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

Research output: Contribution to journalArticle

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 languageEnglish
JournalDrug Safety
DOIs
Publication statusAccepted/In press - Jan 1 2019

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Electronic medical equipment
Electronic Health Records
Italy
Antipsychotic Agents
Cohort Studies
Stroke
Databases
Safety
Incidence
Health
Confidence Intervals
Propensity Score
United Kingdom
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Toxicology
  • Pharmacology
  • Pharmacology (medical)

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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; Tillati, Silvia; Cricelli, Claudio; Pasqua, Alessandro; Patorno, Elisabetta; Ballard, Clive; Sturkenboom, Miriam; Trifirò, Gianluca.

In: Drug Safety, 01.01.2019.

Research output: Contribution to journalArticle

Sultana, Janet ; Fontana, Andrea ; Giorgianni, Francesco ; Tillati, Silvia ; Cricelli, Claudio ; Pasqua, Alessandro ; Patorno, Elisabetta ; Ballard, Clive ; Sturkenboom, Miriam ; Trifirò, Gianluca. / 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. In: Drug Safety. 2019.
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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.",
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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

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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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