October 19, 2012

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What a Great Week For Midlife Women And Menopausal Hormone Therapy – Keeps And Dops!

Ten years ago the bottom dropped out of the use
of estrogens and progestogens (EPT) for menopausal hot flashes and prevention
of chronic disease. Gross exaggeration and misrepresentation of
breast cancer findings in the WHI terrified women and sent them searching for
alternatives.

 

Fortunately good research continued, and this
week 2 major studies were reported. Both presented findings that should be
truly reassuring to women, and highlight the need for major professional
organizations to once again revisit their recommendations for use of hormones
after menopause.

 

Let me first describe the studies and their
findings, and then give you my read of where we now stand.

1. KRONOS EARLY PREVENTION STUDY (KEEPS)
RANDOMIZED TRIAL

 727 women average age 52.7, within 3 years of
menopause

 Randomized prospective placebo-controlled study

 Duration 4 years

 Study medications: cyclic estradiol patch or conjugated
equine estrogens (CEE) and micronized progesterone

 Primary endpoints – intima media thickness (IMT) and
coronary artery calcium (CAC). Additional outcomes include quality of life (QOL)
and cognition

At this time we only have the preliminary
reports presented to the media and at the October Annual Scientific Meeting of
NAMS. The following is a brief summary of the study:

 Reduced
symptoms on both hormone types

 Improved
bone mineral density

 Significant
improvement in sexual function (lubrication, decreased pain)

 Lipid
markers favorable for oral except triglycerides

 IMT
and CAC – no differences

 No
statistical differences in breast cancer, endometrial cancer, MI, TIA, stroke
or VTE but #’s small

 Cognition
– no adverse or beneficial effects

 QOL
– improvement on the Utian global QOL scale

 

2.
DANISH OSTEOPOROSIS STUDY (DOPS)

Published in the
British Medical Journal last week, this is a significant study because of its
duration and that women, unlike in the WHI, were entered into the study on
average at age 50 and around 3 months after menopause:

 1006
women average age 50, recently postmenopause

 Randomized
prospective controlled open-label study

 Duration
11 years with a further 6 years follow up

 Study
medications: cyclic estradiol and norethisterone acetate

 Primary
endpoints – mortality, heart failure, myocardial infarction

 

The results of 10 years continuous therapy
showed the following results:

 Significant
reduction in mortality, heart failure, and myocardial infarction

 No
apparent increase in risk of cancer, venous thromboembolism, or stroke

Previously this group had reported the major
benefit of bone sparing and reduction in all fractures.

 

WHAT
DOES THIS MEAN FOR WOMEN NOW?

 

The combination of the WHI results in women
under age 60 and the KEEPS and DOPS study now present a uniform message. For
women starting estrogen or estrogen-progestogen combinations within 10 years of
menopause and having a clear indication for therapy, reassurance is the key
word. The safety profile is good and the efficacy side is excellent.

 

In future columns I will address potential
benefits and potential risks in detail.

 

In the interim, enjoy good news for once, and
have a great week!

 

 

Wulf Utian MD PhD
DSc

 

www.utianllc.com

 

Author; CHANGE YOUR MENOPAUSE – Why one size does not fit all. http://www.amazon.com/Change-Your-Menopause-size-does/dp/0982845723/

WHO IS WULF UTIAN?

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