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Frequency, regional variation, and predictors of undetermined cause of death in cardiometabolic clinical trials: A pooled analysis of 9,259 deaths in 9 trials

Circulation Feb 16, 2019

Fanaroff AC, et al. - Researchers used data from nine global cardiometabolic clinical trials (2009–2017) with long-term follow-up and blinded, centrally adjudicated cause of death in order to determine the proportion of deaths attributed to cardiovascular, non-cardiovascular, or undetermined causes by therapeutic area (diabetes mellitus/pre–diabetes mellitus, stable atherosclerosis, atrial fibrillation, and acute coronary syndrome), region of patient enrollment, and year of trial manuscript publication. Of 127,049 study participants, 9,259 centrally adjudicated deaths were reported. Findings revealed that approximately 16% of deaths were attributed to undetermined causes. Factors that were related to a greater likelihood of death of undetermined cause in multivariable analysis included acute coronary syndrome or atrial fibrillation trial (vs atherosclerotic vascular disease or diabetes mellitus/pre–diabetes mellitus), longer time from enrollment to death, more recent trial manuscript publication year, enrollment in North America (vs Western Europe), female sex, and older age.

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