Key result
Clozapine treatment for 18 weeks did not significantly change the prevalence of prolonged QTc (p=0.15) or mean QTc (p=0.32) compared to baseline.
Why the study?
Does clozapine treatment cause QTc prolongation in patients without baseline heart disease?
Observational (n=82)
Does clozapine treatment cause QTc prolongation in patients without baseline heart disease?
p-value: p=0.15
Clozapine treatment for 18 weeks does not significantly increase the prevalence of QTc prolongation or mean QTc interval compared to baseline.
Supports cautious QTc monitoring for clozapine in patients with prior prolongation or tachycardia; leaves open randomized confirmation of overall safety.
OBJECTIVE: The most feared cardiological consequence of clozapine is sudden cardiac death. A potential marker of it is QTc interval (QTc) prolongation. This study aimed to determine the prevalence of QTc prolongation in patients before and after 18 weeks of clozapine treatment and to detect predictors of QTc prolongation. METHODS: Patients undergoing treatment with clozapine who had been given an electrocardiogram prior to the treatment and had their electrocardiogram, serum clozapine and norclozapine levels taken on the 18th week were selected. Exclusion criteria were thioridazine, pimozide, diuretics or beta-blocker treatment, electrolytic alteration, heart diseases and substance misuse diagnosis. Prolonged QTc was defined as >450 ms in men and >470 ms in women. RESULTS: No significant differences were detected in prevalence of prolonged QTc or mean QTc before and after 18 weeks of clozapine treatment (p = 0.15, p = 0.32, respectively). Age, heart rate at 18th week and QTc prior to clozapine treatment had significant effects on QTc at follow-up. Prolonged QTc during previous treatment and heart rate >95 beats/min at 18 weeks were found to be predictors of QTc prolongation. CONCLUSION: No significant differences were detected in prevalence of QTc prolongation or mean QTc among patients before and after 18 weeks on clozapine.
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Grande et al. (2011) conducted an observational in Patients undergoing treatment with clozapine (n=82). Clozapine vs. Baseline (before treatment) was evaluated on Prevalence of prolonged QTc (p=0.15). Clozapine treatment for 18 weeks did not significantly change the prevalence of prolonged QTc (p=0.15) or mean QTc (p=0.32) compared to baseline.
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