четверг, 25 августа 2011 г.
Protection Against Cancer May Begin During Pregnancy
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
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.
четверг, 11 августа 2011 г.
Delegates Agree To Focus On HIV/AIDS, Other Issues Hindering African Development At Close Of Tokyo Conference
Conference participants discussed strategies to help African nations meet the United Nations Millennium Development Goals and agreed it would be a "difficult task" for the continent to achieve the goals by 2015 in part because of the spread of HIV/AIDS and other diseases. The delegates also reaffirmed commitments to increase efforts to fight HIV/AIDS, malnutrition, and infant and maternal mortality on the continent. In addition, the delegates called on the Group of Eight industrialized nations to honor their commitments to provide development aid to Africa.
Africa's progress toward meeting the MDGs will be monitored by a three-tier follow-up plan developed at the conference. Under the plan, participants will produce an annual progress report. A list of proposed strategies to help Africa meet the goals, as well as possible contributions from stakeholders, also are included in the plan.
Africa "made its case during this meeting," Tanzanian President Jakaya Mrisho Kikwete said, adding that delegates "heard very strong voices at this meeting championing not just for increased aid but also for increased trade and investment and for more private-sector participation" in helping African nations address HIV/AIDS and other issues that are hindering development. U.N. Deputy Secretary-General Asha-Rose Migiro added that the delegates established "a way forward" to help Africa meet the MDGs and "have charted" out how the continent can achieve the goals.
During the conference, the Japanese government pledged 43 billion yen, or about $409 million, to be used for health programs in Africa over the next five years. Japan also pledged to provide assistance for education, infrastructure, water, sanitation and agriculture (Kyodo News/TMCnet, 5/30). In addition, Japan will train 100,000 health care workers over the next five years to help address Africa's shortage of health care workers.
The conference was co-organized by the Japanese government, the U.N. Office of the Special Adviser on Africa, the U.N. Development Program and the World Bank (Kaiser Daily HIV/AIDS Report, 5/29). More than 2,500 delegates attended the conference, the largest since the first TICAD in 1993. The next conference will be held in 2013, the Kyodo News/TMCnet reports (Kyodo News/TMCnet, 5/30).
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.
© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
четверг, 4 августа 2011 г.
Kaiser Daily Women's Health Policy Report Highlights Recently Released Journal Articles
Public Health
"Efficacy of Naltrexone in Smoking Cessation: A Preliminary Study and an Examination of Sex Differences," Nicotine and Tobacco Research: Andrea King of the Department of Psychiatry at the University of Chicago and colleagues examined 110 adults who smoked 15 to 40 cigarettes daily and had tried to quit several times, the Chicago Sun-Times reports. All participants underwent six sessions of behavioral counseling and wore a nicotine patch for one month. Half of the participants took a naltrexone pill daily, and half took a placebo. According to the study, 58% of the women who took naltrexone after two months had quit successfully, compared with 39% in the placebo group. The results were not statistically significant among men. In addition, about one-third of all participants continued not to smoke after six months (Ritter, Chicago Sun-Times, 10/9). "The results suggest continued examination of naltrexone as an adjunct in smoking cessation, particularly in female smokers, who have historically shown worse outcomes with traditional treatment methods," researchers concluded (King et al., Nicotine and Tobacco Research, October 2006). King is conducting a follow-up study that will monitor 324 smokers for one year (Chicago Sun-Times, 10/9).
"Occupation and Breast Cancer: A Canadian Case-Control Study," Annals of the New York Academy of Sciences: James Brophy -- executive director of the Occupational Health Clinic for Ontario Workers in Sarnia, Canada -- and colleagues compared the work histories of 564 women diagnosed with breast cancer at the Windsor Regional Cancer Centre from 2000 through 2002. Of the 564 women, 154 had worked on farms, the study finds. The women who had worked on farms were compared to an equal number of women living in the same area who did not have breast cancer, Toronto's Globe and Mail reports. The study finds that women with farming experience were 2.8 times more likely to develop breast cancer compared with nonfarmers. In addition, the study finds that women who had worked on farms and then worked in the automotive industry were four times more likely to develop the disease than those who had worked in neither industry (Mittelstaedt, Globe and Mail, 10/12). According to Brophy, environmental contaminants such as antibiotics, growth hormones and diesel fumes are common in agricultural settings and could be a factor in the higher breast cancer rates, but the study could not determine if one type of farming is more dangerous than another. The study is not a "smoking gun," Brophy said, adding that it "shows the importance of looking at occupation as a potential risk factor [for developing breast cancer] and that something is going on ... within the rural population." Ann Chambers, a professor of oncology at the University of Western Ontario's Schulich School of Medicine and Dentistry, said that it was a "good study" but that it is important to understand that the association between cancer and farming that is drawn from the study does not prove there is a causal relationship between the two. Brophy currently is expanding his sample size to 1,000 women to see if the link between breast cancer and farming is seen outside the Windsor area, the Toronto Star reports (Hall, Toronto Star, 10/12).
"Truncating Mutations in the Fanconi Anemia J Gene BRIP1 Are Low-Penetrance Breast Cancer Susceptibility Alleles," Nature Genetics: Nazneen Rahman of the Institute of Cancer Research in the United Kingdom and colleagues screened women for genes that interact with BRCA1 and BRCA2 -- mutations of which have been found to increase the risk of developing breast cancer -- Reuters UK reports. The researchers conducted the study among 1,212 women with breast cancer who did not have mutations in BRCA1 and BRCA2 and more than 2,000 women without breast cancer. The researchers found that nine of the women with breast cancer had mutations in a gene called BRIP1 -- which helps to repair damaged DNA -- while two of the women without cancer had the mutation. According to the researchers, certain mutations in BRIP1 -- which also is called BACH1 -- might cause the blood disorder Fanconi anemia (Reuters UK, 10/9).
"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.
View drug information on Naltrexone Hydrochloride Tablets.