Profile of atypical-antipsychotics use in patients affected by dementia in the University Hospital of Ferrara.

BACKGROUND: The use of off-label atypical antipsychotic drugs (AA) has been noted for the treatment of behavior disorders in older patients affected by Alzheimer's or by other forms of dementia, even though effectiveness data are limited and use seems to be associated with severe cerebrovascular risks. The data concerning such risks caused the Italian Ministry of Health to release a statement discouraging doctors from prescribing olanzapine and risperidone outside of the registered indications, in May 2004. This study aimed to analyze the prescriptive profile of AAs in patients with dementia, in terms of the choice of active substance and of the clinical characteristics of the patients. METHODS: Patients with a diagnosis of dementia and in treatment with AA (risperidone, olanzapine, and quetiapine) were selected from three main Alzheimer Evaluation Centers (Geriatrics, Neurology, Internal Medicine) of the University Hospital in Ferrara, in the period 05/2003-04/2006. For each subject, the following information was collected: the frequency of prescriptions, the drug received, and the amount of AAs in the considered period. In the third year of observation, the intensity of treatment was evaluated (intense treatment: >300 tablets of any AA; weak treatment: <300 tablets of any AA or up to three packages of risperidone drops). Such data were analyzed in terms of the type of dementia, the behavioral disturbance, and the possible presence of psychomotor agitation. In addition, the adverse reactions that occurred during the treatment were gathered. Lastly, the use of acetylcholinesterase inhibitors among the selected subjects was described. RESULTS: Among the 392 subjects (63% female), Alzheimer's (49%) was the most frequent form of dementia, hallucinations were present in 50% of the cases and aggression in 53%.The statement by the Ministry of Health resulted in a foreseeable increase in the consumption of quetiapine and a parallel decrease in risperidone and olanzapine; subsequently, the distribution among the drugs stabilized to similar percentages. The doses used for the control of behavioral disturbances during dementia were on average much lower than those for treating more severe psychoses. Among the patients followed in the third year of observation (n = 159), the number of subjects in intense treatment was greater than those in weak treatment (60 vs 40%). Olanzapine was the AA most frequently used in intense dosages. Among the patients in weak treatment, about 50% used risperidone, available as oral droplets. In the patients at the Geriatric Center (n = 174), in the initial period of analysis 10 adverse events were observed and out of these 10 subjects, all of whom were under intense treatment , 8 out of 10 took quetiapine. The most frequently observed adverse events were tremors, a typical extrapyramidal symptom. CONCLUSIONS: As physicians await next studies helping to identify specific classes of drugs for specific symptoms or subpopulations, they should turn to pharmacological treatment only after a careful risk-benefit evaluation. They should consider both the important role of the relationship between patient and carers and the adverse effects of antipsychotics, which are particularly dangerous in the elderly.