EMAS 2003 Bucharest 24 – 28 May 2003

Welcoming over 1,000 delegates to the 6th European Congress on the Menopause, EMAS chairman Professor Goran Samsioe said he hoped the congress would create a platform of understanding that could provide constructive suggestions to the many health-related problems inside and outside of Europe.

Samsioe also acknowledged that in the aftermath of the WHI, HERS and other randomized trials, these were "complex, challenging and controversial" times. He said that although such trials had further substantiated the benefits of hormone therapy (HT) in relation to colorectal cancer, fractures and the increased risk of thromboembolism, other issues in relation to cardiovascular disease and breast cancer remained difficult to comprehend. He described these as "burning issues" that would be discussed and debated throughout the meeting.

Referring to the many guidelines that had been issued about the use of HT since the publication of the WHI study findings in 2002, Samsioe said that most of these essentially called for caution in relation to its use in nonsymptomatic women.

He noted that the mean age of women continued to increase, particularly in developed countries: "This poses a threat to our limited health care resources. It is therefore of utmost importance to identify and promote a healthy lifestyle, preferably commencing at a young age. EMAS considers this as one pivotal goal. The single most important factor in this respect seems to be education. This 6th congress organized by EMAS aims at highlighting these issues and to contribute to overall health awareness in both women and men."

Increase in breast density is unwanted side effect of therapy
An increase in breast density should be considered as an "unwanted side effect of HRT," say radiologists. Dr. Gunilla Svane of the Department of Diagnostic Radiology, Karolinksa Hospital, Stockholm, Sweden warned delegates that increased density could not only reduce sensitivity of mammography, but may in itself increase breast cancer risk in older women.

Svane pointed out that both endogenous and exogenous hormones influence breast density adding that the effect was highly variable between different hormonal preparations. She presented results from studies showing that continuous combined HRT increases breast density in around 50 percent of women, cyclic combined HRT in 13 percent, estrogen alone in 18 percent, and tibolone in 2-6 percent.

She added: "It is very important to find cancers as early as possible. A dense mammogram pattern is not one that a [radiologist] wants to look at. It is not impossible to read but it is easier to miss small cancers, particularly for the less experienced. An increase in breast density should be considered as an unwanted side effect of HRT."

How women responded to HRT media scares
Despite the media coverage around the publication of the WHI trial, nearly three-quarters of women taking conjugated equine estrogens 0.625 mg and medroxyprogesterone 5.0 mg (Premique; Wyeth) elected to continue with HRT, according to a survey of women at one general practice in the UK.

Investigator Dr. Sarah Gray (Lower Lemon Street Surgery, Truro, UK) commented: "The results indicate that if treatment is individualized in the first place, and if a woman understands the rationale for taking treatment, she is less likely to be influenced by population studies that are not appropriate to her situation."

Gray evaluated the response to the media publicity in all women at her surgery who had been prescribed Premique in the six months prior to July 2002. Premique was chosen because it is the HRT preparation in the UK with the closest composition to the regimen used in the WHI trial. Women were sent a questionnaire to determine their response 3 months after publication of the trial. A total of 50 women responded (94 percent of those who were contacted). Nearly all—93.6 percent—confirmed that they were aware of the media coverage.

Overall, 57 percent of the women elected to continue with the same HRT preparation, and 16 percent switched to a different preparation. Only 16 percent of women discontinued all forms of prescribable HRT. The remaining women were undecided at the time of the survey.

Gray said that just under half of the women surveyed made their decision regarding their HRT without consulting a health care professional. She also reported that of the women who had discontinued treatment, "a significant proportion" had resumed exogenous use subsequently.

Gynecologists remain pivotal in the management of osteoporosis
The role of the gynecologist in the prevention and treatment of osteoporosis remains pivotal, said Professor Claus Christiansen of the Center for Clinical and Basic Research, in Ballerup, Denmark, during a symposium organized by the Scandinavian Menopause Society.

Explaining his reasoning, he told delegates: "Firstly, we see all patients at risk, which in itself is very important. But an even more important reason is to ensure that the people who understand the WHI results—the gynecologists—explain them to women." He highlighted a number of concerns in relation to the study and its design, adding that it used medroxyprogesterone: the "worst progestogen in the world."

Christiansen also questioned whether the results could be extrapolated to other populations and other hormone therapy preparations. Focussing on the study population included, he said: "This was a population of women of whom 69 percent were overweight and 36 percent were hypertensive." He also questioned whether the WHI trial could really be described as a primary prevention trial, pointing out that only 10 percent of the subjects were between 50 and 54 years; and 20 percent between 55 and 59 years. He commented: "I would not describe this as a primary prevention trial. Cardiologists may refer to any trial that precedes an actual clinical event as primary prevention, but the reality is that atherosclerosis is a process that take place over many, many years."

Interestingly, although a survey investigating prescribing practices of Norwegian gynecologists showed that they had become "less liberal" since WHI, it also found that in both this, and a former survey in 1997, more than 70 percent of female gynecologists and partners of male gynecologists of actual age used HRT themselves.

Survey presenter, Dr. Mette Moen (St Olav's University Hospital, Trondheim, Norway) said overall usage of hormone therapy among the general population had dropped by 10 per cent in 2002, adding that all postmenopausal hormone preparations had shown decreases in sales with the exception of the products Livial (tibolone; Organon) and Activelle (17beta-estradiol/NETA; Novo Nordisk).

WHI investigator warns of more bad news
Further analysis of the WHI findings seems likely to suggest that the incidence of breast cancer associated with continuous combined conjugated equine estrogens (CEE) 0.625 mg, and medroxyprogesterone acetate (MPA) 2.5 mg, may have been underestimated in the first years of treatment.

Further analysis of the WHI findings seems likely to suggest that the incidence of breast cancer associated with continuous combined conjugated equine estrogens (CEE) 0.625 mg, and medroxyprogesterone acetate (MPA) 2.5 mg, may have been underestimated in the first years of treatment.

Rossouw also said that delegates could expect to see, soon after the congress, full papers published on the cognitive findings and dementia. Although he did not comment on these findings directly, sources said that they showed a significant increase in dementia in the active treatment group compared to placebo. Further analysis of the coronary heart disease and fracture data are also scheduled for publication in June or July, he said.

During his lecture, Rossouw defended the results against claims that adherence or detection bias may have elevated the results. In relation to detection bias, he acknowledged that the study was unblinded to some extent in the first year of the trial, as a result of bleeding and spotting which affected about 50 percent of the women on active treatment [CEE plus MPA]. However he commented: "There is a lower risk of breast cancer in the active group compared to placebo when the bleeding occurs. Therefore [unblinding] was not associated with an increase in breast cancer. This argument is untenable for breast cancer in particular. In fact we have underdiagnosis in this year because of the mammographic density issue. Therefore, the early decreased risk of breast cancer rules out detection bias."

He also argued that the WHI was a true primary prevention study "by cardiovascular definitions." He said that the only distinction between the population taking part in the trial and the general population was that only 6 percent of women taking part were currently using hormone therapy and only 20 percent had ever used therapies previously. He added "This is very low and compares with 60 percent in the general population who had used hormone therapy previously."

Finally, he insisted that although the WHI results did not necessarily apply to established alternatives or other combination therapies, it would be "unwise to assume the safety of other regimens until they have been tested in equally rigorous methods—that's tough but intellectually right."

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