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 |
|---|---|
| Journal | Drug Safety |
| DOIs | |
| Publication status | Accepted/In press - Jan 1 2019 |
Fingerprint
ASJC Scopus subject areas
- Toxicology
- Pharmacology
- Pharmacology (medical)
Cite this
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 journal › Article
}
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 - 2019/1/1
Y1 - 2019/1/1
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.
UR - http://www.scopus.com/inward/record.url?scp=85074051617&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85074051617&partnerID=8YFLogxK
U2 - 10.1007/s40264-019-00860-z
DO - 10.1007/s40264-019-00860-z
M3 - Article
C2 - 31556019
AN - SCOPUS:85074051617
JO - Drug Safety
JF - Drug Safety
SN - 0114-5916
ER -