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

被引：8

作者：

Ueda, Kengo ^{[1
]}

Katayama, Sadao ^{[2
]}

Arai, Tetsuaki ^{[3
]}

Furuta, Nobuo ^{[4
]}

Ikebe, Shinichiro ^{[5
]}

Ishida, Yoshinori ^{[6
]}

Kanaya, Kiyoshi ^{[7
]}

Ouma, Shinji ^{[8
]}

Sakurai, Hirofumi ^{[9
]}

Sugitani, Masato ^{[10
]}

Takahashi, Makio ^{[11
]}

Tanaka, Toshihisa ^{[12
]}

Tsuno, Norifumi ^{[13
]}

Wakutani, Yosuke ^{[14
]}

Shekhawat, Ankita ^{[15
]}

Das Gupta, Ayan ^{[15
]}

Kiyose, Kazuki ^{[1
]}

Toriyama, Kazuhiro ^{[1
]}

Nakamura, Yu ^{[13
]}

机构：

[1] Novartis Pharma KK, Tokyo, Japan

[2] Katayama Med Clin, Okayama, Japan

[3] Univ Tsukuba, Fac Med, Ibaraki, Japan

[4] Yokufukai Hosp, Tokyo, Japan

[5] Ikebe Clin, Shizuoka, Japan

[6] Takeda Gen Hosp, Fukushima, Japan

[7] Tokyo Med Univ, Hachioji Med Ctr, Geriatr Med, Tokyo, Japan

[8] Fukuoka Univ, Dept Neurol, Fukuoka, Fukuoka, Japan

[9] Tokyo Med Univ, Dept Geriatr Med, Tokyo, Japan

[10] Sagamihara Kyodo Hosp, Sagamihara, Kanagawa, Japan

[11] Osaka Red Cross Hosp, Dept Neurol, Osaka, Japan

[12] Osaka Univ, Grad Sch Med, Dept Psychiat, Osaka, Japan

[13] Kagawa Univ, Sch Med, Dept Neuropsychiat, 1750-1 Ikenobe, Miki, Kagawa 7610793, Japan

[14] Kurashiki Heisei Hosp, Dept Neurol, Okayama, Japan

[15] Novartis Healthcare Pvt Ltd, Data Sci, SSP, PLS, Hyderabad, India

来源：

DEMENTIA AND GERIATRIC COGNITIVE DISORDERS EXTRA | 2019年 / 9卷 / 02期

关键词：

Rivastigmine transdermal patch; Alzheimer's disease; Cholinesterase inhibitors; Switching; DONEPEZIL; DEMENTIA; EVALUATE;

D O I：

10.1159/000501364

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

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.

引用

页码：302 / 318

页数：17