This data was actually released in October of 2012. The Women’s Health Initiative (WHI) study, which was released in 2002 made many women, and their health care providers, afraid of estrogen because of an increased risk of breast cancer. What we understand now is that the population in the WHI study was different. The average age was 63 and 49% were smokers or had other cardiovascular risk factors at the time of entry into the study.
The study released last October, the Kronos Early Estrogen Prevention Study (KEEPS) was a 4-year, randomized, double-blind, placebo-controlled clinical trial involving healthy women aged 42 to 58 (mean age, 52) who were within 3 years after menopause at the time of randomization.
The women were randomly assigned to 1 of the following 3 groups, all also received cyclical micronized progesterone (Prometrium)
- Oral conjugated equine estrogens given as Premarin, 0.45 mg/day, which was a lower dose than the 0.625 mg/day used in the WHI trial
- Transdermal estradiol (Climara patch) 50 mcg/day
To assess cardiovascular harm, the researchers assessed carotid artery intima media thickness (CIMT) and coronary artery calcium (CAC).
In addition, 662 women agreed to participate in the cognitive part of KEEPS, which assessed the effect of HRT on their cognitive function and mood over the 4 years of the KEEPS trial. The study also assessed symptoms of menopausal hormone deficiency and sexual function for the 4 years that the women received HRT.
“KEEPS provides evidence that combined hormone therapy in recently menopausal women shows no evidence for cardiovascular harm in terms of either imaging of the arteries or known biomarkers or risk factors for cardiovascular disease.” Dr Harman stated at the North American Menopause Society (NAMS) meeting 10/2/2012. “That’s a reassuring take away. It goes along with what the breakdown of the WHI found, that when you looked at the younger, more recently menopausal women, that there was no evidence of an increase in progression of atherosclerosis when you treat women with estrogen plus progesterone.”
“Significant Improvement” in Depression, Anxiety, Tension
In the portion of the study that assessed cognitive function and mood, the results were similarly positive. “The key finding here is that in fact there is no adverse effect of hormone therapy when you started in early menopausal women in KEEP. In contrast, there is significant improvement in measures of symptoms of depression, anxiety, and tension,” Dr. Asthana told Medscape Medical News. “One of the theories is that the form of progesterone used in WHI, Medroxyprogesterone is very different than the form that KEEPS used, which is micronized progesterone, the more natural form of progesterone” stated Dr. Sanjay Asthana.
Dr. Wulf Utian, the founding Executive Director Emeritus of NAMS, stated: “The unfortunate finding by the most recent Gallup survey of women, reveal that they fear that taking hormones will give them breast cancer. It’s all based on this massive fear generated from WHI, so nothing has changed. If you go out and ask internists and Family physicians if they are prescribing hormones, they say “no”, because of breast cancer. Ob-Gyns are more likely to be prescribing hormones because they have followed the literature and feel more comfortable with it. . . For women, KEEPS is a good news study. For clinicians treating symptomatic women, it should be reassuring to them and enable them to say the latest study is not showing any increased risk for cardiovascular disease.”
HRT Cuts CVD by 50%, Latest ‘Unique’ Data Show
Another study presented at NAMS and published in a Medscape report was from Denmark. It was a study of 1000 women, aged 45 to 58, who were recently postmenopausal or had perimenopausal symptoms. They were participants in the Danish Osteoporosis Prevention Study and were randomized to receive HRT (n=502) or no treatment (control, n=504) for more than 10 years. “This is the longest randomized trial with hard end points, and we found a 50% reduction in cardiovascular end points for the women who took HRT, and there was no increased risk of cancer” reported Dr. Louise Schierbeck (Hvidovre Hospital, Denmark).
This is all very exciting data for women of today. We can have relief of our hot flashes and night sweats with potential benefit from cardiovascular disease and definite benefit from depression, anxiety and tension that often accompanies menopause. If you would like more information to help your understanding and/or if your doctor has been reluctant to prescribe HRT
for you, a good resource is the North American Menopause Society website, www.menopause.org
. Or, make an appointment with me to chat about your potential risks and/or benefits.