Evaluation and management of cardiac safety using the electrocardiogram in oncology clinical trials: focus on cardiac repolarization (QTc interval).
Clin Pharmacol Ther
; 87(2): 166-74, 2010 Feb.
Article
em En
| MEDLINE
| ID: mdl-20010556
ABSTRACT
Non-antiarrhythmic drugs have been reported to prolong the QTc interval and induce potentially fatal ventricular tachyarrhythmias. An increasing number of drugs that are used for treating malignancies are no exception. Therefore, both oncologists and regulators expect sponsors of oncology drugs to evaluate, during the development of the drugs, their effects on the electrocardiogram (ECG), particularly on the QTc interval. In the case of agents that cannot be administered to healthy volunteers, the primary approach is to carry out an intense ECG evaluation, employing robust ECG recordings, during early-phase clinical trials, together with characterization of the concentration-QTc interval relationship, and follow this up with an appropriate intensity of ECG monitoring in the later phases of development. This article describes the broad principles of these approaches, including recommendations for exclusion criteria (relative to baseline QTc interval and to cardiac comorbidity); it also describes methods for conducting ECG monitoring and a proposed scheme for the management of any QTc-related effects that may emerge.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Síndrome do QT Longo
/
Monitoramento de Medicamentos
/
Eletrocardiografia
/
Antineoplásicos
Tipo de estudo:
Etiology_studies
/
Guideline
/
Prognostic_studies
Limite:
Humans
Idioma:
En
Revista:
Clin Pharmacol Ther
Ano de publicação:
2010
Tipo de documento:
Article
País de afiliação:
Estados Unidos