Effect of regulatory interventions on agomelatine use in Spain: A multiple intervention time‐series analysis in a nationwide electronic healthcare record database
Background Liver injury is an important identified risk for agomelatine and several measures were put in place to prevent and minimize such risk. The study aims to assess the impact of four interventions on the incidence of agomelatine use, particularly among patients aged ≥75 in Spain between 2011...
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Published in | Pharmacoepidemiology and drug safety Vol. 31; no. 3; pp. 294 - 301 |
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Main Authors | , , , , , , |
Format | Journal Article |
Language | English |
Published |
Chichester, UK
John Wiley & Sons, Inc
01.03.2022
Wiley Subscription Services, Inc |
Subjects | |
Online Access | Get full text |
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Summary: | Background
Liver injury is an important identified risk for agomelatine and several measures were put in place to prevent and minimize such risk. The study aims to assess the impact of four interventions on the incidence of agomelatine use, particularly among patients aged ≥75 in Spain between 2011 and 2018.
Methods
Quasi‐experimental interrupted time‐series analysis to examine data from a nationwide electronic healthcare record database (BIFAP). Quarterly cumulative incidence of agomelatine use per 100 000 patients was calculated and the impact of four regulatory interventions was quantified.
Results
The incidence of agomelatine use decreased by 85% and 87% from first quarter 2011 to last quarter 2018 in patients below and above 75 years old, respectively. Regulatory actions taken were not associated with an immediate and significant falling level of use or slope. The incidence was less than expected 6 months after the first and third intervention for patients below and above 75 years old, and more than expected after the second and fourth intervention for both populations, though these analyses were underpowered to observe significant results. The downward trend became less pronounced, reaching a residual level of use, which remained stable in the last segment of the study period.
Conclusion
New users of agomelatine decreased throughout the study period, starting before interventions took place. The effect of specific interventions might be masked by the progressive decrease tendency, constant over the study period. The effects of external factors that might overlap, unintended consequences, and issues concerning statistical modeling in situations where rates are already falling, should be considered when interpreting the results. |
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Bibliography: | Funding information The Spanish Database for Pharmacoepidemiological Research in Primary Care (BIFAP) is fully financed by the Spanish Agency on Medicines and Medical Devices (AEMPS). This document expresses the opinion of the authors of the paper, and may not be understood or quoted as being made on behalf of or reflecting the position of the Spanish Agency of Medicine and Medical Devices or its committees or working parties. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
ISSN: | 1053-8569 1099-1557 |
DOI: | 10.1002/pds.5374 |