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Acetylcholinestarase inhibitors (AChEIs) are the treatment of choice for mild to moderate Alzheimer's disease (AD). Switches between AChEIs are usually performed when the current therapy is not effective or poorly tolerated.
To evaluate the effect of Galantamine treatment in cognition, behavioral symptoms and daily functioning of patients with mild-to-moderate AD.
6-month, non-interventional, prospective study. Treatment-naïve patients or those who had failed on a previous AChEI therapy were enrolled. Naïve patients started treatment on 8 mg daily. Patients switched from other AChEIs started at galantamine therapeutic levels -16 mg- or 24 mg if switched from max dose of rivastigmine. Efficacy was assessed using Mini Mental State Examination (MMSE), Neuropsychiatric Inventory (NPI), Disability Assessment for Dementia (DAD), and Cornell Scale. Caregivers also rated patient's condition using Clinical Global Impression (CGI) scale. Adverse events were closely monitored
333 patients were enrolled (58.6% female). The mean age was 73.5 (SD 6.7) and mean time since diagnosis was 64.2 months (SD 59.1). At the end of the study, the mean galantamine dose was 22.4 mg/day (SD 3.2). 95,2% of patients (317/333) had received another AChEI and inadequate response was the most frequent reason for switching (70.7%).
Efficacy results on all scales had a statistically significant improvement from baseline to month 6. MMSE was increased: 18.7 (SD 4.2) to 19.9 (SD 4.6), p < 0.001; and DAD also increased:68.9 (21.0) to 73.7 (16.2), p = 0.004. NPI, Cornell & CGI were decreased: NPI 12.6 (15.5) to 9.9 (13.2), p < 0.001; Cornell 7.0 (7.7) to 4.6 (5.5), p = 0.003; CGI-Caregivers 3.8 (1.1) to 3.6 (1.2), p < 0.001.
9,9% of patients had at least one adverse event. Most were mild involving nausea (23.3%), vomiting (18.3%) and diarrhea (6.7%). 8 SAEs were recorded.
Discontinuation of a previous AChEI with subsequent treatment with galantamine at a therapeutic dose level may improve all clinical aspects of AD. The safety profile recorded in everyday clinical practice was similar to that reported in double-blind, controlled trials of galantamine.