Real-world evaluation of tolerability, safety and efficacy of Rivastigmine oral solution in patients with mild to moderate Alzheimer’s disease dementia
Sun-Wung Hsieh 1, 2, 3, Jui-Cheng Chen 4, 5, 6, Nai-Ching Chen 7, 8, Kai-Ming Jhang 9, Wenfu Wang 9, 10, Yuan-Han Yang 2, 3, 11*
1Department of Neurology, Kaohsiung Municipal Siaogang Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan, 2Department of Neurology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan, 3Neuroscience Research Center, Kaohsiung Medical University, Kaohsiung, Taiwan, 4Department of Neurology, China Medical University Hsinchu Hospital, Taiwan, 5Department of Neurology, China Medical University Hospital, Taiwan, 6School of Medicine, China Medical University, Taiwan, 7Department of Neurology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan, 8Chang Gung University College of Medicine, Kaohsiung, Taiwan, 9 Department of Neurology, Changhua Christian Hospital, Changhua, Taiwan., 10Department of Holistic Wellness, Ming Dao University, Changhua, Taiwan, 11 Department of Neurology, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
Received: June 24, 2020; Revised: October 9, 2020; Accepted: October 16, 2020; Published online: October 16, 2020.
© The Korean College of Neuropsychopharmacology. All rights reserved.

Abstract
Objective: The purpose of this study is to investigate the safety, tolerability and efficacy of titrating dose of rivastigmine oral solution in patients with mild to moderate Alzheimer’s disease (AD) in Taiwan.
Methods: We recruited 108 mild to moderate AD patients with Rivast ® (rivastigmine oral solution 2mg/ml) treatment for 52 weeks. We recorded the demographic characteristics, initial cognition by mini-mental state examination (MMSE), initial global status by clinical dementia rating (CDR) with CDR-Sum of Boxes (CDR-SB), initial dose, and titrating dose at each visit. We investigated the adherence, proportion of possible side effects, optimal dose, and time to optimal dose. We demonstrated the proportion of cognitive decline and its possible risk factors.
Results: During the course, 9 patients discontinued the rivastigmine oral solution due to poor compliance or preference. Twelve out of 99 patients (12.1 %) reported possible side effects. Among 87 patients, the mean age was 77.2±9.0 years ago with female predominant (65.2%). The optimal dose was 3.6±1.4 ml in average and 4 ml (N=31,35.6%) in mode. The duration to optimal dose was 12.5±10.2 weeks and 24 weeks (N=35,40.2%) in mode. It presented 25% with cognitive decline in MMSE, 27% with global function decline in CDR and 63% with global function decline in CDR-SB.
Conclusion: We demonstrated the clinical experience of rivastigmine oral solution in mild to moderate AD patients. It suggested rivastigmine oral solution 4ml is the optimal dose with 24 weeks to the optimal dose for at least one third of patients.
Keywords: Rivastigmine, Alzheimer’s disease, Dementia, Mini-mental state examination, Tolerability, Efficacy


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