Measuring the Effectiveness of Safety Warnings on the Risk of Stroke in Older Antipsychotic Users: A Nationwide Cohort Study in Two Large Electronic Medical Records Databases in the United Kingdom and Italy

Janet Sultana; Andrea Fontana; Francesco Giorgianni; Silvia Tillati; Claudio Cricelli; Alessandro Pasqua; Elisabetta Patorno; Clive Ballard; Miriam Sturkenboom; Gianluca Trifirò

doi:10.1007/s40264-019-00860-z

Measuring the Effectiveness of Safety Warnings on the Risk of Stroke in Older Antipsychotic Users: A Nationwide Cohort Study in Two Large Electronic Medical Records Databases in the United Kingdom and Italy

Janet Sultana, Andrea Fontana, Francesco Giorgianni, Silvia Tillati, Claudio Cricelli, Alessandro Pasqua, Elisabetta Patorno, Clive Ballard, Miriam Sturkenboom, Gianluca Trifirò

Julius Center, dept. Global Public Health & Bioethics

Research output: Contribution to journal › Article › Academic › peer-review

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.

Original language	English
Pages (from-to)	1471-1485
Number of pages	15
Journal	Drug Safety
Volume	42
Issue number	12
Early online date	25 Sept 2019
DOIs	https://doi.org/10.1007/s40264-019-00860-z
Publication status	Published - Dec 2019

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Sultana, J., Fontana, A., Giorgianni, F., Tillati, S., Cricelli, C., Pasqua, A., Patorno, E., Ballard, C., Sturkenboom, M., & Trifirò, G. (2019). Measuring the Effectiveness of Safety Warnings on the Risk of Stroke in Older Antipsychotic Users: A Nationwide Cohort Study in Two Large Electronic Medical Records Databases in the United Kingdom and Italy. Drug Safety, 42(12), 1471-1485. https://doi.org/10.1007/s40264-019-00860-z

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title = "Measuring the Effectiveness of Safety Warnings on the Risk of Stroke in Older Antipsychotic Users: A Nationwide Cohort Study in Two Large Electronic Medical Records Databases in the United Kingdom and Italy",

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.",

author = "Janet Sultana and Andrea Fontana and Francesco Giorgianni and Silvia Tillati and Claudio Cricelli and Alessandro Pasqua and Elisabetta Patorno and Clive Ballard and Miriam Sturkenboom and Gianluca Trifir{\`o}",

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year = "2019",

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Sultana, J, Fontana, A, Giorgianni, F, Tillati, S, Cricelli, C, Pasqua, A, Patorno, E, Ballard, C, Sturkenboom, M & Trifirò, G 2019, 'Measuring the Effectiveness of Safety Warnings on the Risk of Stroke in Older Antipsychotic Users: A Nationwide Cohort Study in Two Large Electronic Medical Records Databases in the United Kingdom and Italy', Drug Safety, vol. 42, no. 12, pp. 1471-1485. https://doi.org/10.1007/s40264-019-00860-z

Measuring the Effectiveness of Safety Warnings on the Risk of Stroke in Older Antipsychotic Users: A Nationwide Cohort Study in Two Large Electronic Medical Records Databases in the United Kingdom and Italy. / Sultana, Janet; Fontana, Andrea; Giorgianni, Francesco et al.
In: Drug Safety, Vol. 42, No. 12, 12.2019, p. 1471-1485.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Measuring the Effectiveness of Safety Warnings on the Risk of Stroke in Older Antipsychotic Users

T2 - A Nationwide Cohort Study in Two Large Electronic Medical Records Databases in the United Kingdom and Italy

AU - Sultana, Janet

AU - Fontana, Andrea

AU - Giorgianni, Francesco

AU - Tillati, Silvia

AU - Cricelli, Claudio

AU - Pasqua, Alessandro

AU - Patorno, Elisabetta

AU - Ballard, Clive

AU - Sturkenboom, Miriam

AU - Trifirò, Gianluca

PY - 2019/12

Y1 - 2019/12

N2 - 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.

AB - 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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U2 - 10.1007/s40264-019-00860-z

DO - 10.1007/s40264-019-00860-z

M3 - Article

C2 - 31556019

SN - 0114-5916

VL - 42

SP - 1471

EP - 1485

JO - Drug Safety

JF - Drug Safety

IS - 12

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Sultana J, Fontana A, Giorgianni F, Tillati S, Cricelli C, Pasqua A et al. Measuring the Effectiveness of Safety Warnings on the Risk of Stroke in Older Antipsychotic Users: A Nationwide Cohort Study in Two Large Electronic Medical Records Databases in the United Kingdom and Italy. Drug Safety. 2019 Dec;42(12):1471-1485. Epub 2019 Sept 25. doi: 10.1007/s40264-019-00860-z

Measuring the Effectiveness of Safety Warnings on the Risk of Stroke in Older Antipsychotic Users: A Nationwide Cohort Study in Two Large Electronic Medical Records Databases in the United Kingdom and Italy

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