Key result
Low-dose thioridazine was not associated with a higher rate of ventricular arrhythmia or sudden death compared to low-dose haloperidol (adjusted RR 0.9; 95% CI 0.7-1.1).
Why the study?
Does low-dose thioridazine compared to low-dose haloperidol increase the risk of ventricular arrhythmia, sudden death, or unexplained or unattended death in older patients?
Cohort
Does low-dose thioridazine compared to low-dose haloperidol increase the risk of ventricular arrhythmia, sudden death, or unexplained or unattended death in older patients?
Relative Risk: 0.9 (95% CI 0.7–1.1)
Low-dose thioridazine and haloperidol demonstrate similar cardiac safety profiles regarding ventricular arrhythmias and sudden death in older patients.
Supports comparable arrhythmia risk for low-dose thioridazine versus haloperidol in older patients; leaves open need for randomized confirmation.
AIM: To compare the rate of ventricular arrhythmia, sudden death and unexplained or unattended death among users of thioridazine and haloperidol. METHODS: Observational cohort study of thioridazine and haloperidol users in the UK General Practice Research Database (GPRD) using data from 1987 through 29 June 2000. Patients were followed for 30 days following each study prescription. The event of interest was a diagnosis of ventricular arrhythmia, sudden death, or unexplained or unattended death. Cox regression was used to calculate rate ratios (RRs) and 95% confidence intervals (CIs), to examine potential confounding factors, and to examine dose-response relationships. RESULTS: Use of thioridazine and haloperidol in the GPRD was primarily in older patients, at low dose (median daily dose 31 mg thioridazine, 1.8 mg haloperidol). There was no association between thioridazine use and the rate of ventricular arrhythmia, sudden death, and unexplained or unattended death (adjusted RR 0.9, 95% CI 0.7, 1.1). The rate did not appear to increase with dose for either drug over the range observed. CONCLUSIONS: These results suggest that low-dose thioridazine and haloperidol have similar cardiac safety.
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Hennessy et al. (2004) conducted a cohort in Thioridazine and haloperidol users. Thioridazine vs. Haloperidol was evaluated on ventricular arrhythmia, sudden death, or unexplained or unattended death (RR 0.9, 95% CI 0.7-1.1). Low-dose thioridazine was not associated with a higher rate of ventricular arrhythmia or sudden death compared to low-dose haloperidol (adjusted RR 0.9; 95% CI 0.7-1.1).
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