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Study finds dementia risk for HRT

Published on 24/06/04 at 04:35pm

A new study has found that both oestrogen-only and oestrogen plus progestogen hormone replacement therapies may increase the risk of dementia in women over the age of 65.

The findings contradict previous trial data, which had suggested that HRT could delay or prevent the onset of dementia in women, showing instead a small increase in risk in the 3,000 65 to 79-year-old women taking Wyeth's oestrogen only HRT drug Premarin as part of the study.

An earlier study of 4,500  women taking oestrogen plus progestogen (Wyeth's Prempro) had also showed an increased risk of dementia and mild cognitive impairment (MCI). Results from the two groups had to be combined in order for The Women's Health Initiative Memory Study (WHIMS) to reach statistical significance. None of the women had any signs of dementia when the studies began in 1995.

The findings are further bad news for HRT manufacturers already hit by links to increased cancer and heart disease, which saw market leader Wyeth's global sales drop by a third in 2003.

Writing in the Journal of the American Medical Association, the authors of WHIMS concluded the use of hormone therapy to prevent dementia or MCI was not to be recommended.

Wyeth said it would work with the FDA to further update product labelling, having already changed it as a result of the oestrogen plus progestogen study.

But the company questioned whether the data should apply to newly menopausal women; a group not included in WHIMS. Gary Stiles, executive VP and chief medical officer at Wyeth Pharmaceuticals, said: "The women in the WHIMS trial were on average nearly 20 years older than the typical newly menopausal woman. In addition, it is well established that risk of dementia increases dramatically with age, with or without hormone use."

WHIMS was a sub-study within the Women's Health Initiative (WHI) study, the oestrogen plus progestogen part of which was halted in July 2002 when it found that the risks of developing breast cancer, strokes and cardiovascular disease for women taking the combined HRT treatments outweighed the benefits.

The UK Million Women Study reached similar conclusions in August 2003 and the two studies have seriously undermined confidence in the drug, with global sales of Wyeth's Prempro franchise falling 32% in 2003, figures mirrored in the UK where one in three of the 1.7 million women taking the drug 18 months ago have now stopped.

The WHI oestrogen-alone trial was stopped by the US National Institutes of Health in February 2004, because they considered it carried an unacceptable risk of stroke for healthy women with no benefit for coronary heart disease.

Earlier this year a Wyeth-commissioned survey by NOP World of UK women taking HRT showed that most have not been deterred by studies linking the drug to a higher risk of cancer, while others who had stopped are now taking it again.

Related articles:

Women returning to HRT 

Friday , May 14, 2004

Expert resigns over HRT warning 

Monday , December 08, 2003




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