Bayer Healthcare Pharmaceuticals Inc. announced that several studies evaluating the use of Leukine(R) (sargramostim) will be presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting.

“We are excited to see that several studies of Leukine have been accepted at ASCO,” said Pam Cyrus, MD, vice president, Medical Affairs, Oncology, Bayer HealthCare Pharmaceuticals.

Leukine data highlights include the following

ChemotherapyInduced Neutropenia

Budget impact analysis of sargramostim use in patients with chemotherapyinduced neutropenia

Lead investigator M. Duh, Analysis Group, Inc., Boston, MA

Abstract e20596, Publication only

Melanoma

Immunological effects and clinical outcomes in patients with highrisk melanoma given adjuvant therapy with granulocytemacrophage colony stimulating factor (GMCSF, sargramostim)

Lead investigator Lynn Spitler, Northern California Melanoma Center, Saint Marys Medical Center, San Francisco, CA

Abstract e20004, Publication only

Follicular Lymphoma

Idiotype vaccine therapy (BiovaxID) in follicular lymphoma in first complete remission Phase III clinical trial results

Lead investigator S. J. Schuster, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA

Abstract 2, Plenary Presentation, Sunday, May 31, 100 PM to 400 PM, Level 2, West Hall D2

Neuroblastoma

A phase III randomized trial of the chimeric antiGD2 antibody ch14.18 with GMCSF and IL2 as immunotherapy following dose intensive chemotherapy for highrisk neuroblastoma Childrens Oncology Group (COG) study ANBL0032

Lead investigator A. L. Yu, Childrens Oncology Group

Abstract 10067z, Oral Presentation, Tuesday, June 2, 800 AM to 1045 AM, Level 3, W304E

About Leukine(R)

Leukine(R) (sargramostim) is the only growth factor approved in the U.S. for use following induction chemotherapy in older adults (older than 55) with acute myelogenous leukemia (AML) to shorten the time to neutrophil recovery and reduce the incidence of severe and lifethreatening infections and infections resulting in death. Leukine also has been approved in the U.S. for use in four additional indications myeloid reconstitution following allogeneic and autologous bone marrow transplantation (BMT), peripheral blood stem cell (PBSC) mobilization and subsequent myeloid reconstitution in patients undergoing PBSC transplantation and bone marrow transplantation failure or engraftment delay. Leukine is available in two formulations, both of which are suitable for IV infusion and subcutaneous injection

Liquid 500 mcg/mL sterile solution in multiuse vial

Lyophilized powder 250 mcg in singleuse vial ready for sterile reconstitution

Among its indications, Leukine is the only myeloid growth factor approved to reduce the incidence of infections resulting in early death following induction chemotherapy in older adults with AML.

Important Safety Considerations

Leukine is contraindicated in patients with excessive leukemic blasts in bone marrow or peripheral blood (10 percent), in patients with known hypersensitivity to GMCSF, yeast derived products or any component of Leukine, and for concomitant use with chemotherapy and radiotherapy. Serious allergic or anaphylactic reactions have been reported with Leukine. If any serious or anaphylactic reactions occur, Leukine therapy should immediately be discontinued and appropriate therapy initiated. Leukine should be used with caution and monitored in patients with preexisting fluid retention, pulmonary infiltrates or CHF; respiratory symptoms or disease; cardiac symptoms or disease; and renal or hepatic dysfunction. Edema, capillary leak syndrome, pleural and or/pericardial effusion, supraventricular tachycardia, sequestration of granulocytes in the pulmonary circulation and dyspnea have been reported in patients after Leukine administration. Leukine has induced the elevation of serum creatinine or bilirubin and hepatic enzymes in some patients. Monitoring of renal and hepatic function in patients with preexisting renal or hepatic dysfunction is recommended at least every other week during Leukine administration. Adverse events occurring in 10 percent of AML patients receiving Leukine in controlled clinical trials and reported in a higher frequency than placebo were fever, skin reactions, metabolic disturbances, nausea, vomiting, weightloss, edema, and anorexia. If ANC 20,000 cells/mm3 or if platelet counts 500,000 mm3, Leukine administration should be interrupted or the dose reduced by half. Twice weekly monitoring of CBC with differential should be performed. Leukine therapy should be discontinued if disease progression is detected during treatment.

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the worlds leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the U.S., Bayer HealthCare Pharmaceuticals comprises the following business units Womens Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and Oncology. The companys aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

Forwardlooking Statements

This news release contains forwardlooking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our annual and interim reports to the Frankfurt Stock Exchange and in our reports filed with the U.S. Securities and Exchange Commission (including our Form 20F). The company assumes no liability whatsoever to update these forwardlooking statements or to conform them to future events or developments.

Results and additional analyses from the Phase II portion of a Phase II/III clinical trial of Cortheras investigational drug relaxin for the treatment of acute heart failure will be presented at the Heart Failure Congress, the annual meeting of the Heart Failure Association of the European Society of Cardiology in Nice, France.

Marco Metra, M.D., professor of cardiology at the University of Brescia, Italy, and coprincipal investigator of the PreRELAXAHF study, will present the main results from the multicenter, international PreRELAXAHF study at 830 a.m. CET on Sunday, May 31, at the Judges Choice oral abstracts session. Dr. Metra will also present additional analyses of the PreRELAXAHF study during a latebreaking clinical trials session at 1115 a.m. CET on Monday, June 1. Five posters from the PreRELAXAHF study will also be presented from 830 a.m. to 1230 p.m. CET on Monday, June 1.

About Relaxin

Relaxin is a naturally occurring peptide hormone that acts as a systemic and renal vasodilator. Elevated levels of relaxin modulate increases in renal and cardiac function that meet the increased hemodynamic demands of pregnancy. Consistent with this natural role of the hormone, pharmaceutically manufactured relaxin has been shown to have these effects in multiple human studies of men and nonpregnant women, including patients with heart failure.

About Corthera

Corthera Inc. is a private biopharmaceutical company committed to acquiring, developing and commercializing therapies for illnesses in the acute care setting. Cortheras lead product candidate, relaxin, is currently being evaluated in clinical trials for acute heart failure. The company has worldwide rights to develop and commercialize relaxin.

The Foundation for Digestive Health and Nutrition has announced the 2009 American Gastroenterological Association (AGA) Foundation Research Scholars. The grants have been awarded to five outstanding young gastroenterologists who promise to make significant strides in the field of gastrointestinal research.

“With the current economic times, research funding remains elusive for all scientists, especially those young scientists just beginning their career, despite their tremendous promise,” said Sidney Cohen, MD, AGAF, chairman of the Foundation for Digestive Health and Nutrition. “The AGA Foundation for Digestive Health and Nutrition remains committed to continuing to help fund these gifted scholars, enabling them to continue their research programs. The pace of discovery must be sustained, and it is up to those of us in the profession to make it happen. The 75 grants we give out to gifted researchers each year boldly represents our commitment to progress.”

The 2009 AGA Research Scholars are Gregory Austin, MD, MPH, University of Colorado, Denver The effect of macronutrients on gastrointestinal hormones and gastric emptying in obesity

Michele Battle, PhD, Medical College of Wisconsin, Milwaukee Determining the role that GATAs play in intestinal development and function

Rohit Loomba, MD, MHSc, University of California, San Diego (Designated RSA in Geriatric Gastroenterology funded by Sucampo Pharmaceuticals, Inc.) Sexspecific effect of alcohol and obesity and adipocytokines in geriatric fatty liver disease in a prospective populationbased cohort Rancho Bernardo Study

Iryna Pinchuk, PhD, University of Texas Medical Branch, Galveston Colonic CD90+ myofibroblasts/fibroblasts implication in the enhanced expansion of CD$+ CD25 high FoxP3+ regulatory T cells during colorectal cancer progression

Andrew Tai, MD, PhD, University of Michigan, Ann Arbor Functional characterization of a novel role for a phosphatidylinositol 4kinase in hepatitis C virus replication The prestigious Research Scholar Awards offer each scientist a total of $225,000 to help support his or her research over a threeyear period. The goal of the Research Scholar Awards is to guarantee the perpetuation of strong science through the encouragement of young physician investigators and ultimately to improve patient care through digestive diseases research.

These extremely competitive awards ensure that bright, young physicians and scientists devote their careers to advancing the field of digestive health through research. Awards are based on the qualifications of the candidate, the quality of the candidates research proposal and the commitment of the candidates institution to protect 70 percent of his or her time for research.

The Research Scholar Awards program was launched in 1984 to provide crucial early support to investigators who show promise in academic gastroenterological research. The programs premise recognized that resources awarded early on could provide a stable platform from which future research funding would be derived. During and after their time as an AGA Research Scholar, recipients have made important contributions to the field of gastroenterology and many former award recipients have gone on to hold distinguished appointments in major medical institutions in the U.S. and Canada.

Since 1984, the AGA and its Foundation has awarded more than $20 million to fund 150 Research Scholars and has provided a total of $38 million in grant funding. The 2009 Scholars were chosen by a distinguished 30person national advisory committee chaired by David Brenner, MD, Dean and Vice Chancellor for Health Sciences at University of California, San Diego. Members of the committee include leading gastroenterologists from the Harvard University Medical School, Mayo Clinic, Stanford University School of Medicine, University of Chicago, University of North Carolina, Chapel Hill, University of Texas Southwestern Medical Center, and Washington University, St. Louis.

The AGA Research Scholar Awards program addresses the critical problem of a lack of funding for entrylevel researchers in gastroenterology. At a time of unparalleled scientific and clinical opportunity, the field of gastroenterology faces a significant decline in the number of gastroenterologists entering academic research careers. Although the National Institutes of Health (NIH) funds a significant amount of gastroenterology research, it rarely funds young investigators working independently without a research track record. Additionally, NIH gastroenterology research funding is proportionately much smaller than for diseases with less or similar health impact (such as HIV/AIDS or breast cancer).

Source
Alissa J. Cruz

United Therapeutics Corporation (Nasdaq UTHR) announced that the United States Food and Drug Administration (FDA) has approved ADCIRCA(TM) (tadalafil) tablets for oral administration, with a recommended dose of 40 mg, as the first oncedaily phosphodiesterase type 5 (PDE5) inhibitor for the treatment of pulmonary arterial hypertension (PAH). ADCIRCA is indicated to improve exercise ability in WHO Group I PAH patients, which encompasses patients with multiple forms of PAH including etiologies such as idiopathic and familial PAH as well as PAH associated with scleroderma and congenital heart disease.

“Today, thanks to the clinical development efforts led by Eli Lilly & Company, we are thrilled to make available an effective, convenient and economical therapy for PAH patients,” said Martine Rothblatt, Ph.D., United Therapeutics Chairman and Chief Executive Officer. “The FDAs action in approving onceaday ADCIRCA is a big plus for all three Ps patients, physicians and payors.”

In the PHIRST1 randomized, doubleblind, 16week placebocontrolled Phase 3 clinical trial of ADCIRCA for PAH, patients taking ADCIRCA 40 mg (administered as two 20 mg tablets) once daily achieved a 33 meter improvement in sixminute walk distance compared to the placebo group. In addition, PHIRST1 patients taking ADCIRCA 40 mg experienced less clinical worsening (defined as death, lung transplantation, atrial septostomy, hospitalization because of worsening PAH, initiation of new PAH therapy, or worsening WHO functional class) compared to the placebo group. The most common adverse events in the trial were generally transient, mild to moderate in intensity and included headache, muscle pain, flushing, nasopharyngitis, respiratory tract infection, nausea, pain in the arms, legs or back, upset stomach and nasal congestion.

“Our dedicated team at United Therapeutics looks forward to working closely with the PAH community as we prepare to launch ADCIRCA in the United States at the beginning of August this year,” said Roger Jeffs, Ph.D., United Therapeutics President and Chief Operating Officer.

About ADCIRCA

ADCIRCA is a prescription medicine used to treat PAH, a lifethreatening disease that constricts the flow of blood through the pulmonary vasculature.

United Therapeutics licensed the rights to develop, market, promote and commercialize ADCIRCA for pulmonary hypertension in the United States and Puerto Rico from Eli Lilly & Company in November 2008. ADCIRCA contains the same active ingredient as CIALIS (tadalafil), which is marketed by Eli Lilly & Company to treat erectile dysfunction (impotence) in more than 100 countries.

Important Safety Information for ADCIRCA

ADCIRCA should not be used in patients taking medicines that contain nitrates (often used for chest pain) as the combination could cause a sudden, unsafe drop in blood pressure. If a patient experiences anginal chest pain after taking ADCIRCA they should seek immediate medical attention. Patients with a known serious hypersensitivity to tadalafil (ADCIRCA or CIALIS) should not take ADCIRCA.

PDE5 inhibitors, including tadalafil, have mild systemic vasodilatory properties that may result in transient decreases in blood pressure. Before prescribing ADCIRCA, physicians should carefully consider whether their patients with underlying cardiovascular disease could be adversely affected by such effects. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary venoocclusive disease (PVOD) and administration of ADCIRCA to these patients is not recommended. Patients should discuss their medical condition and all medications with their physician before starting ADCIRCA.

The use of ADCIRCA with alpha blockers, blood pressure medications, and alcohol may cause a lowering of blood pressure. Use of ADCIRCA with potent CYP3A inhibitors, such as ketoconazole and itraconazole, should be avoided. For patients on ADCIRCA therapy that require treatment with ritonavir, dosage adjustments are required. Certain populations of PAH patients such as those with mildtomoderate renal or hepatic impairment or those taking the drug ritonavir should use a dose of 20 mg daily when beginning therapy with ADCIRCA. Use of ADCIRCA with potent inducers of CYP3A, such as rifampin, should be avoided. The safety and efficacy of combinations of ADCIRCA with CIALIS or other PDE5 inhibitors have not been studied. Therefore, the use of such combinations is not recommended.

The most common side effects with ADCIRCA seen in the PHIRST1 clinical trial were headache, myalgia, nasopharyngitis, flushing, respiratory tract infection, extremity pain, nausea, back pain, dyspepsia and nasal congestion.

In rare instances, patients taking PDE5 inhibitors (including tadalafil) reported a sudden decrease or loss of vision or hearing, or in men, an erection lasting more than four hours. A patient who experiences a decrease or loss in vision or hearing or prolonged erection should seek immediate medical attention.

About United Therapeutics

United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and lifethreatening cardiovascular and infectious diseases and cancer.

Forwardlooking Statements

Statements included in this press release concerning the benefits of ADCIRCA for patients, physicians and payors, and United Therapeutics plans for the product launch for ADCIRCA are “forwardlooking statements” within the meaning of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. These forwardlooking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10K, Quarterly Reports on Form 10Q and current reports on Form 8K, which could cause actual results to differ materially from anticipated results. We are providing this information as of May 26, 2009, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason. [uthrg]

Source United Therapeutics Corporation

Since 2000, nearly 1,000 “retail clinics” offering routine care like sports physicals and immunizations and treatment for minor illnesses like strep throat have opened their doors inside pharmacies and grocery stores across the United States. Retail chain operators proposed that the new clinics would improve access to medical care among uninsured or underserved populations. However, these clinics have been opened more often in higherincome areas that are less likely to be classified as medically underserved, according to a new study from the University of Pennsylvania School of Medicine published in the May 25 issue of Archives of Internal Medicine.

“There has been a rapid rise in the number of retail clinics across the United States, but this growth is not evenly distributed across communities,” says Craig E. Pollack, MD, MHS, an internist and Robert Wood Johnson Clinical Scholar at Penn. “Poorer neighborhoods are less likely to have access to these clinics.”

By combining mapping software with Census data and a listing of nearly 1,000 retail clinics across the nation, Pollack and his coauthor, Katrina Armstrong, MD, MSCE, an associate professor of Medicine and Epidemiology and chief of the division of General Internal Medicine, found that census tracts with retail clinics had a lower population of black residents, lower poverty rates, and higher median incomes than census tracts without retail clinics.

Housed in stores including WalMart, Target and chain pharmacies like CVS and Kerr Drugs, retail clinics offer walkin appointments, often on weekends and evenings, and the visits generally cost less than paying out of pocket for similar services at a doctors office or emergency department. But the Penn authors say these “convenience” factors may not help disadvantaged populations if clinics are located too far away to be reached easily.

“We know that people living in poorer areas are less likely to have health insurance, less likely to have a regular source of medical care, and may have transportation problems that keep them from getting to the doctor,” Pollack says. “By tending to locate in richer neighborhoods, retail clinics may not be meeting their full potential to help address these problems.”

Previous research shows that a third of retail clinic patients pay for their visits out of pocket, and more than 60 percent of patients report not having a primary care provider. Some opt to pay for afterhours, nowait care because its more convenient, even if they have insurance. The new findings suggest that instead of filling an unmet medical need, placement of clinics in more advantaged neighborhoods may act as an adjunct to existing, more traditional medical care perhaps by staying open later than nearby doctors offices.

The authors say that to further expand their reach, municipalities should consider offering incentives to store operators to open clinics in underserved areas where they already operate retail outlets. Currently, nearly a third of all chain stores are located in medically underserved areas.

“There may be a real opportunity to put up clinics in underserved areas where theres already supermarkets and drug stores” Armstrong says.

PENN Medicine is a $3.6 billion enterprise dedicated to the related missions of medical education, biomedical research, and excellence in patient care. PENN Medicine consists of the University of Pennsylvania School of Medicine (founded in 1765 as the nations first medical school) and the University of Pennsylvania Health System.

Penns School of Medicine is currently ranked #3 in the nation in U.S.News & World Reports survey of top researchoriented medical schools; and, according to the National Institutes of Health, received over $366 million in NIH grants (excluding contracts) in the 2008 fiscal year. Supporting 1,700 fulltime faculty and 700 students, the School of Medicine is recognized worldwide for its superior education and training of the next generation of physicianscientists and leaders of academic medicine.

The University of Pennsylvania Health System (UPHS) includes its flagship hospital, the Hospital of the University of Pennsylvania, rated one of the nations top ten “Honor Roll” hospitals by U.S.News & World Report; Pennsylvania Hospital, the nations first hospital; and Penn Presbyterian Medical Center, named one of the nations “100 Top Hospitals” for cardiovascular care by Thomson Reuters. In addition UPHS includes a primarycare provider network; a faculty practice plan; home care, hospice, and nursing home; three multispecialty satellite facilities; as well as the Penn Medicine at Rittenhouse campus, which offers comprehensive inpatient rehabilitation facilities and outpatient services in multiple specialties.

An emerging form of the pathogenic yeast Candida is able to complete a full sexual cycle in a test tube, even though its missing the genes for reproduction. And it may also do so while infecting us, according to Duke University Medical Center researchers.

“Sex contributes to the Candida yeast species evolutionary success,” said Joseph Heitman, M.D., Ph.D., director of the Center for Microbial Pathogenesis in the Duke Department of Molecular Genetics and Microbiology and coauthor of two papers that tell the story in Nature and Current Biology. “I think the fact that it has a complete sex cycle is likely to play a role in the evolution of drug resistance in this emerging pathogenic yeast species. “

Yeast infections are notoriously hard to treat and yeast are one of the most successful pathogens and commensals in nature, he said. A commensal is an organism that benefits from associating with another organism without affecting the other. Humans are susceptible to three types of yeast infection thrush (in the mouth and throat), vaginal infection, and a sometimes fatal systemic infection of bloodstream and organs, such as the kidney.

In a paper published online May 24 in Nature, Heitmans team reports that eight Candida species which have a sexual cycle were missing many of the genes related to reproduction found in other species.

“The unrecognized sex cycle could mean we need to develop new treatments to combat what is really happening in humans infected by yeast,” said coauthor Jennifer Reedy M.D. Ph.D.

With coauthor Anna Floyd, Heitman and Reedy explored the question further in a study appearing in the May 14 Current Biology. The major question was how could the yeast sexually produce spores when they lack so many genes responsible for meiosis, the process of sexual cell division that reduces chromosomes to half their number in the progeny?

By examining and defining the structure and functions of the matingtype genes in yeast, Reedy learned that forms of Candida yeast undergo meiosis but generate offspring of several types. About twothirds have the classic 5050 division of chromosomes from the split parent cell, but a third of them have an extra chromosome or even double copies of all chromosomes.

“What we found is that the sexual cycle has a new way to create genetic diversity, and it provides a unique vantage point from which we can explore the mechanisms of sexual reproduction,” Reedy said. “This provides a new way to study sexual reproduction and how chromosomal abnormalities arise.”

Heitman said that Candidas meiosis without meiotic genes may be what gives rise to the progeny with unusual numbers of chromosomes. “Or maybe the genes were lost for a reason, to provide a route to genetic diversity,” Heitman said. “Or maybe these differing types of progeny are the unfortunate consequence of undergoing meiosis without the machinery that species normally have when they reproduce sexually.”

Humans, too, have their share of oddly paired chromosomes. “Experts estimate that about 10 to 30 percent of human eggs or fusion products may be aneuploid, with chromosomes from mother and father not paired exactly one to one, but the great majority of those fusions of sperm and egg dont make it to the implantation and pregnancy stage,” Reedy said. “Thats why it is important to find models like this, so that we may shed light on related human conditions.”

The Current Biology study was supported by National Institutes of Health/NIAID grants. Dr. Heitmans work in the Nature study was supported by grants from the NIH/National Institute of Allergy and Infectious Diseases (NIAID).

Source
Mary Jane Gore

A simple genetic test can determine a kidney transplant patients tolerance for a potent antirejection medication, according to an upcoming study in the Journal of the American Society Nephrology (JASN). The test could allow doctors to individualize each patients dose, optimizing the drugs benefits and minimizing its side effects.

Cyclosporine A is an important immunosuppressant therapy for individuals who receive kidney transplants without it, many patients would experience organ rejection and would not survive. Unfortunately, cyclosporine A can cause serious side effects such as elevated blood pressure, increased risk of infections and cancers, and kidney function deterioration. The frequency and severity of cyclosporine Arelated side effects vary among patients, even at comparable cyclosporin A levels in the blood. Determining which patients are more sensitive than others is a challenge for physicians who prescribe the medication.

Giuseppe Remuzzi, MD, FRCP, and Piero Ruggenenti, MD (Mario Negri Institute for Pharmacological Research, Italy), and their colleagues, hypothesized that genetics may influence patients susceptibilities to cyclosporine As side effects. In particular, they suspected that variations in a gene called ABCB1, which creates a protein that transports drugs out of cells, may play a role. In individuals who have certain genetic changes in the ABCB1 gene, the transporting protein is sluggish so that when a drug is present, it lingers within cells and tissues. This can amplify the drugs effects.

After studying the genetics of 147 kidney transplant recipients, the researchers found that patients with these genetic changes in the ABCB1 gene were more likely to experience side effects after receiving cyclosporine A than patients without the variants. These effects included delayed functioning of the transplanted kidney, increased need for antihypertensive medications, and the development of diabetes, infections, and cancers.

“The identification of particular genetic variants performed before transplantation, while patients are on the waiting list, could provide useful information to tailor cyclosporine A dose as early as possible after transplantation, with the ultimate goal to decrease toxicity, improve efficacy, and increase longterm graft survival,” said Dr. Remuzzi.

The authors report no financial disclosures.

ASN is a notforprofit organization of 11,000 physicians and scientists dedicated to the study of nephrology and committed to providing a forum for the promulgation of information regarding the latest research and clinical findings on kidney diseases. ASN publishes JASN, the Clinical Journal of the American Society of Nephrology (CJASN), and the Nephrology SelfAssessment Program (NephSAP). In January 2009, the Society will launch ASN Kidney News, a newsmagazine for nephrologists, scientists, allied health professionals, and staff.

Source American Society of Nephrology (ASN)

The ghrelin hormone not only stimulates the brain giving rise to an increase in appetite, but also favours the accumulation of lipids in visceral fatty tissue, located in the abdominal zone and considered to be the most harmful. This is the conclusion of research undertaken at Metabolic Research Laboratory of the University Hospital of Navarra, published recently in the International Journal of Obesity.

Ghrelin is a hormone produced in the stomach and the function of which is to tell the brain that the body has to be fed. Thus, the level of this secretion increases before eating and decreases after. It is known to be important in the development of obesity, given that, on stimulating the appetite, it favours an increase in body weight, explained Ms Amaia Rodríguez MuruetaGoyena, doctor in biology and main researcher of the study.

However, researchers at the University Hospital of Navarra have discovered that, besides stimulating the hypothalamus to generate appetite, ghrelin also acts on the tabula rasa cortex. They observed how this hormone favoured the accumulation of lipids in visceral fatty tissue. In effect, it causes the overexpression of the fatty genes that take part in the retention of lipids, explained Ms Rodríguez.

It is precisely this accumulated fat in the region of the abdomen that is deemed to be most harmful, as it is accompanied by comorbilities, visceral obesity being related to higher blood pressure or type 2 diabetes. Moreover, being located in the abdominal zone and in direct contact with the liver, this type of fatty tissue favours the formation of liver fat and increases the risk of developing resistance to insulin. It is associated with hypertension, high levels of triglycerides, resistance to insulin and hypercholesterolemia visceral fat favours the metabolic syndrome, the researcher pointed out.

Ghrelin can show itself in acylated or deacylated form, the difference being in the octanoic acid present in the composition of the former, according to Ms Rodriguez. Previously it was thought that only the acylated form was active in the process of weight increase, but many studies point to both hormones being biologically functional.

Future development of pharmaceutical drugs

This discovery of the twin action of ghrelin on the organism opens the door to future treatment for obesity and which, for the time being, is limited to in vitro studies in cell and animal models, the University Hospital researcher pointed out. This inclusive perspective of the functioning of a hormone is necessary in order to design effective pharmaceutical drugs. There are many hormones that intervene in the control of appetite in the hypothalamus and, at the same time, can act on other organs, such as the liver, the muscles or fat, for example. Thus, the medication developed should block the action of ghrelin both on the hypothalamus and on the accumulation of abdominal fat.

At the same time, stated Ms Rodríguez, it has to be taken into account that this hormone also acts on the liver and favours the capturing of glucose in the muscle. They observed that the concentration of acylatedform ghreline in the blood increases amongst obese persons and particularly when these, moreover, suffer from diabetes. Thus, obese persons with diabetes have greater tendency to accumulate visceral fat than normoglycemic obese persons. This is a littlestudied field which has to be investigated in order to develop pharmaceutical drugs which annul this action of ghrelin.

Blood analysis and stimulation of adipocytes

The research undertaken at the Metabolic Research Laboratory of the University Hospital of Navarra principally involved the analysis of the blood of 80 patients, both obese and thin, and in the stimulation with ghrelin of the fatty cells from surgical operations. First they analysed the ghrelin levels in the blood. Then, based on the biopsies of visceral fat obtained from 24 patients subjected to various operations, the adipocytes or fatty cells were separated and subsequently stimulated with hormone, which enabled the researchers to evaluate the changes generated in the genes that favoured the lipid accumulation in these isolated adipocytes, explained the researcher.

Source
Oihane Lakar

Medtronic, Inc. (NYSE MDT), the worlds leading medical technology company, announced it will participate in the Piper Jaffray PCR Post‐Op Summit on Friday, May 22, 2009, in London.

Scott Ward, president of the CardioVascular business and senior vice president at Medtronic, will speak to the attendees of the conference at 8 a.m. British Summer Time (2 a.m. Central Daylight Time). Ward will provide remarks highlighting Medtronics activities and product news from the EuroPCR conference. A live audio webcast of the presentation will be available to all interested parties at Medtronics Investor Relations websit at medtronic.com

Source

An email intervention program is an effective way to significantly improve diet and physical activity by helping people move more, sit less, and make healthier food choices, according to a Kaiser Permanente Division of Research study in the American Journal of Preventive Medicine.

The study was a randomized controlled trial of the ALIVE (A Lifestyle Intervention Via Email) program conducted among 787 Kaiser Permanente Northern California employees at their worksites. Through the ALIVE program, developed by NutritionQuest, (nutritionquest.com) weekly emails were sent to the 351 employees randomized to the intervention group; the 436 employees in the control group received only immediate email feedback at the start of the intervention indicating whether or not their reported physical activity and diet met national guidelines. The messages to the participants in the intervention group suggested small, practical, individually tailored goals, such as eating fruit for a snack three times a week, walking for 10 minutes a day at lunch time, or walking to the store instead of driving.

At the end of the 16week trial, the participants in the intervention group were more physically active, eating more fruits and vegetables, and reducing their intake of saturated fats and trans fats, compared to the control group. The biggest changes occurred among those in the intervention group, who did not meet behavioral recommendations at the start of the trial. For example, employees who were not regularly active before receiving the intervention increased their participation in moderate intensity physical activities by almost an hour a week and decreased the amount of time they spent in sedentary activities, like watching TV and videos, by about two hours a week. These changes had a lasting effect four months after the intervention ended, the study found.

“The takeaway message here for people who want to improve their diet and physical activity, and for employers who want a healthier workforce, is that email intervention programs are a very costeffective way to get healthy,” said study lead investigator Barbara Sternfeld, Ph.D., senior research scientist with the Kaiser Permanente Division of Research and the studys lead investigator. “A tailored email program includes all the things that behavioral scientists have said for years about changing behavior small goals tailored for the individual, reinforcement, and tracking but delivered in a mass, costeffective way.”

Funded by the U.S. Centers for Disease Control and Prevention, this study offers additional support for the effectiveness of the Internet and email to reach large segments of the population to inspire healthier lifestyle choices. It is one of the first studies to send messages directly into individuals email inboxes, rather than requiring individuals to actively access messages via the World Wide Web.

Given that the majority of Americans eat poorly and fail to exercise enough, effective email programs could be a useful way to improve health, researchers say. According to the CDC, 55 percent dont perform the recommended 30 minutes of moderate physical activity most days of the week. Additionally, the daily diet for about threequarters of the population consists of more than 30 percent fat, a percentage thats generally considered too high.

Participants received weekly emails in their work or home accounts for four months that were tailored to their individual needs and life situation (for example, whether they had small children at home or busy schedules that posed barriers to exercise and diet improvement.) The emails linked to a personal home page with tips for achieving the smallstep goals the respondent had selected, educational materials and tracking and simulation tools. Reminder messages were sent between each intervention message.

The study cohort was composed of employees who worked in the regional offices of Kaiser Permanente Northern California. The employees worked in administrative, financial, regulatory, technical and professional services and were not involved with direct patient care. They tend to use computers for much of their work. Participation had no bearing on job performance, employment status, or health benefits. The participants information was kept confidential and did not appear on medical records or employee files.

Before the program began, participants were evaluated on their eating and exercise habits by answering a short, online questionnaire, to which they received immediate feedback. They filled out the online questionnaire twice more, at the end of the program and four months later.

Another paper published in January in the Journal of Medical Internet Research found that the ALIVE email program reduced presenteeism among the trial participants and reduced bodily pain. Presenteeism is lost productivity that occurs when employees come to work but perform below par due to any kind of illness. The study did not look at whether employees used the email program during their lunch hour or during their regular work hour.

“Using email to get people active is a great use of existing technology that is cheap and readily available,” said Bob Sallis, MD, a Kaiser Permanente family physician who is the regional exercise champion for Kaiser Permanentes Southern California region and immediate past president of the American College of Sports Medicine. “Anything we can do to increase activity level is going to improve health because we know that exercise is medicine. Its medicine you can take to live a longer and healthier life.”

This study was a collaboration between Kaiser Permanente and NutritionQuest (nutritionquest.com), and is part of an ongoing body of research by Kaiser Permanente that looks at using technology mobile phones, wireless PDAs, the Internet, etc. to help individuals manage their weight, get more physically active and make healthy food choices.

Source
Danielle Cass