title: Trends in use of antipsychotics in elderly patients with dementia: Impact of national safety warnings.
abstract: Based on evidence of an increased risk of death, drug agencies issued safety warnings about the use of second generation antipsychotics (SGAs) in the elderly with dementia. The French agency issued a warning in 2004. which was extended to all antipsychotics in 2008. Little is known about the impact of these warnings on use. We conducted a quasi-experimental study (interrupted time-series) in France, for 2003-2011, including subjects aged ≥65 with dementia and subjects aged ≥65 without dementia in the EGB database (1/97th representative random sample of claims from the main Health Insurance scheme). Outcomes were monthly rates of use of antipsychotics (by class and agent) and of five comparison drug classes (antidepressants, benzodiazepines, dermatologicals, antidiabetics, antiasthmatics). Trends were analyzed by joinpoint regression, impact of warnings by linear segmented regression. In patients with dementia (n=7169), there was a 40% reduction in antipsychotic use from 14.2% in 2003 to 10.2% in 2011. The reduction began before 2004 and was unaffected by the warnings. Use of first generation antipsychotics declined over the period, while use of SGAs increased and leveled off from 2007. Use of the five comparison drug classes increased on the period. In subjects without dementia (n=91,942), rates of overall antipsychotic use decreased from 2.3% in 2003 to 1.8% in 2011 with no effect of the warnings. Meanwhile, use of SGAs continuously increased from 0.37% to 0.64%. Antipsychotic use decreased in the elderly between 2003 and 2011, especially in dementia. The timing of the decrease, however, did not coincide with safety warnings.
authors.affiliation: Université Paul Sabatier, Toulouse III, Faculté de médecine, Département d'épidémiologie, économie de la santé et santé publique, F-31073, Toulouse, France; INSERM, UMR 1027 Epidémiologie et analyses en santé publique, F-31073, Toulouse, France; CHU de Toulouse, Service d'épidémiologie, F-31073, Toulouse, France. Electronic address: adeline.gallini@univ-tlse3.fr.
authors.forename: Adeline
authors.initials: A
authors.lastname: Gallini
authors.affiliation: Université Paul Sabatier, Toulouse III, Faculté de médecine, Département d'épidémiologie, économie de la santé et santé publique, F-31073, Toulouse, France; INSERM, UMR 1027 Epidémiologie et analyses en santé publique, F-31073, Toulouse, France; CHU de Toulouse, Service d'épidémiologie, F-31073, Toulouse, France.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Andrieu
authors.affiliation: University of Pittsburgh, Graduate School of Public health, Department of Health Policy and Management, Pittsburgh, PA, USA.
authors.forename: Julie M
authors.initials: JM
authors.lastname: Donohue
authors.affiliation: Université Paul Sabatier, Toulouse III, Faculté de médecine, Département d'épidémiologie, économie de la santé et santé publique, F-31073, Toulouse, France; INSERM, UMR 1027 Epidémiologie et analyses en santé publique, F-31073, Toulouse, France.
authors.forename: Naïma
authors.initials: N
authors.lastname: Oumouhou
authors.affiliation: INSERM, UMR 1027 Epidémiologie et analyses en santé publique, F-31073, Toulouse, France; Université Paul Sabatier, Toulouse III, Faculté de médecine, Département de pharmacologie, F-31073, Toulouse, France; CHU de Toulouse, Service de pharmacologie médicale et clinique, F-31073, Toulouse, France.
authors.forename: Maryse
authors.initials: M
authors.lastname: Lapeyre-Mestre
authors.affiliation: Université Paul Sabatier, Toulouse III, Faculté de médecine, Département d'épidémiologie, économie de la santé et santé publique, F-31073, Toulouse, France; INSERM, UMR 1027 Epidémiologie et analyses en santé publique, F-31073, Toulouse, France; CHU de Toulouse, Service d'épidémiologie, F-31073, Toulouse, France.
authors.forename: Virginie
authors.initials: V
authors.lastname: Gardette
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D016208:Databases, Factual / Q000706:statistics & numerical data / Q000639:trends*; D003704:Dementia / Q000188:drug therapy* / Q000453:epidemiology* / Q000401:mortality; D004348:Drug Labeling; D004335:Drug and Narcotic Control / Q000639:trends*; D005260:Female; D005602:France; D006801:Humans; D008297:Male; D015995:Prevalence; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents
keywords: ATC; Alzheimer's disease; Antipsychotics; BPSD; DDD; Dementia; Drug utilization/trends; EGB; Elderly; FGA; ICD; SGA; anatomical, therapeutic and chemical (classification); behavioral and psychological symptoms of dementia; defined daily dose; first generation antipsychotics; international classification of diseases; second generation antipsychotics; échantillon généraliste de bénéficiaires