Objective: To compare the global effects of donepezil and placebo treatment, as assessed by the CIBIC-plus versus the CDR-SB, in vascular dementia (VaD) patients.
Design: Combined analysis of two 24-week, double-blind studies in patients with probable or possible VaD.
Materials and Methods: Patients were randomized to receive placebo or donepezil (5 or 10 mg/day). Data are presented for those patients that showed any improvement from baseline on the CIBIC-plus, and the CDR-SB, for the intent-to-treat population at Week 24 (LOCF analysis).
Results: 1219 VaD patients (placebo, n=392; donepezil 5 mg/day, n=406; 10 mg/day, n=421) were enrolled. More donepezil- than placebo-treated patients showed improvement, on the CIBIC-plus (placebo, 27%; donepezil 5 mg/day, 37%, P<0.001; 10 mg/day, 30%, P=0.06; overall, P<0.01), the CDR-SB (placebo, 30%; donepezil 5 mg/day, 34%, P=0.20; 10 mg/day, 39%, P<0.01; overall, P<0.05), and on a combined measure of both the CIBIC-plus and the CDR-SB (placebo, 15%; donepezil 5 mg/day, 19%, P=0.13; 10 mg/day, 19%, P=0.16).
Conclusion: Donepezil-treated patients were more likely than placebo-treated patients to demonstrate improvement on two independent global measures, the CIBIC-plus and the CDR-SB. In the 5 mg/day group, more patients showed improvement on the CIBIC-plus than the CDR-SB, whereas the reverse was true for the 10 mg/day group. These results suggest that the CIBIC-plus and the CDR-SB can identify benefit in donepezil-treated VaD patients, although differences were observed in the responses on these two measures.
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