ABSTRACT
BACKGROUND: Antipsychotic (AP) drugs are commonly used to manage the behavioural symptoms of dementia. Nevertheless, international (i.e. the European Medicines Agency in Europe) and national (i.e. the Medicines and Healthcare products Regulatory Agency in the UK and the Italian Drug Agency) regulatory agencies issued safety warnings against AP use in dementia in 2004 and 2009. OBJECTIVE: The aim of this study is to investigate the short- and long-term impact of safety warnings on the use of APs in UK and Italian persons with dementia using two nationwide databases: The Health Improvement Network (THIN) from the UK and the Health Search Database-Cegedim-Strategic Data-Longitudinal Patient Database (HSD-CSD-LPD) from Italy. METHODS: We calculated the overall quarterly prevalence of AP use by class and by individual drug in persons with dementia aged ≥65 years and used generalized linear models to explore the effect of the safety warnings. RESULTS: We identified 58,497 and 10,857 individuals aged ≥65 years with dementia from the THIN and HSD-CSD-LPD databases, respectively, over the period 2000-2012. After the 2004 warnings, the use of atypical APs decreased, whereas the use of conventional APs increased, in Italy and the UK until 2009. However, the trend for APs individually showed that the use of risperidone/olanzapine decreased, whereas the use of quetiapine increased in both countries. After the 2009 warnings (until 2012), the use of atypical and conventional APs decreased in the UK (from 11 to 9 and 5 to 3 %, respectively), but such use increased in Italy (from 11 to 18 and 9 to 14 %, respectively). CONCLUSION: The 2004 warnings led to a reduction in the use of olanzapine and risperidone and increased the use of quetiapine/conventional APs in both countries. From 2009, the use of APs decreased in persons with dementia in the UK but not in Italy. Possible reasons for the difference in AP use between the two countries include a more proactive approach towards reducing the use of APs in the UK than in Italy.
Subject(s)
Antipsychotic Agents/adverse effects , Antipsychotic Agents/therapeutic use , Dementia/drug therapy , Aged , Benzodiazepines/adverse effects , Benzodiazepines/therapeutic use , Databases, Factual , Drug Prescriptions , Female , Humans , Italy , Male , Olanzapine , Practice Patterns, Physicians' , Retrospective Studies , Risperidone/adverse effects , Risperidone/therapeutic use , United KingdomABSTRACT
The drive for evidence based practice and cost-effective use of pharmacological therapies has advantages, but can also be problematic. These difficulties are particularly challenging in the context of long-term conditions, such as Alzheimer's disease. The complexity of the illness, the variable and complex pattern of service use and the difficulty of conducting long term clinical trials are extremely difficult to factor into a meaningful cost effectiveness model. In Alzheimer's disease, the additional impact on caregivers as well as the person with dementia should be considered. In the current article we give a brief overview of the clinical effectiveness of cholinesterase inhibitors for the treatment of Alzheimer's disease, discuss in detail the NICE appraisal of these treatments in the UK as an example of an attempt at a standardised evaluation of cost-effectiveness and discuss a proposed way forward to achieve a unified and consistent approach to the assessment of cost-effectiveness for anti-dementia therapies.
