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Activity Number:
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233
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Type:
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Contributed
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Date/Time:
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Monday, August 3, 2009 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304929 |
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Title:
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Analysis of Recurrent Events Could Be Superior to the Time-to-First Event in Assessment of Drug Therapy in Patients with Arrhythmias
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Author(s):
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Hussein Al-Khalidi*+
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Companies:
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STATKING Consulting, Inc.
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Address:
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759 Wessel Drive, Farifield, OH, 45014,
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Keywords:
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recurrent events ; drug efficacy ; antiarrhythmic
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Abstract:
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"Time to first event" (TFE) is often used as the primary endpoint in assessing the efficacy of antiarrhythmic agents. This assumes TFE has the same distribution as inter-event intervals (IEI). We hypothesized that time intervals between VT/VF events in ICD patients would be clustered and appropriately analyzed by "counting" all IEI. In a simulation we were able to show that recurrent events contribute more information in drug efficacy than just the 1st occurrence. Andersen-Gill (AG) model was used to analyze all IEI, and Cox's model was used to analyze TFE. Results from ITT analysis using AG model showed significant reduction in recurrence of all VT/VF. However, when only the 1st event is used, therapy did not significantly prolong TFE. Analyzing all arrhythmias burden is more appropriate than utilizing only first arrhythmic event in evaluating a drug therapy.
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