INTRODUCTION: Safety warnings relating to antipsychotic-associated stroke among older persons in the UK and Italy were issued. However, the impact of these safety warnings on stroke risk has not been measured to date.
OBJECTIVE: The aim of this study was to measure the change in stroke incidence after two safety warnings in both the UK and Italy.
METHOD: A cohort study was conducted using electronic medical records representative of the UK (The Health Improvement Network) and Italy (Health Search-IQVIA Health LPD), containing data on 11 million and 1 million patients, respectively. After each drug safety warning, elderly antipsychotic new initiators were propensity-score matched 1:1:1 on antipsychotic initiators before any safety warning. Stroke incidence within 6 months of antipsychotic initiation, using an intention-to-treat approach, was the main outcome.
RESULTS: In the UK and Italy, 6342 and 7587 elderly antipsychotic initiators were identified, respectively. A 42% stroke incidence reduction was seen in the UK after the first safety warning [42.3 (95% confidence interval (CI) 35.2-50.8) vs. 24.4 [95% CI 19.0-31.2] events per 1000 person-years (PYs)], while there was a 60% stroke incidence reduction after the second warning (16.9 [95% CI 12.2-23.4] events per 1000 PYs) compared to before the first warning. There was no significant reduction in stroke incidence in Italy.
CONCLUSION: Antipsychotic safety warnings were followed by a reduction in stroke incidence among older antipsychotic users in the UK, but not Italy.
|投稿者||Sultana, Janet; Fontana, Andrea; Giorgianni, Francesco; Tillati, Silvia; Cricelli, Claudio; Pasqua, Alessandro; Patorno, Elisabetta; Ballard, Clive; Sturkenboom, Miriam; Trifiro, Gianluca|
|組織名||Department of Biomedical and Dental Sciences and Morpho-Functional Imaging,;University of Messina, 1, Consolare Valeria Street, 98125, Messina, Italy.;Department of Medical Informatics, Erasmus Medical Centre, Rotterdam, Doctor;Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.;Fondazione IRCCS Casa Sollievo della Sofferenza, Unit of Biostatistics, Viale;Cappuccini, 2, 71013, San Giovanni Rotondo, FG, Italy.;Health Search, Italian College of General Practitioners, Sestese Street, 61,;50141, Florence, Italy.;Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine,;Brigham and Women's Hospital, 1620 Tremont Street, Suite 3030, Boston, MA, 02120,;USA.;University of Exeter Medical School, Medical School Building, St Luke's Campus,;Magdalen Road, Exeter, EX1 2LU, UK.;Julius Centre for Global Health, Utrecht University Medical Centre,;Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.;firstname.lastname@example.org.;Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands. email@example.com.|