There’s a new study that puts hope back into women’s menopausal health, and that’s the KEEPS study or Kronos Early Estrogen Prevention Study, presented at the 23rd annual meeting of NAMS in early October. This study has not been released to the public yet but already there are waves of optimism that it will impact women’s health positively. The study looked at 727 newly menopausal women and for the first time studied the micronized bio-identical Progesterone called Prometrium, leaving out the synthetic Progesterone Medroxyprogesterone acetate or Provera that was linked to the increased risk of breast cancer, heart disease and stroke in the Women’s Health Initiative. KEEPS also studied the options of bio-identical Estradiol in Vivelle (transdermal patch) and bridged the WHI study by including Premarin but at a lower dose of 0.45mg. This study focused on quality of life parameters, noninvasive imaging of atherosclerosis of carotid and coronary arteries, cardiovascular risk factor changes and biomarkers, cognitive function, mammographic breast density and several other outcomes. Overall, KEEPS showed many favorable effects of hormone therapy by demonstrating a substantial reduction in multiple menopausal sx’s (hot flashes, night sweats) and also some improvement in bone mineral density. Blood pressure systolic parameters were not increased as they were in the WHI (Women’s Health Initiative). Estradiol as transdermal had a neutral effect on lipids but a favorable effect on insulin resistance as measured by glucose and insulin levels, the best way to predict future trending toward diabetes than a fasting glucose alone. Non-invasive imaging of carotid and coronary arteries showed less development of coronary artery calcification than women taking placebo but this data is only over 3years and needs longer follow-up. A highly significant finding is there was a neutral effect in cognitive function vs the deleterious effect seen in the WHI; this is a highly significant finding that has huge implications for the future of Alzheimer’s in women in this country. Lastly, mammography suggested less follow-up testing on Premarin (equine based) vs those on Vivelle (bio-identical transdermal estradiol patch) but these findings are preliminary. Lastly, mood and sexual function as well as quality of life were seen as showing benefits and an overall favorable benefit risk ratio.
The most surprising statement made in a videotaped comment on the KEEPS study is that the findings in this study are not going to change the prescribing habits or practice patterns of GYN’s. As the KEEPS study is actually a bridge between the WHI (equine estrogen + synthetic Progesterone) and European based studies (Estradiol + Prometrium), what needs to be emphasized is that the KEEPS study actually shows multiple areas of Benefit to patients in both medical and quality of life parameters vs increased risk in medical parameters; how could this not change prescribing habits or practice patterns? Are doctors not interested in actually helping their patients with both quality of life and medical parameters? Are they actually sacrificing their patients health because they won’t take the time to educate their patients? As physicians, we are also trained to critically read and examine the research in our field and come to our own conclusions about the results. So ask yourself and your doctor about the evidence in the KEEPS study vs European research vs WHI and to give their opinion as to what is best for you, the patient. This is the most important study in women’s health to come out in the past 10years because it not only highlights quality of life issues but also several top medical issues that are in the top leading morbidity and mortality issues in women’s health; so yes, this is ground-breaking news! Let’s get the word out about this important new direction in women’s health research; yes, there is hope for quality of life after menopause and we should let women know they can indeed remain vibrant, healthy and happy!