Donepezil for dementia with Lewy bodies: meta‐analysis of multicentre, randomised, double‐blind, placebo‐controlled phase II, III, and, IV studies

Abstract

AbstractBackgroundCurrent evidence for the management of symptoms associated with dementia with Lewy bodies (DLB) using donepezil is limited. We conducted a meta‐analysis of three randomised controlled trials of donepezil in patients with DLB to investigate the overall efficacy of donepezil on Mini‐Mental State Examination (MMSE), Neuropsychiatric Inventory (NPI), and Clinician's Interview‐Based Impression of Change‐plus Caregiver Input (CIBIC‐plus).MethodsA meta‐analysis was performed using the data of 312 patients administered placebo or 10 mg donepezil. Overall mean score differences for MMSE, NPI‐2, and NPI‐10 from baseline to week 12 and their 95% confidence intervals (CI) were estimated. For CIBIC‐plus, which was transformed from a seven‐point grade to a dichotomous outcome (improvements/no improvements), odds ratio (OR) and its 95% CI were estimated. Random‐effects models were used, and heterogeneity was evaluated using the Cochrane's Q test and I2 statistic.ResultsHeterogeneity was suspected for NPI‐2 (P < 0.05; I2 = 87.2%) and NPI‐10 (P < 0.05; I2 = 67.7%) while it was not suspected for MMSE (P = 0.23; I2 = 32.4%) and CIBIC‐plus (P = 0.26; I2 = 19.8%). The overall mean MMSE score difference (mean difference: 1.50; 95% CI, 0.67–2.34) and the overall odds of improving CIBIC‐plus (OR: 2.20; 95% CI, 1.13–4.26) from baseline to week 12 were higher in the donepezil group than in the placebo group.ConclusionResults of our meta‐analysis indicated overall efficacy of donepezil on cognitive impairment and global clinical status in patients with DLB.