Depression and other mental health problems prompted 156 million visits to doctors' offices, clinics, and hospital outpatient departments in 2005, according to the latest News and Numbers from the Agency for Healthcare Research and Quality.
Problems with mental health were one of the top three reasons for Americans to seek treatment. Also, the number of mental health visits has increased 30 percent since 1996.
AHRQ's analysis also ranked the other top reasons for getting non emergency ambulatory care in 2005:
-- Back problems prompted 139 million visits and cost $17.6 billion.
-- Trauma- related disorders, such as fractures, prompted 133 million visits that cost $27 billion.
-- Chronic obstructive pulmonary disease and asthma, grouped together, resulted in 93 million visits that cost $12 billion.
-- High blood pressure resulted in 79 million visits and cost $10 billion.
AHRQ, which is part of the U.S. Department of Health and Human Services, works to enhance the quality, safety, efficiency, and effectiveness of health care in the United States. The data in this AHRQ News and Numbers summary are taken from the Medical Expenditure Panel Survey (MEPS), a detailed source of information on the health services used by Americans, the frequency with which they are used, the cost of those services, and how they are paid.
Agency for Healthcare Research and Quality (AHRQ)
540 Gaither Rd.
Rockville, MD 20850
United States
ahrq
четверг, 29 сентября 2011 г.
четверг, 22 сентября 2011 г.
Resolving Confusion About The Recent FDA Press Release On Bioidentical Hormones, Women To Women Responds With Clarifying Stance On BHRT
"I'm concerned that the recent FDA press release on bioidentical hormones is misleading women," says Marcelle Pick, founder of the renowned Women to Women clinic in Yarmouth, Maine. "The press coverage implies that the FDA is saying bioidentical compounded hormones are unsafe. But they're quite safe, provided they are prescribed by an experienced healthcare professional and are made by a reputable compounding pharmacy. We've prescribed them for over 15 years for thousands of women."
On January 9, 2008, the FDA issued a press release entitled "FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs." At the same time, they issued a number of warning letters to compounding pharmacies taking issue with the use of the word "bio-identical" as a marketing term implying a benefit, where they state "there is no medical or scientific basis."
"First," says Pick, "it is important that women understand the message: the FDA has not outlawed the use of bio-identical HRT."
"Second, it's the job of a reputable compounding lab to prepare a product that has the same molecular structure as the hormones your body produces naturally --- the word 'bio-identical' in this sense means 'identical to life.' If a woman is lacking the hormones she needs to feel balanced, bHRT, as compared to synthetics, allows the body to metabolize the hormones in much the same way as it was designed to do naturally. This is the key to minimizing side effects."
Dixie Mills, MD, renowned breast care specialist and partner in Women to Women's Personal Program, says, "It comes as no surprise to me that a big pharmaceutical company like Wyeth was a part of this press release. Pharmaceutical companies also sell bioidentical hormone products, but with unique delivery methods for bHRT that are patentable, such as special skin patches or vaginal rings."
Pick explains, "Because the hormones created by compounding pharmacies are chemically identical to those found naturally, they cannot be patented --- drug companies can't patent things that occur naturally in the human body."
She continues to say, "At Women to Women, we have found that about 85% of women can find relief through an approach that combines medical-grade nutritional supplements, gentle phytotherapy to normalize the endocrine system, and dietary and lifestyle changes. If prescription-strength relief is necessary due to advanced symptoms of menopause, we always recommend that women consider beginning with bHRT. It is our clinical experience that with the right protocol (including diagnostic blood tests, controlled dosage and duration, and regularly scheduled follow-up blood tests), bHRT can help to alleviate the symptoms of menopause without the negative side effects that may be experienced from the body not being able to process synthetic HRT as well."
"I urge women to consider all their choices," concludes Mills, "and to discuss bHRT with their healthcare practitioners before narrowing their choices based on the titles of FDA press releases."
About Women to Women
Women to Women is America's leading medical practice devoted to health care for women, by women. Founded over 21 years ago, it has always advocated an approach to women's health that combines the best of alternative and conventional medicine. Through its practice, website, and publications, Women to Women supports over a million women a year in their efforts to create health and well-being in their lives.
Women to Women
On January 9, 2008, the FDA issued a press release entitled "FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs." At the same time, they issued a number of warning letters to compounding pharmacies taking issue with the use of the word "bio-identical" as a marketing term implying a benefit, where they state "there is no medical or scientific basis."
"First," says Pick, "it is important that women understand the message: the FDA has not outlawed the use of bio-identical HRT."
"Second, it's the job of a reputable compounding lab to prepare a product that has the same molecular structure as the hormones your body produces naturally --- the word 'bio-identical' in this sense means 'identical to life.' If a woman is lacking the hormones she needs to feel balanced, bHRT, as compared to synthetics, allows the body to metabolize the hormones in much the same way as it was designed to do naturally. This is the key to minimizing side effects."
Dixie Mills, MD, renowned breast care specialist and partner in Women to Women's Personal Program, says, "It comes as no surprise to me that a big pharmaceutical company like Wyeth was a part of this press release. Pharmaceutical companies also sell bioidentical hormone products, but with unique delivery methods for bHRT that are patentable, such as special skin patches or vaginal rings."
Pick explains, "Because the hormones created by compounding pharmacies are chemically identical to those found naturally, they cannot be patented --- drug companies can't patent things that occur naturally in the human body."
She continues to say, "At Women to Women, we have found that about 85% of women can find relief through an approach that combines medical-grade nutritional supplements, gentle phytotherapy to normalize the endocrine system, and dietary and lifestyle changes. If prescription-strength relief is necessary due to advanced symptoms of menopause, we always recommend that women consider beginning with bHRT. It is our clinical experience that with the right protocol (including diagnostic blood tests, controlled dosage and duration, and regularly scheduled follow-up blood tests), bHRT can help to alleviate the symptoms of menopause without the negative side effects that may be experienced from the body not being able to process synthetic HRT as well."
"I urge women to consider all their choices," concludes Mills, "and to discuss bHRT with their healthcare practitioners before narrowing their choices based on the titles of FDA press releases."
About Women to Women
Women to Women is America's leading medical practice devoted to health care for women, by women. Founded over 21 years ago, it has always advocated an approach to women's health that combines the best of alternative and conventional medicine. Through its practice, website, and publications, Women to Women supports over a million women a year in their efforts to create health and well-being in their lives.
Women to Women
четверг, 15 сентября 2011 г.
Fewer Women Entering Heroin Addiction Treatment - More Successfully Completing Treatment, England
Far fewer women are entering treatment for heroin addiction and more women are successfully completing treatment for drug dependency than ever before. A detailed study of statistics about women in treatment in England shows a 19 per cent fall in the number of adult females under 30 entering heroin programmes over the last five years - 1,000 fewer female addicts than in 2005.
The fall is even sharper - 26 per cent - for the 18-25 age-group, providing further evidence that the heroin epidemic of previous decades may have peaked.
Although part of the trend was offset by rising numbers of cocaine and crack addicts seeking treatment over the same period, the numbers of women entering treatment in the under 30 age group fell by nearly nine per cent in four years.
The study also showed that at the same time the numbers of women problem drug users successfully leaving treatment having overcome their addiction almost doubled. In addition, the number of women dropping out of treatment has fallen by well over a third in four years.
The study by the National Treatment Agency for Substance Misuse (NTA) also highlights:
- While women start using drugs at a younger age than men, they are more adept at seeking help for themselves and tend to come into treatment earlier
- Cocaine is the fastest growing treatment need among women drug users, accounting for a 55 per cent increase in new entrants since 2005
- The number of women entering treatment for crack dependency has increased by 14 per cent since 2005
- Almost two-thirds of women entering treatment are mothers, nearly half of whom have a child living with them. The data indicates that treatment outcomes for mothers are stronger than those who were not parents.
"These findings demonstrate how thousands of women have successfully obtained drug treatment and recovered through it," said Rosanna O'Connor, NTA director of delivery. "Treatment is the first step on the road to recovery, so it is encouraging that women tend to seek help of their own volition, enter treatment earlier before their drug misuse has become entrenched and frequently achieve better outcomes sooner. Treatment provides the opportunity for individuals to get better, for families to stabilise, and for children to be looked-after at home."
The bulletin Women in drug treatment: what the latest figures reveal is available to download from nta.nhs
Around 57,000 women were recorded in drug treatment in England in 2008/09, compared to around 153,000 men; a gender breakdown of 1:3.
The NTA was set up by Government in 2001 to improve the availability, capacity and effectiveness of treatment for drug misuse in England.
Source
National Treatment Agency for Substance Misuse
The fall is even sharper - 26 per cent - for the 18-25 age-group, providing further evidence that the heroin epidemic of previous decades may have peaked.
Although part of the trend was offset by rising numbers of cocaine and crack addicts seeking treatment over the same period, the numbers of women entering treatment in the under 30 age group fell by nearly nine per cent in four years.
The study also showed that at the same time the numbers of women problem drug users successfully leaving treatment having overcome their addiction almost doubled. In addition, the number of women dropping out of treatment has fallen by well over a third in four years.
The study by the National Treatment Agency for Substance Misuse (NTA) also highlights:
- While women start using drugs at a younger age than men, they are more adept at seeking help for themselves and tend to come into treatment earlier
- Cocaine is the fastest growing treatment need among women drug users, accounting for a 55 per cent increase in new entrants since 2005
- The number of women entering treatment for crack dependency has increased by 14 per cent since 2005
- Almost two-thirds of women entering treatment are mothers, nearly half of whom have a child living with them. The data indicates that treatment outcomes for mothers are stronger than those who were not parents.
"These findings demonstrate how thousands of women have successfully obtained drug treatment and recovered through it," said Rosanna O'Connor, NTA director of delivery. "Treatment is the first step on the road to recovery, so it is encouraging that women tend to seek help of their own volition, enter treatment earlier before their drug misuse has become entrenched and frequently achieve better outcomes sooner. Treatment provides the opportunity for individuals to get better, for families to stabilise, and for children to be looked-after at home."
The bulletin Women in drug treatment: what the latest figures reveal is available to download from nta.nhs
Around 57,000 women were recorded in drug treatment in England in 2008/09, compared to around 153,000 men; a gender breakdown of 1:3.
The NTA was set up by Government in 2001 to improve the availability, capacity and effectiveness of treatment for drug misuse in England.
Source
National Treatment Agency for Substance Misuse
четверг, 8 сентября 2011 г.
Men, Women Should Share Responsibility For HIV/AIDS Prevention, Treatment, Malaysian Official Says
Men and women should share equal responsibility for preventing HIV/AIDS and providing treatment to people living with the diseases, Ng Yen Yen -- Malaysian minister for women, family and community development -- said last week at the 53rd Session of the U.N. Commission on the Status of Women, Bernama Daily Malaysian News reports. According to Ng, the percentage of new HIV/AIDS cases in Malaysia that occur among women has increased from 1.2% in 1990 to 16.4% in 2007. In addition, most HIV-positive women in the country contract the virus from their husbands, Ng said.
According to Ng, it is "important that both men and women take equal responsibility in preventing the spread of HIV among women." She added that "it is crucial that in the intersection of care-giving and HIV/AIDS, women are given the utmost support" because the "role of care-giving in many societies often falls upon women." Ng said that it is important to increase HIV/AIDS awareness among men in Malaysia so that they can become "involved in shouldering their responsibility in care-giving" for people living with HIV (Bernama Daily Malaysian News, 3/5). In addition, men and women should share equal responsibility for promoting safer sex, she said.
According to Ng, gender stereotypes pose significant challenges to equal responsibility and the advancement of women. She added that policymakers often encounter difficulty discussing stereotypes and implementing initiatives to address the issue. Ng said that "chipping away long-held biases and ways of thinking require strenuous efforts. But the outcome is worthwhile and the international community should not shirk from this" (Malaysia National News/Bernama, 3/4). Ng added that gender equality also can contribute to Malaysia's development at both the family level and the wider community and political levels. According to Ng, the Malaysian government "places the utmost importance on gender equality and Malaysian women have made significant progress in various fields, such as in the education, health and economic sectors" (Bernama Daily Malaysian News, 3/5).
Reprinted with kind 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.
© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
According to Ng, it is "important that both men and women take equal responsibility in preventing the spread of HIV among women." She added that "it is crucial that in the intersection of care-giving and HIV/AIDS, women are given the utmost support" because the "role of care-giving in many societies often falls upon women." Ng said that it is important to increase HIV/AIDS awareness among men in Malaysia so that they can become "involved in shouldering their responsibility in care-giving" for people living with HIV (Bernama Daily Malaysian News, 3/5). In addition, men and women should share equal responsibility for promoting safer sex, she said.
According to Ng, gender stereotypes pose significant challenges to equal responsibility and the advancement of women. She added that policymakers often encounter difficulty discussing stereotypes and implementing initiatives to address the issue. Ng said that "chipping away long-held biases and ways of thinking require strenuous efforts. But the outcome is worthwhile and the international community should not shirk from this" (Malaysia National News/Bernama, 3/4). Ng added that gender equality also can contribute to Malaysia's development at both the family level and the wider community and political levels. According to Ng, the Malaysian government "places the utmost importance on gender equality and Malaysian women have made significant progress in various fields, such as in the education, health and economic sectors" (Bernama Daily Malaysian News, 3/5).
Reprinted with kind 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.
© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
четверг, 1 сентября 2011 г.
Issues Like Abortion Rights Highlight Ongoing Debates Over Judicial Activism, Restraint, Opinion Piece Says
Although it is necessary to give some thought to what should be decided by judges and what should be determined by legislators, the "current fashion of framing substantive issues," such as abortion rights, "in terms of activism or restraint can only take you so far," Ann Althouse, law professor at the University of Wisconsin, writes in a Wall Street Journal opinion piece. According to Althouse, there was a time when people "openly praised the activist judge," but now "we all seem to love to wrap ourselves in the mantle of the new fashion" that "comes at the price of candor." Although the Supreme Court at one time "wrongly" believed that "enshrining abortion rights in the Constitution would spare us a torturous political fight," the court's decision in Roe v. Wade -- the 1973 Supreme Court decision that effectively outlawed state abortion bans -- "laid the groundwork for decades of controversial cases and contentious confirmation battles," according to Althouse. However, it also is a "delusion to think that matters would improve if the court rescinded" its decision in Roe because "[n]ew political fights would spring up and produce a new set of cases that would plunge the courts into even more troublesome legal disputes," Althouse writes. Although this situation "easily translates into the conclusion" that Roe "should not be overturned," such a conclusion is an "oblique argument that avoids speaking directly about the importance or reality of the rights in question," according to Althouse. The argument against overturning Roe "appeals to our preferences and aversions about judicial behavior," Althouse writes, adding that it also "assumes that these days we like our judges restrained. With this assumption, we're reconfiguring arguments into plans for, or limitations about, minimizing judicial activism" (Althouse, Wall Street Journal, 10/21).
"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.
"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, 25 августа 2011 г.
Protection Against Cancer May Begin During Pregnancy
There may be another reason for pregnant and nursing women to eat a nutritious diet that includes generous amounts of cruciferous vegetables like broccoli and cabbage - it could help protect their children from cancer, both as infants and later in life.
A new study by scientists from the Linus Pauling Institute at Oregon State University, done with laboratory mice, found that supplements of a key phytochemical found in certain vegetables provided a very high level of protection against leukemia and lymphoma in young animals, and also significantly protected against lung cancer during the rodent's equivalent of middle age.
The research, published in the journal Carcinogenesis, is one of the first of its type to demonstrate that diet may play a protective role in a fight against cancer that may begin - and could be won or lost - well before a person is ever born. And some of the protective benefits may last into adulthood.
"Research of this type is still in its infancy, but it's pretty exciting," said David Williams, an LPI researcher and director of the Marine and Freshwater Biomedical Sciences Center at OSU.
"There's strong epidemiologic evidence that infant cancers can be caused by exposure of the fetus to carcinogens, either during pregnancy or by nursing," Williams said. "Among all childhood deaths in the U.S., cancer is second only to accidents as the leading cause, and the fetus and neonate are sensitive targets for toxic carcinogens. It would be important if we could affect this through maternal diet."
There are particular concerns about common environmental pollutants called polycyclic aromatic hydrocarbons, or PAHs, which can be produced by cigarette smoking or the combustion of organic materials such as wood, coal, cooking oil or diesel fuel. Exposure of a fetus to PAHs has been shown to cause DNA damage in newborns and is also associated with increased levels of childhood leukemia. It has also been shown that a significant portion of the total lifetime exposure to PAHs and other toxins, including PCBs and dioxins, is transmitted to the fetus across the placental barrier and during nursing.
In laboratory studies, researchers exposed pregnant mice to a single high dose of one PAH called dibenzopyrene, a potent carcinogen, and about 80 percent of their 100 offspring died early in life from an aggressive T-cell lymphoma. Of those that survived to the mouse-equivalent of middle age, 100 percent had lung tumors.
By comparison, in a group of pregnant mice given the same carcinogen but who also received the chemoprotective supplement Indole-3-carbinol, or I3C, deaths from lymphoma were cut in half, and the number of lung tumors later in life was significantly reduced.
"It's clear that in mice this supplement provided significant protection against lymphoma and, later on, lung cancer," Williams said. "It's also worth noting that none of the infant mice received the protective supplement later in their life, at any stage beyond breast feeding. The protective effect of the compound came solely from maternal intake during pregnancy and nursing, but lasted into the animal's middle age. This is somewhat remarkable."
Although lung cancer is the leading cause of cancer death in both men and women, it's also true that only about one smoker in 10 gets lung cancer. It's possible, researchers say, that dietary and other factors in addition to smoking may predispose some smokers to get cancer while others don't. That this process may begin with carcinogens crossing the placental boundary - and might be affected by diet - is an area that has not been adequately studied, Williams said. In this study, both the exposure to carcinogens and the levels of Indole-3-carbinol given to pregnant mice through supplements were higher than those that would ordinarily be found in the environment or a normal diet, researchers said.
The scientists do not recommend that pregnant women take supplements of this compound, which is available in health food stores, because there have been questions about its possible role in causing birth defects when ingested at high levels in the first trimester of pregnancy. That topic needs further study, they said.
However, the amounts of this and other valuable phytochemicals that could be obtained in any normal diet rich in cruciferous vegetables should be safe and useful, they said. These vegetables include broccoli, cabbage, cauliflower, kale, radishes, turnips and other types of greens and cabbages.
Indole-3-carbinol is also being studied by scientists in other U.S. research programs for chemoprotection of women against breast cancer.
Cancer chemoprotection is one of the main research areas at the Linus Pauling Institute, a world leader in the study of vitamins, phytochemicals and other nutrients that may help prevent disease or provide optimum health.
By David Stauth
This research was funded by the National Institutes of Health.
Contact: David Williams
Oregon State University
A new study by scientists from the Linus Pauling Institute at Oregon State University, done with laboratory mice, found that supplements of a key phytochemical found in certain vegetables provided a very high level of protection against leukemia and lymphoma in young animals, and also significantly protected against lung cancer during the rodent's equivalent of middle age.
The research, published in the journal Carcinogenesis, is one of the first of its type to demonstrate that diet may play a protective role in a fight against cancer that may begin - and could be won or lost - well before a person is ever born. And some of the protective benefits may last into adulthood.
"Research of this type is still in its infancy, but it's pretty exciting," said David Williams, an LPI researcher and director of the Marine and Freshwater Biomedical Sciences Center at OSU.
"There's strong epidemiologic evidence that infant cancers can be caused by exposure of the fetus to carcinogens, either during pregnancy or by nursing," Williams said. "Among all childhood deaths in the U.S., cancer is second only to accidents as the leading cause, and the fetus and neonate are sensitive targets for toxic carcinogens. It would be important if we could affect this through maternal diet."
There are particular concerns about common environmental pollutants called polycyclic aromatic hydrocarbons, or PAHs, which can be produced by cigarette smoking or the combustion of organic materials such as wood, coal, cooking oil or diesel fuel. Exposure of a fetus to PAHs has been shown to cause DNA damage in newborns and is also associated with increased levels of childhood leukemia. It has also been shown that a significant portion of the total lifetime exposure to PAHs and other toxins, including PCBs and dioxins, is transmitted to the fetus across the placental barrier and during nursing.
In laboratory studies, researchers exposed pregnant mice to a single high dose of one PAH called dibenzopyrene, a potent carcinogen, and about 80 percent of their 100 offspring died early in life from an aggressive T-cell lymphoma. Of those that survived to the mouse-equivalent of middle age, 100 percent had lung tumors.
By comparison, in a group of pregnant mice given the same carcinogen but who also received the chemoprotective supplement Indole-3-carbinol, or I3C, deaths from lymphoma were cut in half, and the number of lung tumors later in life was significantly reduced.
"It's clear that in mice this supplement provided significant protection against lymphoma and, later on, lung cancer," Williams said. "It's also worth noting that none of the infant mice received the protective supplement later in their life, at any stage beyond breast feeding. The protective effect of the compound came solely from maternal intake during pregnancy and nursing, but lasted into the animal's middle age. This is somewhat remarkable."
Although lung cancer is the leading cause of cancer death in both men and women, it's also true that only about one smoker in 10 gets lung cancer. It's possible, researchers say, that dietary and other factors in addition to smoking may predispose some smokers to get cancer while others don't. That this process may begin with carcinogens crossing the placental boundary - and might be affected by diet - is an area that has not been adequately studied, Williams said. In this study, both the exposure to carcinogens and the levels of Indole-3-carbinol given to pregnant mice through supplements were higher than those that would ordinarily be found in the environment or a normal diet, researchers said.
The scientists do not recommend that pregnant women take supplements of this compound, which is available in health food stores, because there have been questions about its possible role in causing birth defects when ingested at high levels in the first trimester of pregnancy. That topic needs further study, they said.
However, the amounts of this and other valuable phytochemicals that could be obtained in any normal diet rich in cruciferous vegetables should be safe and useful, they said. These vegetables include broccoli, cabbage, cauliflower, kale, radishes, turnips and other types of greens and cabbages.
Indole-3-carbinol is also being studied by scientists in other U.S. research programs for chemoprotection of women against breast cancer.
Cancer chemoprotection is one of the main research areas at the Linus Pauling Institute, a world leader in the study of vitamins, phytochemicals and other nutrients that may help prevent disease or provide optimum health.
By David Stauth
This research was funded by the National Institutes of Health.
Contact: David Williams
Oregon State University
четверг, 18 августа 2011 г.
African-American Women Who Have Received HIV Treatment Are Sought To Participate In GRACE Study
The GRACE study (Gender, Race
And Clinical Experience) is now recruiting participants for the largest
clinical study to date in treatment-experienced adult women with HIV to
evaluate gender and race differences in response to an HIV medication. On
the occasion of the seventh annual National Black HIV/AIDS Awareness Day on
February 7, the study's sponsor, Tibotec Therapeutics Clinical Affairs, a
division of Ortho Biotech Clinical Affairs, LLC, is seeking to raise
awareness among African-American women of the trial and its importance to
the treatment of HIV.
Today, women account for nearly one-third of new HIV diagnoses in the
U.S., and rates of HIV infection are particularly high among women of
color. African-American women, who represent only 13% of the U.S. female
population, account for 64% of female AIDS cases.
"We expect GRACE will be an historic study because HIV treatment trials
in treatment-experienced populations have traditionally included small
numbers of women and people of color, especially in the earliest studies of
new antiretroviral agents. We know that there are gender- and race-specific
complications associated with HIV disease. However, we do not know a great
deal about how gender and race impact the efficacy and side effects of HIV
medications," said Debbie Hagins, M.D., Clinical Director of Outpatient
Services, a Ryan White funded clinic in Savannah, GA, and an investigator
in the GRACE study.
GRACE, a multi-center, open-label Phase IIIb trial, will compare gender
differences in the efficacy, safety and tolerability of PREZISTA
(darunavir) tablets administered with ritonavir and other antiretroviral
agents over a 48-week treatment period. The study also will explore racial
differences in treatment outcomes. Eligibility is open to men and women of
all races.
PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/r) and with
other antiretroviral agents, is indicated for the treatment of human
immunodeficiency virus (HIV) infection in antiretroviral
treatment-experienced adult patients, such as those with HIV-1 strains
resistant to more than one protease inhibitor. PREZISTA received
accelerated approval based on the 24- week analysis of HIV viral load and
CD4+ cell counts from the pooled analysis of the TMC114-C213 (POWER 1) and
TMC114-C202 (POWER 2) studies. Longer-term data will be required before the
FDA can consider traditional approval for PREZISTA (see the full indication
and important safety information below).
"As an African-American woman living with HIV for more than 20 years, I
am encouraged to see studies like GRACE that are designed to learn more
about HIV treatment in treatment-experienced African-Americans and women in
the U.S." said Rae Lewis-Thornton, a renowned AIDS activist and Emmy
Award-winning journalist. "GRACE is an example of the steps that need to be
taken to address the evolving HIV epidemic in the African-American
community, and those who participate in GRACE will play a very important
role in advancing the understanding of HIV treatment in women and people of
color."
The GRACE study will include approximately 50 sites in the United
States, Mexico and Canada, and will seek to enroll approximately 420
participants, 70 percent of whom will be women. Participants must be of 18
years or older, have a viral load of 1000 copies/mL or greater and have
previous intolerance or failure to prior therapy consisting of a protease
inhibitor and/or non- nucleoside reverse transcriptase inhibitor-based
highly active antiretroviral treatment regimen of at least 12 weeks. All
participants will receive PREZISTA/r (600/100mg twice a day) with an
optimized background regimen chosen by the investigator and based on
resistance testing and prior treatment history.
Indication
PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/r) and with
other antiretroviral agents, is indicated for the treatment of human
immunodeficiency virus (HIV) infection in antiretroviral
treatment-experienced adult patients, such as those with HIV-1 strains
resistant to more than one protease inhibitor.
This indication is based on Week 24 analyses of plasma HIV RNA levels
and CD4+ cell counts from two controlled trials of PREZISTA/rtv in
combination with other antiretroviral drugs. Both studies were conducted in
clinically advanced, treatment-experienced (NRTIs, NNRTIs, and PIs) adult
patients with evidence of HIV-1 replication despite ongoing antiretroviral
therapy.
The following points should be considered when initiating therapy with
PREZISTA/rtv:
-- Treatment history and, when available, genotypic or phenotypic testing
should guide the use of PREZISTA/rtv.
-- The use of other active agents with PREZISTA/rtv is associated with a
greater likelihood of treatment response.
-- The risks and benefits of PREZISTA/rtv have not been established in
treatment-na??ve adult patients or pediatric patients.
Important Safety Information
PREZISTA does not cure HIV infection or AIDS, and does not prevent
passing HIV to others.
PREZISTA is contraindicated in patients with known hypersensitivity to
any of its ingredients.
Coadministration of PREZISTA/r is contraindicated with drugs that are
highly dependent on CYP3A for clearance and have a narrow therapeutic index
(e.g., astemizole, terfenadine, dihydroergotamine, ergonovine, ergotamine,
methylergonovine, cisapride, pimozide, midazolam, or triazolam) and for
which elevated plasma concentrations are associated with serious and/or
life- threatening events. Coadministration is not recommended with
carbamazepine, phenobarbital, phenytoin, rifampin, lopinavir/ritonavir,
saquinavir, lovastatin, pravastatin, simvastatin, or products containing
St. John's wort (Hypericum perforatum).
Caution should be used when prescribing agents such as sildenafil,
vardenafil, tadalafil, or other substrates, inhibitors, or inducers of
CYP3A in patients receiving PREZISTA/rtv. This list of potential drug
interactions is not complete.
PREZISTA must be co-administered with 100 mg ritonavir and food to
exert its therapeutic effect. Failure to correctly administer PREZISTA with
ritonavir and food will result in reduced plasma concentration of darunavir
that will be insufficient to achieve the desired antiviral effect. Please
refer to ritonavir prescribing information for additional information on
precautionary measures.
Severe skin rash, including erythema multiforme and Stevens-Johnson
Syndrome, has been reported in subjects receiving PREZISTA during the
clinical development program. In some cases, fever and elevations of
transaminases have also been reported. In clinical trials (n=924), rash
(all grades, regardless of causality) occurred in seven percent of subjects
treated with PREZISTA; discontinuation due to rash was 0.3 percent. Rashes
were generally mild-to-moderate, self-limiting and maculopapular. PREZISTA
should be discontinued if severe rash develops.
PREZISTA should be used with caution in patients with known sulfonamide
allergy.
New-onset or exacerbations of pre-existing diabetes mellitus and
hyperglycemia, and increased bleeding in hemophiliacs have been reported in
patients receiving protease inhibitors. A causal relationship between
protease inhibitors and these events has not been established.
PREZISTA should be used with caution in patients with hepatic
impairment. There are no data regarding the use of PREZISTA in patients
with varying degrees of hepatic impairment; therefore, specific dosage
recommendations cannot be made.
Redistribution and/or accumulation of body fat have been observed in
patients receiving ARV therapy. The causal relationship, mechanism, and
long- term consequences of these events have not been established.
Immune reconstitution syndrome has been reported in patients treated
with ARV therapy.
The potential for HIV-cross-resistance among protease inhibitors has
not been fully explored in PREZISTA/rtv treated patients.
PREZISTA should be used during pregnancy only if the potential benefit
justifies the potential risk. There are no adequate and well-controlled
studies in pregnant women. The effects of PREZISTA on pregnant women or
their unborn babies are not known.
In the pooled analysis of POWER 1 and 2 studies, the most frequently
reported drug-related adverse events of at least moderate to severe
intensity in patients receiving PREZISTA/rtv-containing regimen were
headache (3.8 percent), diarrhea (2.3 percent), abdominal pain (2.3
percent), constipation (2.3 percent), and vomiting (1.5 percent).
Please see full Prescribing Information for more details.
About PREZISTA
PREZISTA was developed by Tibotec Pharmaceuticals Ltd. and is marketed
in the U.S. by Tibotec Therapeutics, a division of Ortho Biotech Products,
L.P.
About Tibotec Therapeutics
Tibotec Therapeutics, a division of Ortho Biotech Products, L.P.,
headquartered in Bridgewater, N.J., is dedicated to delivering innovative
virology therapeutics that help healthcare professionals address serious
unmet needs in people living with HIV.
About Tibotec Pharmaceuticals Ltd.
Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a
pharmaceutical research and development company. The Company's main
research and development facilities are in Mechelen, Belgium with offices
in Yardley, PA. Tibotec is dedicated to the discovery and development of
innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet
medical need.
Tibotec Pharmaceuticals is developing a Global Access Program to
facilitate access to its antiretrovirals for patients living with HIV/AIDS
in developing countries. The Global Access Program includes access pricing,
registration, medical education for appropriate use and voluntary
licensing.
Tibotec Therapeutics
tibotectherapeutics
View drug information on Prezista.
And Clinical Experience) is now recruiting participants for the largest
clinical study to date in treatment-experienced adult women with HIV to
evaluate gender and race differences in response to an HIV medication. On
the occasion of the seventh annual National Black HIV/AIDS Awareness Day on
February 7, the study's sponsor, Tibotec Therapeutics Clinical Affairs, a
division of Ortho Biotech Clinical Affairs, LLC, is seeking to raise
awareness among African-American women of the trial and its importance to
the treatment of HIV.
Today, women account for nearly one-third of new HIV diagnoses in the
U.S., and rates of HIV infection are particularly high among women of
color. African-American women, who represent only 13% of the U.S. female
population, account for 64% of female AIDS cases.
"We expect GRACE will be an historic study because HIV treatment trials
in treatment-experienced populations have traditionally included small
numbers of women and people of color, especially in the earliest studies of
new antiretroviral agents. We know that there are gender- and race-specific
complications associated with HIV disease. However, we do not know a great
deal about how gender and race impact the efficacy and side effects of HIV
medications," said Debbie Hagins, M.D., Clinical Director of Outpatient
Services, a Ryan White funded clinic in Savannah, GA, and an investigator
in the GRACE study.
GRACE, a multi-center, open-label Phase IIIb trial, will compare gender
differences in the efficacy, safety and tolerability of PREZISTA
(darunavir) tablets administered with ritonavir and other antiretroviral
agents over a 48-week treatment period. The study also will explore racial
differences in treatment outcomes. Eligibility is open to men and women of
all races.
PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/r) and with
other antiretroviral agents, is indicated for the treatment of human
immunodeficiency virus (HIV) infection in antiretroviral
treatment-experienced adult patients, such as those with HIV-1 strains
resistant to more than one protease inhibitor. PREZISTA received
accelerated approval based on the 24- week analysis of HIV viral load and
CD4+ cell counts from the pooled analysis of the TMC114-C213 (POWER 1) and
TMC114-C202 (POWER 2) studies. Longer-term data will be required before the
FDA can consider traditional approval for PREZISTA (see the full indication
and important safety information below).
"As an African-American woman living with HIV for more than 20 years, I
am encouraged to see studies like GRACE that are designed to learn more
about HIV treatment in treatment-experienced African-Americans and women in
the U.S." said Rae Lewis-Thornton, a renowned AIDS activist and Emmy
Award-winning journalist. "GRACE is an example of the steps that need to be
taken to address the evolving HIV epidemic in the African-American
community, and those who participate in GRACE will play a very important
role in advancing the understanding of HIV treatment in women and people of
color."
The GRACE study will include approximately 50 sites in the United
States, Mexico and Canada, and will seek to enroll approximately 420
participants, 70 percent of whom will be women. Participants must be of 18
years or older, have a viral load of 1000 copies/mL or greater and have
previous intolerance or failure to prior therapy consisting of a protease
inhibitor and/or non- nucleoside reverse transcriptase inhibitor-based
highly active antiretroviral treatment regimen of at least 12 weeks. All
participants will receive PREZISTA/r (600/100mg twice a day) with an
optimized background regimen chosen by the investigator and based on
resistance testing and prior treatment history.
Indication
PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/r) and with
other antiretroviral agents, is indicated for the treatment of human
immunodeficiency virus (HIV) infection in antiretroviral
treatment-experienced adult patients, such as those with HIV-1 strains
resistant to more than one protease inhibitor.
This indication is based on Week 24 analyses of plasma HIV RNA levels
and CD4+ cell counts from two controlled trials of PREZISTA/rtv in
combination with other antiretroviral drugs. Both studies were conducted in
clinically advanced, treatment-experienced (NRTIs, NNRTIs, and PIs) adult
patients with evidence of HIV-1 replication despite ongoing antiretroviral
therapy.
The following points should be considered when initiating therapy with
PREZISTA/rtv:
-- Treatment history and, when available, genotypic or phenotypic testing
should guide the use of PREZISTA/rtv.
-- The use of other active agents with PREZISTA/rtv is associated with a
greater likelihood of treatment response.
-- The risks and benefits of PREZISTA/rtv have not been established in
treatment-na??ve adult patients or pediatric patients.
Important Safety Information
PREZISTA does not cure HIV infection or AIDS, and does not prevent
passing HIV to others.
PREZISTA is contraindicated in patients with known hypersensitivity to
any of its ingredients.
Coadministration of PREZISTA/r is contraindicated with drugs that are
highly dependent on CYP3A for clearance and have a narrow therapeutic index
(e.g., astemizole, terfenadine, dihydroergotamine, ergonovine, ergotamine,
methylergonovine, cisapride, pimozide, midazolam, or triazolam) and for
which elevated plasma concentrations are associated with serious and/or
life- threatening events. Coadministration is not recommended with
carbamazepine, phenobarbital, phenytoin, rifampin, lopinavir/ritonavir,
saquinavir, lovastatin, pravastatin, simvastatin, or products containing
St. John's wort (Hypericum perforatum).
Caution should be used when prescribing agents such as sildenafil,
vardenafil, tadalafil, or other substrates, inhibitors, or inducers of
CYP3A in patients receiving PREZISTA/rtv. This list of potential drug
interactions is not complete.
PREZISTA must be co-administered with 100 mg ritonavir and food to
exert its therapeutic effect. Failure to correctly administer PREZISTA with
ritonavir and food will result in reduced plasma concentration of darunavir
that will be insufficient to achieve the desired antiviral effect. Please
refer to ritonavir prescribing information for additional information on
precautionary measures.
Severe skin rash, including erythema multiforme and Stevens-Johnson
Syndrome, has been reported in subjects receiving PREZISTA during the
clinical development program. In some cases, fever and elevations of
transaminases have also been reported. In clinical trials (n=924), rash
(all grades, regardless of causality) occurred in seven percent of subjects
treated with PREZISTA; discontinuation due to rash was 0.3 percent. Rashes
were generally mild-to-moderate, self-limiting and maculopapular. PREZISTA
should be discontinued if severe rash develops.
PREZISTA should be used with caution in patients with known sulfonamide
allergy.
New-onset or exacerbations of pre-existing diabetes mellitus and
hyperglycemia, and increased bleeding in hemophiliacs have been reported in
patients receiving protease inhibitors. A causal relationship between
protease inhibitors and these events has not been established.
PREZISTA should be used with caution in patients with hepatic
impairment. There are no data regarding the use of PREZISTA in patients
with varying degrees of hepatic impairment; therefore, specific dosage
recommendations cannot be made.
Redistribution and/or accumulation of body fat have been observed in
patients receiving ARV therapy. The causal relationship, mechanism, and
long- term consequences of these events have not been established.
Immune reconstitution syndrome has been reported in patients treated
with ARV therapy.
The potential for HIV-cross-resistance among protease inhibitors has
not been fully explored in PREZISTA/rtv treated patients.
PREZISTA should be used during pregnancy only if the potential benefit
justifies the potential risk. There are no adequate and well-controlled
studies in pregnant women. The effects of PREZISTA on pregnant women or
their unborn babies are not known.
In the pooled analysis of POWER 1 and 2 studies, the most frequently
reported drug-related adverse events of at least moderate to severe
intensity in patients receiving PREZISTA/rtv-containing regimen were
headache (3.8 percent), diarrhea (2.3 percent), abdominal pain (2.3
percent), constipation (2.3 percent), and vomiting (1.5 percent).
Please see full Prescribing Information for more details.
About PREZISTA
PREZISTA was developed by Tibotec Pharmaceuticals Ltd. and is marketed
in the U.S. by Tibotec Therapeutics, a division of Ortho Biotech Products,
L.P.
About Tibotec Therapeutics
Tibotec Therapeutics, a division of Ortho Biotech Products, L.P.,
headquartered in Bridgewater, N.J., is dedicated to delivering innovative
virology therapeutics that help healthcare professionals address serious
unmet needs in people living with HIV.
About Tibotec Pharmaceuticals Ltd.
Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a
pharmaceutical research and development company. The Company's main
research and development facilities are in Mechelen, Belgium with offices
in Yardley, PA. Tibotec is dedicated to the discovery and development of
innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet
medical need.
Tibotec Pharmaceuticals is developing a Global Access Program to
facilitate access to its antiretrovirals for patients living with HIV/AIDS
in developing countries. The Global Access Program includes access pricing,
registration, medical education for appropriate use and voluntary
licensing.
Tibotec Therapeutics
tibotectherapeutics
View drug information on Prezista.
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