., and research fees including payment for clinical trials from Daiichi Sankyo Co., Ltd., and Biogen Japan Ltd. The other authors have no conflict of interest to declare. (Copyright © 2019 by S. Karger AG, Basel.)
Databáze:	MEDLINE
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