Researchers at the Carnegie Institution’s Department of Plant Biology have discovered a key missing link in the so-called signaling pathway for plant steroid hormones (brassinosteroids). Many important signaling pathways are relays of molecules that start at the cell surface and cascade to the nucleus to regulate genes. This discovery marks the first such pathway in plants for which all the steps of the relay have been identified. Since this pathway shares many similarities with pathways in humans, the discovery not only could lead to the genetic engineering of crops with higher yields, but also could be a key to understanding major human diseases such as cancer, diabetes, and Alzheimer’s.

Steroids are important hormones in both animals and plants. Brassinosteroids regulate many aspects of growth and development in plants. Mutants deficient in brassinosteroids are often stunted and infertile. Brassinosteroids are similar in many respects to animal steroids, but appear to function very differently at the cellular level. Animal cells usually respond to steroids using internal receptor molecules within the cell nucleus, whereas in plants the receptors, called receptor-like kinases, are anchored to the outside surface of the cell membranes. For over a decade, scientists have tried to understand how the signal is passed from the cell surface to the nucleus to regulate gene expression. The final gaps were bridged in the study published in the advanced on-line issue of Nature Cell Biology September 6, 2009.

The research team unraveled the pathway in cells of Arabidopsis thaliana, a small flowering plant related to cabbage and mustard often used as a model organism in plant molecular biology.

“This is the first completely connected signaling pathway from a plant receptor-like kinase, which is one of the biggest gene families in plants,” says Carnegie’s Zhi-Yong Wang, leader of the research team. “The Arabidopsis genome encodes over 400 receptor-like kinases and in rice there are nearly 1,000. We know the functions of about a dozen or so. The completely connected brassinosteroid pathway uses at least six proteins to pass the signal from the receptor all the way to the nuclear genes expressed. This will be a new paradigm for understanding the functional mechanism of other receptor-like kinases.”

Understanding the molecular mechanism of brassinosteroid signaling could help researchers develop strategies and molecular tools for genetic engineering of plants with modified sensitivity to hormones, either produced by the plant or sprayed on crops during cultivation, resulting in higher yield or improved traits. “We perhaps could engineer plants with altered sensitivity in different portions of the plant,” says Wang. “For example, we could manipulate the signal pathway to increase the biomass accumulation in organs such as fruits that are important as agricultural products, an area highly relevant for food and biofuel production.”

Another of the study’s findings has potentially far-reaching consequences for human health. The newly identified brassinosteroid signaling pathway component shares evolutionarily conserved domains with the glycogen synthase kinase 3 (GSK3). “GSK3 is found in a wide range of organisms, including mammals,” says Wang. “Our study identified a distinct mechanism for regulating GSK3 activity, different from what had been identified in earlier work. GSK3 is known to be critical in the development of health issues such as neural degeneration, cancer, and diabetes, so our finding could open up new avenues for research to understand and treat these diseases.”

The research was supported by grants from the National Institutes of Health (R01GM066258), National Science Foundation (0724688), U.S. Department of Energy (DE-FG02-08ER15973), and the Herman Frasch Foundation.

Source:
Zhi-Yong Wang

Carnegie Institution

The U.S. Food and Drug Administration issued draft guidance intended to help reduce the development of resistance to medically important antimicrobial drugs used in food-producing animals.

Today’s draft guidance outlines the FDA’s current thinking on strategies to assure that antimicrobial drugs that are important for therapeutic use in humans are used judiciously in animal agriculture. The FDA acknowledges the efforts to date by various veterinary and animal producer organizations to institute guidelines for the judicious use of antimicrobial drugs, but the agency believes additional steps are needed.

The draft guidance summarizes a number of published reports on antimicrobial resistance and states that the overall weight of evidence available to date supports the conclusion that using medically important antimicrobial drugs for production or growth enhancing purposes (i.e., non-therapeutic or subtherapeutic uses) in food-producing animals is not in the interest of protecting and promoting the public health.

The document recommends phasing in measures that would limit medically important antimicrobial drugs to uses in food-producing animals that are considered necessary for assuring animal health and that include veterinary oversight or consultation. These steps would help reduce overall use of medically important antimicrobial drugs, thereby reducing the pressure that generates antimicrobial resistance.

The FDA recognizes the importance of antimicrobial drugs for addressing the health needs of animals. Antimicrobial drugs have been widely used in human and veterinary medicine for more than 50 years with benefits to both human and animal health. The development of resistance to these drugs, and the resulting loss of their effectiveness, poses a serious public health threat.

“Using medically important antimicrobial drugs as judiciously as possible is key to minimizing resistance development and preserving the effectiveness of these drugs as therapies for humans and animals,” said Bernadette Dunham, D.V.M., Ph.D., director of the FDA’s Center for Veterinary Medicine. “FDA is committed to working with animal drug sponsors, the veterinary and public health communities, the animal agriculture community, and all other interested stakeholders in developing a practical strategy to address antimicrobial resistance concerns that is protective of both human and animal health.”

The agency invites comments on the draft guidance, available online and titled The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals.

Source:
U.S. Food and Drug Administration

ORLANDO, FL (UroToday) – Professor Montorsi gave the SIU lecture on PDE5 inhibitors. He discussed the molecular mechanisms of PDE5 inhibitors. The nitric oxide pathway was reviewed. PDE5 inactivates cGMP to 5′-GMP. The effects of PDE5 inhibitors last beyond their half-lives, suggesting a cellular memory effect. This may be due to other phosphorylation actions or retention in the vascular tissues. The concentration of PDE5 inhibitors over time changes due to binding to other molecules in the cell. In a rat model, sildenafil treatment resulted in upregulation of muscarinic receptors. He showed that daily dosing in clinical trials supports these observations.

PDE5 inhibitors are used for other problems such as BPH are reported. NOS levels are decreased in the prostate and this is also mediated by Rho-kinase and PDE5 inhibitors can change this. PD5 is also found at high levels in the bladder. Thus 3 clinical trials were performed, but while symptoms improved, flow-rates did not.

PDE5 inhibitors are also used in the treatment of priapism. Nitrous oxide (NO) bioactivity is downregulated and cGMP is not degraded and accumulates in tissues. Treating priapism patients with daily morning low-dose PDE5 inhibitors decreased episodes of priapism in 6 of the 7 pilot patients studied.

For premature ejaculation, 83% of clinical trials have shown benefit. The combination of paroxitene with sildenafil was superior to paroxitene alone. There are some limitations to the study designs, but this treatment may improve patient outcomes.

Regarding infertility, PDE5 inhibitors improve sperm motility but causes premature acromsome reaction. Sildenafil improved motility, while tadalafil decreased the motility. The different PDE5 inhibitors have not been compared in a prospective, randomized fashion and the doses used were high. The endpoint of live births was not used.

He also mentioned that sildenafil may provide benefit to women with sexual dysfunction, but this is not yet clearly known.

PDE5 inhibitors can have side effects that must be understood.

Presented by Francesco Montorsi, MD, at the Annual Meeting of the American Urological Association (AUA) – May 17 – 22, 2008. Orange County Convention Center – Orlando, Florida, USA.

Reported by UroToday Contributing Editor Christopher P. Evans, MD, FACS

UroToday – the only urology website with original content global urology key opinion leaders actively engaged in clinical practice.

To access the latest urology news releases from UroToday, go to:
www.urotoday

Copyright © 2008 – UroToday

Health and Safety Executive (HSE) figures show that in the 10 year-period between 1997/98 to 2006/07 there were 399 fatal accidents involving farm workers and 134 of these fatal incidents occurred during the harvest months of August, September and October.

HSE is urging all farmers to take extra precautions with agricultural machinery during the harvest season.

HSE inspector Alan Plom said, “Clearly the nature of farm work carries more inherent risk than most other occupations – these risks include use of heavy machinery, the use of chemicals, working in poor or dangerous weather conditions and working at heights.”

He continued, “When it comes to agricultural machinery our message to the farming community is “Stop it before you unblock it.” We want farmers to take action to improve safety during their harvest season.”

For a safer harvest season the HSE recommends that workers in the agricultural sector take some simple measures to limit their risk of a serious injury.

- Brakes on tractors are crucial, but recent research suggests about one in eight handbrakes are defective. They are easy to check and generally simple to adjust – do it now before you get too busy with the harvest.

- Ensure that any blocked machine is brought to a complete stop, the handbrake applied and engine shut-off before attempting to clear the blockage.

- Suitable checks must be made to ensure that dangerous parts of the machine (e.g. rotating cutters on harvesters) have come to a complete rest before removing any fixed guards.

- Only trained and competent operators should be employed to operate harvesters and other agricultural machinery, and they should be aware of the actions to take when a blockage occurs.

- Don’t jump on or off the harvester while it is moving.

- Don’t leave the driving position of a moving or running tractor or harvester.

- Don’t park or carry out maintenance when under or near overhead power lines.

- Don’t allow children on or near tractors or harvesters.

- Ensure guards are always in place covering dangerous parts of machinery, e.g. chain and sprockets, vee belts and pulley drives on all machines, including augers and graders.

- Never wear loose clothing, remove any dangling jewellery and tie back long hair.

- When produce is packed into boxes or stacked in piles, watch your back when manual handling and always ensure adequate and safe access, particularly when working at height.

- Take a few seconds to think before you act. Many accidents are caused by rushing to get the job done, particularly trying to make up lost time caused by spells of bad weather (as we have experienced recently).

More information on health and safety on the farm is available here.

Notes

1. In the 10 year period from 1996/97 to 2006/07 there were 134 deaths during harvest. Not all of the harvest-period deaths were the result of harvest-related activities – some were related to livestock and forestry activities. However, the slight increase in fatalities confirms there is an increased risk to the health and safety of agricultural workers during this time. Factors relating to this increase include the long hours, use of heavy machinery, worker fatigue, inadequate training of staff, inexperience and the dangers of overhead power lines.

2. The HSE is working closely with the industry to help it reduce the number of work-related deaths and injuries. HSE produces health and safety guidance for farmers; organise health and safety awareness days; provide information and advice through farm visits, by phone or at agricultural events; monitor the health and safety performance of the industry; and, when necessary, take enforcement action against employers who endanger lives.

hse

Using a special ultrasound technique to spot areas of blood flow in the prostate gland may substantially reduce the number of unnecessary biopsies, according to a new study by urologists and radiologists at the Jefferson Prostate Diagnostic Center and the Kimmel Cancer Center at Jefferson in Philadelphia. The researchers found that biopsies targeted to areas of increased blood flow in the prostate were twice as likely to be positive for cancer compared with conventional prostate biopsy techniques. They reported their initial results from a clinical trial at the annual meeting of the American Urological Association in Orlando.

According to Prostate Diagnostic Center co-director Edouard Trabulsi, M.D., assistant professor of Urology at Jefferson Medical College of Thomas Jefferson University, finding the best areas to perform biopsies in the prostate has always been difficult. Standard methods entail simply dividing the prostate into a dozen regions within the gland, almost randomly. Center co-director Ethan Halpern, M.D., who is principal investigator on the four-year, National Cancer Institute-supported trial, has been developing and refining techniques to enhance targeted biopsy of the prostate for more than a decade.

Dr. Trabulsi, Ethan Halpern, M.D., professor of Radiology and Urology at Jefferson Medical College, and their co-workers randomly divided 63 prostate biopsy patients into two groups. One group was given the drug dutasteride, which can reduce the blood flow in benign prostate tissue, while the other half received a placebo. They then compared the results from biopsies targeted by blood flow changes using contrast-enhanced ultrasound to those that were done the standard way. The study involved 979 biopsies.

“We’ve previously shown that a two-week course of the drug Avodart (dutasteride) before biopsy reduces the benign blood flow, or background noise,” Dr. Trabulsi explains, “allowing us to see subtle flow changes to target for biopsy. When we did this, we found that targeted biopsies based on the contrast-enhanced ultrasound are much more likely to detect prostate cancer. That’s the exciting part about this.”

Dr. Halpern explains that standard procedures fail to diagnose prostate cancer in approximately 30 percent of men with the disease, even though the biopsy protocol may sample 12 to 18 tissue cores from the prostate. “In the future, our goal is to perform a limited number of targeted biopsies and leave the rest of the prostate alone,” he says. “This will provide a safer, more cost-effective approach to diagnosing prostate cancer.”

The doctors say that the current study involves a novel ultrasound algorithm called flash replenishment imaging to show fine vascular flow differences. “The novelty is using the dutasteride before biopsy, using contrast-enhanced ultrasound and using the latest ultrasound technology to look for blood flow changes associated with prostate cancer.”

“We are beginning to have patients who were operated on come back in,” Dr. Trabulsi notes. “If we can show that we reliably hit the areas of cancer based on the ultrasound results and didn’t miss any, it’s a home run.”

###

The trial is continuing and the team is hoping to enroll about 450 men in the trial. For more information, please see the Prostate Diagnostic Center site, prostate.tju.edu/.

Source: Steve Benowitz

Thomas Jefferson University

View drug information on dutasteride.

Ever stood on the tee and as you feel the eyes on the other golfers on you, your heart starts to race, your palms become
sweaty, and you worry about making a mess of the shot? If this has happened, you are experiencing performance stress. A new
study from the University of Alberta shows the strategies that elite golfers use to manage performance stress effectively.

A study of 18 of Ireland’s best young international male golfers aged 14 to 21 revealed differences between golfers’ attempts
at coping with stress. The golfers were asked to report on times when they coped very well under stress, and times when they
coped badly.

“We found some interesting differences between effective and ineffective coping. In general, effective coping involved
gaining a sense of control, while ineffective coping involved the golfers trying to force their play,” said co-author Dr.
Nick Holt, a professor of Physical Education and Recreation at the University of Alberta, and a Certified Consultant with the
Association for the Advancement of Applied Sport Psychology. The study, published in the June edition of The Sport
Psychologist, was conducted jointly with Dr. Adam Nicholls from the University of Hull in the United Kingdom.

During effective coping golfers maintained a positive mindset by using positive self-talk, blocking negative thoughts, and
focusing on the next shot (rather than on past shots). They stayed physically relaxed by using deep breathing exercises and
stretching. Finally, they sought advice from their caddies, and were sure to follow their playing routine.

Alternatively, the golfers had very different thoughts and behaviors during ineffective coping episodes. Ineffective coping
strategies were identified as trying too hard, speeding up, and making sudden changes to their learned playing routine.
Changing the playing routine is a common mistake, Dr. Holt said. “Rather than making changes during a round, they should be
sticking with what they know. Pre-shot routines can be adapted during practice, but not under the stress of competition.”

Common stressors for players included worries about scores, missing putts, making mistakes, using the wrong club, being
watched and opponent performance.

A key observation was that when they were asked to reflect on their ineffective coping experiences, some of the golfers
realized that they had not even tried to cope. “We found it surprising. We thought at this level they would already be aware
of the importance of coping with stress. It goes to show that technical ability got them this far, but if they could build up
their mental skills, that would probably help them make the transition as players from an elite youth to an elite adult,”
said Dr. Holt.

Golfers at every level need to be proactive about forming and then practicing strategies for effectively coping with stress,
Dr. Holt said. “In a lot of sports people focus on the technical side and the mental side is neglected. But like the
technical skills, you have to learn mental skills and practice them. If you look at the best golfers–people like Tiger
Woods–they are renowned for really strong mentality. They can cope really well with stress.”

Contact: Bev Betkowski
beverly.betkowskiualberta
780-492-3808
University of Alberta
ualberta

In the Journal of Clinical Investigation, Marjan Huizing and colleagues from the National Human Genome Research Institute report the first kidney disease caused by a genetic defect in the production of sialic acid. Remarkably, they show that, in mice, disease symptoms can be reversed by addition of a precursor of sialic acid, raising the intriguing possibility that dietary supplementation in this manner may have therapeutic benefit for patients with certain forms of kidney disease.

Humans with mutations in the GNE gene suffer from a neuromuscular disorder known as hereditary inclusion body myopathy (HBIM), in which sialic acid biosynthesis is disrupted and for which there is currently no effective therapy. In the current study, the investigators sought to develop a mouse model to test whether dietary supplementation of sialic acid or its precursor, uridine diphospho-N-acetylmannosamine (ManNAc), could reverse the defect.

In mice, the Gne/Mnk gene encodes ManNAc kinase (GNE/MNK), a key enzyme in sialic acid biosynthesis. In the current study the authors found that mice carrying one of the most common mutations observed in patients with HBIM – a mutation in Gne/Mnk – produced lower amounts of sialic acid, had blood and excess protein levels in their urine, and had structural defects in the glomerulus (a bundle of capillaries in the kidney that are actively involved in the filtration of blood). The authors show that these effects were caused by a reduction in the number of sialic acid residues on critical glomerular proteins such as podocalyxin, which was associated with a breakdown of the glomerular basement membrane and surrounding structures. This breakdown allows red blood cells and proteins that are normally retained in the glomerulus, to pass into the urine. They went on to show that dietary supplementation with ManNAc improved the structure of this membrane and prolonged the life of these animals.

In an accompanying commentary, Susan Quaggin from the University of Toronto comments that “based on the dramatic effects of dietary ManNAc supplementation…along with the simplicity and tolerability of this intervention, it seems plausible that this pathway might be used as a more general therapeutic approach for glomerular diseases of many causes.” This is especially attractive as current therapies are associated with significant side effects and are often ineffective.

TITLE: Mutation in the key enzyme of sialic acid biosynthesis causes severe glomerular proteinuria and is rescued by N-acetylmannosamine

AUTHOR CONTACT:

Marjan Huizing

National Human Genome Research Institute, NIH, Bethesda, Maryland, USA.

Raymond MacDougall

Associate Director for Communications

National Human Genome Research Institute, Bethesda, Maryland, USA.

###

JCI table of contents — June 1, 2007

Contact: Brooke Grindlinger

Journal of Clinical Investigation

New NICE guidance being published on 25 March will outline the best way to treat and manage adults with schizophrenia in primary and secondary care. This is an update of NICE’s first ever clinical guideline. New recommendations include treatment with arts therapy and tailoring treatment for disadvantaged groups. The guideline also updates NICE guidance on the use of newer (atypical) antipsychotic drugs for the treatment of schizophrenia. NICE technology appraisal guidance 43 (2002).

Schizophrenia is a condition that affects a person’s mental state, including their thoughts, mood and behaviour. The nature of the condition varies from person to person but the main symptoms are ‘psychotic’ experiences, for example hearing voices and other hallucinations or having fixed beliefs that are false but which the person believes in completely (delusions). The symptoms can be distressing for the person and upsetting for families and friends. The diagnosis of schizophrenia is still associated with considerable stigma, fear and limited public understanding. This can lead to social exclusion, reduced opportunities to get back to work or study, and problems making new relationships. People from black and minority ethnic (BME) groups with schizophrenia are more likely than people from other groups to have problems accessing mental health services, often finding difficulty engaging in services and are more likely to be subject to the Mental Health Act.

About 1% of people have schizophrenia at some point in their lives. For most people their symptoms start when they are young adults, but they can occur at any age. Some people may only have symptoms for a short time, but others may have them for months or years. Some people will recover completely from their symptoms; others will improve but may become ill again. This guideline sets out how best to
treat and manage people with schizophrenia, from the first episode through to management of further acute episodes and longer term care. It emphasises a collaborative approach to treatment and the need to tailor treatment for BME groups in particular.

Key recommendations include:

• Healthcare professionals should ensure they are competent in working with people with schizophrenia from diverse ethnic and cultural backgrounds.

• Mental health services should work in partnership with local organisations, including those representing BME groups, to enable people with schizophrenia to access local employment and educational opportunities.

• Offer cognitive behavioural therapy (CBT) to all people with schizophrenia.

• Offer family intervention to all families of people with schizophrenia who live with or are in close contact with the service user.

• For people with newly diagnosed schizophrenia, offer oral antipsychotic medication. Provide information and discuss the benefits and side-effect profile of each drug with the service user. The choice of drug should be made by the service user and healthcare professional together.

• People with schizophrenia are at higher risk of cardiovascular disease than the general population. GPs and other primary healthcare professionals should monitor the physical health of people with schizophrenia at least once a year with a focus on cardiovascular disease risk assessment.

• Consider offering arts therapies to all people with schizophrenia, particularly for the alleviation of negative symptoms.

Professor Elizabeth Kuipers, Guideline Development Group Chair and Professor of Clinical Psychology, Head of Department, Institute of Psychiatry, Kings College London, said: “Schizophrenia is still associated with considerable stigma, fear and limited public understanding. People with schizophrenia and their carers need to be involved in decisions with professionals about their care. Firstly, to be able to choose together about medication, bearing in mind side effects. Secondly, to be offered psychological therapies, cognitive behaviour therapy for distressing symptoms and family intervention when there are carers, and offered arts therapies for negative symptoms. We have also emphasised the importance of regular health checks from GPs, because of evidence of impaired physical health for this group. There is good evidence that people with schizophrenia will recover. To
ensure this, we need to find ways to help manage continuing problems and overcome remaining difficulties.”

Dr Tim Kendall, Joint Director, National Collaborating Centre for Mental Health, Consultant Psychiatrist Sheffield Health and Social Care NHS Foundation Trust, said: “People from ethnic minorities with schizophrenia are six times more likely to be sectioned under the Mental Health Act than people from other backgrounds. They often present too late and end up getting a raw deal from the service. With this guideline we are looking for significant changes to be made in the way that people with schizophrenia are treated and managed and have tacked this issue head on with specific recommendations on how care should be tailored for people in this disadvantaged group.”

Ms Anna Maratos, Head of Profession, Arts Therapies, Central and North West London NHS Foundation Trust, said: “There is good evidence to show that arts therapies are particular effective on the ‘negative symptoms’ of schizophrenia such as withdrawal and poor motivation. While anecdotally we have known for a long time that people with schizophrenia from a wide range of backgrounds find the arts therapies accessible and helpful across all phases of the illness, high-quality services run by trained therapists are patchy across the UK. This guideline will hopefully result in improved access to these therapies for all.”

Professor Irwin Nazareth, GP representative, Professor of Primary Care and Population Sciences; Director, MRC General Practice Research Framework, said: “People with schizophrenia have poorer physical health. General practitioners play a key role in managing people with schizophrenia. This guideline emphasises the importance of cardiovascular and diabetes risk monitoring by general practitioners and the need for secondary health care professionals to ensure that this occurs as a part of the care programme of people with schizophrenia.”

Ms Janey Antoniou, Service User Representative on the GDG, said: “It has been an interesting and informative process being one of the two mental health service users on the NICE schizophrenia guideline development group. The guideline recommends that cognitive behavioural therapy and arts-based therapies should be offered to people with schizophrenia and that a choice about medication is made in collaboration with the person who is going to take them. As someone who has tried over twelve different antipsychotics before finding one I could live with, it would have
been helpful to be told about the side effects ahead of having to take them and being asked about my lifestyle and what side effects I would definitely like to avoid.”

About the guideline

1. The schizophrenia guideline is available at: nice/CG082

About NICE

2. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.
3. NICE produces guidance in three areas of health:
- public health – guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
- health technologies – guidance on the use of new and existing medicines, treatments and procedures within the NHS
- clinical practice – guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

Source
NICE

Patients treated with Toviaz® (fesoterodine fumarate) 8 mg extended release tablets had greater and statistically significant reductions in urge urinary incontinence episodes at week 12 (P=0.017) compared with Detrol® LA (tolterodine tartrate extended release capsules) in a placebo-controlled randomized clinical trial. The primary endpoint of the study was reductions in urge urinary incontinence episodes. This new study, published today in the January issue of BJU International, is the first head-to-head superiority trial specifically designed to compare the two medications.

When looking at prespecified secondary endpoints, patients treated with Toviaz 8 mg had a significantly greater increase in the average volume of urine voided per micturition from baseline to week 12 compared with those who received Detrol LA (P=0.005). The differences between Toviaz 8 mg and Detrol LA in urinary frequency (P=0.380) and urgency episodes (P=0.054) were not statistically significant.

“This is the first clinical trial that has been designed to assess the superiority of an antimuscarinic agent for the treatment of overactive bladder. This new data provides important information to physicians making treatment decisions for patients with overactive bladder since it compares two available medicines. This study showed that Toviaz 8 mg was significantly more efficacious than Detrol LA in treating urge urinary incontinence,” said lead author Dr. Sender Herschorn, Sunnybrook Health Sciences Centre, Toronto.

About the Study

Of the 1,712 patients enrolled in this 12-week, randomized, double-blinded, placebo-controlled superiority study, 1,697 were randomized to receive either Toviaz 8 mg (n=679), Detrol LA 4 mg (n=684) or placebo (n=334) once daily for 12 weeks. All patients in the Toviaz group started on Toviaz 4 mg for one week, followed by Toviaz 8 mg for 11 weeks.

The most frequently reported adverse events were dry mouth (28 percent in the Toviaz 8 mg group, 16 percent in the Detrol LA group and 6 percent in the placebo group), headache (6 percent in the Toviaz 8 mg group, 3 percent in the Detrol LA group and 2 percent in the placebo group), and constipation (5 percent in the Toviaz 8 mg group, 4 percent in the Detrol LA group and 3 percent in the placebo group). Discontinuations due to treatment-related adverse events were 2 percent in the placebo group, 4 percent in the Detrol LA group and 6 percent in the Toviaz group.

After the study was completed, additional analyses (post hoc analyses) were done. In one post hoc analysis, patients in the study who were treated with Toviaz 8 mg showed statistically significant improvements over those treated with Detrol LA (P=0.015) as assessed by the three-day diary dry rate at week 12. Toviaz 8 mg also produced significantly greater improvements compared with Detrol LA as measured by the Patient Perception of Bladder Condition (P

Earlier today, U.S. Department of Health and Human Services Secretary Kathleen Sebelius; President’s Council on Fitness, Sports and Nutrition (PCFSN) Co-Chair Dominique Dawes; and Let’s Move! Executive Director Robin Schepper launched the “Million PALA Challenge” at the Council’s first official meeting in Washington, D.C. The goal of the campaign is to get one million or more Americans to sign up for and achieve the Presidential Active Lifestyle Award (PALA) between now and September, 2011.

“There are more than 300 million people in America today, and we want every single one of them to live a healthy lifestyle”

“Ending obesity is critical to children’s health and to their health as adults. Nearly one in three American kids is overweight or obese, which puts them at a much greater risk of diabetes, heart disease and cancer,” said HHS Secretary Kathleen Sebelius. “There are more than 300 million people in America today, and we want every single one of them to live a healthy lifestyle,” she added.

The PALA program is for people of all ages, backgrounds and abilities and is a great way to jumpstart or maintain a healthy lifestyle by engaging in moderate to intense physical activity for 60 minutes a day, five days per week over six weeks for kids, and 30 minutes a day over the same period of time for adults. The “Million PALA Challenge” supports the First Lady’s Let’s Move! initiative to end childhood obesity within a generation by getting more youth and families committed to getting active and eating better.

The challenge is being launched during National Childhood Obesity Awareness Month, as designated by President Obama’s signing of a proclamation on September 1, 2010, and kicks off the start of the 2010-2011 school year. In addition to promoting increased physical activity and healthier eating for youth, the First Lady has also challenged the White House staff to lead by example and sign up for PALA during the challenge period, September 2010-September 2011.

The Challenge is supported by school and after-school programs across the nation, including four key partners: Boys and Girls Clubs of America; the YMCA; National Recreation and Park Association (the three largest after-school programs in America); as well as the General Mills Foundation; who were all in attendance at the kickoff announcement at the PCFSN meeting today.

Also in attendance at today’s announcement were Council members Carl Edwards (NASCAR Champion); Allyson Felix (Olympic Track and Field Athlete); Grant Hill (NBA Forward, Phoenix Suns); Donna Richardson Joyner (International Fitness Expert); Michelle Kwan (Olympic Figure Skater); Dr. Risa Lavizzo-Mourey (President and CEO, Robert Wood Johnson Foundation); Cornell McClellan (First Family’s Personal Trainer); Dr. Stephen McDonough (North Dakota-based Pediatrician); Chris Paul (NBA Point Guard, New Orleans Hornets); Curtis Pride (Head Baseball Coach, Gallaudet Univ., retired MLB Player); and Dr. Ian Smith (Medical/Diet Expert); and Dan Barber (Sustainable Farming Chef).

Turning to the President’s Council members, Co-Chair Dominique Dawes said: “It’s our time to shine and I know that, with all of the amazing talent sitting in this room and at these tables, we will make an impact and we will get more Americans of all ages, backgrounds and abilities to take that first step toward leading a healthy lifestyle.”

About PCFSN

The President’s Council on Fitness, Sports and Nutrition (PCFSN) is a committee of up to 25 volunteer citizens appointed by the President to serve in an advisory capacity through the Secretary of Health and Human Services (HHS). Through its programs and partnerships with the public, private and non-profit sectors, PCFSN serves as a catalyst to promote healthy lifestyles through fitness, sports and nutrition programs and initiatives that educate, empower and engage Americans of all ages, backgrounds and abilities.

About Let’s Move

The Let’s Move! campaign, started by First Lady Michelle Obama, has an ambitious national goal of solving the challenge of childhood obesity within a generation so that children born today will reach adulthood at a healthy weight. Let’s Move! will combat the epidemic of childhood obesity through a comprehensive approach that will engage every sector impacting the health of children and will provide schools, families and communities simple tools to help kids be more active, eat better, and get healthy.

Source:

HHS