Objective: Having obtained good results in a previous study comparing rivastigmine, an inhibitor of acetylcholinesterase (AChE) and butyrylcholinesterase (BuChE), versus aspirin in patients with subcortical vascular dementia (VaD), we aimed to compare the efficacy and tolerability of rivastigmine versus aspirin plus nimodipine. (Both aspirin and nimodipine have demonstrated benefits in patients with VaD.)
Design: Patients with a diagnosis of probable VaD received rivastigmine 3-6 mg/day (Group A) or aspirin 100 mg/day plus nimodipine 60 mg/day (Group B) in an open study for 16 months.
Materials and Methods: Cognitive function was assessed using the Mini-Mental State Examination (MMSE). Attention and memory functions were assessed using the Trail Making A test (TMA), the Digit Span forward and backward tests (DS-F, DS-B), and a three-minute phonological fluency task. Executive function was assessed using the Ten Point Clock Drawing test (TPC). Daily living activities were tested using the Barthel Index (BI) and an Instrumental Activity of Daily Living (IADL) scale. Neuropsychiatric symptoms were assessed using the Behavioural Pathology in AD Rating Scale, BEHAVE-AD, the Ryden scale, and the Geriatric Depression Scale (GDS). Global health status was assessed using the Cumulative Illness Rating Scale (CIRS). Suspected side effects were recorded throughout the study. Within-group changes from baseline were tested using the Wilcoxon Signed Ranks test. Between-group comparisons of changes from baseline were tested using the Wilcoxon two-sample test.
Results: 64 patients (32 per treatment group) with a diagnosis of probable subcortical VaD were included in the study. At 16 months, rivastigmine-treated patients showed significantly superior benefits, compared with those treated with aspirin and nimodipine, on the TMA, DS-F, DS-B, TPC, IADL, BEHAVE-AD, Ryden scale, GDS and CIRS (all p < 0.05). No statistically significant between-group differences were reported for the MSME, BI or phonological task scores. Side effects were mild in both groups and did not lead to study withdrawals.
Conclusion: This study demonstrated the sustained efficacy of rivastigmine over 16 months follow-up in patients with probable subcortical VaD. The efficacy of rivastigmine was greater than that observed with a combination of aspirin plus nimodipine. Future studies may help confirm rivastigmine as a safe and efficacious treatment option for VaD patients.
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