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New research questions official warnings on HRT heart dangers

New findings on hormone replacement therapy have cast doubt on previous studies that helped prompt a Government warning about cardiovascular risk.

Researchers believe that data from two US trials more accurately reflects the population of women taking HRT than that from the Women's Health Initiative study which – taken with other findings – led to a warning from the Medicines and Healthcare products Regulatory Agency in December.

The new data, published in a commentary in Archives of Internal Medicine this month, show that of 4,065 women taking conjugated equine oestrogen HRT, none suffered an MI and there were only seven adverse vascular events.

Commenting on the findings, Professor Rogerio Lobo, professor of obstetrics and gynaecology at New York Presbytarian Hospital, said the research undertaken by Wyeth Pharmaceuticals, a manufacturer of HRT products, was more relevant than the WHI because it followed up 1.5 times as many healthy women aged 50-60.

Professor Lobo concluded that the benefits outweighed the risks from HRT in young postmenopausal and symptomatic menopausal women.

But GPs and experts are pessimistic about changing public attitudes.

Dr David Sturdee, from the Committee on Safety of Medicines HRT working group, said the findings were to be cautiously welcomed. 'It's too short a time and too small a number to draw full conclusions from – but it's reassuring'.

Dr Sturdee, consultant in obstetrics and gynaecology at Solihull Hospital, West Midlands said: 'There is considerable evidence of benefit if started early enough, but it's difficult to judge'.

Commenting on the fact that the data was extracted from pharmaceutical company research, Dr Sturdee said: 'There's no way we can do research without the support of the pharmaceutical industry. The problem is that the WHI data was not applicable to the population in this country'.

Dr Sarah Jarvis, RCGP spokesperson on women's health, said: 'This won't go a long way to redeem HRT – the evidence on breast cancer is too damning.'

It would have to have a huge benefit for CVD to out-weight the breast cancer risk'.

– the WHI and HERS studies both had tremendous input, but it's a two-edged sword

HRT in the headlines

2002

July

lWomen's Health Initiative study aborted due to significantly increased rates of breast cancer

October

lWISDOM trial halted over difficulties in recruitment

2003

May

lWHI analysis finds a 31 per cent increase in risk of stroke for women on oestrogen plus progestogen HRT

June

lHRT manufacturers ordered to update product information to reflect increased stroke risk

August

lUK Million Women Study reveals that HRT could double breast cancer risk

lCSM tries to allay fears and urges GPs not to 'necessitate any urgent changes' to treatment

lData from the WHI study shows no cardioprotective effect and an 81 per cent increase in risk of CHD in the first year of treatment

October

lRoyal College of Physicians in Edinburgh states that the risks of HRT outweigh bone-protection benefits

lFurther WHI results show a 58 per cent increase in risk of ovarian cancer from oestrogen-progestogen HRT

December

lMHRA recommends that 'the lowest effective dose should be used for the shortest duration' and that HRT should not be used first line for prevention of osteoporosis.

lScandinavian HABITS trial of HRT in women recovering from breast cancer stopped

2004

January

lUK trial of HRT in women recovering from breast cancer 'frozen' in recruitment phase – women on the trial have been informed of the latest results and given choice of whether to continue treatment

February

lWHI memory study finds increased risk of dementia from oestrogen-progestogen HRT – MHRA says advice will be updated

March

lUS trials give backing to HRT on short-term CVD risk

By Rob Finch

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