Analysis of the QTc Interval During Olanzapine Treatment of Patients With Schizophrenia and Related Psychosis
J Clin Psychiatry 2001;62(3):191-198
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Background: There may be a temporal association
between some antipsychotics and prolongation of the
heart-rate-corrected QT interval (QTc) representing a delay in
ventricular repolarization. QTc prolongation significantly
exceeding normal intraindividual and interindividual variation
may increase the risk of ventricular tachydysrhythmias,
especially torsade de pointes, and therefore, sudden cardiac
Method: Electrocardiogram recordings obtained as
part of the safety assessment of olanzapine in 4 controlled,
randomized clinical trials (N = 2700) were analyzed. These
analyses were conducted to characterize any change in QTc
temporally associated with olanzapine, compared with placebo,
haloperidol, and risperidone, in acutely psychotic patients
(DSM-III-R and DSM-IV) and to characterize variability and
temporal course of the QTc in this patient population. Changes
from baseline to minimum and maximum QTc were tested for
significance, and baseline to acute-phase endpoint change in mean
QTc was tested for significance within treatments and for
differences between olanzapine and comparators. The possibility
of a linear relationship between dose of olanzapine and mean
change in QTc, as well as incidence of treatment-emergent
prolongation of QTc (change from < 430 msec at baseline to
>= 430 msec at endpoint), was tested.
Results: The incidence of maximum QTc >= 450
msec during treatment was approximately equal to the incidence of
QTc >= 450 msec at baseline.
Conclusion: Results of these analyses suggest
that olanzapine, as therapeutically administered to patients with
schizophrenia and related psychoses, does not contribute to QTc
prolongation resulting in potentially fatal ventricular