четверг, 27 октября 2011 г.

Breast Cancer Guidelines Confirm Central Role Of 'Switch Strategy'

Guidelines from the 2007 St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer, published in the Annals of Oncology (annonc.oxfordjournals), confirm the value of switching from tamoxifen to an aromatase inhibitor (AI), such as exemestane, for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.[i]


Approximately 360,000 women in Europe are diagnosed with breast cancer each year. With up to two thirds of breast cancers requiring the hormone estrogen to grow, medicines such as exemestane are crucial for women affected by this disease, because they work by interfering with the supply of estrogen to the cancer and preventing it from growing. Switching from tamoxifen to exemestane has the potential to save lives among women diagnosed with hormone receptor positive early breast cancer.ii



The St Gallen guidelines are the consensus of breast cancer experts from around the world, who have assessed and recommended optimal treatment strategies for this disease, which affects the lives of thousands of women and their families.



"Guidelines are essential for physicians, as they ensure we are up to date with the latest recommendations for patient care," said Professor Charles Coombes, Head, Department of Oncology, Imperial College, London. "The St Gallen guidelines have confirmed the value of starting treatment with tamoxifen then switching to an aromatase inhibitor, enabling women to benefit from the advantages of both medicines. Exemestane, one of the aromatase inhibitors, has been proven to offer an overall survival benefit in the switch setting, and these latest guidelines confirm to physicians that we should continue to use it in this way to offer patients the very best care."



In hormone receptor positive breast cancer, the St Gallen panel expressed a clear preference for switching patients from tamoxifen to an AI, such as exemestane, which means more patients can benefit from exemestane's proven results in extending lives.



The guidelines follow publication of the Intergroup Exemestane Study (IES) in The Lancet earlier this year, which showed an overall survival benefit for women who switched from tamoxifen to exemestane, the only AI to have demonstrated overall survival in a single, double-blind trial.[ii] The IES, which randomized 4,724 patients across 37 countries, demonstrated that postmenopausal women[1] with early breast cancer, who switched to exemestane after 2-3 years of tamoxifen, experienced a 17% reduction in the risk of death compared to those who stayed on tamoxifen for the full 5 years of therapy.ii Exemestane was the first AI to receive approval in the switch setting.



Professor Coombes, who was lead investigator of the IES, continued, "The IES results, and now the St Gallen guidelines, confirm that switching to exemestane rather than staying on tamoxifen gives women an improved chance of survival. Furthermore, switching to exemestane has also been proven to have no significant adverse effect on quality of life compared to tamoxifen alone,[iii] making it a good all-round option for women."
















About exemestane[iv]


Exemestane is currently indicated for the adjuvant treatment of postmenopausal women with estrogen receptor positive invasive early breast cancer who have received 2-3 years of tamoxifen and are switched to exemestane for the completion of a total of 5 consecutive years of adjuvant hormonal therapy. Exemestane is also indicated for the treatment of advanced breast cancer in women with natural or induced postmenopausal states, whose disease has progressed following anti-estrogen therapy.



Exemestane should not be used in women who are premenopausal, are nursing or pregnant, have a known hypersensitivity to the drug, or are taking estrogen-containing agents. Exemestane should be used cautiously with drugs that are metabolised via CYP3A4 and have a narrow therapeutic window.


Exemestane was generally well tolerated across all clinical studies; undesirable effects were usually mild to moderate. The withdrawal rate due to adverse events in studies was 6.3% in patients with early breast cancer receiving adjuvant treatment with exemestane following initial adjuvant tamoxifen therapy and 2.8% in the overall patient population with advanced breast cancer receiving the standard dose of 25 mg. In patients with early breast cancer the most commonly reported adverse reactions were hot flushes (22%), arthralgia (17%) and fatigue (17%). In patients with advanced breast cancer the most commonly reported adverse reactions were hot flushes (14%) and nausea (12%). Most adverse reactions can be attributed to the normal pharmacological consequences of estrogen deprivation (e.g. hot flushes).


pfizeroncology


[i] Women with estrogen receptor positive or unknown status of disease.


[ii] Coombes RC et al. Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial. Lancet. 2007 Feb 17;369(9561):559-70


[iii] Fallowfield LJ et al. Quality of Life in the Intergroup Exemestane Study (IES) - a Randomized Trial of Exemestane versus Continued Tamoxifen after 2-3 years of Tamoxifen in Postmenopausal Women with Primary Breast Cancer. Journal of Clinical Oncology. Vol 24, No 6, Feb 20, 2006


[iv]Exemestane prescribing information (Summary of Product Characteristics dated 24 August 2005)

четверг, 20 октября 2011 г.

FDA To Conduct Surveys About STI, Pregnancy Prevention Language On Condom Packaging

FDA plans to survey 1,200 people in shopping malls nationwide on their understanding of a condom's efficacy in preventing sexually transmitted infections, including HIV, and unplanned pregnancies based on current labeling, the agency said on Thursday in a notice on its Web site, Bloomberg/Arizona Republic reports. According to the notice, survey responses will be "considered in FDA's condom labeling recommendations to provide important risk/benefit and use information associated with condoms in easily understood language."

Congress in 2000 directed FDA to "determine whether [condom] labels are medically accurate regarding the overall effectiveness or lack of effectiveness," Bloomberg/Republic reports. The agency in a 2005 review found that many people who use condoms are unsure how often the contraceptive fails to prevent pregnancy with typical use or that they provide less protection from certain STIs, such as genital herpes, Bloomberg/Republic reports. FDA in 2005 also proposed that labels on condom boxes and wrappers show data on unplanned pregnancies and varying levels of protection against STIs (Bloomberg/Arizona Republic, 6/14).

In addition, the agency in November 2005 published a draft guidance document for latex condom manufacturers. The document included a proposal that labels be required to state that condoms "greatly reduce but do not eliminate" the risk of pregnancy and HIV infection when used correctly during sexual intercourse but provide "less protection" from other STIs, including human papillomavirus and herpes, because those STIs can be spread through skin-to-skin contact. However, the guidance also says that "using latex condoms every time you have sex may still give you some benefits against these" STIs (Kaiser Daily HIV/AIDS Report, 6/22/06). FDA also recommended that condoms with spermicidal lubricant nonoxynol-9 include a warning that the lubricant can cause irritation that raises the risk of HIV transmission.

Any label changes would apply only to male condoms made with natural rubber latex, which account for almost 98% of sales in the U.S., FDA said. Guidelines for products made with lambskin or synthetic materials will be issued at a later date, the agency said (Bloomberg/Arizona Republic, 6/14).

"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

четверг, 13 октября 2011 г.

LA Times Examines Health Risks of, Alternatives to Hysterectomy

The LA Times on Monday examined the health risks of undergoing a hysterectomy and how many women's health experts increasingly are questioning the need for many of the 615,000 procedures that are performed annually in the U.S. The rate of hysterectomies performed in the U.S. decreased from 45.7 per 10,000 women in 2002 to 41.7 in 2003, according to the American College of Obstetricians and Gynecologists. More than 90% of hysterectomies performed in the U.S. are conducted because a woman has fibroids, endometriosis, abnormal bleeding, or a prolapsed or fallen uterus -- all conditions for which less-invasive surgery or nonsurgical treatments are available (Foreman, Los Angeles Times, 8/15). According to a study conducted by William Parker, a clinical professor at the University of California-Los Angeles David Geffen School of Medicine, and colleagues and published in the Aug. 1 issue of Obstetrics & Gynecology, more than half of the women who undergo hysterectomy each year in the U.S. also have their ovaries removed in order to eliminate their risk of developing ovarian cancer. However, the prophylactic removal of the ovaries -- which continue to produce small amounts of hormones even after a woman experiences menopause -- does not provide a health benefit, regardless of a woman's age at surgery, the study found. In addition, women who have their ovaries removed before age 65 might be at increased risk of heart disease because of a lack of estrogen in the body, Parker said. Overall, the younger a woman is when she has her ovaries removed, the more substantial the negative impact on her health and her chances of living to age 80 (Kaiser Daily Reproductive Health Report, 8/2). Some health advocates suggest that women seek alternative treatments to hysterectomy, such as myomectomy, the surgical removal of fibroids without removing the uterus; uterine artery embolization, which involves inserting small plastic pellets into blood vessels to cut off blood supply; or laparoscopic surgery, in which surgery to remove ovarian tumors is performed through a keyhole incision (Foreman, Los Angeles Times, 8/15).


Los Angeles Times


"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

четверг, 6 октября 2011 г.

More About Sex And Relationships Needed At Gynaecological Visits

Visits to a gynaecologist or midwife are generally associated with different tests and/or prescriptions for contraceptives, but could offer so much more. Women, doctors and midwives are agreed that gynaecological visits presents great opportunities for dialogue about sexual health, reveals a thesis from the Sahlgrenska Academy at the University of Gothenburg, Sweden.


Many young women see sex as a problem, the thesis shows. Almost 500 women aged 23-29 answered questions about their sex lives, their relationships and how they view gynaecological visits. One in five had a reduced sex drive and found it difficult to be satisfied together with their partner. Just as many said that they had been taken advantage of sexually or experienced other forms of sexual abuse.


"Many young women actually know little about their sexuality," says midwife Eva Wendt, who wrote the thesis. "If you feel confident about your body and understand how it works, sex is much easier and much more fun."


Nine out of ten young women think it natural to be asked questions about sexuality at a visit to a gynaecologist or midwife, the survey shows. Seven out of ten think it natural to be asked questions about sexual abuse.


"Women trust their doctor and their midwife - they are independent parties who have both expertise and a duty of confidentiality," says Wendt. "This paves the way for a dialogue when these professionals ask questions and can help women to reflect and see their own situation more clearly."


This view is shared by midwives, general practitioners and gynaecologists, but it is still relatively unusual for medical professionals to invite women to engage in in depth discussion of sexuality and relationships. Instead, visits are primarily medically oriented discussion of sexuality gets forgotten or time runs out.


"Both doctors and midwives describe opportunities to create respectful meetings and strengthen women by giving them information and encouraging them to have a positive view of sexuality," says Wendt. "Now that we know that women and medical professionals both want the same thing, perhaps sexuality and dialogue with the patient can be allotted more time at gynaecological visits."


Source: University of Gothenburg

четверг, 29 сентября 2011 г.

CMACE Release: National Enquiry Into Maternal Obesity - Implications For Women, Babies And The NHS

The Centre for Maternal and Child Enquiries (CMACE) releases its report Maternal obesity in the UK: Findings from a national project today after its three-year UK-wide national enquiry into Obesity in Pregnancy.


This major national study, which collected information from every maternity unit in the UK, has revealed for the first time the prevalence of severe maternal obesity (body mass index 35+) in the UK. The report also details the complications and consequences of obesity during pregnancy, and outlines the implications for the care of obese pregnant women.


This study found that around 5% of the UK maternity population were severely obese. In real terms, this equates to around 38,478 (1 in 20) pregnant women each year, and, with growing levels of obesity in the general population, this number is expected to increase. Wales was found to have the highest rate (6.5%, 1 in every 15 pregnant women) of severe maternal obesity in the UK. In England, the region with the highest rate was East of England (6.2%, 1 in every 16 pregnant women), while London had the lowest rates (3.5%, 1 in every 29 pregnant women).


The report highlighted that pregnancy outcomes for severely obese women are poorer when compared to the general population. The study found that the stillbirth rate in women with a BMI 35+ (8.6 per 1000 singleton births) was twice as high as the overall national stillbirth rate (3.9/1000 singleton births), and that the risk of stillbirth increases with increasing obesity. Also, in women with a BMI 35+, stillbirths occurring during labour and birth were three times higher than the overall national rate in England, Wales and Northern Ireland.


The risks of obesity in pregnancy extend to the mother too. Pregnant women, and especially obese pregnant women, are more at risk of developing venous thromboembolism (VTE), which is a potentially fatal condition that involves a blood clot forming in a vein which may break away, travel through the circulatory system and obstruct a blood vessel. The CMACE study revealed how VTE risk was poorly documented for obese pregnant women at their first antenatal appointment and fewer than 50% of the women at moderate or high risk of VTE were offered treatment to prevent the condition. For those women who did receive treatment antenatally, the prescribed doses were considered to be insufficient for their body weight, according to current guidelines published by the Royal College of Obstetricians and Gynaecologists (RCOG). Similar findings were found for postnatal treatment for the prevention of VTE, with only 55% of eligible women being prescribed the appropriate medication. These findings highlight that improvements in this area are required to reduce the risk of VTE in obese women during and after pregnancy.















The CMACE report also revealed that obese women have an increased risk of medical conditions both before and during pregnancy. Thirty-eight per cent of women in the study had at least one medical condition diagnosed prior to and/or during pregnancy. The most common conditions were gestational diabetes and pregnancy induced hypertension, which affect 8-9% of women with a BMI 35+; these conditions affect approximately 2-2.5% of women in the general maternity population. The presence of medical conditions increases the risk of complications for both the mother and baby, and increased surveillance and medical intervention are therefore required.


Only 55% of women with a BMI 35+ gave birth naturally. The caesarean section rate for singleton babies was 37%, which is 1.5 times higher than the rate in the general maternity population. In addition, severely obese women were at least four times more likely to suffer from postpartum haemorrhage within 24 hours of birth than women in the general maternity population.


The CMACE study also identified gaps in anaesthetic care for obese women. According to current joint CMACE/RCOG guidance, women with a BMI ?‰?40 (morbidly obese) should receive an antenatal consultation with an obstetric anaesthetist so that potential problems can be identified and an anaesthetic management plan for labour and delivery can be made. Only 45% of eligible women had such a plan.


A set of ten key recommendations has been developed by CMACE in response to the findings in the report. The purpose of providing these recommendations is to highlight areas requiring better clinical practice. The general points are:



- Better preconception care and advice is needed for women with overweight and obese BMIs. The joint CMACE/RCOG guideline on managing women with obesity in pregnancy, issued in March 2010, notes that women of childbearing age with a BMI 30+ should be provided with good information and advice on the risks of obesity during pregnancy and childbirth; and they should be supported to lose weight before conception and in the postnatal period. Pre-pregnancy counselling must also include taking an accurate height and weight measurement for a BMI calculation to identify women who may be at further risk or require additional services or care.


- Women with obesity have an increased risk of pregnancy complications such as gestational diabetes and pre-eclampsia. CMACE recommends that surveillance and screening according to existing guidelines occur so that referrals for specialist care can be made early in pregnancy.


- Women with a BMI 40+ should have a consultation with an obstetric anaesthetist, as recommended by the joint CMACE/RCOG guideline on obesity in pregnancy, so that potential problems such as venous access can be identified before the birth.


Professor James Walker, Chair of CMACE said, "The numbers of obese mothers are on the rise and this group of women require specialist care since they are more susceptible to illnesses and complications. So far, there hasn't been a UK-wide study on the extent of the problem but we now have very good data on how these women are cared for and the areas where improvements are urgently needed".


Dr Imogen Stephens, CMACE Clinical Director said, "This CMACE report shows that much more needs to be done in the NHS to deal with the growing numbers of obese pregnant women. We have already shown in our previous survey how specialist equipment such as wheelchairs, trolleys and beds are needed to care for this unique group of women. The findings from this new study show that the risks of clinical intervention increase with increasing levels of obesity and that specialist obstetric care is needed. All this requires improved, and better integrated, care for these women".


Dr Tony Falconer, President of the Royal College if Obstetricians and Gynaecologists (RCOG) said, "Pregnant women who are obese need to know about the associated risks for them and their baby and must be supported to lose weight before they embark on pregnancy. This will involve counselling and advice from a range of healthcare professionals including GPs, midwives, maternity support workers and nutritionists.


When a woman finds out she is pregnant, she tends to adopt positive behaviours to ensure that she is as healthy as she can possibly be and this includes sensible eating and lower alcohol consumption. However, we need to think about being more proactive by encouraging and enabling women to lead healthier lives before they fall pregnant and after giving birth so that they take a more long-term approach to being healthy".


Professor Cathy Warwick, General Secretary of the Royal College of Midwives, said "Our own research backs up these recommendations. Women have told us that they are not getting the level of care that they should from maternity services.


"There is no doubt that being obese and pregnant can leave women open to more problems in pregnancy than non- obese women. However with high quality care these problems can be identified and treated and women can have a very positive experience of pregnancy and birth. It is therefore crucial that midwives and other health professionals work together to ensure that these women get the best possible care, support and advice. Many women have told the RCM that one of the big barriers to this is that there are simply not enough midwives to spend time with them especially in the antenatal period.


"There is also a much wider and long-term public health message here. There is a real need to reduce obesity in the population as a whole, tackling the issue before women become pregnant."


Notes


The research lead for this project and author of the report is Dr Kate Fitzsimons (Senior Research Fellow, CMACE). The editor of the report is Professor Ian Greer (Executive Pro-Vice-Chancellor, Faculty of Health & Life Sciences, University of Liverpool; Chair of the National Advisory Committee for CMACE).


To view Maternal obesity in the UK: Findings from a national project, please click here. The launch of the report accompanies the CMACE conference 'Obesity in Pregnancy: Improving care and effecting change'. To view the conference programme, click here.


This new report follows the publication of the CMACE survey on NHS maternity provision to obese women and the joint CMACE/RCOG clinical guideline 'Management of Women with Obesity in Pregnancy' in March this year.


Body mass index (BMI) offers a useful measure of obesity and is a simple index of weight-for-height used to classify underweight, overweight and obesity in adults. BMI is calculated by dividing a person's weight in kilograms by the square of their height in metres (kg/m2). The table below shows a widely accepted classification published by both the World Health Organization and the National Institute for Health and Clinical Excellence (NICE). This report focused on women with a BMI 35+ (severely obese) in pregnancy. A woman with a height of 5ft 5" and a weight of 15 stone would have a BMI of 35.


BMI (kg/m2) Classification

четверг, 22 сентября 2011 г.

Condom Promotion Campaigns In Sub-Saharan Africa Have Been Successful

There has been a substantial rise in the use of condoms reported by young, sexually active, single women in sub-Saharan Africa, according to an Article in this week's issue of The Lancet. The study found that most women who reported using a condom stated pregnancy avoidance as their reason. The authors therefore suggest that condoms may be promoted more effectively if the emphasis was on pregnancy prevention rather than prevention of sexually transmitted disease.



John Cleland (London School of Hygiene and Tropical Medicine, UK) and Mohamed Ali (WHO) assessed trends in sexual abstinence, contraception, and condom use by single women aged 15-24 years in 18 African countries. They used data from comparable surveys involving 132 800 women in total. The researchers found that between 1993 and 2001, the proportion of women declaring themselves virgins rose significantly in seven of the 18 countries and fell significantly in six. On average, abstinence over the 3 months preceding the survey increased from 43.8% to 49.2% in the 18 countries. For women who reported having sex in the 3 months preceding the survey, use of any contraceptive method rose slightly from an average of 32.6% to 36.5%. Use of non-barrier methods (mainly contraceptive pills) changed little, whereas use of periodic abstinence fell slightly. Use of condoms rose substantially during the study period, from an average of 5.3% to 18.8%. This rise was significant in 13 of the 18 countries. In the most recent surveys from these 13 countries, 60% of the women said they were using condoms for pregnancy prevention.



Professor Cleland concludes: "The finding that condoms have now become the dominant method of contraception is to be welcomed because of their dual protection against HIV transmission and pregnancy - A young woman might find it easier to negotiate use of condoms with a partner for prevention of pregnancy than for protection against HIV transmission. Therefore, we suggest that condoms might be promoted more effectively if the emphasis was on pregnancy prevention rather than prevention of sexually transmitted disease."







Contact: Joe Santangelo


Lancet

четверг, 15 сентября 2011 г.

Non Communicable Diseases: The World's Number One Killer For Women

Non-communicable diseases (NCDs), including cancer, cardiovascular disease, chronic respiratory disease and diabetes, are the world's number one killer causing 60% of deaths globally. A staggering 35 million people die from NCDs, of which 18 million are women. These diseases represent a major threat to women's health, increasingly impacting on women in developing countries in their most productive years. To voice their outrage at the international neglect of these silent killers, the NCD Alliance convened a high-profile side event on women and NCDs at the United Nation's 55th Commission on the Status of Women.


The panel session, "Non-communicable diseases: A neglected dimension of women's health and development" called for the global health and development community to focus their attention on the impact of NCDs on women, particularly in low and middle income countries. High profile panelists included Ann Keeling, CEO of the International Diabetes Federation and Chair of the NCD Alliance Steering Committee, Sania Nishtar, Founder and President of NGO think tank Heartfile, Patricia Lambert, Director of the International Legal Consortium at the Campaign for Tobacco-Free Kids and Vice President of the International Network of Women Against Tobacco, and Vivien Tsu, Associate Director of the Reproductive Health global program at PATH.


During this event the panel discussed the unique vulnerability of girls and women to the socioeconomic determinants and risk factors of NCDs; the impact of NCDs on the health and socio-economic position throughout the lifecycle; and the importance of women's empowerment for the prevention of the global NCD epidemic. The session also focused on the UN High-Level Summit on NCDs in September 2011, and the opportunity it presents for securing commitments for the biggest killer of women worldwide. Failure to act now on NCDs will undermine development gains made to date on the Millennium Development Goals (MDGs 4 & 5), including progress on women's empowerment.


This event also marked the official launch of the landmark publication "Non-communicable diseases: A priority for women's health and development". This publication is the first to focus on the specific needs and challenges of girls and women at risk of, or living with NCDs. It aims to draw attention to these diseases and key risks factors particularly tobacco control as a priority for women's health and development, stimulate policy dialogue in the run-up to the UN Summit on NCDs in September.


Concluding the afternoon, Ann Keeling, NCD Alliance, called for a unified approach to the NCD epidemic "By pooling our collective expertise and strengths in a coordinated movement to make NCDs a priority for women's health and development, we will inspire a new level of commitment that will benefit the millions of girls and women worldwide".


Source:

World Heart Federation