Drug-Drug Interactions Between ADHD and Cardiometabolic Medications: a Pharmacovigilance Study

Study identification

• EU PAS number:
  EUPAS1000000761
• Study ID:
  1000000761
• Official title and acronym:
  Drug-Drug Interactions Between ADHD and Cardiometabolic Medications: a Pharmacovigilance Study
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Denmark

  Sweden

  United States
• Study description:
  Attention-deficit/hyperactivity disorder (ADHD) is increasingly recognized as a lifelong condition, with rising diagnoses and medication use among adults. ADHD medications, while effective, can influence cardiovascular function, and many patients are co-prescribed cardiometabolic treatments. This project investigates the safety of concurrent use of ADHD and cardiometabolic medications, given elevated cardiometabolic risks and overlapping pharmacological effects. We first screened for drug–drug interaction (DDI) signals using disproportionality analyses in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) and the European Medicines Agency’s EudraVigilance database, and then estimated the prevalence of concurrent ADHD and cardiometabolic medication use with potential DDIs among ADHD medication users using population-based prescription databases from four countries.
• Study status:
  Planned

Research institutions and networks

Institutions

Department of Medical Epidemiology and Biostatistics, Karolinska Institutet

Sweden

University of New South Wales (UNSW Sydney)

Australia

Aarhus University

SUNY Upstate Medical University

Networks

TIMESPAN

Australia

Denmark

Germany

Hong Kong

Iceland

Ireland

Italy

Netherlands

Norway

Spain

Sweden

United Kingdom

United States

Study timelines

Date when funding contract was signed

Planned:01/04/2024

Study start date

Planned:01/10/2025

Date of final study report

Planned:30/03/2026

Sources of funding

EU institutional research programme

More details on funding

This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 965381. This research reflects only the authors' view, and the European Commission is not responsible for any use that may be made of the information it contains.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable