Journal article
Dual Outcome Intention-to-treat Analyses in the Women's Health Initiative Randomized Controlled Hormone Therapy Trials
American journal of epidemiology, Vol.189(9), pp.972-981
04/21/2020
DOI: 10.1093/aje/kwaa033
PMID: 32314781
Abstract
Dual outcome intention-to-treat hazard rate analyses have potential to complement single outcome analyses for the evaluation of treatments or exposures in relation to multivariate time-to-response outcomes. Here we consider pairs formed from important clinical outcomes for further insight into menopausal hormone therapy influences on chronic disease. The Women's Health Initiative randomized, placebo controlled, hormone therapy trials (1993 to present, at 40 U.S. clinical centers) of conjugated equine estrogens (CEE) among post-hysterectomy participants, and of these same estrogens plus medroxyprogesterone acetate (CEE+MPA) among participants with uterus, provides the context for analyses over the trial intervention periods, and over a nearly 20-year (median) cumulative follow-up. The rates of multiple outcome pairs were significantly influenced by hormone therapy, especially over cumulative follow-up, providing potential clinical and mechanistic insights. For example, hazard ratios for pairs defined by fracture during intervention followed by death from any cause were reduced, and by gallbladder disease followed by death were increased, among women randomized to either regimen, though these may primarily reflect single outcome associations. In comparison, hazard ratios for diabetes followed by death were reduced with CEE but not with CEE+MPA, and for hypertension followed by death were increased with CEE+MPA but not with CEE.
Details
- Title: Subtitle
- Dual Outcome Intention-to-treat Analyses in the Women's Health Initiative Randomized Controlled Hormone Therapy Trials
- Creators
- Ross L Prentice - Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WashingtonAaron K Aragaki - Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WashingtonRowan T Chlebowski - Division of Medical Oncology/Hematology, Los Angeles Biomedical Institute at Harbor-UCLA Medical Center, Torrance, CaliforniaShanshan Zhao - Biostatistics, National Institute of Environmental Health Sciences, Research Triangle Park, North CarolinaGarnet L Anderson - Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WashingtonJacques E Rossouw - Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, MarylandRobert Wallace - Department of Epidemiology, University of Iowa, Iowa City, IowaHailey Banack - Department of Epidemiology, State University of New York, Buffalo, New YorkAladdin H Shadyab - Department of Family Medicine and Public Health, University of California, San Diego, CaliforniaLihong Qi - Public Health Sciences, University of California, Davis, CaliforniaBeverly M Snively - Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North CarolinaMargery Gass - North American Menopause Society, Mayfield Heights, OhioJo Ann E Manson - Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts
- Resource Type
- Journal article
- Publication Details
- American journal of epidemiology, Vol.189(9), pp.972-981
- DOI
- 10.1093/aje/kwaa033
- PMID
- 32314781
- NLM abbreviation
- Am J Epidemiol
- ISSN
- 0002-9262
- eISSN
- 1476-6256
- Publisher
- United States
- Grant note
- DOI: 10.13039/100000054, name: National Cancer Institute, award: R01 CA119171, R01 CA210921; DOI: 10.13039/100000050, name: National Heart, Lung and Blood Institute, award: HHSN268201100046C, HHSN268201600001C, HHSN268201600002C, HHSN268201600003C, HHSN268201600004C, HHSN271201600004C
- Language
- English
- Date published
- 04/21/2020
- Academic Unit
- Epidemiology; Injury Prevention Research Center; Internal Medicine
- Record Identifier
- 9984066116602771
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