Discordance in investigator-reported and adjudicated sudden death in TIOSPIR

Robert A. Wise, Peter R. Kowey, George Austen, Achim Mueller, Norbert Metzdorf, Andy Fowler, Lorcan P. McGarvey

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Abstract

Accurate and consistent determination of cause of death is challenging in chronic obstructive pulmonary disease (COPD) patients. TIOSPIR® (N=17 135) compared the safety and efficacy of tiotropium Respimat® 5/2.5 µg with HandiHaler® 18 µg in COPD patients; all-cause mortality was a primary end-point. A mortality adjudication committee (MAC) assessed all deaths. We aimed to investigate causes of discordance in investigator-reported and MAC-adjudicated causes of death and their impact on results, especially, cardiac and sudden death.
The MAC provided independent, blinded assessment of investigator-reported deaths (n=1302) and assigned underlying cause of death. Discordance between causes of death was assessed descriptively (shift tables).
There was agreement between investigator-reported and MAC-adjudicated deaths in 69.4% of cases at the system organ class level. Differences were mainly observed for cardiac deaths (16.4% investigator, 5.1% MAC) and deaths assigned to general disorders including sudden death (17.4% investigator, 24.6% MAC). Reasons for discrepancies included investigator-attribution to the immediate (e.g. myocardial infarction [MI]) over the underlying cause of death (e.g. COPD) and insufficient information for a definitive cause.
Cause-specific mortality varies in COPD, depending on the method of assignment. Sudden death, witnessed and unwitnessed, is common in COPD and often attributed to MI without supporting evidence.
Original languageEnglish
JournalERJ Open
Volume3
Issue number1
Early online date20 Mar 2017
DOIs
Publication statusEarly online date - 20 Mar 2017

Keywords

  • Chronic obstructive pulmonary disease, bronchodilator, cause of death (underlying), clinical trials, mortality.

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