An open-label, comparative study of rivastigmine, donepezil and galantamine in a real-world setting.

OBJECTIVE: We analysed the effects of donepezil, rivastigmine and galantamine, prescribed for the treatment of Alzheimer disease in a real-world setting in Italy.

METHODS: Outcome measures included the MiniMental State Examination (MMSE), the Alzheimer Disease Assessment Scale cognitive subscale (ADAS-cog), Instrumental Activity of Daily Living (IADL) and ADL scales.

RESULTS: Seventy patients were treated with donepezil, 121 with rivastigmine and 51 with galantamine. At 6 months, rivastigmine-treated patients improved by 1.29 points from baseline on the ADAS-cog, while donepezil- and galantamine-treated patients showed 'no change' (changes of < 0.2 points). On the IADL, patients treated with rivastigmine, donepezil and galantamine showed decreases of 0.42, 0.58 and 0.75 points, respectively. On the ADL, donepezil- and galantamine-treated patients showed decreases of 0.44 and 0.86 points, respectively, while there was 'no change' with rivastigmine. On the MMSE, donepezil- and rivastigmine-treated patients showed 'no change' and galantamine-treated patients showed a mean decrease of 1.19 points. A subgroup analysis of 'pseudo-randomised' patients (rivastigmine, n = 63; donepezil, n = 55; galantamine, n = 51) supported the main findings. Side effects were similar (in type and frequency) in the three treatment groups.

CONCLUSIONS: This is the first study to compare the effects of the three most commonly-used cholinesterase inhibitors on the MMSE, ADAS-cog, IADL and ADL. Limitations included its small population size, its open-label design, and the fact that patients were randomised only after the introduction of galantamine. There were no statistically significant differences between the three drugs at 3 months. While numerical trends were observed suggesting the effect of rivastigmine > donepezil > galantamine, larger, longer-term prospective studies are needed to confirm whether there are important differences in the long-term efficacy of the three drugs.