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 - ?.
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: |
|
Details
| Item Type: |
Article
|
| Status: |
Published |
| Creators/Authors: |
| Creators | Email | Pitt Username | ORCID  |
|---|
| Hsia, Judith | | | | | Manson, Joann E | | | | | Kuller, Lewis | kuller@pitt.edu | KULLER | | | 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: |
School of Public Health > Epidemiology |
| Refereed: |
Yes |
| PubMed ID: |
17016543 |
| Date Deposited: |
11 Jul 2012 17:30 |
| Last Modified: |
02 Nov 2022 11:55 |
| 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 |
![[img]](http://d-scholarship.pitt.edu/style/images/fileicons/text_plain.png)
![[feed]](/images/feed-icon-32x32.png){kind=icon}