Title

 

Authors

MG Sullo¹, R. Formica¹, S. Potenza², I. Putaturo¹, R. Cusano¹, T. Pisapia¹, S. Ruggiero¹, B. Rinaldi¹,  A. Capuano¹, F. Rossi¹

1. Department of Experimental Medicine, Section of Pharmacology L. Donatelli, Regional Center for Pharmacovigilance and Pharmacoepidemiology, Faculty of Medicine and Surgery, Second University of Naples, Naples, Italy.
2. Italian Medicines Agency, Office of Pharmacovigilance, Rome, Italy.  

 

Abstract

Dementia is a clinical syndrome characterized by acquired loss of cognitive and emotional abilities, severe enough to interfere with daily functioning and quality of life. BPSD are a common feature in all dementias and their management should involve non-pharmacological measures when possible. If pharmacological therapy is deemed necessary the conventional and atypical antipsychotic drugs are commonly prescribed (1). Although antipsychotics are widely used to treat BPSD, little evidence supports their efficacy and, more importantly, there are concerns about the increased risk of cerebrovascular AdverseEvents (AEs) and mortality associated with their use (2-4). Objectives: 1. To evaluate whether the mortality and incidence of serious AEs (in particular cerebrovascular accidents, cardiac arrhythmias, extrapyramidal and metabolic disturbances) are significantly different in patients treated with typical or atypical antipsychotics. 2. To assess: - prevalence use of antipsychotics (typical and atypical), dosage and duration of antipsychotic treatment, reason and time of discontinuation of the antipsychotics, demographic and clinical characteristics influencing the appearance of AEs, incidence of AEs between patients treated with different typical and atypical antipsychotics, concomitant administration of other drugs and the risk of drug interactions. Methods: An observational cohort study  is being carried out, in Regione Campania, in a sample of non-institutionalised patients affected by dementia and BPSD, treated with antipsychotics. All the patients will be followed till the end of the study or death and will be re-assessed every six months. All data are collected using an ad-hoc questionnaire and all AEs and clinical outcomes are carefully monitored. Results: Our data show that patients with dementia and BPSD are 2841 (1908 females; 67.2%). 1513 (53.2%) patients are affected by dementia of the Alzheimer's type, 890 (31.0 %) by vascular dementia and 140 (4.9%) by mixed dementia. Agitation (21%), aggression (22%), hallucinations (23 %), delirium (16%) are the most common BPSD. At the time of enrolment, 31.7% of patients were receiving antihypertensive drugs, 12.2% anticoagulant drugs, 8.7% antiplatelet drugs and 6.1% antidiabetic drugs. Most patients are treated with atypical antipsychotics; the most frequently prescribed antipsychotics are quetiapine, risperidone, olanzapine. Adverse reactions  frequently described are drug’s failure (55.3%), extrapyramidal symptoms (9.5%). Conclusions: The results of this study will supply elements in the determination of the risk-benefit profile of conventional and atypical antipsychotic drugs in non-institutionalised patients affected by dementia and BPSD. These data should also reveal subpopulations at higher risk of developing AEs and suggest safer dosages and therapy duration profiles.