The Kronos Early Estrogen Prevention Study (KEEPS): what have we learned?

Area of Science:

• Cardiovascular Health
• Menopause Research
• Hormone Therapy

Background:

• The Women's Health Initiative's premature termination created a need to understand menopausal hormone treatments (HT).
• The Kronos Early Estrogen Prevention Study (KEEPS) aimed to fill knowledge gaps regarding HT's cardiovascular and menopausal effects.

Purpose of the Study:

• To test if initiating HT in healthy, recently postmenopausal women slows atherosclerosis progression.
• To evaluate the effects of oral conjugated equine estrogens (o-CEE) and transdermal 17β-estradiol (t-E2) on carotid artery intima-media thickness (CIMT).

Main Methods:

• A randomized, double-blinded, placebo-controlled trial involving 727 healthy, recently postmenopausal women.
• Primary endpoint: change in carotid artery intima-media thickness (CIMT) over 4 years.
• Ancillary studies assessed effects on mood, sleep, bone density, sexual function, cognition, and adverse events.

Main Results:

• Neither o-CEE nor t-E2 significantly affected the rate of CIMT increase.
• A trend towards reduced coronary artery calcium accumulation was observed with o-CEE.
• No severe adverse effects, including venous thrombosis, were reported.
• Ancillary studies showed benefits in mood (o-CEE), hot flashes, sleep, bone density (both), and sexual function (t-E2).

Conclusions:

• KEEPS supports the value and safety of HT initiation in recently postmenopausal women.
• HT demonstrated benefits beyond cardiovascular endpoints, including symptom relief and bone maintenance.
• Future research should focus on optimizing HT for postmenopausal women's health.