Researchers at McGill University have revealed that the HPV screening test is superior to the traditional Pap test in detecting cervical cancer. Accuracy for the HPV test was 94.6%, compared to 55.4% for the Pap test, say researchers.
Dr. Marie-H?©l??ne Mayrand, Centre hospitalier de l'Universit?© de Montr?©al (CHUM), and team from McGill, Universit?© de Montr?©al, the Newfoundland and Labrador Public Health Laboratory and McMaster University, published their findings in The New England Journal of Medicine, October 18th issue.
The controlled randomized trial, called CCCast, was the first of its kind carried out in North America for HPV testing as a stand-alone screening test for cervical cancer. Initially, it involved 10,154 women during the period 2002-2005 - they were aged 30-69 years.
Although HPV tests were 40% more accurate than Pap tests, as far as the specifity scale was concerned, the Pap test faired better. Pap tests' ability to accurately detect pre-cancerous lesions without false positives was better - 96.8% compared to 94.1%.
The researchers explained "We already knew before conducting this study that the sensitivity of Pap left a lot to be desired. However, 55.4% accuracy is only slightly above chance. Flipping a coin gives you 50%."
The Pap test, which was created by Dr. Georgios Papanicolaou during the 1940s, require that cell samples are gathered from the patients cervix and examined under a microscope by technicians. This procedure has been the norm for more than half a century. The HPV test, on the other hand, although requiring cervical samples, is analyzed automatically - it detects the DNA of HPV strains which are known to cause cervical cancer.
A test's sensitivity is generally thought of as more useful than specifity. Event though a false positive is psychologically distressing, the patient is free of the disease, explain the researchers.
Even though the results of this study may have some relevance regarding the current debate about HPV vaccinations on young females, the issues should be looked at separately, say the scientists. Vaccination is all about primary prevention (screening), while this study focuses on secondary prevention, the researchers stress.
Women who receive the vaccine will still have to be screened because their vaccine only protects them against 70% of cervical cancers.
Read the article at McGill University web site
суббота, 31 марта 2012 г.
суббота, 24 марта 2012 г.
Abused women less likely to be in stable relationships
Poor women who are physically or sexually abused at some point in their lives are less likely to maintain stable intimate
relationships, according to a new study of more than 2,500 women by sociologists from The Johns Hopkins University and Penn
State University.
The women involved in the study said they want fair treatment and companionship from their partners, just like everybody
does, the researchers said. Many of those who had been abused as adults told ethnographers that they had decided to forego
marriage and cohabiting relationships, at least temporarily. Those who were sexually abused in childhood were not as likely
to avoid relationships altogether; rather, they tended to engage in a series of short-term, transient relationships, many of
them abusive.
While there is no evidence that abuse rates have increased, the number of women postponing intimate relationships may be
growing, said Andrew Cherlin, the Griswold Professor of Public Policy at Johns Hopkins and lead author of the report, "The
Influence of Physical and Sexual Abuse on Marriage and Cohabitation," to be published in the Jan. 21 issue of American
Sociological Review.
"What's changed over the past few decades is the social context of abuse," Cherlin said. "Women don't have to stay with
abusive men anymore because they have alternatives to marriage."
The researchers, working in Boston, Chicago and San Antonio as part of the long-term research project called "Welfare,
Children and Families: A Three-City Study," surveyed a random sample of 2,402 Hispanic, African American, and white women.
Ethnographic research teams studied another 256 women in depth for several years, observing day-to-day activities and
conducting repeated interviews. All of the women studied were the primary caregivers of at least one child.
Fifty-two percent of women in the random-sample survey reported being physically or sexually abused at some point during
their lives. Twenty-four percent said they were sexually abused during childhood or adolescence. Forty-two percent of women
who had never been abused were married at the time of the survey, compared to 22 percent of women who had ever been abused.
Of the 256 women studied in depth, one-sixth -- many of whom had been physically abused as adults -- said they were taking a
timeout from intimate relationships with men.
"Women's decision to take a timeout from such relationships is an important one for policymakers to understand," said
co-author Linda Burton, director of the ethnographic component and Penn State professor of human development and sociology.
"These women are not saying they will never enter intimate relationships again, but, rather, they need recovery and
reflection time from abuse they experienced as adults to avoid entering a subsequent abusive relationship."
Cherlin and Burton suggest that reducing levels of sexual abuse and physical violence in families could increase the number
of healthy, stable, long-term unions. They argue that current marriage promotion policy debates at the federal and state
levels, which tend to blame declining cultural values or unemployment for lower marriage rates among the poor, should also
focus on the consequences of abuse.
Other authors are: Tera Hurt, University of Georgia; and Diane Purvin, Wellesley College.
Funding support came from National Institute of Child Health and Human Development, Office of the Assistant Secretary for
Planning and Evaluation, Administration on Developmental Disabilities, Administration for Children and Families, Social
Security Administration, National Institute of Mental Health, The Boston Foundation, The Annie E. Casey Foundation, The Edna
McConnell Clark Foundation, The Lloyd A. Fry Foundation, Hogg Foundation for Mental Health, The Robert Wood Johnson
Foundation, The Joyce Foundation, The Henry J. Kaiser Family Foundation, W. K. Kellogg Foundation, Kronkosky Charitable
Foundation, The John D. and Catherine T. MacArthur Foundation, Charles Stewart Mott Foundation, The David and Lucile Packard
Foundation, and Woods Fund of Chicago.
To speak with Andrew Cherlin, contact Amy Cowles at 443-287-9960. To speak with Linda Burton, contact Vicki Fong at
vfongpsu.edu or 814-865-9481. For a copy of the report, e-mail amycowlesjhu.edu.
Johns Hopkins University
relationships, according to a new study of more than 2,500 women by sociologists from The Johns Hopkins University and Penn
State University.
The women involved in the study said they want fair treatment and companionship from their partners, just like everybody
does, the researchers said. Many of those who had been abused as adults told ethnographers that they had decided to forego
marriage and cohabiting relationships, at least temporarily. Those who were sexually abused in childhood were not as likely
to avoid relationships altogether; rather, they tended to engage in a series of short-term, transient relationships, many of
them abusive.
While there is no evidence that abuse rates have increased, the number of women postponing intimate relationships may be
growing, said Andrew Cherlin, the Griswold Professor of Public Policy at Johns Hopkins and lead author of the report, "The
Influence of Physical and Sexual Abuse on Marriage and Cohabitation," to be published in the Jan. 21 issue of American
Sociological Review.
"What's changed over the past few decades is the social context of abuse," Cherlin said. "Women don't have to stay with
abusive men anymore because they have alternatives to marriage."
The researchers, working in Boston, Chicago and San Antonio as part of the long-term research project called "Welfare,
Children and Families: A Three-City Study," surveyed a random sample of 2,402 Hispanic, African American, and white women.
Ethnographic research teams studied another 256 women in depth for several years, observing day-to-day activities and
conducting repeated interviews. All of the women studied were the primary caregivers of at least one child.
Fifty-two percent of women in the random-sample survey reported being physically or sexually abused at some point during
their lives. Twenty-four percent said they were sexually abused during childhood or adolescence. Forty-two percent of women
who had never been abused were married at the time of the survey, compared to 22 percent of women who had ever been abused.
Of the 256 women studied in depth, one-sixth -- many of whom had been physically abused as adults -- said they were taking a
timeout from intimate relationships with men.
"Women's decision to take a timeout from such relationships is an important one for policymakers to understand," said
co-author Linda Burton, director of the ethnographic component and Penn State professor of human development and sociology.
"These women are not saying they will never enter intimate relationships again, but, rather, they need recovery and
reflection time from abuse they experienced as adults to avoid entering a subsequent abusive relationship."
Cherlin and Burton suggest that reducing levels of sexual abuse and physical violence in families could increase the number
of healthy, stable, long-term unions. They argue that current marriage promotion policy debates at the federal and state
levels, which tend to blame declining cultural values or unemployment for lower marriage rates among the poor, should also
focus on the consequences of abuse.
Other authors are: Tera Hurt, University of Georgia; and Diane Purvin, Wellesley College.
Funding support came from National Institute of Child Health and Human Development, Office of the Assistant Secretary for
Planning and Evaluation, Administration on Developmental Disabilities, Administration for Children and Families, Social
Security Administration, National Institute of Mental Health, The Boston Foundation, The Annie E. Casey Foundation, The Edna
McConnell Clark Foundation, The Lloyd A. Fry Foundation, Hogg Foundation for Mental Health, The Robert Wood Johnson
Foundation, The Joyce Foundation, The Henry J. Kaiser Family Foundation, W. K. Kellogg Foundation, Kronkosky Charitable
Foundation, The John D. and Catherine T. MacArthur Foundation, Charles Stewart Mott Foundation, The David and Lucile Packard
Foundation, and Woods Fund of Chicago.
To speak with Andrew Cherlin, contact Amy Cowles at 443-287-9960. To speak with Linda Burton, contact Vicki Fong at
vfongpsu.edu or 814-865-9481. For a copy of the report, e-mail amycowlesjhu.edu.
Johns Hopkins University
суббота, 17 марта 2012 г.
Internet Kiosks Help Reduce Infant Mortality Rates
A new study by a researcher at the University of Arkansas shows that Internet kiosks providing information on prenatal and postnatal care for mother and baby have helped reduce infant, child and maternal mortality rates in rural India. Contrary to traditional assumptions about the positive effects of social networks, the study's findings demonstrated that strong social ties in rural villages did not help women seek and obtain appropriate medical care.
"Based on our knowledge of religious beliefs and various customs within rural Indian culture, as well as the basic tendency of people to associate and bond with others similar to themselves, we hypothesized that strong network ties would be detrimental to women seeking good information about health care," said Viswanath Venkatesh, professor in the Sam M. Walton College of Business. "The results of this study provided evidence that this was indeed the case. Women with strong network ties seemed to be influenced by strong pressure not to change traditional practices and customs."
Although in recent years India has experienced a growing economy and burgeoning middle class in primarily urban centers, most people in rural areas live in extreme poverty. For example, according to a recent study that used a multidimensional poverty index, eight Indian states are worse off than people in sub-Saharan Africa. As part of this problem, India has high infant mortality rates - approximately 55 per 1,000 live births - and child mortality rates - 78 per 1,000 live births. In response to this problem, several private organizations have installed Internet kiosks to provide valuable information about prenatal and postnatal care for mother and baby. The kiosks are public Internet stations, similar to those found in a library or caf?©, where rural Indians can gain access to the World Wide Web.
In direct connection to a United Nations Millennium Development Goal to reduce infant, child and maternal mortality rates in underdeveloped areas, Venkatesh examined the impact of the Internet kiosks. He wanted to know if the kiosks had contributed to systematic benefits related to reducing infant, child and maternal deaths, and if so, who was most likely to benefit.
Venkatesh and former doctoral student Tracy Sykes, now assistant professor at the Australian National University, conducted a five-year study of women in 20 rural villages, 10 with Internet kiosks and 10 with no such intervention. They used surveys and health records from government archives to gather data. A general survey was taken at the deployment of each kiosk. In each village, approximately 300 women participated.
From 2004 to 2009, infant and child mortality rates in both groups decreased, but overall the intervention group - those villages with Internet kiosks - experienced a more rapid decline. In 2004, the year the Internet kiosks were installed, overall mortality rates were approximately the same number - 68 per 1,000 live births. Below are results from an equally weighted index of infant, child and maternal mortalities over the five-year period:
Control group Intervention group
2004 68.4 68.5
2005 66.2 65.1
2006 64.1 61.8
2007 61.8 56.4
2008 59.4 52.2
2009 57.3 49.1
The percentage of women using the kiosks was low, only 4.8 percent in 2004 and rising steadily each year to 8.8 percent in 2009. Venkatesh said this information was valuable because it showed that the transfer of information about health issues depended not only on the kiosk but also on women's ties to other women who had used them.
Venkatesh and Sykes then tested the classic social network hypothesis, which argues that strong ties among community members result in positive social benefits. In this case, they found the opposite, that strong community ties among women in the villages were associated with negative effects on them seeking health information and medical care. They found positive effects - access to health information and medical care - for women with weak community ties.
"Mortality rates in rural India have shown a steady decline, which is great," Venkatesh said. "But it's important to dig a little deeper and find out why. We have empirical evidence of the positive impact of Internet kiosks and, perhaps counterintuitively, both the detrimental effects of a strong social network and positive effects of a weak network."
Venkatesh presented these results to a United Nations panel of experts on gender, science and technology. At a conference in Paris, the group explored gender dimensions of science and technology and identified policies and programs to accelerate progress toward Millennium Development Goals.
Venkatesh holds the George and Boyce Billingsley Chair in Information Systems.
Source:
University of Arkansas, Fayetteville
"Based on our knowledge of religious beliefs and various customs within rural Indian culture, as well as the basic tendency of people to associate and bond with others similar to themselves, we hypothesized that strong network ties would be detrimental to women seeking good information about health care," said Viswanath Venkatesh, professor in the Sam M. Walton College of Business. "The results of this study provided evidence that this was indeed the case. Women with strong network ties seemed to be influenced by strong pressure not to change traditional practices and customs."
Although in recent years India has experienced a growing economy and burgeoning middle class in primarily urban centers, most people in rural areas live in extreme poverty. For example, according to a recent study that used a multidimensional poverty index, eight Indian states are worse off than people in sub-Saharan Africa. As part of this problem, India has high infant mortality rates - approximately 55 per 1,000 live births - and child mortality rates - 78 per 1,000 live births. In response to this problem, several private organizations have installed Internet kiosks to provide valuable information about prenatal and postnatal care for mother and baby. The kiosks are public Internet stations, similar to those found in a library or caf?©, where rural Indians can gain access to the World Wide Web.
In direct connection to a United Nations Millennium Development Goal to reduce infant, child and maternal mortality rates in underdeveloped areas, Venkatesh examined the impact of the Internet kiosks. He wanted to know if the kiosks had contributed to systematic benefits related to reducing infant, child and maternal deaths, and if so, who was most likely to benefit.
Venkatesh and former doctoral student Tracy Sykes, now assistant professor at the Australian National University, conducted a five-year study of women in 20 rural villages, 10 with Internet kiosks and 10 with no such intervention. They used surveys and health records from government archives to gather data. A general survey was taken at the deployment of each kiosk. In each village, approximately 300 women participated.
From 2004 to 2009, infant and child mortality rates in both groups decreased, but overall the intervention group - those villages with Internet kiosks - experienced a more rapid decline. In 2004, the year the Internet kiosks were installed, overall mortality rates were approximately the same number - 68 per 1,000 live births. Below are results from an equally weighted index of infant, child and maternal mortalities over the five-year period:
Control group Intervention group
2004 68.4 68.5
2005 66.2 65.1
2006 64.1 61.8
2007 61.8 56.4
2008 59.4 52.2
2009 57.3 49.1
The percentage of women using the kiosks was low, only 4.8 percent in 2004 and rising steadily each year to 8.8 percent in 2009. Venkatesh said this information was valuable because it showed that the transfer of information about health issues depended not only on the kiosk but also on women's ties to other women who had used them.
Venkatesh and Sykes then tested the classic social network hypothesis, which argues that strong ties among community members result in positive social benefits. In this case, they found the opposite, that strong community ties among women in the villages were associated with negative effects on them seeking health information and medical care. They found positive effects - access to health information and medical care - for women with weak community ties.
"Mortality rates in rural India have shown a steady decline, which is great," Venkatesh said. "But it's important to dig a little deeper and find out why. We have empirical evidence of the positive impact of Internet kiosks and, perhaps counterintuitively, both the detrimental effects of a strong social network and positive effects of a weak network."
Venkatesh presented these results to a United Nations panel of experts on gender, science and technology. At a conference in Paris, the group explored gender dimensions of science and technology and identified policies and programs to accelerate progress toward Millennium Development Goals.
Venkatesh holds the George and Boyce Billingsley Chair in Information Systems.
Source:
University of Arkansas, Fayetteville
суббота, 10 марта 2012 г.
Researchers Discover New Way Men Can Transmit HIV To Women
Researchers at Northwestern University have discovered a critical new way a man can transmit the HIV virus to a woman.
Scientists had long believed that the normal lining of the female vaginal tract was an effective barrier to invasion of the HIV virus during sexual intercourse. They thought the large HIV virus couldn't penetrate the tissue.
But new research from Northwestern University's Feinberg School of Medicine has shown for the first time that the HIV virus does indeed penetrate a woman's normal, healthy genital tissue to a depth were it can gain access to its immune cell targets.
"This is an unexpected and important result," said Thomas Hope, principle investigator and professor of cell and molecular biology at the Feinberg School. "We have a new understanding of how HIV can invade the female vaginal tract."
"Until now, science has really had no idea about the details of how sexual transmission of HIV actually works," Hope added. "The mechanism was all very murky."
Hope, his Northwestern colleagues, and collaborators at Tulane University discovered that interior vaginal skin is vulnerable to HIV invasion at the level where it naturally sheds and replaces skin cells, a point where the cells are not as tightly bound together. He will present his findings December 16 at the American Society for Cell Biology 48th annual meeting in San Francisco.
Women and female adolescents now account for 26 percent of all new HIV cases in the U.S., according to the Centers for Disease Control. Based on its most recent analysis of 2005 data, the CDC estimated that there were 56,300 new HIV infections that year and traced 31 percent of the total to high-risk heterosexual contact. More than half of the new cases of HIV infection worldwide are in women.
Hope said he hopes his findings, if confirmed by future studies, will provide information to help develop microbicides and vaccines to protect against HIV.
"We urgently need new prevention strategies or therapeutics to block the entry of HIV through a woman's genital skin," Hope said. While condoms are 100% effective in blocking the virus, "people don't always use them for cultural and other reasons," he noted.
By labeling the HIV viruses with photo-activated fluorescent tags, Northwestern researchers were able to view the virus as it penetrated the outermost lining of the female genital tract, called the squamous epithelium, in female human tissue obtained from a hysterectomy and in animal models.
Researchers found that HIV penetrated the genital skin barrier primarily by moving quickly -- in just four hours -- between skin cells to reach 50 microns beneath the skin, a depth similar to the width of a human hair. This is the depth at which some of the immune cells targeted by HIV are located.
HIV penetration was more common in the outermost superficial layers of skin and likely occurred during the normal turnover and shedding of skin cells. In the shedding process, the skin cells are no longer as tightly bound together so water -- and HIV -- can easily enter.
"As pieces of the skin flake off, that's the loose point in the system where the virus can get in," Hope said.
Previously, scientists thought that the HIV virus invaded a woman's immune system through the single layer of skin cells that line her cervical canal. "That was always thought to be the weak point in the system," Hope said.
However, a previous trial in Africa in which women used a diaphragm to block the cervix did not reduce transmission. Nor are women who have had hysterectomies less vulnerable to contracting HIV through sex.
Hope said researchers had also believed the only way HIV could enter the vaginal tract was if a woman had an open lesion on her skin, for example caused by the herpes virus. When breaks are present in the skin it should be easier for HIV to enter the skin and bind to and infect immune cells. But in studies where women were given anti-herpes drugs to decrease their lesions, there was no decrease in transmission. In light of the new results, it is possible that HIV can enter the vaginal tissue and initiate infection without any physical breaks.
"A big mistake in this field is the idea that transmission only takes place one way," Hope said. "Our perspective is the viruses can infect people in more than one way. We say one of those ways that needs to be in the equation is that the virus can be transmitted directly through the skin."
The next step will be to prove that the virus actually infects the immune cells in the vaginal tract. "A key experiment in the future is to identify the first cells to get infected in the epithelium, which is not necessarily where people would have looked for them before," Hope said.
Source:
Marla Paul
Northwestern University
Scientists had long believed that the normal lining of the female vaginal tract was an effective barrier to invasion of the HIV virus during sexual intercourse. They thought the large HIV virus couldn't penetrate the tissue.
But new research from Northwestern University's Feinberg School of Medicine has shown for the first time that the HIV virus does indeed penetrate a woman's normal, healthy genital tissue to a depth were it can gain access to its immune cell targets.
"This is an unexpected and important result," said Thomas Hope, principle investigator and professor of cell and molecular biology at the Feinberg School. "We have a new understanding of how HIV can invade the female vaginal tract."
"Until now, science has really had no idea about the details of how sexual transmission of HIV actually works," Hope added. "The mechanism was all very murky."
Hope, his Northwestern colleagues, and collaborators at Tulane University discovered that interior vaginal skin is vulnerable to HIV invasion at the level where it naturally sheds and replaces skin cells, a point where the cells are not as tightly bound together. He will present his findings December 16 at the American Society for Cell Biology 48th annual meeting in San Francisco.
Women and female adolescents now account for 26 percent of all new HIV cases in the U.S., according to the Centers for Disease Control. Based on its most recent analysis of 2005 data, the CDC estimated that there were 56,300 new HIV infections that year and traced 31 percent of the total to high-risk heterosexual contact. More than half of the new cases of HIV infection worldwide are in women.
Hope said he hopes his findings, if confirmed by future studies, will provide information to help develop microbicides and vaccines to protect against HIV.
"We urgently need new prevention strategies or therapeutics to block the entry of HIV through a woman's genital skin," Hope said. While condoms are 100% effective in blocking the virus, "people don't always use them for cultural and other reasons," he noted.
By labeling the HIV viruses with photo-activated fluorescent tags, Northwestern researchers were able to view the virus as it penetrated the outermost lining of the female genital tract, called the squamous epithelium, in female human tissue obtained from a hysterectomy and in animal models.
Researchers found that HIV penetrated the genital skin barrier primarily by moving quickly -- in just four hours -- between skin cells to reach 50 microns beneath the skin, a depth similar to the width of a human hair. This is the depth at which some of the immune cells targeted by HIV are located.
HIV penetration was more common in the outermost superficial layers of skin and likely occurred during the normal turnover and shedding of skin cells. In the shedding process, the skin cells are no longer as tightly bound together so water -- and HIV -- can easily enter.
"As pieces of the skin flake off, that's the loose point in the system where the virus can get in," Hope said.
Previously, scientists thought that the HIV virus invaded a woman's immune system through the single layer of skin cells that line her cervical canal. "That was always thought to be the weak point in the system," Hope said.
However, a previous trial in Africa in which women used a diaphragm to block the cervix did not reduce transmission. Nor are women who have had hysterectomies less vulnerable to contracting HIV through sex.
Hope said researchers had also believed the only way HIV could enter the vaginal tract was if a woman had an open lesion on her skin, for example caused by the herpes virus. When breaks are present in the skin it should be easier for HIV to enter the skin and bind to and infect immune cells. But in studies where women were given anti-herpes drugs to decrease their lesions, there was no decrease in transmission. In light of the new results, it is possible that HIV can enter the vaginal tissue and initiate infection without any physical breaks.
"A big mistake in this field is the idea that transmission only takes place one way," Hope said. "Our perspective is the viruses can infect people in more than one way. We say one of those ways that needs to be in the equation is that the virus can be transmitted directly through the skin."
The next step will be to prove that the virus actually infects the immune cells in the vaginal tract. "A key experiment in the future is to identify the first cells to get infected in the epithelium, which is not necessarily where people would have looked for them before," Hope said.
Source:
Marla Paul
Northwestern University
суббота, 3 марта 2012 г.
FDA Approves New Indication For Mirena(R) To Treat Heavy Menstrual Bleeding In IUD Users
Bayer HealthCare Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) approved a new indication for Mirena® (levonorgestrel-releasing intrauterine system) for the treatment of heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception. Mirena provides an effective, non-surgical option for the treatment of heavy menstrual bleeding and is the first and only contraceptive approved in the U.S. for this indication.
Heavy menstrual bleeding is a problem that affects between nine and 14 percent of otherwise healthy women(1) and is a common reason a woman sees her doctor. Heavy menstrual bleeding is defined as menstrual cycles with 5 tablespoons or more of blood loss (> 80 mL). Signs of heavy menstrual bleeding include:
-- the need to use double sanitary protection to control the heavy flow
-- menstrual flow that soaks through one or more sanitary pads or tampons every hour
-- the need to change sanitary protection during the night(2)
"Many women with heavy periods often suffer privately with their symptoms. And because approved effective non-surgical treatment options are limited, women who do seek treatment for heavy periods often face the choice of having surgical procedures, such as hysterectomies" said Dr. Andrew Kaunitz, M.D., FACOG, Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine-Jacksonville. "In a clinical trial, nearly nine out of 10 women were treated successfully for heavy menstrual bleeding with Mirena -- meaning it reduced monthly blood loss by more than 50 percent from baseline and to below 80 milliliters. This makes it an effective, nonsurgical first-line option."
"Mirena has a proven track-record as an effective contraceptive that lasts for up to five years. We are pleased to now also offer Mirena as a treatment option for women with heavy menstrual bleeding who choose to use an IUD for contraception," said Stefan Oelrich, Vice President and General Manager, Women's Health Care, Bayer HealthCare Pharmaceuticals. "Today's announcement demonstrates our continuing efforts to improve women's health."
Only a woman and her healthcare provider can decide if Mirena is right for her. Mirena is recommended for women who have had a child. Mirena should not be used by a woman who has a pelvic infection, gets infections easily or has certain cancers. Less than 1% of users get a serious infection called pelvic inflammatory disease. A woman should talk to her healthcare provider about problems related to this condition. Mirena may attach to or go through the wall of the uterus and cause other problems. If Mirena comes out, a woman should use back-up birth control and call her healthcare provider. In the uncommon event a woman gets pregnant while using Mirena, she should seek emergency care because pregnancy with an intrauterine device may result in loss of pregnancy or loss of fertility. Pelvic and/or abdominal pain may occur. If persistent, women should talk to their healthcare provider. Ovarian cysts may occur and usually disappear. Bleeding and spotting may increase in the first few months and continue to be irregular. Periods may become shorter, lighter or even stop. Mirena does not protect against HIV or STDs.
About the Heavy Menstrual Bleeding Study
FDA approval is based on data from a randomized, open-label, active-control, parallel-group clinical trial of 160 healthy women of reproductive age who had confirmed heavy menstrual bleeding and did not have any medical conditions known to cause HMB, with the exception of small uterine fibroids in some patients. Heavy menstrual bleeding, defined as menstrual blood loss (MBL) of greater than or equal to 80 mL, was determined using the alkaline hematin method. In the study, Mirena (n=79) was compared to an approved first-line hormonal therapy, medroxyprogesterone acetate (n=81), over six menstrual cycles. Successful treatment was defined when two outcomes were met: 1) a proportion of subjects with end-of-study MBL < 80 mL and 2) a greater than or equal to 50% decrease in MBL from baseline to end-of-study. Mirena demonstrated a significantly superior reduction in MBL. Additionally, a greater number of women in the Mirena arm achieved successful treatment vs. those in the medroxyprogesterone acetate arm (85% vs. 22%: respectively, p= 5 mL). The most common reported adverse events for Mirena in the study were uterine bleeding/spotting at irregular intervals, headache, ovarian cysts, vaginitis, pain during menstruation (dysmenorrhea), pelvic pain, and breast tenderness.
About Mirena
Mirena (levonorgestrel-releasing intrauterine system) is a removable intrauterine contraceptive that delivers small amounts of hormone directly to the uterus. It is among the most efficacious forms of birth control and works for up to five years. Mirena received FDA approval for the prevention of pregnancy in December 2000. It is currently used by approximately two million women in the U.S. and has been used by more than 15 million women worldwide.(3)
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals operation of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the United States, Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, Hematology/Neurology, and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
BAYER, the Bayer Cross, and Mirena are registered trademarks of Bayer HealthCare Pharmaceuticals.
References
(1) van Eijkeren MA, Christiaens GC, Sixma JJ, Haspels AA. Menorrhagia: A review. Obstet Gynecol Surv 1989; 44:421.
(2) Mayo Clinic
(3) Bayer: data on file.
Source: Bayer HealthCare Pharmaceuticals
View drug information on Mirena.
Heavy menstrual bleeding is a problem that affects between nine and 14 percent of otherwise healthy women(1) and is a common reason a woman sees her doctor. Heavy menstrual bleeding is defined as menstrual cycles with 5 tablespoons or more of blood loss (> 80 mL). Signs of heavy menstrual bleeding include:
-- the need to use double sanitary protection to control the heavy flow
-- menstrual flow that soaks through one or more sanitary pads or tampons every hour
-- the need to change sanitary protection during the night(2)
"Many women with heavy periods often suffer privately with their symptoms. And because approved effective non-surgical treatment options are limited, women who do seek treatment for heavy periods often face the choice of having surgical procedures, such as hysterectomies" said Dr. Andrew Kaunitz, M.D., FACOG, Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine-Jacksonville. "In a clinical trial, nearly nine out of 10 women were treated successfully for heavy menstrual bleeding with Mirena -- meaning it reduced monthly blood loss by more than 50 percent from baseline and to below 80 milliliters. This makes it an effective, nonsurgical first-line option."
"Mirena has a proven track-record as an effective contraceptive that lasts for up to five years. We are pleased to now also offer Mirena as a treatment option for women with heavy menstrual bleeding who choose to use an IUD for contraception," said Stefan Oelrich, Vice President and General Manager, Women's Health Care, Bayer HealthCare Pharmaceuticals. "Today's announcement demonstrates our continuing efforts to improve women's health."
Only a woman and her healthcare provider can decide if Mirena is right for her. Mirena is recommended for women who have had a child. Mirena should not be used by a woman who has a pelvic infection, gets infections easily or has certain cancers. Less than 1% of users get a serious infection called pelvic inflammatory disease. A woman should talk to her healthcare provider about problems related to this condition. Mirena may attach to or go through the wall of the uterus and cause other problems. If Mirena comes out, a woman should use back-up birth control and call her healthcare provider. In the uncommon event a woman gets pregnant while using Mirena, she should seek emergency care because pregnancy with an intrauterine device may result in loss of pregnancy or loss of fertility. Pelvic and/or abdominal pain may occur. If persistent, women should talk to their healthcare provider. Ovarian cysts may occur and usually disappear. Bleeding and spotting may increase in the first few months and continue to be irregular. Periods may become shorter, lighter or even stop. Mirena does not protect against HIV or STDs.
About the Heavy Menstrual Bleeding Study
FDA approval is based on data from a randomized, open-label, active-control, parallel-group clinical trial of 160 healthy women of reproductive age who had confirmed heavy menstrual bleeding and did not have any medical conditions known to cause HMB, with the exception of small uterine fibroids in some patients. Heavy menstrual bleeding, defined as menstrual blood loss (MBL) of greater than or equal to 80 mL, was determined using the alkaline hematin method. In the study, Mirena (n=79) was compared to an approved first-line hormonal therapy, medroxyprogesterone acetate (n=81), over six menstrual cycles. Successful treatment was defined when two outcomes were met: 1) a proportion of subjects with end-of-study MBL < 80 mL and 2) a greater than or equal to 50% decrease in MBL from baseline to end-of-study. Mirena demonstrated a significantly superior reduction in MBL. Additionally, a greater number of women in the Mirena arm achieved successful treatment vs. those in the medroxyprogesterone acetate arm (85% vs. 22%: respectively, p= 5 mL). The most common reported adverse events for Mirena in the study were uterine bleeding/spotting at irregular intervals, headache, ovarian cysts, vaginitis, pain during menstruation (dysmenorrhea), pelvic pain, and breast tenderness.
About Mirena
Mirena (levonorgestrel-releasing intrauterine system) is a removable intrauterine contraceptive that delivers small amounts of hormone directly to the uterus. It is among the most efficacious forms of birth control and works for up to five years. Mirena received FDA approval for the prevention of pregnancy in December 2000. It is currently used by approximately two million women in the U.S. and has been used by more than 15 million women worldwide.(3)
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals operation of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the United States, Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, Hematology/Neurology, and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
BAYER, the Bayer Cross, and Mirena are registered trademarks of Bayer HealthCare Pharmaceuticals.
References
(1) van Eijkeren MA, Christiaens GC, Sixma JJ, Haspels AA. Menorrhagia: A review. Obstet Gynecol Surv 1989; 44:421.
(2) Mayo Clinic
(3) Bayer: data on file.
Source: Bayer HealthCare Pharmaceuticals
View drug information on Mirena.
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