Psychiatric Bulletin (2004) 28: 431. doi: 10.1192/pb.28.11.431
© 2004 The Royal College of Psychiatrists
Psychiatric Bulletin (2004) 28: 431
© 2004 The Royal College of Psychiatrists
DARE: the Drug-Induced Arrhythmia Risk Evaluation Study
Ventricular arrhythmias due to psychiatric and other drugs can cause
life-threatening events that are usually due to prolongation of cardiac
repolarisation, Torsades de Pointes (TdP) and ventricular fibrillation (VF).
These events have generated public and medical concern due to their
unpredictability and the lack of understanding of their epidemiological and
clinical significance. Drugs such as thioridazine and droperidol have been
withdrawn from the market because of this side-effect.
The DARE Study is a collaboration between St George’s Hospital
(London) and the Drug Safety Research Unit (DSRU) (Southampton), funded by the
British Heart Foundation. The lead researchers are Professors A. J. Camm and
S. A. Shakir. The study was launched officially on July 1 2003 and will run
for 5 years.
The study’s principal aims and components are: (1) an epidemiological
study to systematically document and follow up incident cases in England,
comparing them with controls - the relative risk of predisposing clinical
factors will be calculated and both epidemiological cohorts will be described
and the outcomes compared; (2) a genetic study to analyse blood samples from
cases and controls for mutations and polymorphisms of the cardiac sodium and
potassium ion channel genes implicated in the Long QT and Brugada syndromes.
We hypothesise that there is a significant association of genotype with
drug-induced arrhythmia.
We expect that the predictability and awareness of the condition will thus
be increased and result in safer prescribing and drug development.
The study will rely on recruiting patients (cases) who have had a
proarrhythmic event via psychiatrists and hospital physicians in England.
Inclusion criteria will be at least one of the following,
diagnosed as secondary to therapeutic drugs administration or drug
overdose:
- Documented TdP, VF or nonpolymorphic ventricular tachycardia.
- Exacerbation of an already existent ventricular arrhythmia.
- Severe drug-induced QT prolongation (QTc interval
500 ms).
- Moderate drug-induced QT prolongation (QTc interval 450 ms (male) or
470 ms (female)) and a clinical history of syncope or
presyncope.
An information pack will be provided to all psychiatrists interested in
participating in this study. The pack will include ‘consent to contact
cards’ for both the patient and psychiatrist, to briefly complete and
return to the DSRU. This is all that will be required and we will address any
local research ethics committee issues that may arise. If the patient permits
contact to be made then a Research Nurse will arrange to visit him or her at
home to discuss the study further and obtain consent. A questionnaire will be
completed and an ECG and blood sample taken if the patient consents. The
patient will also be asked to separately consent to access to their hospital
and general practice medical notes.
We would be delighted to provide further details to interested health
professionals, and are keen to visit any interested units in order to make a
brief presentation. Please contact us on (023) 8040 8615,
dare{at}dsru.org,
or via
www.dsru.org
for further details, or if you feel that you may have a patient meeting the
inclusion criteria.
