Janet Sultana1,2, Andrea Fontana3, Francesco Giorgianni1, Silvia Tillati1, Claudio Cricelli4, Alessandro Pasqua4, Elisabetta Patorno5, Clive Ballard6, Miriam Sturkenboom7, Gianluca Trifirò8,9. 1. Department of Biomedical and Dental Sciences and Morpho-Functional Imaging, University of Messina, 1, Consolare Valeria Street, 98125, Messina, Italy. 2. Department of Medical Informatics, Erasmus Medical Centre, Rotterdam, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands. 3. Fondazione IRCCS Casa Sollievo della Sofferenza, Unit of Biostatistics, Viale Cappuccini, 2, 71013, San Giovanni Rotondo, FG, Italy. 4. Health Search, Italian College of General Practitioners, Sestese Street, 61, 50141, Florence, Italy. 5. Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, 1620 Tremont Street, Suite 3030, Boston, MA, 02120, USA. 6. University of Exeter Medical School, Medical School Building, St Luke's Campus, Magdalen Road, Exeter, EX1 2LU, UK. 7. Julius Centre for Global Health, Utrecht University Medical Centre, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. 8. Department of Biomedical and Dental Sciences and Morpho-Functional Imaging, University of Messina, 1, Consolare Valeria Street, 98125, Messina, Italy. trifirog@unime.it. 9. Department of Medical Informatics, Erasmus Medical Centre, Rotterdam, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands. trifirog@unime.it.
Abstract
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.
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.
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