Second-generation antipsychotics in dementia: beyond safety concerns. A clinical, systematic review of efficacy data from randomised controlled trials.

RATIONALE: Antipsychotic drugs are widely used as a first-line pharmacological approach to treat dementia-related psychiatric symptoms. However, in this population of patients, such drugs have been associated with severe safety concerns. Hence, the aim of this review is to asses systematically the efficacy of second-generation antipsychotics (SGAs) in treating dementia-related neuropsychiatric symptoms in order to establish if the potential clinical benefits of such treatment outweigh the hypothesised risks related to pharmacological intervention.
METHODS: The Cochrane Library, MEDLINE, EMBASE and PsycINFO were searched (from 1980 to June 22, 2010) using terms for included drugs (aripiprazole, clozapine, olanzapine, quetiapine, risperidone, ziprasidone, SGAs) and indications (elderly, dementia, Alzheimer's disease). Electronic database search were supplemented with hand search of references lists of electronically identified articles. Peer-reviewed, randomised, controlled trials published in English and investigating the efficacy of SGAs in patients with different forms of dementia were included in the review process. Information was drawn from the 30 articles that met the inclusion criteria.
RESULTS: Nearly all reviewed studies suffer from methodological limitations too severe to draw definitive conclusions that may inform the decision-making process. Moreover, studies conducted with similar methodological design show conflicting efficacy results.
CONCLUSIONS: Because of their undemonstrated effectiveness, SGAs should be avoided in patients with dementia complicated by psychotic and/or behavioural symptoms. Hence, further researches are urgently needed to identify useful pharmacological strategies that can be used to improve the clinical condition of such patients and to reduce burden to caregivers when behavioural interventions are ineffective.