16 APS exercise research highlights, from reduced flu mortality to proteomics & obesity

Keynote speaker Bengt Saltin bridges latest research, historic U.S.-European physiology, mentoring at APS exercise meeting, Oct. 6-9


BETHESDA, Md. (Sept. 28, 2004) - Bengt Saltin, keynote speaker at the 2004 APS Intersociety exercise meeting in Austin, Texas Oct. 6-9, weaves together a lifetime of learning and research experience that bridges the 1920 Nobel Prize for Physiology, the 1935 High Altitude Expedition to Chile, and the latest in international exercise physiology.


Dr. Saltin, director of the Copenhagen Muscle Research Centre, will draw on his early medical training with Erik Hohwu Christensen, a pupil of 1920 Nobel Prize in Physiology August Krogh who won for his work on increased muscle activity and oxygen diffusion. Christensen would later become famous for his work on the International High Altitude Expedition to Chile where he and his coauthors "fully confirmed...the opinion of Krogh, Barcroft and others that diffusion can account for the transfer of oxygen in the lung…."


Completing the circle, Saltin and several collaborators published an article on altitude effects on oxygen consumption in the September 2004 issue of the American Journal of Physiology-Heart and Circulatory Physiology. (See below for references.) Saltin will discuss how Krogh and Christensen "conceived and formed the field of human integrative physiology using exercise as a key intervention," how American and European approaches to exercise physiology bifurcated, and where this type of physiology might be leading.


Among his many honors, Bengt Saltin received the International Organizing Committee 2002 Olympic Prize, which is underwritten by Pfizer Inc. In 1990 Saltin received the Honor Award from the American College of Sports Medicine, which honored Erik Hohwu-Christensen with the same award in 1981.



Editors note: Saltin is speaking at the American Physiological Society's 2004 Intersociety Meeting, "The Integrative Biology of Exercise," Oct. 6-9 in Austin. Information about the meeting can be found at (the-aps/meetings/aps/austin).


A detailed program, including abstracts, for the entire meeting is available upon request to members of the media.


Arrangements for on-site interviews, or telephone interviews during the meeting can be arranged through APS from Mayer Resnick (cell: 301-332-4402, mresnickthe-aps) or Stacy Brooks 301-634-7253 (sbrooksthe-aps). From Oct. 5-9, the onsite phone number in Austin is 512-482-8000, room 602.



The meeting is cosponsored by APS, the American College of Sports Medicine and the Canadian Society for Exercise Physiology. Additional support through unrestricted educational grants came from: the National Aeronautics and Space Administration (NASA), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMSD), Gatorade Sports Sciences Institute, Pfizer Inc. and the U.S. Army Research Institute of Environmental Medicine (USARIEM).















* * *


Summaries of 16 selected presentations at the Austin exercise meeting Oct. 6-9, 2004.


Ronald L. Terjung, chair of the meeting organizing committee and professor in the Department of Biomedical Science at the University of Missouri-Columbia, College of Veterinary Medicine, noted that in addition to the 12 symposia of invited speakers, ample time each day has been set aside for discussing the over 380 presentations with the authors.


Below are summaries of a few of the top presentations, with their program references.


1.5

Charles H. Turner (Indiana University, Indianapolis)

Mechanisms for increasing bone mass by exercise.

Mechanical loading through exercise builds bond mass, with the effects most pronounced during skeletal growth and development; rest periods reduce the effect of desensitization though it's unclear how this process is effected.


2.4.

David Proctor and Dennis Koch (Pennsylvania State University, University Park)

Influence of aging on skeletal muscle blood flow in healthy humans.

Active leg sympathetic vasoconstrictor responsiveness appears to be greater in older men during exercise.


4.17

Adrienne Visocchi, et al. (McMaster University, Hamilton, Canada)

The effect of isometric arm or leg exercise on resting blood pressure and arterial distensibility in persons medicated for hypertension.

Isometric handgrip (IHG) exercise seems to significantly reduce systolic blood pressure and carotid arterial distensibility.


6.3

Cheri L.M. McGowan, et al. (McMaster University, Hamilton, Canada)

IHG training improves blood pressure and endothelial function in persons medicated for hypertension.
Reduced reactive hyperemic flow, accompanied by improvements in normalized flow mediated dilation suggests a heightened vasoactive sensitivity to the reactive hyperemic stimulus, implicating it as a mechanism for improved cardiovascular function.


12.3

Thomas J. Hawke (York University, Toronto, Canada)

Molecular mechanisms of skeletal muscle regeneration.

Completion of the Human Genome Project and advent of microarray and proteomics technologies should facilitate an expanded analysis of the complex processes that regulate the myogenic progenitor cell and characterize the discrete stages of the muscle repair process.


12.4

Natasha Frank, et al. (Children's Hospital Boston, Mass.)

Expression of early developmental genes by human fetal skeletal muscle side population cells.
Early developmental mechanisms may be preserved in later stages of muscle cell commitment and differentiation and are likely to be involved in maintaining muscle side population cells in an undifferentiated state and available on demand for muscle regeneration.


13.4

Bente Klarlund Pedersen (University of Copenhagen, Denmark)

The biological role of the myokine IL-6. Muscle-derived IL-6 fulfils the criteria of an overriding exercise factor and such classes of cytokines should be renamed "myokines."


17.7

Steven E. Black, et al. (University of Massachusetts, Amherst)

Improved insulin action following short-term exercise training: effects of exercise or energy balance?
Study suggests that subtle changes in energy balance that precede measurable fat loss play a key role in mediating the beneficial effects of exercise on whole-body insulin action.


20.23

Elizabeth Mitchell, et al. (University of Massachusetts, Amherst)

Effects of short-term exercise in negative or zero energy balance on cardiovascular disease (CVD) risk factors. CVD risk factors trended down in overweight, sedentary people after exercise with negative energy controls.


22.1

Arnt Erik Tjonna, et al. (Norwegian Univ. of Science & Technology, Trondheim)

Maximal strength training improves work economy in patients with chronic obstructive pulmonary disease (COPD).

Substantial improved rate of force development indicates that strength training with emphasis on maximal mobilization in the concentric part of a leg press device improves work economy in COPD patients.


23.5

Stan L. Lindstedt, et al. (Northern Arizona University, Flagstaff)

Design of muscle for function as a spring.

Titin may function as a major component in the vertebrate muscle spring and the "spring properties" of muscle can be exploited clinically.


24.4

Rainer P. Hambrecht (Heart Center, Leipzig, Germany) Effects of exercise training on vascular function and myocardial perfusion.

Since the degree of coronary endothelial dysfunction has been identified as a predictor of cardiac events, exercise may contribute to long-term reduction of cardiovascular morbidity and mortality.


24.5

Jeff Woods and Tom Lowder (University of Illinois, Urbana)

Protective effect of exercise on mortality due to influenza in mice.

Moderate exercise for four consecutive days post-infection significantly increased survivability to influenza infection.


28.1

Ronald N. Cortright, et al. (East Carolina University, Greenville, SC)

African-American women have increased rates of fat oxidation after 10 days of endurance exercise training (EET).

Since 10 days of EET increases skeletal muscle fatty acid oxidation similarly in African-American and Caucasian women, EET should work as a treatment against obesity and diabetes for both.


33.14

L. Lawrenson, et al. (University of California at San Diego)

COPD patients reveal attenuated muscle plasticity following isolated quadriceps training.
Findings support the restoration of skeletal muscle power and metabolic capacity in COPD patients towards sedentary control levels, yet even during isolated small muscle mass exercise, provide evidence of attenuated muscle plasticity associated with COPD.


36.6

Dustin Hittel, et al. (Children's National Medical Center, Washington, D.C.)

Using genomic and proteomic techniques to investigate exercise adaptation in untrained and overweight men and women.

Comparative mRNA and proteomic profiling provides unique insight into underlying metabolic crisis in chronically untrained muscle and clues as to how exercise reverses these effects.





References


Several of August Krogh's articles from the American Journal of Physiology are available in the American Physiological Society's recently completed Legacy Project, as is one by Christensen.


"Kinematographic methods in the study of capillary circulation," by August Krogh and P. Brandt Rehberg, from the Laboratory of Zoophysiology, University of Copenhagen, Denmark, AJP April 1924.



"The progress of physiology," by August Krogh, AJP October 1929.


"Gas equilibria in the lungs at high altitudes," by D.B. Dill, E.H. Christensen and H.T. Edwards (from the Fatigue Laboratory, Harvard University, Boston, and the Laboratory of Zoophysiology, Copenhagen University), AJP April 1936.


"Plasma volume expansion does not increase maximal cardiac output or maximal oxygen consumption in lowlanders acclimatized to altitude" by Jose A.L. Calbet, Goran Radegran, Robert Boushel, Hans Sondergaard, Bengt Saltin, and Peter D. Wagner appears in the September 2004 issue of AJP-Heart, which is published by the American Physiological Society. Calbet is at the Dept. of Physical Education, University of Las Palmas, Canary Islands, Spain; Calbet, Radegran, Boushel, Sondergaard and Saltin are at the Copenhagen Muscle Research Center, Rigshospitalet, Copenhagen; Boushel is also at Dept. of Exercise Science, Concordia University, Montreal, Canada; and Wagner is at the University of California at San Diego.


* * *


The American Physiological Society was founded in 1887 to foster basic and applied bioscience. The Bethesda, Maryland-based society has more than 10,000 members and publishes 14 peer-reviewed journals containing almost 4,000 articles annually.


APS provides a wide range of research, educational and career support and programming to further the contributions of physiology to understanding the mechanisms of diseased and healthy states. In May, APS received the Presidential Award for Excellence in Science, Mathematics and Engineering Mentoring (PAESMEM).


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High-fat Low-carb Diets Could Mean Significant Heart Risk

New scientific research has shown that low-carbohydrate high-fat diets, made popular by the likes of the Atkins diet, do not achieve more weight loss than low-fat high-carbohydrate diets. Worryingly, the research, lead by Dr Steven Hunter from the Royal Victoria Hospital, Belfast, also shows significantly increased risks of cardiovascular disease for people following low-carbohydrate high-fat diets.


The research shows that the risks of low-carbohydrate high-fat diets far outweigh the potential benefits gained by overweight and obese people through weight loss, including improvements in blood pressure and risk factors for coronary heart disease.


The research results, released hot on the heels of both National Obesity Week and World Diabetes Day, are particularly important for nearly a quarter (24%??) of the UK adult population, and 16% of the child population, now classified as obese and at risk of Type 2 Diabetes - 80%?? of all people diagnosed with Type 2 diabetes are overweight. Type 2 Diabetes is the result of inadequate insulin production and/or insulin resistance, which means that the right levels of glucose (our main source of energy from food) are not maintained naturally by the body. There are 180 million people in the world with diabetes and the World Health Organisation predicts this number will double in the next 20 years.


Dr Hunter, Royal Victoria Hospital, Belfast, said: "The worldwide obesity pandemic is a major public health concern and strongly linked to rises in diabetes and cardiovascular disease. By advocating low-carbohydrate high-fat diets as a weapon against obesity and diabetes, health professionals could be contributing to a dangerous rise in cardiovascular disease".


The research study, conducted among a group of obese pre-diabetic adults, compared the results of following a low-fat high-carbohydrate diet (20% fat, 60% carbohydrate) with a high-fat low-carbohydrate diet (60% fat, 20% carbohydrate). It showed that in all areas, other than the risk of cardiovascular disease, the diets have equal health benefits. The same amount of weight is lost; there is no significant difference in the body's glucose uptake or production; and meal tolerance-related insulin secretion is comparable. However, the study revealed a significant difference in overall systemic arterial stiffness and pointed to increased cardiovascular risk factors from high-fat low-carbohydrate diets.


Dr Hunter continued: "High-fat diets have become popular because they seemingly promote more rapid weight loss and because of their palatability. However, we now have proof that they do not help people lose weight any faster than more conventional diets, and the potential negatives of increased cardiovascular risks far outweigh the potential positives of more easily sustained dieting/weight loss, especially when there is a proven and safe alternative in low-fat high-carbohydrate weight loss diets."


According to Dr Hunter, the challenge now is to find ways to make low-fat high-carbohydrate diets more palatable and easier to maintain, so that a long-term positive outcome is achieved.


The Food Standards Agency says that saturated fat should account for less than 11% of the total diet for a normal person, and Dr Hunter concludes: "If your New Year's resolution is to lose weight, make sure you do it the right way and don't burden your body with additional unnecessary health risks by falling for the lure of the seemingly easy and fast weight loss offered by high-fat diets. The best approach for your overall health is a low-fat high-carbohydrate diet, coupled with exercise."


?? NHS Statistics on obesity, physical activity and diet: England, January 2008, published 31 January 2008


?? Diabetes UK


Reference


Bradley U et al.

"Low-fat versus low-carbohydrate weight reduction diets: effects on weight loss, insulin resistance and cardiovascular risk. A randomised trial."

Diabetes. December 2009, vol.58, no. 12, 2741-2748. doi: 10.2337/db09-0098

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Data Shows ENBREL Provides Sustained Clinical Improvements For People With Ankylosing Spondylitis For Up To Three Years

Amgen (NASDAQ:AMGN), today announced that data from an ongoing open-label, multinational, phase 4 extension study showed that patients with ankylosing spondylitis (AS) who received treatment with Enbrel(R) (etanercept) experienced sustained improvement in signs and symptoms, spinal mobility and physical function over 148 to 160 weeks of therapy. These results are consistent with an ENBREL phase 3 clinical trial at 24 weeks. The 160-week results will be presented at the American College of Rheumatology (ACR) Scientific Meeting in Washington, D.C.


"These data demonstrate that ENBREL can provide substantial long-term improvement in AS symptoms such as total back pain and spinal mobility," said Joachim Sieper, M.D., professor of rheumatology, Charite University in Berlin, Germany. "Because AS is a chronic inflammatory disease that requires ongoing management, it is important to offer patients a treatment option that is effective, has an established safety profile, and can be used over the long-term."


Data presented at ACR showed that 59 patients who received open-label ENBREL treatment for up to 160 weeks experienced sustained clinical improvements. Overall, 78 percent of patients (n=46) continuing treatment with ENBREL achieved a 20 percent improvement in the Assessment on Ankylosing Spondylitis Response Criteria (ASAS 20) after 160 weeks of treatment. ASAS is a composite measure of improvement in AS symptoms that include total back pain, patient assessment of disease activity, inflammation and physical function. Thirty-one percent of patients (n=18) achieved partial remission at week 160. Partial remission, as defined by ASAS, is a low disease activity level (score less than 20 units out of 100 in each of the four ASAS criteria).


Additional ENBREL data presented at ACR from this phase 4 extension study show that improvement in spinal mobility was also sustained through 148 to 160 weeks of treatment with ENBREL.


Patients with ankylosing spondylitis have reported that their condition has negatively impacted their ability to perform daily activities including exercising, rising from a seated position and climbing stairs without aid. Overall, patients treated with ENBREL achieved a 46 percent improvement in physical function, as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI), and these results were sustained through 160 weeks. The BASFI is a 10-question, patient self-assessment instrument consisting of 8 specific questions regarding physical function in AS and 2 questions reflecting the patient's ability to cope with everyday life. Each question is answered on a 10 cm horizontal visual analog scale, the mean of which gives the BASFI score (0-10).


ENBREL was generally well tolerated over 148 to 160 weeks of therapy.















This study was designed to assess the safety and long-term efficacy of ENBREL in patients with AS, using clinical measures to assess disease activity, physical function, improvement in AS symptoms, and ongoing surveillance to assess the incidence of adverse events. The study is a 96-week open-label, multinational, phase 4 extension study in 59 patients with AS who completed each of two earlier trials, a 12-week randomized, double-blind, placebo-controlled study and a 96-week open-label study. The data presented at ACR is from the first 52-weeks of an ongoing 96-week extension study (total ENBREL treatment 148 - 160 weeks).


Enbrel received FDA approval to treat the signs and symptoms of active AS in 2003 following a randomized, double-blind, placebo-controlled phase 3 study in 277 patients with active ankylosing spondylitis. Treatment with ENBREL (n=138) resulted in significant clinical improvements through 24 weeks, compared to placebo (n=139). At 12 weeks, the ASAS 20 response was achieved by 60 percent of patients receiving ENBREL, compared to 27 percent of patients receiving placebo (p less than or equal to 0.0001, ENBREL vs. placebo). These results were maintained through 24 weeks. Patients in this study were between 18 and 70 years of age and had ankylosing spondylitis as defined by the modified New York Criteria for Ankylosing Spondylitis. Patients with complete ankylosis of the spine were excluded from study participation. Patients taking hydroxychloroquine, sulfasalazine, methotrexate, or prednisone (less than or equal to 10 mg/day) could continue these drugs at stable doses for the duration of the study. Doses of 25 mg ENBREL or placebo were administered subcutaneously twice a week for 6 months. The primary measure of efficacy was a 20 percent improvement in the Assessment in Ankylosing Spondylitis (ASAS) response criteria.


ABOUT AS


Ankylosing spondylitis, which affects up to half a million people in the United States, is a chronic, painful and progressive inflammatory disease affecting joints and ligaments that normally allow a person's back to move and flex. The disease most often occurs in the lower back but can affect the upper spine, chest and neck. In more advanced disease, the spine can fuse, causing loss of motion and a permanent stooped-over posture. AS may also involve other joints, such as the hips, shoulders, knees and ankles. Unlike other forms of arthritis, AS frequently affects individuals between the ages of 17 and 35. It tends to affect more men than women.


ABOUT ENBREL


ENBREL is a fully human soluble TNF receptor. ENBREL has more than 14 years of collective clinical experience.


ENBREL is indicated for:


-- reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderate to severe rheumatoid arthritis. ENBREL can be taken with methotrexate or used alone.


-- reducing signs and symptoms of moderate to severe polyarticular-course juvenile rheumatoid arthritis in patients who have failed one or more disease modifying anti-rheumatic drugs (DMARDs).


-- reducing signs and symptoms, keeping joint damage of active arthritis from getting worse, and improving physical function in patients with psoriatic arthritis. ENBREL can be used with methotrexate in patients who do not respond adequately to methotrexate alone.


-- reducing signs and symptoms in patients with active ankylosing spondylitis.


-- the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.


ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance your body's immune system makes called TNF. People with an immune disease, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis, have too much TNF in their bodies. ENBREL can reduce the amount of TNF in the body to normal levels, helping to treat your disease. But, in doing so, ENBREL can also lower the ability of your immune system to fight infections.


All medicines have side effects, including ENBREL. Possible side effects of ENBREL include:


-- Serious infections


-- Many occurred in people prone to infection, such as those with advanced or poorly controlled diabetes


-- Some serious infections have been fatal


-- Rare cases of tuberculosis have occurred


-- What not to do


-- Do not start ENBREL if you have an infection, such as an open sore or the flu, or are allergic to ENBREL or its components


-- What to do


-- Tell your doctor if you are prone to infection


-- Stop ENBREL if a serious infection occurs


-- Contact your doctor if you have questions about ENBREL or develop an infection

-- Tell your doctor if you have ever been treated for heart failure


-- Serious nervous system disorders, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes


-- Tell your doctor if you have ever had any of these disorders or if you develop them after starting ENBREL


-- Rare reports of serious blood disorders (some fatal)


-- Contact your doctor immediately if you develop symptoms, such as persistent fever, bruising, bleeding, or paleness


-- In medical studies of all TNF blockers, including ENBREL, a higher rate of lymphoma (a type of cancer) was seen compared to the general population. The risk of lymphoma may be up to several-fold higher in rheumatoid arthritis and psoriasis patients


-- The role of TNF blockers, including ENBREL, in the development of lymphoma is unknown
-- ENBREL can cause injection site reactions


-- In a medical study of patients with JRA, infections, headaches, abdominal pain, vomiting, and nausea occurred more frequently than in adults


-- The kinds of infections reported were generally mild and similar to those usually seen in children


-- Other serious adverse reactions were reported rarely, including serious infections (2%) and depression/personality disorder (1%)


About Amgen and Wyeth


Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL in North America. Wyeth markets ENBREL outside of North America. Immunex Corporation, a wholly owned subsidiary of Amgen, manufactures ENBREL. Additional information about ENBREL, including full Prescribing Information, can be found on the Web site sponsored by the companies at enbrel or by calling toll free 888-4ENBREL (888-436-2735).


Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit amgen.


Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.


Forward-Looking Statement


This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in Amgen's Form 10-K for the year ended December 31, 2005, and in Amgen's periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.


No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. In addition, sales of Amgen's products are affected by the availability of reimbursement and the reimbursement policies imposed by third party payors, including governments, private insurance plans and managed care providers, and may be affected by domestic and international trends toward managed care and healthcare cost containment as well as possible U.S. legislation affecting pharmaceutical pricing and reimbursement. Government regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, Amgen competes with other companies with respect to some of Amgen's marketed products as well as for the discovery and development of new products. Amgen believes that some of the newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen's products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with its products. In addition, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors and there can be no guarantee of Amgen's ability to obtain or maintain patent protection for its products or product candidates. Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of its existing products. Amgen's stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of its products or product candidates. Further, the discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.


The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include risks associated with the inherent uncertainty of the timing and success of product research, development and commercialization (including with respect to our pipeline products), drug pricing and payment for our products by government and third-party payors, manufacturing, data generated on the safety and efficacy of our products, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade buying patterns, global business operations, product liability and other types of litigation, the impact of legislation and regulatory compliance, intellectual property rights, strategic relationships with third parties, environmental liabilities, and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, RISK FACTORS." We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.


An electronic version of this news release may be accessed via our Web site at amgen. Journalists and media representatives may sign up to receive all news releases electronically at time of announcement by filling out a short form in the Media section of the Web site.



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Herbal Medicines For Treatment Of Gastrointestinal Disease

Herbal medicines could benefit patients suffering from gastrointestinal (GI) motility disorders that cannot be treated using conventional drug therapy. In a study published in Neurogastroenterology and Motility, researchers reviewed data on Japanese herbal medicines and found them to be effective in reducing the symptoms of GI disorders such as functional dyspepsia, constipation, and postoperative ileus.


"Japanese herbal medicines have been used in East Asia for thousands of years," says lead researcher Hidekazu Suzuki, Associate Professor at the Keio University School of Medicine. "Our review of the world medical literature reveals that herbal medicines serve a valuable role in the management of patients with functional gastrointestinal disorders."


Many of the drugs used to treat GI motility disorders are ineffective or cause unwanted side effects and, in some cases, this has led to drugs being withdrawn from the market. Herbal medicine is an attractive alternative.



The researchers reviewed data from studies looking at the effect of several different Japanese herbal medicines including the use of Rikkunshi-to, Dai-Kenchu-to, and other herbal medicines. Rikkunshi-to, which is prepared from eight crude herbs, was effective in reducing discomfort caused by functional dyspepsia. Dai-Kenchu-to, a mixture of ginseng, ginger, and zanthoxylum fruit, was beneficial for constipation in children and patients suffering from post-operative ileus - disruption of normal bowel movements following an operation. Another herbal medicine, hangeshashin-to, reduced the severity and frequency of diarrhoea caused by anti-cancer drugs.


In Japan, herbal medicine is manufactured in standardised form with regards to quality and quantity of ingredients. The researchers say the health benefits of standardised formulations of herbal medicines require more rigorous examination, particularly in the Western world.
"There is a mandate to provide accurate data regarding the effectiveness of non-traditional therapy, not only to our patients but also to healthcare providers who face the dilemma of recommending or opposing management strategies that incorporate herbal medicine," says Suzuki.


Full citation: Suzuki, H., Inadomi, J.M. and Hibi, T.; Japanese Herbal Medicine in Functional Gastrointestinal Disorders; Neurogastroenterology and Motility (2009); DOI: 10.1111/j.1365-2982.2009.01290.x


Neurogastroenterology & Motility is the official Journal of the European Society of Neurogastroenterology and Motility, the American Neurogastroenterology & Motility Society and the Functional Brain-Gut Research Group. Edited by Jan Tack, Keith Sharkey and Joseph Szurszewski, it has an ISI Journal Citation Reports® Ranking: 2007 of 14/50 (Gastroenterology & Hepatology) and 68/211 (Neurosciences), and an Impact Factor of 3.364. The field of gastrointestinal motility has undergone phenomenal growth and change in the past three decades since it emerged as a distinct speciality. Neurogastroenterology & Motility provides a forum where current issues and advances relating to the motor function of the GI tract can be presented and discussed. It is of interest to both clinicians and researchers. For further information please visit www3.interscience.wiley/journal/118498177/home


Wiley-Blackwell was formed in February 2007 as a result of the acquisition of Blackwell Publishing Ltd. by John Wiley & Sons, Inc., and its merger with Wiley's Scientific, Technical, and Medical business. Together, the companies have created a global publishing business with deep strength in every major academic and professional field. Wiley-Blackwell publishes approximately 1,400 scholarly peer-reviewed journals and an extensive collection of books with global appeal.

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Study Results Present Paradigm Shift; REDUCE Trial Shows New Hope For The Risk Reduction Of Prostate Cancer

The recent announcement of the REDUCE trial results at the American Urological Association annual meeting in Chicago brings optimism to the prostate cancer community as dutasteride (Avodart), a drug used to treat benign prostatic hyperplasia, has shown to lower by 23 percent the risk of prostate cancer in men with an increased risk of the disease.


Men's Health Network looks forward to this becoming an additional tool in the fight against prostate cancer.


The REDUCE trial is a placebo-controlled study that evaluates whether dutasteride decreases the risk of biopsy-detectable prostate cancer.


As this disease continues to strike one in six American men, with African American men having an incidence rate up to 60% higher than white men, it is important that patients and physicians engage in a meaningful conversation about prostate cancer, an individual's risk of getting the disease, and the value of early detection and prevention.


Scott Williams, Vice President, Men's Health Network commented, "We continually stress the importance for men to receive a baseline Prostate Specific Antigen or PSA and physical exam of the prostate at age 40 and to engage in a continual dialogue with their physician about their individual risk and need for annual prostate exams. It could mean the difference between living with the disease or dying from the disease."


PSA is currently the most effective tool physicians and patients have to detect a disease that kills an estimated 28,000 men a year in the US.


In addition to the approximately 200,000 men who are diagnosed with prostate cancer each year, we must remember that the disease can have a devastating effect on entire families and communities. Spouses, significant others, and children are often emotionally, financially, and physically strained and the diagnosis reaches beyond the family to impact friendships, employers, and churches.


"It is also important to note that families can impact the prevention and early detection of prostate cancer," said Theresa Morrow of Women Against Prostate Cancer. "Just a little encouragement from a spouse or family member can get a man to the doctor for prostate screening."


The REDUCE trial is the first step in a paradigm shift in the way prostate cancer is viewed, changing the conversation to focus on the value of prevention and early detection of this deadly disease.

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CINVENTION And Relisys Medical Devices Enroll First Patients In Clinical Trial Of The Corel + C Drug-Eluting Stent

COREL is a prospective,
open label randomized clinical trial that will enroll 150 patients in 10
centers in India. The primary endpoint is 9-month in-stent late loss within
the stented segment post-procedure and historical comparison with 6 to
9-month in-stent late loss with other drug-eluting stents. The secondary
endpoints include Angiographic Binary Restenosis, Target Lesion
Revascularization (TLR), Target Vessel Revascularization (TVR) and Target
Vessel Failure (TVF) rates at nine months, Major Adverse Cardiac Events
(MACE), acute, sub-acute and late Stent thrombosis at 30 days and 9 and 12
months, Lesion, Device as well as Procedure success. The Principal
Investigator of the study is Dr. Balram Barghava MD. of All India Institute
of Medical Sciences, New Delhi, India.


Relisys' new Corel + C drug-eluting stent comprises a Cobalt-Chromium
Stent that is coated with a macro-porous nano-structured carbon-composite
matrix containing the active drug paclitaxel. The coating has been
developed and provided by CINVENTION, the Germany based company specialized
in nano- composite materials and surface engineering. The coating
eliminates the use of polymers and provides a bioactive coating with less
thrombogeneity and pro- endothelialization surface design - thus,
completely reducing tissue inflammation and reaction, but additionally
enhancing engraftment and endothelialisation.


Dr. Balram Bhargava, the principal investigator, explained that he
expects significant improvements in the short, mid and long-term clinical
outcomes. "This is the first time that a nano-structured coating is used as
an elution platform. The coating itself is made out of non-thrombogenic
glassy carbon, the bio-availability of paclitaxel is nearly hundred percent
and, additionally, the surface structure of the coating promotes
endothelial cell attachment and proliferation. We are confident that this
trial will show excellent results and demonstrate that the non-polymeric
bioactive nano- composite coating will reduce the late thrombosis issue
significantly," said Dr. Balram Bhargava.



The enrolment of the study will be carried out throughout 10 clinical
trial centers in Bangalore, Ahmadabad, Vellore, Bangalore, Chandigarh,
Hyderabad, New Delhi and Mumbai. Dr. Soheil Asgari, Chief Executive Officer
and Chief Technology Officer of CINVENTION, pointed out, that the enrolment
will be finished within 4 weeks. "The investigators community has access to
a large collective of patients and we expect the stenting of the patients
within four to five weeks." He also referred to previous pre-clinical data
that showed excellent histomorphometric and histopathology data indicating
the non- inflammatory and pro-healing properties of the coating. "The
CINVENTION coating replaces inflammatory polymers - either durable or
absorbable - by the most inert material known, i.e. carbon. CINVENTION's
technology enables the embedding of drug control properties together with a
surface design that attracts endothelial cells and allows attachment and
proliferation on the nano-structured surface". Furthermore, he said that
CINVENTION has created significant knowledge in surface design for tissue
engineering and mammalian cell cultivation. This knowledge was transferred
to the nano-structured design of the carbon-coating material.
















Badari Narayan, Managing Director of Relisys Medical, stated that he
expects a clear result demonstrating the superior performance of the Corel
+ C stent. "The Corel+ C stent has unique advantages. While other companies
are still in the early development phase of non-polymeric stents, Relisys
has gained a head start over the community. We combine the advantages of a
Cobalt Chromium stent with an excellent profile and deliverability together
with the proven drug paclitaxel and the most advanced coating platform. The
Corel + C stent was specifically designed to eliminate the potential
complications of thrombosis that are now identified as the main issues of
Drug-Eluting Stents."


The animal trials for the advanced Corel + C drug-eluting stent were
completed at the Cardiovascular Research Institute, Washington D.C., and
published in April 2006. The animal data have shown the safety and efficacy
of the Corel + C drug-eluting stent, including its innovative porous
carbon/carbon composite coating technology.



CINVENTION AG


CINVENTION AG is a leading technology company focusing on
nano-composite materials in biomedical applications (learn more about
CINVENTION at cinvention/.


CINVENTION's unique portfolio of Nano-Composite Systems includes: Drug
Delivery Coatings, Multifunctional Device Coatings, Advanced Cultivation
Systems for Bio-Processing and Systems for Tissue Engineering.


CINVENTION's mission is to exploit its proprietary and highly
innovative technology platform for materials and surface engineering of
nano-structured composites. Providing a sustainable portfolio of
applications in medical device engineering, bio-processing and chemical
processing CINVENTION solutions enable its customers to acquire superior
technologies for next generation applications.


Relisys Medical Devices


Relisys Medical Devices Limited is a leading Indian medical device
manufacturer, which has taken a lead in the indigenous development of
medical devices like coronary stents, catheters and critical care products
in India.



Relisys focus products includes: Drug-eluting stents,
Angiographic/Angioplasty catheters, Occlusive devices, Cardiac surgery
disposables and Critical care products.



Relisys Medical Devices mission is to make quality medical care
affordable through development of cutting edge technology and competitive
pricing. Relisys Manufacturing facilities include a stent coating division
and an integrated catheter manufacturing facility with in-house
compounding, extrusion, injection molding, braiding, welding, tipping,
grinding, sterilization and others.


Cinvention AG

cinvention/

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'Counseling Suicidal Clients' By Andrew Reeves

Counselling Suicidal Clients by Andrew Reeves, from University of Liverpool Counselling Service, is a new title for counselling practitioners published today by SAGE. This title addresses the important professional considerations when working with clients who are suicidal. It covers work on the 'bigger picture', including legal and ethical considerations and organisational policy and procedures, including how practitioners can work with the dynamics of suicide potential in the therapeutic process.



The book is divided into six main parts:
The changing context of suicide


The prediction-prevention model, policy and ethics


The influence of the organisation


The client process


The practitioner process


The practice of counselling with suicidal clients.

The book also contains chapters on the discourse of suicide, suicide and self-injury, and self-care for the counsellor. It is written for counsellors and psychotherapists, and for any professional who uses counselling skills when supporting suicidal people.



About the author:



Andrew Reeves is a Senior BACP Accredited Counsellor at the University of Liverpool Counselling Service. He is also a Registered Social Worker, with a professional background in child protection and adult mental health services. His research interests focus on developing therapeutic approaches to assessing suicide risk, and he has written extensively on this subject. He is also Editor of Counselling and Psychotherapy Research journal, and a regular columnist in Therapy Today.



Praise for the title:



"A uniquely accessible, comprehensive and practical guide. Essential reading for counsellors and psychotherapists and all helping professionals who work with clients at risk of suicide." Mick Cooper, Professor of Counselling, University of Strathclyde



"A 'must read' for counsellors of all experience levels, offering sound practical strategies alongside thought-provoking case studies and discussion points. Reeves addresses this difficult topic with depth, breadth and integrity. Excellent." Denise Meyer, developer and lead author of studentdepression



"Andrew Reeves brings together his experience as a social worker, counsellor and academic to explore the essential elements in working with suicidal clients. His openness and integrity in writing about this complex topic creates a valuable resource for reflective practice." Barbara Mitchels, Solicitor and Director of Watershed Counselling Service, Devon.



Paperback ISBN: 9781412946360 ??22.99



Hardcover ISBN: 9781412946353 ??65.00


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