Objective: To compare safety, tolerability, and efficacy of three approved medications for the treatment of Alzheimer's disease (AD) in naive patients.
Design: prospective study
Methods: All patients in our clinical practice who were treated for 6 months with one of the three FDA approved medications were evaluated during a one month period. Patients previously treated with any of these medications were excluded. All met the DSM-IV and NINCDS-ADRA criteria for possible Alzheimer's disease. Donepezil was initiated at 5 mg/day at 12 P.M. and titrated to 10 mg/day after 1-2 months. Rivastigmine was initiated at 1.5 mg/day and the dose was increased after one week to 3 mg/day in 2 divided doses. After one month, the dose was increased again to 4.5 mg/day for one week, and then to 6 mg/day in 2 divided doses. The same pattern of titration was used until 12 mg/day was achieved. Galantamine was initiated at 8 mg/day in 2 divided doses, and then was increased by 8 mg/month until a maximum of 24 mg/day was reached. Evaluation at monthly intervals included adverse event and the MMSE.
Results: 21 patients were evaluated (7 on each donepezil, rivastigmine, and galantamine). Average age was 80.0, 81.4, and 78.6 respectively. Average initial MMSE were 17, 13, and 18 respectively. One patient had increased irritability when donepezil was increased to 10 mg/day, but the symptoms resolved after the dose was reduced to 5 mg/day. Weight loss was reported in one patient treated with rivastigmine, and two patients experienced increased somnolence (all were receiving 12 mg/day when adverse events reported). Three patients treated with galantamine experienced adverse events. One had nausea at 16 mg/day which resolved by decreasing the dose to 12 mg/day. Average MMSE increased by 1.4 in the donepezil adn galantamine groups, and by 3.8 in the rivastigmine group. The overall average increase in MMSE was 1.8. In all groups, caregivers denied any noticeable memory improvement.
Conclusion: During a 6 month head to head comparison, there were no significant differences in safety or efficacy between these three medications.
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