Results of a reevaluation of cardiovascular outcomes in the RECORD trial

Mahaffey, K. W. et al. (2013) Results of a reevaluation of cardiovascular outcomes in the RECORD trial. American Heart Journal, 166(2), 240-249.e1. (doi:10.1016/j.ahj.2013.05.004) (PMID:23895806)

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Abstract

Background The US Food and Drug Administration (FDA) required a reevaluation of cardiovascular (CV) outcomes in the RECORD trial. This provided an opportunity to assess the implications of event adjudication by 2 groups and quantify the differences as well as to use new FDA end point definitions in development.

Methods Original data were used to systematically identify all potential deaths, myocardial infarctions (MIs), and strokes. Site investigators were approached for additional source documents and information about participants lost to follow-up. Suspected events were adjudicated using standard procedures, and the results were compared with the original trial outcomes.

Results Follow-up for mortality was 25,833 person-years, including an additional 328 person-years identified during the reevaluation effort. A total of 184 CV or unknown-cause deaths (88 rosiglitazone, 96 metformin/sulfonylurea), 128 participants with an MI (68 rosiglitazone, 60 metformin/sulfonylurea), and 113 participants with a stroke (50 rosiglitazone, 63 metformin/sulfonylurea) were included. The hazard ratio (HR) for rosiglitazone versus metformin/sulfonylurea for the end point of CV (or unknown cause) death, MI, or stroke was 0.95 (95% CI 0.78-1.17) compared with 0.93 (95% CI 0.74-1.15) for the original RECORD results. Treatment comparisons for MI (HR 1.13, 95% CI 0.80-1.59) and mortality (HR 0.86, 95% CI 0.68-1.08) were also the same compared with the original RECORD results. Sensitivity analyses were also consistent with the original RECORD results. Analyses using the FDA definitions showed similar results.

Conclusions Only a modest number of additional person-years of follow-up were ascertained from this reevaluation of CV end points in RECORD. Observed HRs and CIs from these analyses using the original RECORD or new FDA end point definitions showed similar treatment effects of rosiglitazone compared with the original RECORD results.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:McMurray, Professor John
Authors: Mahaffey, K. W., Hafley, G., Dickerson, S., Burns, S., Tourt-Uhlig, S., White, J., Newby, L. K., Komajda, M., McMurray, J., Bigelow, R., Home, P. D., and Lopes, R. D.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
Journal Name:American Heart Journal
Journal Abbr.:Am. heart j.
Publisher:Elsevier
ISSN:0002-8703
ISSN (Online):1097-6744
Copyright Holders:Copyright © 2013 The Authors
First Published:First published in American Heart Journal
Publisher Policy:Reproduced under a Creative Commons License

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