A 52-week, open-label, observational study evaluating tolerability, efficacy and physicians satisfaction of rivastigmine oral solution in Alzheimer's disease in Taiwan.

Abstract

Background: There is limited data on the use of rivastigmine oral solution in patients with Alzheimer's disease (AD).

Objective: To evaluate the tolerability, efficacy and physicians' satisfaction of Rivast^® (rivastigmine oral solution 2 mg/ml) in Taiwanese patients with mild to moderate AD over a 52-week period.

Methods: An open-label, non-comparative, observational study was conducted across four hospitals in Taiwan. 142 Patients with mild to moderate AD were enrolled. Adverse events and adherence rates were monitored throughout the 52-week study period, while cognitive (Mini-Mental State Examination (MMSE)) and global functional outcomes (Clinical Dementia Rating (CDR)-Sum of Boxes) were recorded at baseline and at week 52. Factors associated with discontinuation, adverse events, and declines in cognitive and global function were determined.

Results: The study achieved a 92.3% adherence rate, with 19% experiencing adverse events. The optimal dose was 3.8 ml, reached within 8.3 weeks. 43.7% of the patients reached an optimal dose of 4 ml and 59.8% achieved optimal dose within 4 weeks. Age and clinically significant electrocardiogram (EKG) abnormalities were associated with a higher risk of discontinuation, while female patients exhibited a lower risk. Additionally, both a higher initial dose and a higher optimal dose were associated with a reduced risk of adverse effects. Abnormal EKG findings were significantly associated with cognitive decline. More time to optimal dose was significantly associated with worse global function. All physicians regarded the medication is ease of use and the administration schedule is simple.

Conclusions: This study provides valuable insights into the tolerability and efficacy of rivastigmine oral solution in Taiwanese patients with mild to moderate AD.