Gastrointestinal adverse events in a general population sample of nursing home residents taking cholinesterase inhibitors.

Objective: To assess the occurrence of gastrointestinal (GI) adverse events in a national sample of nursing home residents taking donepezil, galantamine, or rivastigmine.

Design: A retrospective analysis of the Minimum Data Set (MDS) was performed.

Setting: Four hundred-fifty-two nursing facilities across the United States.

Participants/interventions: During 2000, 2001, and 2002, eligible residents began donepezil, galantamine, or rivastigmine monotherapy. Among these treatment groups, 5,846, 750, and 1,672 residents, respectively, were included in the analysis. All MDS assessments were analyzed if completed. Analyses were conducted at baseline and within one year of initiating therapy.

Main Outcome Measures: Occurrence of vomiting, stomach pain, diarrhea, weight loss, and insomnia.

Results: Overall, GI adverse events ranged from 2% to 9% and were comparable among the groups. Residents taking galantamine were more likely to experience diarrhea relative to those taking rivastigmine or donepezil (8.9% versus 6.8% versus 6.4%, respectively; P = 0.035), and less likely to lose weight relative to these groups (15.6% versus 20.0% versus 20.3%, respectively; P = 0.01). GI adverse events were less frequent during the maintenance phase compared with the initial drug-titration phase.

Conclusion: GI events generally occurred with similar frequency in a national sample of nursing home residents taking donepezil, galantamine, or rivastigmine in the usual clinical practice setting.