Limited HRT use for osteoporosis advised

In conjunction with other European medicinal regulatory authorities, the Medicines Regulatory Unit (MRU) advised that conventional oestrogen-only and oestrogen plus progestogen (combined) HRT should no longer be considered as first choice of therapy for prevention of osteoporosis.

The MRU advised women currently using these products that there is no need for immediate action but that they should make a routine appointment with their doctor to discuss the most appropriate options available to them based on their personal medical history.

The announcement follows an extensive European-wide review of the balance of risks and benefits of HRT in response to growing concerns about the safety of HRT in long-term use. The review found that for the treatment of menopausal symptoms, HRT is beneficial in the short-term with the minimum effective dose used for the shortest duration.

However, the balance of risks and benefits of HRT when used in the long term for preventing osteoporosis suggest that it should not be the first choice of therapy.

It also concluded that HRT is of no benefit in healthy women without symptoms.

Findings published in 2003 from the notable Women's Health Initiative (WHI) Study and the UK Million Women Study, as well as previous scientific research, indicate that HRT is associated with an increase in the risk of breast cancer, endometrial cancer and ovarian cancer, which is dependent on the duration of treatment.

In addition, HRT is no longer thought to have a beneficial effect on cardiovascular disease and has been shown to increase the risk of heart attacks and venous thromboembolism (VTE or blood clots) especially in the first year and to increase the risk of stroke. The risk of most of these conditions increases with age, therefore the overall risks increase the longer HRT is taken.

For further information contact the Medicines Regulatory Unit, 198, Rue d'Argens, Gzira, tel. 2343 9000, fax 2343 9161

http://www.health.gov.mt/mru

Recommendations 'potentially harmful'

The International Menopause Society said it was profoundly concerned that the European Medicines Evaluation Agency had ignored important information when recommending that HRT should not be used as a first-line therapy for the prevention of osteoporosis in women.

The society said HRT was a most effective therapy for the prevention of osteoporosis and related fractures. Indeed, the Women's Health Initiative (WHI) had confirmed the fracture reduction at both the spine and hip. No other intervention had been shown to be so cost-effective in reducing hip and spine fractures, IMS said.

In early postmenopausal women, there was no evidence that alternative treatments were as beneficial. Individual risk/benefit considerations should be left to the woman and her doctor.

Because of the age of the population studied in the WHI, safety concerns could not be extrapolated to early postmenopausal women. The Million Women Study did not make any assessment of the risk/benefit ratio for osteoporosis and related fractures in postmenopausal women, the society said.

Therefore, it considers the recommendations to be unjustified and potentially harmful for the health of postmenopausal women.

http://www.imsociety.org/pages/news.html

Expert opinion

Mark Brincat, the head of the gynaecology department at St Luke's Hospital, explained that HRT is rarely used as first-line treatment prevention for osteoporosis per se.

"First-line treatment implies the use of a medication to hit osteoporosis only and that it is regarded as first choice treatment for that condition.

"In this case, these drugs are used when there are other multiple-associated problems pertaining to menopause," he said.

He reassured patients that the recommendations do not apply to women suffering from short-term symptoms of menopause and other menopause-related problems.

"The International Menopause Society has strong reservations about the conclusions of the review since it feels that more study needs to be carried out.

"HRT has over 60 years' history of use and is one of the most widely researched forms of therapy around and, relatively speaking, it has an excellent safety record.

"One has to emphasise that the use of HRT, just like the first- line treatment for osteoporosis, should be supervised by a specialist and be held under constant review."

Dr Brincat is now awaiting the formal reply of the society (see below) and will be commenting in more detail in due course.

Sources

Throughout Europe, Hormone Replacement Therapy (HRT) products are indicated for the treatment of menopausal symptoms, and many are also licensed for the prevention of osteoporosis.

A statement regarding this review is available via the website of the European Medicines Evaluation Agency at www.emea.eu.int.

Information is also available on the website of the Heads of European Medicines Regulatory Agency, which can be found at http://heads.medagencies.org.