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Titolo:
DRUG-INDUCED TORSADE-DE-POINTES - PRECLIN ICAL AND CLINICAL-STUDIES FOR THE PREDICTION OF A POTENTIAL PROARRHYTHMIC ADVERSE DRUG REACTION
Autore:
JAILLON P; DUPUIS B; DAHAN R; BOTTINEAU G; CARON J; CAZOR JL; CHAUVENET M; CLEMENT JP; ESCANDE D; FAISANDIER Y; FUNCKBRENTANO C; KOLSKY H; KOEN R; LACROIX D; LEENHARDT A; LEHNER JP; PROST JF; SWYNGHEDAUW B; VASSORT G; WEISSENBURGER J; WOHLHUTER C;
Indirizzi:
HOP ST ANTOINE,UNITE PHARMACOL CLIN,184 RUE FG ST ANTOINE F-75012 PARIS FRANCE CHRU LILLE,SERV PHARMACOL HOSP LILLE FRANCE LAB ASTRA FRANCE NANTERRE FRANCE
Titolo Testata:
Therapie
fascicolo: 4, volume: 52, anno: 1997,
pagine: 271 - 280
SICI:
0040-5957(1997)52:4<271:DT-PIA>2.0.ZU;2-N
Fonte:
ISI
Lingua:
FRE
Soggetto:
QT-INTERVAL; RATE-DEPENDENCE; HEART-RATE; EXERCISE; HUMANS; DURATION;
Keywords:
TORSADES DE POINTES; PROARRHYTHMIC ADVERSE DRUG REACTION; QT INTERVAL;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
14
Recensione:
Indirizzi per estratti:
Citazione:
P. Jaillon et al., "DRUG-INDUCED TORSADE-DE-POINTES - PRECLIN ICAL AND CLINICAL-STUDIES FOR THE PREDICTION OF A POTENTIAL PROARRHYTHMIC ADVERSE DRUG REACTION", Therapie, 52(4), 1997, pp. 271-280

Abstract

The risk of drug-induced torsade de pointes, a potentially lethal ventricular arrhythmia, raises the problem of the early detection of the effects of any new chemical entity (NCE) on Ventricular repolarizationsince prolongation of myocardial repolarization isa major trigger among others (hypokalaemia, bradycardia, congenital abnormalities in cellular ionic channels) for this arrhythmia. During pre-clinical studies,the effects of a range of concentrations (10(-9) M to 10(-4) M) of NCE on the duration of the action potential of Purkinje and left ventricular myocardial cells (guinea-pig and rabbit) have to be measured. If these effects are present, the duration of QT interval on ECG recordedin animal studies (dogs) has to be carefully measured and correlated with plasma concentrations of NCE and/or its metabolite(s). During clinical trials, additional studies have to be performed in order to document QT interval-plasma concentration relationships and the influence of heart rate on QT interval duration. Ambulatory ECG recordings will attest to the safety of the NCE and precautions for use of the drug will be established according to our knowledge of predisposing factors for a proarrhythmic effect. Should there be a notification of a case oftorsade de points after a new drug has been launched, urgent consultations with the drug file will be necessary in order to assess which pre-clinical and clinical studies may be needed for a better evaluation of the benefit/risk ratio of the new drug.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 15/07/20 alle ore 14:27:23