Comparative cardiovascular side effects of medications for attention-deficit/hyperactivity disorder: protocol of a case non-case study based on the WHO international pharmacovigilance database

Study identification

• EU PAS number:
  EUPAS47582
• Study ID:
  47583
• Official title and acronym:
  Comparative cardiovascular side effects of medications for attention-deficit/hyperactivity disorder: protocol of a case non-case study based on the WHO international pharmacovigilance database
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Treatment for individuals with ADHD includes both non-pharmacological and pharmacological strategies. Medications approved by the U.S. Food and Drug Administration (FDA) include stimulants (amphetamines and methylphenidate) and non-stimulants (atomoxetine, clonidine, guanfacine extended release, and viloxazine). In the past few decades, prescriptions for ADHD drugs have increased significantly across many countries. Overall, these medications are effective and generally well tolerated, although their use may be associated with adverse effects, in particular decreased appetite, decreased height and weight gain, sleep disturbances, tics, seizures, psychotic symptoms, and increased blood pressure and heart rate. To our knowledge, no study has been carried out using VigiBase® to compare ADHD drugs in terms of the risk of reporting cardiovascular adverse effects. Here, we present the protocol of a study aimed at comparing the risk of reporting cardiovascular events among 12 medications used to treat ADHD, individually and grouped according to their major pharmacological classes.
• Study status:
  Planned

Research institutions and networks

Institutions

Toulouse University Hospital

Pharmacologie En Population cohorteS et biobanqueS

Study timelines

Date when funding contract was signed

Planned: 02/05/2022

Study start date

Planned: 30/05/2022

Data analysis start date

Planned: 02/06/2022

Date of final study report

Planned: 21/06/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Toulouse University Hospital

Regulatory

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