Background:
Compared with men, women have more evidence of myocardial ischemia in the setting of no obstructive coronary artery disease (CAD). While low endogenous estrogen levels are associated with endothelial dysfunction, the role of low dose hormone therapy has not been fully evaluated in women suffering from myocardial ischemia and no obstructive CAD.
Objective:
This WISE ancillary trial evaluated the effect of low dose hormone therapy in postmenopausal women with myocardial ischemia and no obstructive CAD on:
endothelial dysfunction, assessed by brachial artery reactivity,
physical functional disability assessed by exercise testing, and
quality of life assessed by cardiac symptoms and psychological questionnaires.
Methods:
Using a multicenter, randomized, placebo-controlled design, seventy-four participants with normal/minimally diseased epicardial coronary arteries (<50% luminal diameter stenosis) who fulfilled the inclusion criteria were planned to be randomized to receive either 1 mg norethindrone/10 mcg ethinyl estradiol (1/10 NA/EE) or placebo for twelve weeks. Baseline and exit brachial artery reactivity (BART), exercise stress testing, WISE psychosocial questionnaires, SF-36, blood lipids and hormone levels were evaluated.
Results:
Recruitment was closed prematurely due to failure to recruit in the year following publication of the Women’s Health Initiative hormone trial results. Of the 37 women randomized, 35 completed the study. While there was no difference in the frequency of chest pain between groups at the baseline visit, at study exit there was less frequent chest pain in the 1/10 NA/EE group compared to the placebo group (p=0.02). Women taking 1/10 NA/EE also showed a trend to improved BART and exercise tolerance, and had significantly fewer hot flashes/night sweats (p=0.003), less avoidance of intimacy (p=0.05), and borderline differences in sexual desire and vaginal dryness (p=0.06).
Conclusion:
Among postmenopausal women with myocardial ischemia and no obstructive CAD, hormone therapy with 1/10 NA/EE is associated with reduced chest pain symptoms, menopausal symptoms and improved quality of life with trends for improved endothelial function and exercise performance.
External Validation of Early Quality of Life (QOL) Declines Correlated with Late QOL after Intensity Modulated, Low Dose Rate Brachytherapy, or Stereotactic Radiation for Prostate Cancer within a Prospective Trial