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: | Shinichiro Ikebe, Yoshinori Ishida, Ankita Shekhawat, Sadao Katayama, Tetsuaki Arai, Yosuke Wakutani, Yu Nakamura, Norifumi Tsuno, Kazuki Kiyose, Nobuo Furuta, Kengo Ueda, Kazuhiro Toriyama, Toshihisa Tanaka, Hirofumi Sakurai, Ayan Das Gupta, Shinji Ouma, Kiyoshi Kanaya, Makio Takahashi, Masato Sugitani |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Transdermal patch
Cognitive Neuroscience lcsh:Geriatrics lcsh:RC346-429 Rivastigmine transdermal patch 03 medical and health sciences 0302 clinical medicine Clinical endpoint Galantamine Outpatient clinic Medicine Donepezil lcsh:Neurology. Diseases of the nervous system Cholinesterase Rivastigmine 030214 geriatrics biology business.industry Cholinesterase inhibitors Alzheimer's disease Psychiatry and Mental health lcsh:RC952-954.6 Tolerability Anesthesia Switching biology.protein business Alzheimer’s disease 030217 neurology & neurosurgery medicine.drug Research Article |
| Zdroj: | Dementia and Geriatric Cognitive Disorders Extra, Vol 9, Iss 2, Pp 302-318 (2019) Dementia and Geriatric Cognitive Disorders EXTRA |
| ISSN: | 1664-5464 |
| Popis: | 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 cm2; loaded dose 9 mg, delivery rate 4.6 mg/24 h) with a 1-step titration in week 4 (10 cm2; 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. |
| Databáze: | OpenAIRE |
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