Research Highlights Need For Smoke-Free Car Laws, Public Health Campaigns To Protect Youngsters From Toxins

It is absolutely unacceptable to subject children to any tobacco smoke exposure in cars, according to the authors of an abstract to be presented Sunday, May 1, at the Pediatric Academic Societies (PAS) annual meeting in Denver.

“An infant strapped into a car seat is involuntarily and intensely exposed to more than 400 toxic chemicals in tobacco smoke,” said abstract co-author Jonathan P. Winickoff, MD, MPH, FAAP. “They have no voice and no choice in whether their parents smoke in the car.”

Dr. Winickoff and his colleagues conducted the analyses to determine the prevalence of tobacco smoke exposure in cars among children and to examine factors associated with parents strictly enforcing a ban on smoking in their cars.

Parents were invited to participate in a survey after their children had been seen for a well or sick visit at one of seven pediatric practices in six states. Parents who smoked were asked if they had a car, whether they had smoking rules in their car, their child’s age and if their pediatrician advised them to have a smoke-free car. Parents were considered to have a strictly enforced car smoking ban if they reported having a smoke-free car rule and that no one had smoked in their car for the past three months.

The results are based on a Pediatric Research in Office Settings (PROS) trial called the Clinical Effort Against Secondhand Smoke Exposure (CEASE), which addressed parental smoking. PROS is a network of pediatric primary care practices established by the American Academy of Pediatrics (AAP) to conduct research on child health problems.

Results showed that 146 of 528 parents who smoked (28 percent) reported having a smoke-free car rule, and 114 (22 percent) reported having a strictly enforced car smoking ban. Factors associated with having a smoking ban included having a younger child and smoking fewer cigarettes per day.

Of the parents who reported smoking in their car, 52 percent said smoking occurred with children present. Only 14 percent of parents said they were advised by a pediatric health care provider to have a smoke-free car.

“Because they have smaller air passages than adults, infants and children are more sensitive to chemicals in tobacco smoke and suffer increased asthma attacks and severe respiratory infections,” said Dr. Winickoff, CEASE principal investigator and associate professor of pediatrics at MassGeneral Hospital for Children.

“Coupled with the finding that few pediatric health care providers advise against smoking in cars, these results highlight the need for improved pediatric interventions, public health campaigns and health policy regarding smoke-free car laws to protect children from tobacco smoke toxins,” he said. “Setting strict rules about never smoking in cars will benefit the whole family and help reduce tobacco use nationally.”

Other abstracts based on the CEASE data presented on Saturday, April 30, during the PAS meeting include:

“Are Strictly Enforced Smoke-free Home and Car Rules Associated with Parent Quit Attempts?” A strictly enforced no-smoking policy in the home and car was associated with recent quit attempts by parents who smoked. “This research suggests that completely protecting children from tobacco smoke in the home and car may also help parents quit smoking,” said lead author Stacia Finch.

“What Factors Are Associated with Smoke-free Homes Among Smoking Parents?” Parents were more likely to report having a smoke-free home if they had a child younger than 10 years old; fewer than three smokers lived in the home; and if parents banned smoking in the car.

“Parent/Smoker Identity Conflict and Readiness to Quit.” Parents who agreed with the statement, “My being a smoker gets in the way of my being a parent,” were considered to have identity conflict and were more likely to be seriously planning to quit smoking than those who disagreed with the statement. “Interventions that increase identity conflict among parents who smoke might increase their readiness to quit smoking,” Dr. Winickoff said.

Source:
Susan Martin
American Academy of Pediatrics

Specialized Exercise Regimen At UB Shown To Relieve Prolonged Concussion Symptoms

University at Buffalo researchers are the first to show that a controlled individualized exercise training program can bring athletes and others suffering with post-concussion syndrome (PCS) back to the playing field or to their daily activities.

In a paper published in the January issue of the Clinical Journal of Sport Medicine, the researchers report that a program of progressive exercise developed individually for each participant and performed at levels just below the onset of symptoms is safe and can relieve nearly all PCS symptoms.

Their results counter the accepted wisdom that PCS should be treated with rest, reassurance and antidepressants, and that physical activity should be avoided.

“Perhaps the most exciting aspect of this study is that all of the subjects that participated, both athletes and non-athletes, got better eventually, although the athletes certainly improved the fastest,” says Barry Willer, PhD, UB professor of psychiatry and rehabilitation sciences and senior author on the study.

“It also was reassuring to discover that the use of exercise was safe and did not prolong symptoms, a worry expressed by other practitioners.”

John J. Leddy, MD, associate professor of orthopaedics and co-director of UB’s Sports Medicine Institute, where the study was conducted, is first author on the study. Willer, Leddy and Karl Kozlowski, PhD, UB clinical instructor of exercise and nutrition sciences, developed the exercise protocol. (To view a slide show about a patient who participated in the UB program, go to youtube/watch?v=pUEmfnIIhwM.)

For unknown reasons, 5-10 percent of people who experience a concussion have symptoms that persist beyond six weeks. These persons are diagnosed with PCS. Previously there was no treatment for the condition with proven success.

The UB regimen is based on the hypothesis that the regulatory system responsible for maintaining cerebral blood flow, which may be dysfunctional in people with a concussion, can be restored to normal by controlled, graded, symptom-free exercise.

The researchers developed their program in 2004. “We were testing athletes for return to sport using an exercise test,” says Willer, “and we decided that if an athlete becomes symptomatic at a heart rate of, say, 140, maybe they could exercise at a heart rate of 125, without complications. We soon discovered that the athletes got better much quicker if they exercised.”

Physicians in UB’s Sports Medicine Concussion Clinic initially used their approach only with athletes from UB teams, but word spread, and they now have assessed and treated many professional athletes, especially those from the National Hockey League.

“One of the advantages we offer to professional teams is a more precise test of post-concussion syndrome,” says Leddy. “If the patient does not develop symptoms during the exercise test, then the cause of their difficulties is likely to be another source. Most commonly it is neck strain, which tends to cause headaches that mimic post-concussion headache.”

For the preliminary study just published, the researchers enrolled six non-athletes who suffered concussions in auto accidents or falls, along with six athletes, five who were injured in their sport and one in a car accident.

Participants were tested initially on a treadmill to determine the exercise intensity that triggered symptoms. With individual baselines established, each participant exercised at 80 percent of that intensity every day for three weeks and then returned for a repeat test. In most instances, retesting demonstrated that participants could work at a higher intensity and the exercise protocol then was increased. This pattern continued until participants could exercise completely without experiencing PCS symptoms.

As might be expected, the athletes recovered more quickly than the non-athletes, results showed. They returned to normal within 11 to 36 days, while the non-athletes required 41 to 112 days of intervention. All participants had returned to work, school or athletic activities at a three month post-program follow-up.

Ten of the 12 participants were completely free of symptoms at follow-up. One participant still experienced cognitive and visual symptoms, and another, who had a history of migraines, continued to experience headaches.

“The data suggest that some PCS symptoms are related to disturbed cerebral autoregulation, and that after this treatment, the brain was able to regulate blood flow when the blood pressure rose during exercise,” says Leddy. “We think progressive stepwise aerobic training may improve cerebral autoregulation by conditioning the brain to gradually adapt to repetitive mild elevations of systolic blood pressure.”

Kozlowski adds that although each concussion should be considered a “unique injury,” a randomized trial that included a PCS control group should be conducted to address the possibility that PCS symptoms would have resolved spontaneously without intervention.

“All of our subjects had been symptomatic for months before treatment and were not getting better on their own,” says Kozlowski, “so we are pretty convinced that the regulated exercise program did the trick.” A grant application to NIH to conduct such a randomized trial currently is under review.

James P. Donnelly, PhD, from the UB Department of Counseling, School and Educational Psychology; David R. Pendergast, EdD, UB professor of physiology and biophysics; and Leonard H. Epstein, PhD, UB professor of pediatrics, also contributed to the study.

The study received financial support from the Buffalo Sabres Foundation and the Robert Rich Family Foundation.

Source: Lois Baker

University at Buffalo

First Prospective Evidence To Support A Directional Link Between Common Sleep Complaints And Incident Metabolic Syndrome

A study in the journal SLEEP found that loud snoring and two common insomnia symptoms – difficulty falling asleep and unrefreshing sleep – each significantly predicted the development of the metabolic syndrome. The study emphasizes the importance of screening for common sleep complaints in routine clinical practice.

Results of multivariate logistic regression models show that the risk of developing the metabolic syndrome over a three-year follow-up period was more than two times higher in adults who reported frequent loud snoring (odds ratio = 2.30). This risk also was increased by 80 percent in adults who reported having difficulty falling asleep (OR = 1.81) and by 70 percent in those who reported that their sleep was unrefreshing (OR = 1.71).

Further analysis found that unrefreshing sleep was reduced to marginal significance with additional adjustment for loud snoring. However, when simultaneously entered in a statistical model, both loud snoring and difficulty falling asleep remained significant independent predictors of the metabolic syndrome.

“This is the first prospective study to show that a broader array of commonly reported sleep symptoms, including insomnia and sleep-disordered breathing symptoms, predict the development of the metabolic syndrome, a key risk factor for cardiovascular disease,” said lead author Wendy M. Troxel, PhD, assistant professor of psychiatry and psychology at the University of Pittsburgh in Pittsburgh, Pa. “It was rather striking that the effects of difficulty falling asleep and loud snoring were largely independent of one another.”

According to the National Heart, Lung, and Blood Institute, metabolic syndrome is a group of obesity-related risk factors that increases an individual’s risk of heart disease, diabetes and stroke. A person with at least three of these five risk factors is considered to have metabolic syndrome: excess abdominal fat, high triglycerides, low HDL cholesterol, high blood pressure and high blood sugar.

Analyses of these five individual components of the metabolic syndrome revealed that loud snoring significantly predicted the development of high blood sugar (OR = 2.15) and low HDL cholesterol (1.92). Difficulty falling asleep and unrefreshing sleep did not predict any of the individual metabolic abnormalities.

Only loud snoring continued to predict the development of the metabolic syndrome after accounting for the number of metabolic abnormalities present at baseline. According to the authors, this suggests that loud snoring may be a causal risk factor cardiometabolic dysregulation.

The study involved 812 participants in Heart SCORE, an ongoing, community-based, prospective study of adults between 45 and 74 years of age. People who were classified as having the metabolic syndrome or diabetes at baseline were excluded form the study. During the three-year follow-up period, 14 percent of participants developed the metabolic syndrome.

Self-reported sleep disturbances were assessed using the Insomnia Symptom Questionnaire and the Multivariable Apnea Prediction Questionnaire. The development of the metabolic syndrome was unrelated to difficulty staying asleep and frequent awakening from sleep, which are two other insomnia symptoms that are commonly reported.

Apnea-hypopnea index (AHI), an average of the combined episodes of partial reductions (hypopneas) and complete pauses (apneas) in breathing per hour of sleep, was calculated in a subset of 290 participants who wore a portable monitor that measured nasal airflow. In an analysis of this subset, loud snoring remained an independent predictor of the development of the metabolic syndrome (OR = 3.01) even after adjusting for AHI, while difficulty falling asleep was reduced to marginal statistical significance.

The study was supported by the Commonwealth of Pennsylvania Department of Health; and the National Heart, Lung, and Blood Institute and the Clinical & Translational Science Awards of the National Institutes of Health.

Source:
Emilee McStay

American Academy of Sleep Medicine

Identification Of Genes That Control Embryonic Stem Cell Fate

Scientists have identified about two dozen genes that control embryonic stem cell fate. The genes may either prod or restrain stem cells from drifting into a kind of limbo, they suspect. The limbo lies between the embryonic stage and fully differentiated, or specialized, cells, such as bone, muscle or fat.

By knowing the genes and proteins that control a cell’s progress toward the differentiated form, researchers may be able to accelerate the process – a potential boon for the use of stem cells in therapy or the study of some degenerative diseases, the scientists say.

Their finding comes from the first large-scale search for genes crucial to embryonic stem cells. The research was carried out by a team at the University of California, San Francisco and is reported in a paper in the July 11, 2008 issue of Cell.

“The genes we identified are necessary for embryonic stem cells to maintain a memory of who they are,” says Barbara Panning, PhD, associate professor of biochemistry and biophysics at UCSF, and senior author on the paper. “Without them the cell doesn’t know whether it should remain a stem cell or differentiate into a specialized cell.”

The scientists used a powerful technique known as RNA interference, or RNAi, to screen more than 1,000 genes for their role in mouse embryonic stem cells. The technique allows researchers to “knock down” individual genes, reducing their abundance in order to determine the gene’s normal role.

The research focused on proteins that help package DNA. In the nucleus, DNA normally wraps around protein complexes called nucleosomes, forming a structure known as chromatin. This is what makes up chromosomes.

They found 22 proteins, each of which is essential for embryonic stem cells to maintain their consistent shape, growth properties, and pattern of gene expression.

Most of the genes code for multi-protein complexes that physically rearrange, or “remodel” nucleosomes, changing the likelihood that the underlying genes will be expressed to make proteins.

The main player they identified is a 17-protein complex called Tip60-p400. This complex is necessary for the cellular memory that maintains embryonic stem cell identity, Panning explains. Without it, the embryonic stem cells turned into a different cell type, which had some features of a stem cell but many features of a differentiated cell.

The scientists believe that Tip60-p400 is necessary for embryonic stem cells to correctly read the signals that determine cell type. These findings are not only important for understanding cellular memory in embryonic stem cells, but will also likely be relevant to other cell types, they say.

Inactivation of other genes disrupted embryonic stem cell proliferation. These genes were already known to have only slight influence on viability of mature cells in the body. This suggests that embryonic stem cells are “uniquely sensitive to certain perturbations of chromatin structure,” the scientists report.

If other types of stem cells are also found to be sensitive to these chromatin perturbations, this could lead to novel cancer therapies in the future, Panning says.

###

Lead author on the paper is Thomas G. Fazzio, PhD, a postdoctoral fellow. Co-author is Jason T. Huff, BSc, a graduate student. Both are in Panning’s lab.

The research is supported by the National Institutes of Health.

UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.

Source: Kristen Bole

University of California – San Francisco

Invatec Introduces AMPHIRION DEEP™ Long Balloon To More Easily Access And Treat Arteries Below The Knee

Invatec, a comprehensive innovator of interventional products, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Amphirion Deep 150 mm Long PTA Balloon and Tapered 210 mm Long PTA Balloon in the United States. The Amphirion Deep Long Balloons join the preexisting Amphirion Deep family of dedicated below the knee (BTK) PTA catheters, which are specifically designed to reach, access and treat arteries below the knee.

With the introduction of the 150 mm and Tapered 210 mm Long Balloons to the US market, physicians can now reach and treat arteries in the feet more easily than ever before. The 150 mm and Tapered 210 mm Long Balloons are indicated to dilate stenoses in the femoral, popliteal and infra-popliteal arteries, while sharing the same unique design and quality features as the rest of the Amphirion Deep product line. The unique Tapered 210 mm Long Balloon is anatomically-designed to provide more precise balloon-to-vessel conformability in the narrowed and tapered distal regions of the leg and foot.

Krishna Rocha-Singh, M.D., F.A.C.C., director of the Prairie Vascular Institute (Springfield, Ill.) commented, “Deep in the lower limb, below the ankle, the vessels narrow. The design of the Tapered 210 mm Long Amphirion allows the effective treatment of the most distal lesions. The Tapered 210 mm is an exceptional aid in the treatment of this very challenging patient population and greatly welcomed.”

“The availability of the Amphiron Deep 150 mm and 210 mm Long Balloons underscores our commitment to offering a full range of peripheral solutions,” commented Jack Springer, president of Invatec, Inc. “The 510(k) for the 150 mm and unique Tapered 210 mm balloons has allowed us to offer more products to physicians, enabling the treatment of additional patients with BTK disease. For many physicians, the Amphirion has become the product of choice and we are pleased to be able to extend the line to these new lengths.”

The entire Amphirion Deep line is 4 French compatible and has a differentiated shaft diameter designed to promote flexibility and trackability without compromising the balloon’s pushability. Invatec’s Amphirion line also boasts a low-profile, enabling ease of crossability. The Amphirion Deep BTK PTA Balloon Catheter line is now available in the US in diameters of 1.5 – 4.0 mm and 20 – 210 mm in length.

About Invatec

Invatec is a comprehensive innovator of vascular interventional products with global headquarters based in Italy. Driven by research and technology, Invatec actively collaborates with physicians and centers of excellence to develop products that will improve life expectancy and quality of life for patients. The company’s core competencies include polymer processing, metal technology and surface technology. Invatec is vertically integrated with full in-house capabilities to design, develop, manufacture and assemble a complete line of product families focusing on interventional peripheral, coronary and neuro products, which are offered in more than 70 countries. Dedicated to “making ideas come alive,” the company was founded in 1996 by Andrea Venturelli and Stefan Widensohler, and has grown to almost 1,000 employees. For more information, visit invatec.

Source
Invatec

Pesticides Need Sunscreen To Beat The Heat

A pesticide with a new in-built sunscreen will help farmers beat the heat in crop protection. This means that the bug sprays last longer, as they are protected from the strong rays of sunshine, reports Chemistry & Industry, the magazine of the SCI. This is becoming increasingly important as temperatures rise, with the Met Office announcing that several heat records were broken in the UK this year.

The team of scientists, led by Dr Li-Xiong Wen, has developed a new type of capsule that shields pesticides from UV light. The research, to be published on Monday in Pest Management Science (DOI 10.1002/ps.1301) shows that the pesticides can be exposed to sunlight for at least twice as long without degrading.

Dr Wen, of the Bejing University of Chemical Technology, believes that the pesticide will be more effective as a result, thereby reducing the amount required and the cost to the farmer. It could also mean cleaner waters, as the risks of excess pesticide contamination will be lowered.

“It can be used for many other pesticides. We are considering it as a platform carrier material for pesticides and have looked at several pesticides, including this oil-soluble avermectin, and water-soluble validamycin, and a couple of others, all demonstrating the same behaviors,” Wen said.

About Chemistry & Industry

Chemistry & Industry magazine from SCI delivers news and comment from the interface between science and business. As well as covering industry and science, it focuses on developments that will be of significant commercial interest in five- to ten-years time. Published twice-monthly and free to SCI Members, it also carries authoritative features and reviews. Opinion-formers worldwide respect Chemistry & Industry for its independent insight.

chemind

About SCI

SCI is a unique international forum where science meets business on independent, impartial ground. Anyone can join, and the Society offers a chance to share information between sectors as diverse as food and agriculture, pharmaceuticals, biotechnology, environmental science and safety. As well as publishing new research and running events, SCI has a growing database of member specialists who can give background information on a wide range of scientific issues.

Originally established in 1881, SCI is a registered charity with members in over 70 countries.

www.chemind

About Wiley

John Wiley & Sons, Ltd., based in Chichester, England, is the largest subsidiary of John Wiley & Sons, Inc. Founded in 1807, John Wiley & Sons, Inc., provides must-have content and services to customers worldwide. Their core businesses include scientific, technical, and medical journals, encyclopedias, books, and online products and services; professional and consumer books and subscription services; and educational materials for undergraduate and graduate students and lifelong learners. Wiley has publishing, marketing, and distribution centres in the United States, Canada, Europe, Asia, and Australia. The company is listed on the New York Stock Exchange under the symbols JWa and JWb. Wiley’s recently re-launched Internet site can be accessed at www.wileyeurope

Pest Management Science (PMSci) is an international, peer-reviewed journal of research and technology on crop protection and pest control. Since its launch in 1970, the journal has become the premier forum for papers covering all aspects of research and development, application, use and impact on the environment of products designed for pest control and crop protection.

PMSci is an SCI journal, published by John Wiley & Sons, on behalf of the Society of Chemical Industry, and is available in print (ISSN: 1526-498X)
Online (ISSN: 1526-4998) via Wiley InterScience www.interscience.wiley

Click here for more information on the journal

A Good Source Of Vitamin A: Corn Bred To Contain Beta-Carotene

A new Iowa State University study has found that corn bred to contain increased levels of beta-carotene is a good source of vitamin A. The discovery gives added support to the promise of biofortified corn being developed through conventional plant breeding as an effective tool to combat vitamin A deficiency in developing countries.

Beta-carotene is converted in the body to vitamin A. The researchers found that the beta-carotene in the corn was converted to vitamin A at a higher rate than what’s predicted for corn, and higher than the rate for beta-carotene in vegetables – including spinach and carrots, among others.

Wendy White, an ISU associate professor of food science and human nutrition, led the six-week study conducted at Iowa State’s Nutrition and Wellness Research Center. The results validate the promise of ‘orange’ maize that will soon be released to combat vitamin A deficiency in sub-Saharan Africa.

According to a 2009 World Health Organization estimate, vitamin A is deficient in more than half of the world’s countries, with Africa and Southeast Asia having the highest deficiencies. Medical researchers have reported vitamin A deficiency to be one of the most serious causes of malnutrition in developing countries and can cause blindness, poor immune function and even premature death — particularly in young children.

Working with HarvestPlus on biofortified corn

The effort to biofortify corn with beta-carotene is being led by HarvestPlus – a global research initiative directed, in part, by the Washington, D.C.-based International Food Policy Research Institute.

“Biofortification is a revolutionary approach to combating micronutrient malnutrition in developing countries and it has the potential to be self-sustaining,” White said. “The seeds are bred by plant breeders to be naturally high in key micronutrients, such as vitamin A, zinc and/or iron. And then the seeds will ultimately be distributed to poor farmers in developing countries and they’ll be able to reproduce the seeds so they can share them with their communities.

“This study answered a major feasibility concern for the biofortification program because plant breeders were quickly successful in ramping up the beta-carotene content in the corn, but then the question was, ‘Would it be available to be absorbed and utilized by people?,’” she continued. “So what we’ve shown is the beta-carotene is bioavailable to be converted to vitamin A in the body, and much more so than previously expected.”

The study was posted online this month by the American Journal of Clinical Nutrition, which is published by the American Society for Nutrition. Iowa State graduate students Shanshan Li and Angela Nugroho, and Purdue University researcher Torbert Rocheford — who was at the University of Illinois at Urbana-Champaign at the time the research was conducted — collaborated with White on the study. An abstract is available here.

The researchers had their six healthy female subjects, between the ages of 18 and 30, consume 250-gram portions of maize porridge three times at two-week intervals. Each subject consumed the beta-carotene biofortified maize porridge, as well as two white maize control porridges that were naturally devoid of beta-carotene, but contained known amounts of added beta-carotene or vitamin A. Blood samples were drawn after they ate each porridge to determine the amount of vitamin A that was absorbed in the blood.

An important step in fighting malnutrition

White says the study’s findings provide an important step in the process of making the biofortified corn available to the people who desperately need vitamin A in their diets.

“These [their subjects] were mostly graduate students based in the U.S. who were screened for excellent health. So this study was conducted under ideal conditions,” White said. “And so the next step — knowing that under ideal conditions the beta-carotene can be well absorbed — is to take it into a more field setting.”

White reports that there is already a pilot program being conducted in Zambia to feed the beta-carotene, biofortified maize to young children to increase their vitamin A intake. HarvestPlus is conducting that project and supported the development of the maize for the Iowa State study.

The HarvestPlus Challenge Program was launched when it became the first recipient of funding for biofortification research granted by the Bill and Melinda Gates Foundation.

Source:
Mike Ferlazzo
Iowa State University

PSA Screening May Be Biased Against Obese Men, Leading To More Aggressive Cancers

Testing men for elevated levels of prostate-specific antigen (PSA) in the blood — the gold standard screening test for prostate cancer — may be biased against obese men, whose PSA levels tend to be deceptively low. And this bias may be creating more aggressive cancers in this population by delaying diagnosis, according to a new study led by investigators in the Duke Prostate Center and the Durham Veterans Affairs (VA) Medical Center.

“We know that obese men tend to have lower PSA values than their normal-weight counterparts, possibly caused by larger blood volumes which dilute the readings,” said Stephen Freedland, M.D., a urologist at Duke and the Durham VA, and lead investigator on this study. “Now we know some of the real implications of this — that these men are at a disadvantage in terms of prognosis compared to normal-weight men.”

The researchers published their findings online in the journal BJU International. The study was funded by the United States Department of Veterans Affairs, the National Institutes of Health, the Georgia Cancer Coalition, the United States Department of Defense, the Prostate Cancer Research Program and the American Urological Association Foundation’s Astellas Rising Star in Urology Award, given to Freedland.

“We used patient data to examine the association between body mass index, or BMI — a measure of obesity — and the amount of disease discovered after surgery to remove the prostate, ” Freedland said. “We compared men who had their cancers detected by PSA screening to those who had an abnormal digital rectal exam, which may not confer the same bias against obese men.”

The researchers looked at a total of nearly 3,400 men in the years since 2000, when PSA screening became the gold standard test for prostate cancer.

Obese patients whose cancer was diagnosed by PSA testing had more than twice the risk of cancer recurrence after surgery than their normal-weight counterparts, Freedland said. “In contrast, obese men with abnormal digital rectal exams had similar outcomes as normal-weight men,” Freedland said.

Another Duke study published in the same issue of the journal provides further substantiation of the concern that obese men have poorer prognoses than normal-weight men. This study showed that obese men have a higher rate of positive surgical margins after surgery to remove the prostate, meaning that there was a higher chance cancer was left behind.

This suggests that prostate cancer surgery is technically more challenging in obese men, making complete tumor removal harder, according to Jayakrishnan Jayachandran, M.D., a urological oncology fellow at Duke and lead investigator on the second study.

“The aggressiveness of obese men’s tumors, coupled with the fact that they may be more difficult to remove, is like a double whammy for being obese,” Jayachandran said.

“The least we can do is find a way to level the playing field when it comes to diagnostic tools,” Freedland said.

PSA screening has been the most common tool used to detect prostate cancer over the past eight to ten years; men are less commonly diagnosed based on digital rectal exam alone.

The researchers are hopeful that this data, coupled with the earlier data on which it builds, may be a catalyst to encourage alternative screening methods for obese men, or a lower threshold for worrisome PSA levels in obese men.

“Obesity is very common in the United States, so this potentially affects a lot of people,” Freedland said. “We can’t forget that when we use the term obese we are not just talking about very, very large men. A man who is 5 foot 9 and weighs 203 pounds would be considered obese.”

Other researchers involved with the PSA study include Leon Sun and Judd Moul of Duke; Christopher Kane of the University of California – San Diego; Joseph Presti of Stanford; Martha Terris of the Medical College of Georgia; and William Aronson of the University of California – Los Angeles.

Duke University Medical Center

Affymax Completes Treatment And Last Patient Follow-up In Phase 3 Program For Investigational Drug, Hematide, To Treat Anemia In Chronic Renal Failure

Affymax, Inc. (Nasdaq:AFFY) announced completion of treatment and follow-up of patients with anemia due to chronic renal failure enrolled in the four-trial, Phase 3 clinical program for the investigational drug Hematide. The company expects to report topline results from all four Phase 3 trials in the second quarter of 2010. The Phase 3 clinical program enrolled approximately 2,600 chronic renal failure patients at approximately 400 clinical trial sites.

“Completion of this comprehensive Hematide program marks a major milestone and we anticipate an intensive period of data compilation and analysis,” said Arlene Morris, president and chief executive officer of Affymax, Inc. “We look forward to sharing top-line data in the coming months that, if positive, will support our plan to file a NDA for Hematide in chronic renal failure later this year.”

The Hematide Phase 3 program consisted of four open-label, randomized active-controlled clinical trials in the U.S. and Europe, including two trials in dialysis patients and two others in patients not on dialysis. The PEARL 1 and PEARL 2 trials conducted in non-dialysis patients were designed to evaluate the safety and efficacy of Hematide compared with darbepoetin alfa for treating anemia and maintaining hemoglobin levels over time based on the trial protocol.

In dialysis patients, the EMERALD 1 and EMERALD 2 trials evaluated the safety and efficacy of Hematide in its ability to maintain hemoglobin levels in the target range when patients were switched from epoetin alfa or epoetin beta to Hematide.

Analysis of efficacy for each of the four studies is based on assessments of non-inferiority to the comparator drugs. The primary efficacy endpoint is the mean change in hemoglobin from baseline. The hemoglobin target range is 11-12 g/dL for non-dialysis patients and 10-12 g/dL for those on dialysis.

In all studies, Hematide was dosed once every four weeks while comparator drugs were dosed more frequently according to their product labels. Treatment in each trial was continued until the last patient had been treated for at least 52 weeks. The primary safety assessment will be determined by the analysis of non-inferiority to comparator drugs using a composite cardiovascular endpoint from a safety database pooled from the four Phase 3 trials. The duration of the Phase 3 program was contingent on collecting a sufficient number of cardiovascular safety events for statistical analysis.

About Hematide

Hematide is a novel synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an erythropoiesis stimulating agent (ESA).

Affymax and Takeda are collaborating on the development of Hematide and plan to co-commercialize the product once approved in the United States. Phase 3 clinical trials investigated the potential for Hematide to treat anemia associated with chronic renal failure. The product, upon approval, will be commercialized in the European Union by Takeda.

About Anemia in Chronic Renal Failure (CRF)

Anemia in CRF affects many individuals with Chronic Kidney Disease (CKD). According to the National Kidney Foundation, 26 million Americans – 1 in 9 U.S. adults – have CKD. Anemia develops in the early stages of CKD and worsens as patients progress towards total kidney failure and need a dialysis machine to eliminate waste and water from their blood. In severe or prolonged cases of anemia, the lack of oxygen in the blood can cause serious and sometimes fatal damage to the heart and other organs. Benefits of anemia correction in patients with CKD may include decreased morbidity, hospitalization, and mortality.1

1 anemia/pdf/mon_Anemia_and_CKD.pdf

Source
Affymax, Inc.

Autotomy Reduces Immune Function And Antioxidant Defence

In their struggle for life, many animals have evolved a fascinating mechanism to avoid being eaten: sacrificing a body part.

When a prey animal is grasped by a predator, the body part is amputated so that the animal itself can escape. Despite the obvious short-term survival benefit, there are long-term costs like reduced lifespan. These costs were traditionally explained by reduced locomotion after limb loss.

We identified a novel type of cost, impaired immunity, which should make prey more vulnerable to parasites. Trying to escape from one enemy can therefore drive prey in the arms of another one.

Royal Society Journal Biology Letters

Biology Letters publishes short, innovative and cutting-edge research articles and opinion pieces accessible to scientists from across the biological sciences. The journal is characterised by stringent peer-review, rapid publication and broad dissemination of succinct high-quality research communications.

www.publishing.royalsociety/biologyletters