Informations générales (source: ClinicalTrials.gov)
Hydroxyzine and Risk of Prolongation of QT Interval (HYDROXYZINE-QT)
Observational
University Hospital, Caen (Voir sur ClinicalTrials)
novembre 2015
octobre 2017
29 juin 2024
On 04/30/2015, ANSM (the National Security Agency of Medicines and Health Products)
shared an information for general practicioners, pediatricians, anesthesiologists,
dermatologists, geriatricians, psychiatrists, community pharmacists and hospital about
using hydroxyzine and the associated risk of QT prolongation on the electrocardiogram.
Drugs containing hydroxyzine (the best known and most used is the Atarax®) are used in
France in various indications including the treatment of minor manifestations of anxiety,
premedication with general anesthesia and the symptomatic treatment of urticaria.
A prolonged QT interval is a known risk factor for occurrence of torsades de pointes
which can cause sudden death. We distinguish congenital and acquired long QT interval.
The main cause of acquired long QT interval is a drug inhibition of the HERG potassium
channel 1. Many drugs have been reported to cause sudden death by prolongation of QT
interval and occurrence of torsades de pointes (macrolides, anti -arythmics, some
psychotropic ...) The molecules based on hydroxyzine are known to be at risk of
prolongation of QT interval in an experimental point of view but is not clearly
identified in daily clinical practice. Pharmacology unit of Caen was the first to publish
a case of QT prolongation under hydroxyzine . Through this publication, associated with
other clinical data, hydroxyzine has been added to the list of drugs that can induce QT
prolongation .
Despite these recent recommendations, it does not seem that hydroxyzine prescriptions
were changed daily and therefore the risk of QT prolongation persists. We therefore
propose the study of the impact of hydroxyzine on the QT interval measured on the
electrocardiogram in patients hospitalized at the University Hospital of Caen.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Alexandre Joachim - 14000 - Caen - Basse Normandie - France | Joachim Alexandre, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patients hospitalized at the University Hospital of Caen with a new prescription of
oral hydroxyzine by their referring doctor.
- Patient 'stable' in hospital in a health service or surgery.
- Age > 18 years old.
- Patients hospitalized at the University Hospital of Caen with a new prescription of
oral hydroxyzine by their referring doctor.
- Patient 'stable' in hospital in a health service or surgery.
- Age > 18 years old.
- Unstable Patient hospitalized in an intensive care unit or intensive care.
- Patient refusing participation in the study.
- Age <18 years old.