Link to the University of Pittsburgh Homepage
Link to the University Library System Homepage Link to the Contact Us Form

Impact of cyclooxygenase inhibitors in the Women's Health Initiative hormone trials: secondary analysis of a randomized trial.

Hsia, Judith and Manson, Joann E and Kuller, Lewis and Pettinger, Mary and Choe, John H and Langer, Robert D and Limacher, Marian and Oberman, Albert and Ockene, Judith and O'Sullivan, Mary Jo and Robinson, Jennifer G and Women's Health Initiative Research, (2006) Impact of cyclooxygenase inhibitors in the Women's Health Initiative hormone trials: secondary analysis of a randomized trial. PLoS Clin Trials, 1 (5). e26 - ?.

[img]
Preview
PDF
Published Version
Available under License : See the attached license file.

Download (598kB) | Preview
[img] Plain Text (licence)
Available under License : See the attached license file.

Download (1kB)

Abstract

OBJECTIVES: We evaluated the hypothesis that cyclooxygenase (COX) inhibitor use might have counteracted a beneficial effect of postmenopausal hormone therapy, and account for the absence of cardioprotection in the Women's Health Initiative hormone trials. Estrogen increases COX expression, and inhibitors of COX such as nonsteroidal anti-inflammatory agents appear to increase coronary risk, raising the possibility of a clinically important interaction in the trials. DESIGN: The hormone trials were randomized, double-blind, and placebo-controlled. Use of nonsteroidal anti-inflammatory drugs was assessed at baseline and at years 1, 3, and 6. SETTING: The Women's Health Initiative hormone trials were conducted at 40 clinical sites in the United States. PARTICIPANTS: The trials enrolled 27,347 postmenopausal women, aged 50-79 y. INTERVENTIONS: We randomized 16,608 women with intact uterus to conjugated estrogens 0.625 mg with medroxyprogesterone acetate 2.5 mg daily or to placebo, and 10,739 women with prior hysterectomy to conjugated estrogens 0.625 mg daily or placebo. OUTCOME MEASURES: Myocardial infarction, coronary death, and coronary revascularization were ascertained during 5.6 y of follow-up in the estrogen plus progestin trial and 6.8 y of follow-up in the estrogen alone trial. RESULTS: Hazard ratios with 95% confidence intervals were calculated from Cox proportional hazard models stratified by COX inhibitor use. The hazard ratio for myocardial infarction/coronary death with estrogen plus progestin was 1.13 (95% confidence interval 0.68-1.89) among non-users of COX inhibitors, and 1.35 (95% confidence interval 0.86-2.10) among continuous users. The hazard ratio with estrogen alone was 0.92 (95% confidence interval 0.57-1.48) among non-users of COX inhibitors, and 1.08 (95% confidence interval 0.69-1.70) among continuous users. In a second analytic approach, hazard ratios were calculated from Cox models that included hormone trial assignment as well as a time-dependent covariate for medication use, and an interaction term. No significant interaction was identified. CONCLUSIONS: Use of COX inhibitors did not significantly affect the Women's Health Initiative hormone trial results.


Share

Citation/Export:
Social Networking:
Share |

Details

Item Type: Article
Status: Published
Creators/Authors:
CreatorsEmailPitt UsernameORCID
Hsia, Judith
Manson, Joann E
Kuller, LewisKullerL@edc.pitt.eduKULLER
Pettinger, Mary
Choe, John H
Langer, Robert D
Limacher, Marian
Oberman, Albert
Ockene, Judith
O'Sullivan, Mary Jo
Robinson, Jennifer G
Women's Health Initiative Research,
Date: 10 August 2006
Date Type: Acceptance
Journal or Publication Title: PLoS Clin Trials
Volume: 1
Number: 5
Page Range: e26 - ?
DOI or Unique Handle: 10.1371/journal.pctr.0010026
Schools and Programs: Graduate School of Public Health > Epidemiology
Refereed: Yes
PubMed ID: 17016543
Date Deposited: 11 Jul 2012 17:30
Last Modified: 30 Oct 2018 13:59
URI: http://d-scholarship.pitt.edu/id/eprint/12852

Metrics

Monthly Views for the past 3 years

Plum Analytics

Altmetric.com


Actions (login required)

View Item View Item