Transcript Updated recommendations on postmenopausal hormone therapy

2013 IMS recommendations on menopausal hormone therapy
and preventive strategies for midlife health – what’s new?
Dobar Dan, Kako Ste?
Nick Panay
Immediate Past Chairman, British Menopause Society
Co-Editor in Chief, Climacteric
www.imsociety.org
Brijuni 2013 Memories!
Introduction – “the new consensus”

The International Menopause Society took the initiative to
arrange a round table discussion between representatives of the
major regional menopause societies to agree on core
recommendations regarding MHT

It is acknowledged that in view of the global variance of disease
and regulatory restrictions, these core recommendations should
be read in the context of the more detailed recommendations
prepared by the national and regional societies
Key aims of the workshop were, using new data,
to reach a consensus on…

Global variations in presentation of menopause and usage of HRT
and alternatives

The influence of age and time since menopause regarding HRT
outcomes

The importance of dosage and type of estrogen and progestogen
on safety and efficacy outcomes

Differences in the therapeutic benefit-risk ratio between estrogen
therapy (ET) and combined estrogen-progestogen therapy (EPT)
IMS Consensus Workshop: 9th November 2012 Paris
hosted by Prof Anne Gompel
Introductory lectures, followed by updates from International experts and focused
discussion on text of the new IMS recommendations to produce
(1) A Global Consensus Document for simultaneous publication in Climacteric &
Maturitas: April 2013
(2) Full evidence based updated recommendations : June 2013
Introduction 1 – Robert Langer: “Review of HT studies”

Future data may come from patient registries and prospective
observation of practice rather than RCTs

Regimens with transdermal estradiol and natural progesterone
should be studied in younger cohorts to confirm efficacy and
safety outcomes such as breast cancer

Journals should standardise they way in which data on HRT are
presented to facilitate uniform reporting and interpretation of
data by the media and public.
Introduction 2 – Rod Baber: “When East meets West”
•
Racial / ethnic differences evident in symptomatic responses to
• menopause,
• hormone levels,
• burden of diseases
•
Results of Caucasian-based studies cannot be systematically
extrapolated to Asian women
•
Any global consensus on the use of HRT should take into
account global variations in menopausal symptoms and
menopause related disorders
Introduction 3 – David Archer: “A world without HT”

The WHI resulted in a significant decline in prescribing of Hormone Therapy

Cardiovascular outcomes have not changed based on limited data – however,
changes may be seen in the next 5-10 years

Breast Cancer Incidence in the United States fell post WHI but had started to
fall prior to initial reporting

Hip Fracture Risk increased after Hormone Therapy was stopped

Other outcomes e.g. mortality rates may become evident as time goes by……
Estrogen-only therapy in women aged 50 to 59 declined nearly
79 percent between 2001 and 2011
Minimum 18,601 – maximum 91,610 (probably around 50,000)
excess deaths can be attributed to estrogen avoidance!
Sarrel PM, Njike VY, Vinante V, Katz DL. The Mortality Toll of Estrogen Avoidance: An Analysis of Excess Deaths
Among Hysterectomized Women Aged 50 to 59 Years. Am J Public Health. 2013; 103(9): 1583-1588.
Introduction 4 : Tom Parkhill: HT and the Media

Any criticism of the media should be positive; the message is often complex –
tell them what is important!

There is a “media culture”. Bad news make headlines, but they have a
responsibility to keep things in context

Breast Cancer is the main issue because women fear this the most.

Need to make journalists and public realise that WHI opinion has moved on

Put benefits and risks into context – absolute rather than relative risk
Published in Climacteric and Maturitas April 2013
Published in Climacteric June 2013
Consensus 2013: MHT

The option of MHT is an individual decision in terms of quality of
life and health priorities as well as personal risk factors such as
age, time since menopause and the risk of thrombo-embolism,
stroke, ischemic heart disease and breast cancer

The dose and duration of MHT should be consistent with
treatment goals and should be individualized

MHT is the most effective treatment for moderate to severe
menopausal symptoms before the age of 60 years or within 10
years after menopause
Consensus 2013: MHT

Local low dose estrogen therapy is preferred for
women whose symptoms are limited to vaginal
dryness or associated discomfort with intercourse.

Estrogen as a single systemic agent is appropriate in
women after hysterectomy but additional progestogen
is required in the presence of a uterus

The use of custom compounded bio-identical hormone
therapy is not recommended
Consensus 2013: Osteoporosis

MHT is an effective treatment for the prevention of
fracture in at risk women before age 60 years or within
10 years after menopause
Tobie De Villiers
Consensus 2013: Cardiovascular Disease

Randomised clinical trials (RCT) and observational data
as well as meta-analyses have provided strong evidence
that standard dose estrogen alone MHT decreases
coronary disease and all cause mortality in women
younger than 60 years of age and within 10 years of
menopause.

Data on estrogen plus progestogen in this population
show a similar trend but with less precision.
Roger Lobo
Consensus 2013: Cardiovascular disease

MHT does not cause an increase in coronary events in
healthy women less than 60 years of age or within 10
years of menopause.
Roger Lobo Key Data: KEEPS 2012 NAMS & DOPS 2012 BMJ
Consensus 2013: Venous thromboembolism

The risk of venous thromboembolism (VTE) and
ischemic stroke increases with oral MHT but the
absolute risk is rare below age 60 years.

Observational studies point to a lower risk with
transdermal therapy.
Genevieve Plu Bureau
Consensus 2013: Breast Cancer

The risk of breast cancer in women over 50 years
associated with MHT is a complex issue

The increased risk of breast cancer is primarily
associated with the addition of a progestogen to
estrogen therapy and related to the duration of use
Anne Gompel
Consensus 2013:Breast Cancer

The risk of breast cancer attributable to MHT is small
and the risk decreases after treatment is stopped.

There is a lack of safety data supporting the use of MHT
(estrogen therapy(ET) or estrogen progestogen therapy
(EPT)) in breast cancer survivors.
Anne Gompel
Consensus 2013: Early Menopause

In women with premature ovarian insufficiency,
systemic MHT is recommended until the average age of
the natural menopause.
Recommendations 2013: Testosterone

The primary indication for testosterone is for the
treatment of desire/arousal disorder

Several large placebo-controlled RCTs have consistently
show benefits of testosterone for for sexual
satisfaction, desire, arousal, pleasure and orgasm in..

…surgical, natural menopause, no HT and in pre
menopause
Susan Davis
Recommendations 2013: Testosterone

Other potential benefits of testosterone therapy which require
confirmation in large RCTs, include prevention of bone loss,
maintenance of muscle mass and strength, maintenance of
cognitive performance and favourable cardiovascular effects.

Androgenic side effects with testosterone therapy are dose
related and avoidable.

There is no evidence from large placebo controlled RCTs that
transdermal testosterone in appropriate doses for women
results in adverse metabolic or endometrial effects
Susan Davis
Recommendations 2013: Vaginal Atrophy

Postmenopausal women have a poor understanding of vaginal
atrophy. Vaginal atrophy is still a taboo subject, even among
mothers and their daughters

While most women say they would talk to their doctors about
the symptoms of vaginal atrophy, in reality, many wait too long
to discuss their symptoms with their doctors

It is essential that health-care attendants routinely engage in
open and sensitive discussion with postmenopausal women
about their urogenital health to ensure that symptomatic
atrophy is detected early and managed appropriately.
David Sturdee
Recommendations 2013: Vaginal Atrophy

All local estrogen preparations are effective and patient
preference will usually determine the treatment used.

Use of local estrogen in women on tamoxifen or
aromatase inhibitors needs careful counselling and
discussion with the patient and the oncology team

Estriol and testosterone preparations may be more
appropriate for such patients but studies are needed
David Sturdee
Recommendations 2013: Cognitive Aging & Alzheimer’s

For midlife women, observational evidence indicates no persisting effects of
the natural menopause on memory or other cognitive functions.

During the menopausal transition, some women experience transient
problems.

The long-term cognitive consequences of HRT initiated during the
menopausal transition or early postmenopause are unknown. There remains
an urgent need for further research in this area.

For healthy postmenopausal women, there is clinical trial evidence that
isoflavone supplements in a daily dose comparable to that consumed in
traditional Asian diets has no overall effect on cognition.
Victor Henderson
Updated IMS Recommendations 2013: What’s Next?
Updated IMS Recommendations 2013: What’s Next?
Six Action Points to Maximise Impact of Recommendations
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1)Health Departments & Regulators – Encourage change of policy
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2)The Prescribers – Expand education and training in menopause

3)Media – Engage positively highlighting favourable data

4)Pharma Industry – Reverse negative commercial/R&D decisions

5)The Menopausal Woman – Improve her access to information
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6) HRT – Clarification of differences in action/risk profile
Updated IMS Recommendations 2013
 HVALA!