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Original Research

Analysis of the QTc Interval During Olanzapine Treatment of Patients With Schizophrenia and Related Psychosis

Jöerg Czekalla, Charles M. Beasley, Jr., Mary Anne Dellva, Paul H. Berg, and Starr Grundy

Published: March 1, 2001

Article Abstract

Background: There may be a temporal associationbetween some antipsychotics and prolongation of theheart-rate-corrected QT interval (QTc) representing a delay inventricular repolarization. QTc prolongation significantlyexceeding normal intraindividual and interindividual variationmay increase the risk of ventricular tachydysrhythmias,especially torsade de pointes, and therefore, sudden cardiacdeath.

Method: Electrocardiogram recordings obtained aspart of the safety assessment of olanzapine in 4 controlled,randomized clinical trials (N = 2700) were analyzed. Theseanalyses were conducted to characterize any change in QTctemporally associated with olanzapine, compared with placebo,haloperidol, and risperidone, in acutely psychotic patients(DSM-III-R and DSM-IV) and to characterize variability andtemporal course of the QTc in this patient population. Changesfrom baseline to minimum and maximum QTc were tested forsignificance, and baseline to acute-phase endpoint change in meanQTc was tested for significance within treatments and fordifferences between olanzapine and comparators. The possibilityof a linear relationship between dose of olanzapine and meanchange in QTc, as well as incidence of treatment-emergentprolongation of QTc (change from = 430 msec at endpoint), was tested.

Results: The incidence of maximum QTc >= 450msec during treatment was approximately equal to the incidence ofQTc >= 450 msec at baseline.

Conclusion: Results of these analyses suggestthat olanzapine, as therapeutically administered to patients withschizophrenia and related psychoses, does not contribute to QTcprolongation resulting in potentially fatal ventriculararrhythmias.

Volume: 62

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