Should class III drugs be initiated in hospital to prevent drug-induced torsade de pointes arrhythmias?

Abstract

OBJECTIVES:

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).

METHOD:

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.

CONCLUSION:

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: S C Verduyn, S K G Winckels, A P M Gorgels, P A Doevendans, M A Vos
• Journal: Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation (Neth Heart J) Vol. 11 Issue 2 Pg. 70-76 (Feb 2003) ISSN: 1568-5888 [Print] Netherlands
• PMID: 25696183 (Publication Type: Journal Article)