title: Should class III drugs be initiated in hospital to prevent drug-induced torsade de pointes arrhythmias?
abstract: OBJECTIVE
  In the US, the FDA requires in-hospital institution of class III drugs. This study retrospectively assessed whether these criteria, which differ markedly from the Dutch exclusion criteria, could predict sotalol-induced torsade de pointes arrhythmias (TdP).
  
  
  METHODS
  Oral sotalol effect in a control group (50 patients, 62±12 years, 23 men, 27 women) was compared with five patients developing TdP (75±5years, all women), using known and new (JTU area measured in lead V2) risk parameters. Paroxysmal atrial fibrillation was the most common indication for sotalol treatment.
  
  
  RESULTS
  At baseline the strict US regulations would have identified four of five TdP patients on the basis of individual K+levels, creatinine clearance and QTc. However, 7 of 49 controls would also have been excluded, although they did not develop documented TdP in the >2 years follow-up. Sotalol slightly increased QTc(361±34 to 387±33ms) in controls, due to heart rate reduction. In the TdP group, sotalol dramatically increased QTc(467±33 to 626±52 ms, +35%, p<0.05) accompanied by deep negative TU waves and an increased JTU area and all could be identified as risk patients.
  
  
  CONCLUSIONS
  Patients developing TdP on oral sotalol can be identified using the FDA risk criteria and hospitalisation may therefore be appropriate. A European prospective study is required to investigate the costs, sensitivity and specificity of this strategy.
authors.forename: S C
authors.initials: SC
authors.lastname: Verduyn
authors.forename: S K G
authors.initials: SK
authors.lastname: Winckels
authors.forename: A P M
authors.initials: AP
authors.lastname: Gorgels
authors.forename: P A
authors.initials: PA
authors.lastname: Doevendans
authors.forename: M A
authors.initials: MA
authors.lastname: Vos
keywords: JTU area; electrocardiography; gender; proarrhythmia; repolarisation; torsade de pointes