September 9, 2009 (VIVUS) - VIVUS, Inc. (Nasdaq: VVUS) today announced positive results from two final, phase 3 pivotal 56-week studies, EQUIP (OB-302) and CONQUER (OB-303), evaluating the safety and efficacy of Qnexa(TM), an investigational drug, in more than 3,750 patients across 93 sites. The EQUIP and CONQUER studies met all primary endpoints by demonstrating statistically significant weight loss with all three doses of Qnexa, as compared to placebo. Patients taking Qnexa also achieved significant improvements in cardiovascular and metabolic risk factors including blood pressure, lipid levels, and type 2 diabetes.The outstanding results from the EQUIP and CONQUER studies, in addition to the results from EQUATE that were reported late last year, confirm the positive effect of Qnexa and underscore the important role this therapy may play in the lives of patients battling obesity and related co-morbidities, if approved by the FDA," stated Leland Wilson, president and chief executive officer of VIVUS. "The results of the phase 3 program, designed and executed after Special Protocol Assessments were completed by the FDA, exceed the FDA benchmarks for clinically significant weight loss. The results support the company's plan to file a New Drug Application with the FDA by the end of 2009 and submit the results from the studies for publication in peer-reviewed journals. We believe these results may provide a compelling opportunity for global pharmaceutical companies, and we intend to initiate partnering discussions now that we have the full data set in hand."

Wilson added, "We are proud of the results of our Qnexa phase 3 program, and I would like to thank Dr. Thomas Najarian, the inventor of Qnexa, the entire development team at VIVUS, Dr. David Orloff and his staff at Medpace, the clinical research organization that managed these studies, and the clinical investigators and patients who participated in the Qnexa clinical trials."

Qnexa is a proprietary formulation and unique dosing regimen that combines two well known pharmaceutical therapies - phentermine and topiramate - to create a novel, patented therapy. The phase 3 program evaluated three doses of Qnexa (numbers reflect milligrams of phentermine and controlled release topiramate, respectively):

-- Qnexa 15/92 (full dose)
-- Qnexa 7.5/46 (mid dose)

-- Qnexa 3.75/23 (low dose)

"The weight loss observed with Qnexa in these two one-year, double-blind, randomized trials far exceeds the weight loss observed for other agents reported in literature," said Kishore Gadde, MD, director of obesity clinical trials at Duke University and a lead investigator. "The efficacy and safety results confirm the earlier findings of our phase 2 study, which showed a very good efficacy and benefit/risk profile. Importantly, the medical benefits of this treatment in reducing the risk of weight-related co-morbidities such as hypertension, diabetes, and dyslipidemia could establish Qnexa as a major advancement in the management of obesity."

EQUIP (OB-302) Results

The EQUIP study included 1,267 morbidly obese patients (1,050 females and 217 males) across 93 centers in the United States. The average baseline BMI of the study population was 42.1 kg/m(2) and baseline weight was 256 pounds. Patients had a 4-week dose titration period followed by 52 weeks of treatment. The study was a randomized, double-blind, placebo-controlled, 3-arm, prospective trial with patients randomized to receive once-a-day treatment with low-dose Qnexa, full-dose Qnexa or placebo. Patients were asked to follow a hypocaloric diet representing a 500-calorie/day deficit and advised to implement a simple lifestyle modification program. Results from the study are as follows:

-- Average weight loss for Qnexa patients completing the EQUIP study was 37
pounds and 18 pounds with full-dose Qnexa and low-dose Qnexa,
respectively, as compared to 6 pounds in the placebo group;
-- 60% of the full-dose Qnexa patients who completed the study lost at
least 10% of their baseline weight;
-- 43% of the full-dose Qnexa patients who completed the study lost at
least 15% of their baseline weight;
-- Completion rate for EQUIP was 47%, 57%, 59% for patients taking placebo,
low-dose Qnexa and full-dose Qnexa, respectively; and

-- Patients treated with full-dose Qnexa had significant improvements in
blood pressure, triglycerides and cholesterol.

CONQUER (OB-303) Results

The CONQUER study included 2,487 overweight and obese patients (1,737 females and 750 males) with high blood pressure, high cholesterol or type 2 diabetes across 93 centers in the United States. The average baseline BMI of the study population was 36.6 kg/ m2 and baseline weight was 227 pounds. Patients had a 4-week dose titration period followed by 52 weeks of treatment. The study was a randomized, double-blind, placebo-controlled, 3-arm, prospective trial with patients randomized to receive once-a-day treatment with mid-dose Qnexa, full-dose Qnexa or placebo. Patients were asked to follow a hypocaloric diet representing a 500-calorie/day deficit and advised to implement a simple lifestyle modification program. Results from the study are as follows:

-- Average weight loss for Qnexa patients who completed the CONQUER study
was 30 pounds and 24 pounds with full-dose Qnexa and mid-dose Qnexa,
respectively, as compared to 6 pounds in the placebo group.
-- In the CONQUER study subset analysis, higher risk patients, defined as
those in the upper 25th percentile of a specific co-morbidity, who were
treated with full-dose Qnexa for 56 weeks achieved the following changes
in cardiovascular risk factors:
-- Reduction in systolic blood pressure of 20 mmHg from 147 mmHg at
baseline, as compared to a reduction of 14 mmHg in the placebo group
(p<0.0001). This improvement occurred in the presence of a
significant reduction in blood pressure medications in Qnexa-treated
patients as compared to placebo;
-- Reduction in triglyceride levels of 98 mg/dL from 268 mg/dL at
baseline, as compared to a decrease of 42 mg/dL from 262 mg/dL at
baseline in the placebo group (p<0.0001);
-- Reduction in hemoglobin A1c levels of 0.6% from 7.3% at baseline as
compared to a reduction of 0.1% from 7.4% at baseline for the
placebo patients (p<0.0001). These improvements occurred in the
presence of a significant reduction in antidiabetic medications in
Qnexa-treated patients compared with placebo. All patients were
treated to standard of care for type 2 diabetes. 64% of the
full-dose Qnexa patients who completed the study lost at least 10%
of their baseline weight;
-- 39% of the full-dose Qnexa patients who completed the study lost at
least 15% of their baseline weight; and

-- Completion rates for CONQUER were 57%, 69%, 64% for patients taking
placebo, mid-dose Qnexa, and full-dose Qnexa, respectively.

Across both 56-week studies comprised of more than 3,750 patients, the most commonly reported side effects were dry mouth, tingling, constipation, altered taste and insomnia. Monthly assessments using prospective psychometric instruments in accordance with FDA's guidance showed no signal for suicidality risk. There were no suicide attempts or suicidal behaviors, and there was no signal for suicidal ideation across all treatment groups including placebo. Depression or depressed mood adverse events of a moderate to severe nature were less than 2% and were similar among patients in the Qnexa and placebo groups. Overall, depression scores, quality of life including self esteem and general health significantly improved for patients on Qnexa.

"I have seen dramatic and sustained weight loss with Qnexa as well as notable improvements in cardiovascular risk factors, diabetes, emotional well being and quality of life in my patients," commented Michelle Look, M.D., FAAFP, of the San Diego Sports Medicine and Family Health Center and a lead investigator in the studies. "What is so striking for me is how many of my patients were able to achieve weight loss with Qnexa for the first time after many years of battling weight problems without success. The excellent tolerability of Qnexa allowed patients to stay on therapy for a year, as evidenced by the strong completer rates."

Other Safety Studies

VIVUS completed a thorough QT prolongation (TQT) study evaluating subjects taking Qnexa. The study was completed with no signal for QT prolongation. Subjects taking Qnexa also underwent complex and extensive cognitive and psychomotor testing using validated, FDA accepted testing methodologies. There was no clinically significant change in overall cognitive function or effect on psychomotor skills seen in patients taking Qnexa.

"These data are significant, and when coupled with my own experience treating patients with Qnexa, clearly demonstrate that it is one of the promising pharmaceutical therapies in development to assist patients in achieving significant weight loss," stated Louis Aronne, MD, Clinical Professor of Medicine and Director of the Comprehensive Weight Control Program at New York-Presbyterian Hospital/Weill Cornell Medical Center and one of the investigators involved in the clinical trials. "People with weight problems have a truly biologic disease, and we are in desperate need of more options and effective tools to help our patients combat this disease and the other serious medical conditions that arise as a result of weight gain. I am encouraged by the efficacy and safety seen in these late stage Qnexa trials."

October 9, 2009 (Newswise) - According to a recent study of clinical characteristics of teens who underwent laparoscopic Roux-en-Y gastric bypass surgery from 2002 until 2007, doctors may have a much narrower window of opportunity to reverse morbid obesity in teens than previously thought.The study, conducted at Cincinnati Children's Hospital Medical Center, appears in the current online edition of the Journal of Pediatrics.

The study focused on 61 teens who underwent laparoscopic Roux-en-Y gastric bypass at Cincinnati Children's. The results of the study showed that one year after the study, BMI in the overall group of teens pre-surgery decreased by 37 percent, however because of their starting weights, the teens were still considered to be morbidly obese. This means that doctors can predict what a patient's weight will be one-year post weight loss surgery.

Lead author of the study, Thomas Inge, MD, PhD, Associate Professor of Surgery and Pediatrics, explains that "Current guidelines for adolescent weight loss surgery suggest that we begin to consider surgery only after a teen is 80-100 percent overweight. Our new data show that when we intervene when a patient is between 100 and 150 percent over ideal weight, we can expect successfully resolution of obesity. But by the time the teen is 200 percent over their ideal weight for age, the surgery will reduce their weight substantially, but many of the patients will still remain morbidly obese.

This is the first study in adolescents to specifically show that the postoperative weight is strongly influenced by the patient's starting weight. This finding raises a concern that waiting until children are super obese to begin to think of surgery may result in major weight loss, but not resolution of obesity and certain medical problems than intervening at an early stage of the disease. For instance, in those who remain significantly obese following surgery, this excess weight can have negative effects on joints and mobility; the long-term risks of remaining seriously overweight are unknown.

Co-author Dr. Stavra Xanthakos, Assistant Professor of Pediatrics and pediatric gastroenterologist feels that, "We [doctors] have to do a better job of identifying teens who are gaining enormous amounts of weight quickly and get help for them earlier." Dr. Xanthakos says that when doctors or parents notice that a teen is beginning to gain weight rapidly, there should be a staged approach to managing the weight problem. "If the weight gain is not effectively stopped with initial nutritional or exercise measures, then even more intensive treatments or programs are indicated, and ultimately some very serious thought has to be given to surgery," said Dr. Xanthakos.

Prior to weight loss surgery, teens with extreme obesity present with the most significant and global impairments in quality of life relative to other pediatric chronic illness populations and rates of depressive symptoms that are 3-4 times higher than national rates, says pediatric psychologist and co-author Dr. Meg Zeller, Associate Professor of Pediatrics. "We cannot underestimate the psychological impact on the adolescent when obesity progresses to such extreme levels and is not durably treated." In fact, Zeller's recent data (published in the journal Obesity) from the same group of teens demonstrated significant psychosocial improvements following surgery at one-year. "As we learn more about the benefits of surgery in this age group, it pushes the medical community to ask when is the optimal time to intervene surgically and potentially change a young person's developmental course in a more positive direction?"

Mary L. Brandt, MD, Professor and Vice Chair of the Michael E. DeBakey Department of Surgery and a pediatric surgeon at Texas Children's Hospital worries about these results as well. "We are trying to help teenagers who are at high risk for preventable but life-threatening diseases such as diabetes or obesity induced liver disease. Bariatric surgery will improve the medical condition of obese teenagers regardless of the starting weight of the patient. But our ability to help these children prevent or reverse their life-threatening diseases will be even greater if our patients are able to approach a normal weight."

According to Brandt, "The other major implication of this new data is that many insurance companies will delay surgery for years, usually by requiring documentation of multiple attempts at weight loss. Severely obese teenagers only rarely respond to these kinds of treatments and, despite intense efforts to lose weight, often will gain weight during these efforts. Although it is ethically important for these children to have a least one well supervised attempt to lose weight without surgery, this report shows us that delaying the surgery while trying multiple times may not be in their best interest."

This study, like others, found that after surgery, patients generally show significant improvement or resolution of cardiovascular risk factors such as blood pressure, cholesterol, and triglyceride levels.
Dr. Inge said that the study indicates that families and communities need to take childhood weight problems seriously and aggressively pursue the best treatment options available for them before the weight problem gets out of hand. "As doctors who take care of kids, we have an obligation to identify those patients who are at highest risk and start explaining treatment options to families earlier before the child or teen gets to be two or three times his or her ideal weight, " said Dr. Inge.

October 9, 2009 (Newswise) - According to new research from the Monell Center and the Mount Sinai School of Medicine, certain common herbicides and lipid-lowering fibrate drugs act in humans to block T1R3, a nutrient-sensing taste receptor also present in intestine and pancreas.Commonly used in agriculture and medicine, these chemical compounds were not previously known to act on the T1R3 receptor.

October 8, 2009 (EurekAlert) - Celiac disease (CD) is an inherited intestinal disorder characterized by life-long intolerance to the ingestion of gluten, a protein found in wheat, rye, and barley. Although CD can be diagnosed at any age, it commonly occurs during early childhood (between 9 and 24 months). Reduced bone mineral density is often found in individuals with CD. A new article in the journal Nutrition Reviews examines the literature on the topic and reveals that a gluten-free diet can affect children's recovery.Metabolic bone disease remains a significant and common complication of CD. Reduced bone mineral density can lead to the inability to develop optimal bone mass in children and the loss of bone in adults, both of which increase the risk of osteoporosis. There also exists an additional risk of fracture in people with CD.

However, evidence suggests that a gluten-free diet (GFD) promotes a rapid increase in bone mineral density that leads to complete recovery of bone mineralization in children. A GFD improves, although rarely normalizes, bone mineral density in adults. Children may attain normal peak bone mass if the diagnosis is made and treatment is given before puberty, thereby preventing osteoporosis in later life.

Also, nutritional supplements consisting of calcium and vitamin D seem to increase the bone mineral density of children and adolescents with CD.

"Our findings reinforce the importance of a strict gluten-free diet, which remains the only scientific proven treatment for celiac disease to date," the authors conclude. "Early diagnosis and therapy are critical in preventing celiac disease complications, like reduced bone mineral density."

October 7, 2009 (Newswise) - An international team of scientists, led by Monash University researchers, has found that anti-oxidants commonly touted for their health-promoting benefits, could contribute to the early onset of Type 2 diabetes.The team, led by Professor Tony Tiganis from the Monash Department of Biochemistry and Molecular Biology, has found that molecules known as Reactive Oxygen Species (ROS) may play a protective role in the early stages of Type 2 diabetes by enhancing insulin action. Anti-oxidants prevent the beneficial effects of ROS.

The team showed that when ROS levels were elevated in muscles of genetically-modified mice they could prevent the onset of insulin resistance and diabetes that is induced by a high-fat diet.

However when these animals received anti-oxidants, which 'mop up' ROS, the improved insulin response was lost and the mice became more 'diabetic'.

The findings, published today in the prestigious journal Cell Metabolism, challenge the widely-held view that ROS are always harmful and that anti-oxidants are always beneficial.

"ROS molecules, such as hydrogen peroxide, are important for normal cell function. We have shown that ROS present in muscle enhance insulin action and help lower blood sugar levels," Professor Tiganis said.

"However, our studies do not negate the role of ROS in late-stage disease. There's a 'yin and yang' relationship that takes place, wherein ROS are beneficial in the early stages of Type 2 diabetes and shift to being harmful at later stages of the disease. We are now trying to find out when ROS make the switch from being 'good' to 'bad'.

"Although we need to undertake further studies in humans, our results indicate that the widespread use of anti-oxidants by the general public as a preventative measure is something that should be discouraged, particularly if you are otherwise healthy," Professor Tiganis said.

"Eat healthy and exercise as this is a natural source of ROS that promotes insulin action."

Diabetes is Australia's fastest growing disease, with an estimated 275 people developing the disorder each day. Type 2 diabetes, which is linked to genetic and lifestyle factors including obesity, low physical activity and poor diet, costs our health care system an estimated $3 billion dollars annually.

Professor Tiganis led a team of 12 Monash researchers, scientists from the Baker IDI Heart and Diabetes Institute, University of Melbourne, and Cold Spring Harbor Laboratory in the US.

October 6, 2009 (EurekAlert) - More research is required to establish whether Chinese herbal medicines can reduce the likelihood of developing diabetes, according to Cochrane Researchers. Although herbal medicines are widely used in Asian countries to treat pre-diabetes (impaired glucose tolerance or IGT), the precursor of the disease, researchers say there is still not enough hard scientific evidence to confidently recommend their use."People with impaired glucose tolerance are more likely to develop full blown diabetes and it may be possible to prevent or delay the onset of the disease through lifestyle changes and medication. Chinese herbal medicines have been used for this purpose for a long time, so there is plenty of anecdotal evidence for their safety and effectiveness, but we were interested to find out whether scientific research could provide a basis for recommending these alternative treatments," says lead researcher, Suzanne Grant of the Centre for Complementary Medicine Research at the University of Western Sydney in Australia.

Pre-diabetes is recognised by higher than normal blood sugar levels. People with pre-diabetes are advised to change their diets to control their blood glucose levels and prevent progress to diabetes. In China, Korea and Japan herbal pills, teas and powders have been used for a long time to treat pre-diabetes and diabetes. They are thought to work in a number of different ways to help normalise blood sugar levels, including by improving pancreatic function and increasing the availability of insulin, a hormone that regulates blood sugar levels.

The researchers considered data from 16 clinical trials including 1,391 people who received 15 different herbal formulations. According to their findings, combining herbal medicines with lifestyle changes is twice as effective as lifestyle changes alone at normalising patients' blood sugar levels. Those given the herbal formulations were less likely to develop full blown diabetes during the study period. Trials included in the review lasted from one month to two years. No adverse effects were reported in any of the trials.

"Our results suggest that some Chinese herbal medicines can help to prevent diabetes, but we really need more research before we can confidently say that these treatments work," says Grant. "The real value of the study is as guidance for further trials. We need to see more trials that make comparisons with placebos and other types of drugs, and better reporting on the outcomes of these trials."

October 5, 2009 (EurekAlert) - To help draw attention to National Child Health Day (today), the Preventive Cardiovascular Nurses Association (PCNA) has released findings from a new national consumer survey and launched a campaign to educate families about heart disease, the leading cause of death in the U.S.he national survey revealed that more than three in five (61%) Americans incorrectly believe that the processes related to heart disease do not begin until adulthood.

Alarmingly, fewer than four in ten (38%) correctly surmise that people should be concerned about living a heart-healthy lifestyle to prevent a future heart attack beginning in childhood, and continuing throughout every life stage.

While the old adage says "an apple a day will keep the doctor away," a new study on heart disease shows that a more comprehensive approach to being heart-healthy is key.

According to the study, published in September in an advance online edition of the journal Circulation, even with the success of past heart disease awareness and education campaigns the trend toward reducing cardiovascular risk is now headed in a negative direction. The vast majority (92%) of Americans are still at risk, primarily because of the rise in obesity.

"This is a wake up call for parents and their children in particular," says Laura Hayman, Ph.D., RN, a member of the PCNA Board of Directors and a leading researcher on obesity and cardiovascular disease in children, adolescents, and families. "Some strides have been made; however, since more and more children are currently overweight, they are more likely at risk for obesity-related conditions later in life such as hypertension and type 2 diabetes."

As two Harvard professors noted in an accompanying editorial in the Circulation e-publication, millions of Americans enter adulthood already overweight and thus are putting themselves at risk for a lifetime of disease and early death. "Much potential exists to reverse ominous trends in cardiovascular risk factors and mortality in the United States, but this is unlikely to occur without making prevention of overweight and obesity a clear national priority," they stated.

Recent research has found that when children learn about heart-healthy eating habits, it can strongly influence their behavior to reduce heart disease risk later in life. Yet, according to the PCNA survey, less than one-third of Americans follow a diet that is healthy for their heart. Also, seven in ten (70%) would not want their kids to adopt their eating habits because they do not think they set a good example when it comes to food choices (26%) or some of the time they eat food that is not healthy (44%).

"We are at a critical juncture," explains Hayman. "It is imperative for parents to lead by example with an all encompassing hearty-healthy lifestyle, making the necessary changes both in diet and physical exercise."

Since the survey found that the majority of Americans are at risk of heart disease due to some lifestyle factor, such as being overweight or having high cholesterol, small incremental changes in diet and physical activity can have a lasting healthy effect.

To help parents learn how to make important lifestyle changes and become better role models for their children, to help reduce their risk of heart disease in the future, PCNA has launched a national education campaign called "Family at Heart."

October 5, 2009 (EurekAlert) - A team of pharmacists from the University of Santiago de Compostela (USC) has established that the levels of vitamin C in many fruit juices and soft drinks are far higher than those indicated on their labels by the manufacturers. This finding has been possible owing to a new technique developed by the researchers to determine the content of vitamin C in these kinds of drinks.Ascorbic acid or vitamin C is a natural antioxidant in fruits and vegetables, but the European Commission permits its use as an additive in juices, jams, dairy products and other foods. The involvement of this substance in the immune response and other biochemical processes such as the formation of collagen and the absorption of iron is well-known. However, high levels of ascorbic acid can cause diarrhoea and gastrointestinal problems, as a result of which scientists are attempting to determine the content of vitamin C in foods with greater and greater accuracy.

Now, a group of researchers from the Faculty of Pharmacy of the USC has developed a new chromatographic technique (these are used to separate and identify chemical elements) aimed at accurately measuring the ascorbic acid in fruit juices and soft drinks. By applying this method, they have found that the amounts of vitamin C stipulated on the labels of many drinks are not real. In a sample of 17 fruit juices, soft drinks and isotonic drinks, only two correspond to what is indicated on the bottle.

Ana Rodríguez Bernaldo de Quirós is a member of the team which has developed the new technique, whose details have recently been published in the Food Chemistry magazine. "The other drinks contain much higher levels than those specified by the manufacturer because, as has already been indicated in a previous study, the label probably only shows the amount of added ascorbic acid, without taking into account the fruit's natural vitamin C content", she explained to SINC.

Bernaldo de Quirós highlights the greater resolution and sensitivity of the method, by means of which it is possible to detect up to 0.01 milligrams of vitamin C per litre, "thanks to the use of new column chromatography, based on spherical particles of ultra pure silica 3 microns in size".

"Another advantage of the method is its simplicity and speed, as the total time taken to carry out the analyses is no more than six minutes", the researcher remarked.

With the new technique, the valuation of the ascorbic acid in the drinks has revealed some curious data. Of the 17 samples analyzed, the one with the highest vitamin C content was an apple juice (840 mg/l), more than the orange juices (352-739 mg/l). The results for the pineapple and grape juices were 702 mg/l and between 30.2 and 261 mg/l for the soft drinks (orange, lemon and apple).

The researchers also evaluated how the vitamin C content of the orange juices and tea drinks varies while they are on the shelves in the temperature conditions specified by the manufacturer. After six days, the former barely lose 8% of their ascorbic acid while, in the tea drinks, this substance falls by 54% at 4ºC and practically disappears at room temperature.

October 5, 2009 (EurekAlert) - Functional food is the food industry's fastest-growing product group, its leading products including dairy products which contain probiotics, that is, bacteria promoting health. Valio's Lactobacillus rhamnosus GG (LGG®) is the most frequently studied and used probiotic. Under the supervision of researchers at the Institute of Biotechnology, and the Department of Basic Veterinary Sciences at the University of Helsinki, an international research team determined the genome sequences of LGG and a bacterium closely related to it. The results, published in the renowned PNAS journal, shed light on the origin of probiotic mechanisms and promote product development in the food industry.
Functional food includes products designed for daily use, which have been shown by clinical studies to have positive health effects. Scientific study results have particularly contributed to the success of dairy products containing probiotic bacteria. Many research publications have confirmed that these bacteria promote health and boosts immune system and improve digestion. Some probiotics can also alleviate the symptoms suffered by those with irritable bowel syndrome. As many as every fifth westerner suffers from this pain, also called spastic colon. Studies say that LGG probiotics are also an effective treatment method for reducing children's atopic symptoms, and the risk of respiratory infections.

In its recent publication, the research team showed that the protein component found by the team has a fundamental role in LGG binding with the human intestinal mucus. The team found out that the surface structures of LGG has a specific adhesion component. Remarkably, the binding feature has been assumed to be one of the most important characteristics of bacteria with health-benefiting effects. Moreover, the researchers assume that the protein structure in question enables the health-promoting effects of LGG and other probiotic bacteria, and the positive immune modulation produced by them.

The research is a prime example of productive co-operation between researchers and the food industry. According to Tuomas Salusjärvi, research manager for Valio, the successful sequencing provides valuable additional information to support the already existing research information. The safety of the LGG probiotic and its advantages to consumers can now be shown in an even better way than before. A significant research field has been established around probiotic bacteria. So far, thousands of scientific articles have been published on the subject. For this line of research, the findings of the genome, and the molecular mechanism possibly behind probiotics, is a downright breakthrough.

October 1, 2009 (Newswise) - For men with type 2 diabetes, a cell type linked to allergic inflammation is closely linked to a key indicator of diabetic kidney disease (nephropathy), suggests a study in the November Clinical Journal of the American Society of Nephrology (CJASN). "Allergy is a common disease that is increasing worldwide, so our findings may have important implications for diabetic nephropathy," comments Michiaki Fukui, MD (Kyoto Prefectural University of Medicine, Japan).The researchers compared the eosinophil count with albumin excretion rate in nearly 800 patients with type 2 diabetes. Eosinophils are a type of white blood cell that contributes to inflammation in allergic diseases. The albumin excretion rate is a key indicator of kidney disease, one of the major complications of diabetes.

In men, a higher number of eosinophils in the blood correlates with higher urinealbumin-a critical early sign of diabetic kidney disease. Surprisingly, the link between eosinophil count and albumin excretion rate was even stronger than for known risk factors like high blood pressure and poor diabetes control. The eosinophil count was unrelated to albumin excretion in diabetic women.

Previous studies have suggested that patients with asthma and other allergic diseases are at increased risk of heart disease. Heart disease is the main cause of death in diabetics, and nephropathy is a major risk factor for heart disease. If the results are confirmed by future studies, then the eosinophil count might help in estimating the risk of diabetes-related kidney and heart disease in men.

Some of the anti-inflammatory treatments used by patients with allergies can lower the eosinophil count, and it's possible that these treatments could also benefit male patients with diabetes, Fukui believes. He adds, "The intriguing concept of a role for eosinophils in diabetic nephropathy holds great promise for the development of new preventive measures involving anti-allergic agents."

The study can't prove any cause-and-effect relationship between eosinophil count and albumin excretion rate. More research will be needed to determine why the relationship was found only in men, and whether a similar link is also present in patients without diabetes.

The authors reported no financial disclosures. Other authors were Muhei Tanaka, Masahide Hamaguchi, Takafumi Senmaru, Kazumi Sakabe, Emi Shiraishi, Ichiko Harusato, Masahiro Yamazaki, Goji Hasegawa, all of Kyoto Prefectural University of Medicine.