A Joint Drug Utilisation Study (DUS) of valproate and related substances, in Europe, using databases

Date of Approval
Application Number
Technical Summary

An assessment of the impact of dissemination of risk minimisation measures (i.e. educational materials and Dear Healthcare Professional Communication) and an assessment of these measures is planned. To meet the primary study objective, a main analysis will be performed on two 3-year periods before and after the implementation of risk minimisation measures, by subgroup of population (girls and women of childbearing potential). The main analysis will be descriptive and will provide information on demographics; medical history; valproate indication, dosage and duration; usage of medications related to any of the valproate indications; concomitant medications prescribed; hormonal contraceptives and IUD; co-morbidities; pregnancies.

Interim reports will be conducted every 6 months until the final report. An interrupted time series report will be considered for the final report if conditions are met in which data are evaluated at multiple time points before and after an intervention in order to detect whether or not an intervention had a significantly greater effect than any underlying trend. Regression analysis will be used to define the trends of each proportion in pre- and post implementation periods. The angle between the trends will be calculated for the two periods to provide insights into the impact of the implementation.

Health Outcomes to be Measured

The main analysis will compare the prescribing patterns of valproate during the pre- and post- implementation periods in females to meet the study objective. The analysis will be descriptive in nature. Descriptive statistics will be provided for the patients, treatments and diagnosis characteristics.


Catrina Richards - Chief Investigator - IQVIA Ltd
Peter McMahon - Corresponding Applicant - IQVIA Ltd
Birgit Ehlken - Collaborator - IQVIA ( IMS Health ) France
Jacco Keja - Collaborator - IQVIA ( IMS Health ) France
Massoud Toussi - Collaborator - IQVIA ( IMS Health ) France
Stephanie Tcherny-Lessenot - Collaborator - Sanofi UK


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