Don't use HRT as first choice for preventing osteoporosis, say UK regulators

[Guest guest]

Rheumawire

Dec 4, 2003

Don't use HRT as first choice for preventing osteoporosis, say UK

regulators

London, UK - Hormone replacement therapy is no longer recommended as a

first choice of treatment for the prevention of osteoporosis, says the

UK Medicines and Healthcare products Regulatory Agency (MHRA). This

echoes advice already issued in the US.

This advice, issued in a letter sent on December 3, 2003 to physicians

and healthcare professionals [1], follows a European-wide review of the

balance of risks and benefits of HRT in response to growing concerns

about the safety of this therapy in long-term use, most notably after

publication of the US Women's Health Initiative (WHI) study [2] and the

UK Million Women Study [3]. The review has been adopted by the European

Committee for Proprietary Medicinal Products (CPMP) and endorsed by

regulatory authorities throughout Europe. In the UK, this involved the

Committee on Safety of Medicines (CSM) expert working group on HRT.

The conclusions of the review are as follows:

The risk/benefit of HRT is favorable for the treatment of

menopausal symptoms, but the minimum effective dose should be used for

the shortest duration.

The risk/benefit of HRT is unfavorable for the prevention of

osteoporosis as a first-line use.

In healthy women without symptoms, the risk/benefit of HRT is

generally unfavorable.

The letter to physicians also summarizes the current risk/benefit

balance of HRT, with a long paragraph listing the risks and a short

sentence summarizing the benefits, as follows.

The review found " good evidence " that use of HRT increases the risk of

breast cancer, endometrial cancer, and ovarian cancer in a

duration-dependent manner. " There is no evidence for a beneficial effect

of HRT on cardiovascular disease - in fact, HRT has been shown to

increase the risk of myocardial infarction and venous thromboembolism,

especially in the first year of use, and to increase the risk of

ischemic stroke. The risk of most of these conditions increases with

age, therefore increasing the overall risks the longer HRT is taken, "

the letter says. In addition, HRT has no beneficial effect on cognitive

function and may increase the risk of dementia in the elderly and has

shown no beneficial effects on quality of life in women who do not have

menopausal symptoms.

Benefits of HRT include effective relief of menopausal symptoms,

prevention of osteoporosis and fractures in the long term, and a

reduction in the risk of colorectal cancer.

However, despite its effectiveness in preventing osteoporosis, the

review concluded that for long-term use, the balance of risks and

benefits is such that HRT should no longer be considered as a first-line

therapy for this use. The letter tells physicians that it remains an

option for women over 50 and at increased risk of fractures who cannot

take other osteoporosis-prevention therapies, either because of

contraindications or a lack of response or because they cannot tolerate

them. However, in these cases, the risks and benefits should be

carefully assessed for each individual, it adds.

" The latest recommendation should come as no surprise to most clinicians

in the UK, " says Prof Gordon Duff, chair of the CSM. The CSM has already

written to physicians on HRT once this year, in August 2003, following

the publication of the Million Women Study, which showed a doubling in

the risk of breast cancer after 10 years on HRT. This latest letter

provides further advice and is based on a more detailed review of the

recent studies, says Duff.

This new advice does not require any urgent change in treatment, but

women who are currently on HRT as long-term prophylaxis should have

their treatment reviewed at the next routine appointment, he adds.

This curb on HRT for use in the prevention of osteoporosis echoes advice

issued in the US some time ago: the US Preventive Services Task Force

said in October 2002 that HRT should not be used for preventing chronic

conditions, including osteoporosis.

It also ties in with recommendations made recently in the UK in a

consensus statement on HRT issued recently by the Royal College of

Physicians of Edinburgh [4]. However, while this consensus statement

also says that HRT cannot be recommended as first line therapy for the

prevention and treatment of osteoporosis, it emphasizes that the

decision to take HRT and the balance of risks and benefits should be

considered individually for each woman.

The difference between this and the current advice put out by the UK

regulators has caused one of the experts involved, Professor

Purdie (director of the Edinburgh Osteoporosis Centre) to resign from

the CSM expert working group on HRT. He disagrees with " a blanket ban on

HRT use for osteoporosis " and believes the CSM has rushed its judgment,

as there is other research producing contradictory evidence on the

threat to women's health.

Other experts have voiced concerns that banning HRT use for osteoporosis

could lead to an epidemic of fractures in elderly women. Professor

son, chairman of the independent charity Women's Health Concern,

has written to the CSM asking it to withdraw the advice it has just

issued.

Zosia Chustecka

Sources

1. Duff G. Further advice on safety of HRT: risk:benefit unfavourable

for first line use in prevention of osteoporosis. December 3, 2003.

Available at:

http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/safetymessages/hrtepinet\

_31203.pdf.

2. Rossouw JE, GL, Prentice RL, et al. Risks and benefits of

estrogen plus progestin in healthy postmenopausal women: principal

results from the Women's Health Initiative randomized controlled trial.

JAMA 2002 Jul 17; 288(3):321-333.

3. Beral V. Breast cancer and hormone-replacement therapy in the Million

Women Study. Lancet 2003 Aug 9; 362(9382):419-427.

4. Royal College of Physicians of Edinburgh. Consensus Conference of

Hormone Replacement Therapy October 2003 Final Consensus Statement.

October 2003. Available at:

http://www.rcpe.ac.uk/esd/consensus/hrt_03.html.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org