Newsletter 67 April 2006
NEWSLETTER / 67 / April 2006letter from the president
Dear Members
IMS on the move
The first year after any World Congress is usually ‘quiet’. But this time it is not like that. The momentum continues. The IMS had another very high-standard World Congress in Buenos Aires, attended by more than 3700 participants. We congratulate the organizers and the local Congress organizer for all their efforts. Our colleague, Santiago Palacios, is already working hard on the next World Congress, scheduled in Madrid, May 19–23, 2008. The 6th and 7th IMS Workshops are on their way too: the 6th will have the title ‘Menopause and aging, quality of life and sexuality’ and will take place in Pisa, Italy, December 1–4, 2006. The 7th Workshop will review the new information on menopause management that has accumulated since the Vienna Workshop (December 2003). Delegates from all menopause societies will be invited to attend the 7th Workshop, where a revised version of the IMS Position Statement on hormone treatment will be formulated.
As a result of the independent views expressed by the IMS since the WHI study, and the global appreciation of the voice and views of the IMS, many national menopause societies have expressed their wish to have IMS scientific and educational activities as part of their local events. The book Health Plan for the Adult Woman has been distributed all over the world and we look forward to its translation from English into other major languages. Recently, another successful Adult Women’s Health & Medicine Workshop took place in Istanbul, chaired and supervised by Morris Notelovitz. However, following discussions in the last Board meeting on that project (Florence, March 2006), it was decided that the IMS will not be able to continue the implementation of that project in its current format. As a result, Dr Notelovitz decided to resign from his position as Director of Development of the IMS so that he can continue to develop his project from a neutral position. The IMS Board will continue its internal discussions to consider possible ways of future collaboration on this project.
Since the Buenos Aires Congress, and the change in the Articles of Association in regard to the affiliation of national menopause societies to the IMS, we have received applications from national societies that wish to become new members of our Council of Affiliated Menopause Societies (CAMS). The Sociedad Dominicana de Menopausia (SODOME) and the South African Menopause Society (SAMS) have
been accepted as CAMS members, and the Israel Menopause Society has renewed its membership. Applications are being processed for affiliation to the IMS and membership of CAMS from at least eight other national societies. These are in addition to the 11 present CAMS members. We look forward to even more societies joining us in the near future. One of the immediate projects of CAMS is to provide material for the next World Menopause Day (October 18, 2006). A subcommittee, headed by Alice MacLennan, is currently discussing ways of IMS involvement and assistance in commemorating that day.
Last, but not least, our journal Climacteric is now published in six issues per year. The journal has received a very good impact factor (1.932), and the Editors extend an invitation to our readers to submit articles on all aspects of adult women’s health.
Amos Pines, President
Formation of the Rapid Response Team
The IMS Board has appointed a subcommittee of its Officers, Professor Amos Pines, Dr David Sturdee and Professor Martin Birkhäuser, to serve as a Rapid Response Team to react speedily to the publication of reports on new studies on menopause and related topics. Their comments, on behalf of the IMS, on the published studies are issued in the form of press releases which are e-mailed to the media and national societies and posted on the IMS website (www.imsociety.org). The Rapid Response Team has swung into action twice since its formation, once in response to the publications from the Women’s Health Initiative and the Nurses’ Health Study on hormone therapy and coronary heart disease in February 2006 and once in response to the Women’s Health Initiative publication on estrogen-only therapy and breast cancer in April 2006. These two Press Statements are reproduced below.
More data on hormone therapy and coronary heart disease:
Comments on recent publications from the WHI and Nurses’ Health Study
Almost 2 years after the first publication of the results of the estrogen-alone arm of the WHI study1, a more detailed analysis of the coronary data has been published2. The aim of the study was to investigate the possibility that conjugated estrogen at a standard dose is cardioprotective. The mean age for the participants was 63.6 years, with 70% of them above the age of 60 years. Although the exact numbers of adverse coronary events in the current paper are a little different from those published initially, there is no change in basic interpretation. There were slightly more coronary events, statistically insignificant, only in women who were older than 70 years at the beginning of the study, and in those who had been menopausal for at least 20 years. These formed a unique group of very late starters of hormone therapy. However, in the younger women, there were less coronary heart disease (CHD) events in the hormone users compared to women in the placebo arm, although these data were also not statistically significant due to a relatively small sample size and the low incidence of CHD in this age group anyway. In the Discussion section of the article, the authors say "the challenges of designing an appropriate trial to address the issues of safety and efficacy in perimenopausal and early menopausal women are considerable, since the coronary event rate in the 50- to 54-year-old women in the estrogen-alone trial was 0.21% per year." This should be the main message of the new article: the WHI study was not designed, and therefore was not powered, to investigate the consequences of hormone therapy (HT) in women below 60 years of age. Therefore, any attempt to present the results of the study as indicating that HT may inflict damage to the heart in general – a message that was accepted by many medical societies and regulatory authorities – is simply wrong and must be amended. The estrogen plus progestogen arm of the WHI and the estrogen-alone arm actually showed that HT does not increase the risk of coronary heart disease in the peri- and early menopause, and may even carry beneficial effects. Additional evidence has just come from the most recent analysis of the Nurses’ Health Study3, which with larger numbers was able to demonstrate that for women starting HT near the menopause there was a significantly reduced risk of CHD (RR = 0.66, 95% CI 0.54–0.80 for estrogen alone; RR = 0.72, 95% CI 0.56–0.92 for estrogen with progestogen). Also, in a subgroup of women demographically similar to those in the WHI, there was no significant relation between HT and CHD among women who initiated therapy at least 10 years after the menopause (RR = 0.87, 95% CI 0.69–1.10 for estrogen alone; RR = 0.90, 95% CI 0.62–1.29 for estrogen with progestogen).
Initiating hormone therapy in older women with established atherosclerosis is not likely to produce any cardiac or neuroprotection and therefore should not be recommended for those indications; but, for the younger age groups, these recent results of the WHI and Nurses’ Health Study are in line with the "window of opportunity" theory, which is based on the assumption that estrogen is cardioprotective when the arterial endothelium is still intact.
February 13, 2006
References
1. The Women’ Health Initiative Steering Committee. Effects of conjugated estrogen on postmenopausal women with hysterectomy: the Women’ Health Initiative randomized controlled trial. JAMA 2004;291:1701–12
2. Hsia J, Langer RD, Manson JE, et al. Conjugated equine estrogens and coronary heart disease. The Women’s Health Initiative. Arch Intern Med 2006;166:357–65
3. Grodstein F, Manson JE, Stampfer MJ. Hormone therapy and coronary heart disease: the role of time since menopause and age at hormone initiation. J Women’s Health 2006;15:35–44
WHI and breast cancer
Shortly after reports from the Women’s Health Initiative (WHI) and Nurses’ Health Study indicating that there is after all a window of opportunity to provide a reduction in the risk of coronary heart disease by early initiation of hormone therapy (HT), another sub-analysis of the unopposed estrogen arm of the WHI study has modified further the original alarmist messages. The WHI study investigators have released the details of breast cancer and mammography screening data for 10,739 women with prior hysterectomy, who received either estrogen treatment (ET) or placebo for a mean follow-up of 7.1 years1. Thirty per cent of the subjects were aged 50–59 years and 24% were 70–79 years old at study entry; over half had never taken ET prior to the study. The initial report on the estrogen-only arm2 concluded that there was a non-significant (p < 0.06) decreased risk for breast cancer in ET users, but subgroup analyses now reveal that first lifetime exposure to ET at the trial was associated with significantly fewer breast cancer cases as compared to placebo (hazard ratio (HR), 0.76; 95% confidence interval (CI), 0.58–0.99; p < 0.05); women who took ET had significantly fewer breast cancers with localized disease and significantly fewer breast cancers with ductal carcinoma (HR, 0.71; 95% CI, 0.52–0.99). Furthermore, women who were adherent to study medications had significantly fewer invasive breast cancers (HR, 0.67; 95% CI, 0.47–0.97). Absence of first-degree relatives with breast cancer, or a personal history of benign breast disease were also associated with significantly fewer breast cancers in the ET users compared with the control group. On the other hand, mammographic breast density increased in ET users, with 9.2% having abnormalities in the ET group vs. 5.5% in the placebo group at 1 year (p < 0.001) and a cumulative percentage of 36.2% and 28.1%, respectively, leading to more breast biopsies.
Overall, this study carries the very clear message that ET for postmenopausal women does not increase the risk of breast cancer and, in certain subgroups of hormone users, may even be protective. Once again, it is apparent that the alarmist reports that spread world-wide when the first results of the WHI study were published in 2002 were unjustified based on the more recent further analyses, particularly in peri- and early postmenopausal women. It is very regrettable that, as a result, so many women and their medical advisors have lost confidence in the merits of HT, which will now be difficult to redress. Nevertheless, they should be reassured that, once recommended for an approved indication, with correct timing and after proper individual considerations, ET is an effective therapy which may even have some extra benefits (cardiac, metabolic, breast cancer) in certain subgroups of women, for the period of time investigated in the WHI study. The risks of ET have been overstated and now are mainly those of venous and arterial thromboembolism. Lower or ultra-low dosages of HT may have an even better safety profile.
April 11, 2006
References
1. Stefanic ML, Anderson GL, Margolis KL, et al. Effects of conjugated equine estrogens on breast cancer and mammography screening in postmenopausal women with hysterectomy. JAMA 2006;295:1647–57
2. The Women’s Health Initiative Steering Committee. Effects of conjugated estrogen on postmenopausal women with hysterectomy: the Women’s Health Initiative randomized controlled trial. JAMA 2004;291:1701–12
WORLD MENOPAUSE DAY, 2005
The first day of the World Congress in Buenos Aires was very appropriately chosen to coincide with World Menopause Day on October 18, 2005. A few reports have been received about the celebration of the Day from national societies, two of which are given below.
The Belgian Menopause Society
The Society had two important initiatives for menopausal women in 2005: a large press conference was held at the national level attended by representatives of all the lay press to give more information about hormone therapy at the menopause. Very good and informative responses were received from the Press. The Belgian Society also devoted much time to reviewing the text of an extended leaflet concerning the menopause, which has just been published and is orientated towards menopausal women. However, there was no opportunity for specific activities on World Menopause Day, as it coincided with the World Congress in Buenos Aires, which the whole Board of the Society attended.
The Serbian Menopause and Andropause Society
The Society traditionally celebrated World Menopause Day in many ways, for a period of almost 1 month. Liaison with the media continued during all this period and many lectures and talks on the menopause were given – by Vujovic Svetlana on sexuality in the menopause, by Durbaba Mirjana on HRT after endometrial carcinoma, by Ilic-Stojanovic Olivera on the latest news about osteoporosis, by Beljic Teodora on quality of life in the menopause, and by Drezgic Milka on the EMAS statements.
Please send information of how your Society celebrated the Day to the Executive Director so that it can be published in a future edition of the Newsletter.
The Corporate Liaison Board
We are pleased to announce that six pharmaceutical companies have become Corporate Members of the IMS: Merck Theramex, Novo Nordisk FemCare AG, Organon NV, Schering AG, Solvay Pharmaceuticals GmBH, and Wyeth Pharmaceuticals. We are very grateful for the continued support from these companies of the Society’s activities.