Micturin (Terodiline Hydrochloride), Torsades de Pointe and other Arrhythmias — A Study using the VAMP Database

In a preliminary open study using the VAMP database only one confirmed case of torsades de pointe was identified from 9176 terodiline-treated patients. The risk of torsades de pointe with terodiline is therefore 1.1 per 10,000. This preliminary study was followed by a retrospective cohort study which compared the risk of a patient treated with terodiline developing torsades de pointe, or other arrhythmias, with the risk in a matched reference population. In this study the follow-up period of the patients treated with terodiline averaged 5 months (range 2 weeks to 41 months) and that of the controls averaged 6 months (range 2 weeks to 40 months). This comparative study showed that there was no significant difference in the risk of developing a cardiac arrhythmia between the cohort treated with terodiline and their reference patients. The incidence rate was 3.68 per 1000 in the group treated with terodiline and 3.33 per 1000 in the reference group. There was no significant difference in the risk of developing an arrhythmia in the terodiline-treated patients compared with the controls (relative risk 1.1, 95% confidence intervals 0.64–1–90).