Want to Avoid Type 2 Diabetes? Eat More Whole Grains

It may seem counter intuitive, but eating bread, pasta and cereal may actually help prevent type 2 diabetes, as long as those foods are made from whole grains, new research suggests.

The study found that each serving of whole-grain foods per day was linked to as much as an 11 percent drop in the risk of type 2 diabetes.

"Whole grains appear to play an important role in the prevention of type 2 diabetes, and choosing whole grains over refined grains is highly recommended," said study author Cecilie Kyro. She is a post-doctoral researcher at the Danish Cancer Society Research Center in Copenhagen.

Kyro added that, in addition to preventing type 2 diabetes, there is evidence that whole grains can help prevent heart disease and colon cancer.

More than 30 million Americans have diabetes, and most have type 2 diabetes, according to the American Diabetes Association (ADA). People with type 2 diabetes don't use the hormone insulin efficiently.

Insulin normally ushers blood sugar into cells to be used as energy. But some people are resistant to the effects of insulin, and then more and more insulin is needed to do the same job. Eventually, the insulin-producing cells in the pancreas can't keep up with the demand, and blood sugar levels rise, resulting in type 2 diabetes, according to the ADA.

Lifestyle factors, such as diet and exercise, are known to play a role in type 2 diabetes. In the latest study, researchers wanted to see what role specific whole grains played in type 2 diabetes.

To do this, they reviewed diet information from more than 55,000 people, aged 50 to 65, in Denmark. On average, the group was slightly overweight.

Overall, about 7,400 people were diagnosed with type 2 diabetes during the study's average 15-year follow-up.

The study volunteers completed food diaries. From these food diaries, the researchers calculated how many grams of whole grains each person ate daily.

The investigators found that for every serving of whole-grain food, the risk of type 2 diabetes dropped by 11 percent for men and 7 percent for women.

In women, only wheat and oats seemed to reduce the risk of diabetes. But for men, all whole grains -- wheat, rye and oats -- were linked to a lower risk of the blood sugar disorder. Kyro said this difference may just be a statistical anomaly because fewer women developed diabetes.

She added that all whole-grain products can be recommended for preventing type 2 diabetes in both men and women.

Exactly how whole grains help prevent type 2 diabetes isn't clear from this study. Because it's an observational study, it isn't designed to prove a cause-and-effect relationship.

Still, the scientists suspect that there may be several reasons why whole grains could be protective, including reduced blood sugar secretion after a meal.

Registered dietician Samantha Heller said the findings fall in line with previous research.

"People who consume whole grains have lower risks of type 2 diabetes, as well as inflammation, coronary heart disease and cancer," she said. In addition, a diet including whole grains also helps with weight management and may improve digestive health.

"Whole grains contain fiber, vitamins, minerals, protein and phytonutrients, all of which play important roles in maintaining a healthy body. Dietary fiber decreases insulin resistance, after-meal blood sugar spikes and decreases inflammation, all of which may contribute to its beneficial effects on type 2 diabetes," Heller explained. (Phytonutrients are nutrients from plant sources.)

Kyro said one serving of whole grain contained 16 grams of whole grain. That can vary depending on the type or brand of a product, but 16 grams is approximately one slice of whole-grain bread, she said.

Heller said that U.S. dietary guidelines recommend three to four servings of whole grains a day. A serving is one slice of bread, one-cup of ready-to-eat cereal or 1/2-cup cooked rice, pasta or cereal. She said those recommendations are for people who are sedentary. If you're more active, you may need more grains each day.

Findings from the study were published in the September issue of The Journal of Nutrition.

New Drug Fingolimod (Gilenya) Could Help Kids With MS

In continuation of my update on Fingolimod

Researchers say the first drug for children with multiple sclerosis vastly outperformed another common MS medication in a new clinical trial.

Fingolimod(Gilenya) reduced relapse rates by 82 percent in patients aged 10 to 17 compared with interferon beta-1a, a drug commonly used to slow the progression of the degenerative nerve disease.

Nearly 86 percent of children on fingolimod remained relapse-free after two years of treatment, compared with only 39 percent of children taking interferon beta-1a, researchers reported.

"I do recommend doctors consider using fingolimod as first-line treatment in pediatric MS," said lead researcher Dr. Tanuja Chitnis, director of the Partners Pediatric MS Center at the Massachusetts General Hospital for Children.

Based on results from this clinical trial, the U.S. Food and Drug Administration in May approved the use of fingolimod in children, Chitnis said.

That makes fingolimod "the first drug approved in the U.S. for pediatric MS," Chitnis said.

Other drugs like interferon beta-1a are used in children, but their use is considered "off-label," said Bruce Bebo, executive vice president of research for the National MS Society.

"We consider this a major development, a major milestone in the MS treatment landscape," Bebo said of fingolimod's approval for use in children.

Multiple sclerosis occurs when the immune system turns on the nervous system and attacks the protective sheath that covers nerve fibers, disrupting communication between the brain and the rest of the body.

MS causes vision problems, numbness or tingling, tremors, slurred speech and fatigue in patients. If left unchecked, it eventually will make it difficult for the person to walk.

Fingolimod is believed to treat MS by suppressing blood levels of lymphocytes, white blood cells that promote the immune system attack on nerve fibers, said Bebo, who was not involved with the trial.

"It slows down dramatically the pathways that lead to relapsing MS," Bebo explained.

The FDA approved fingolimod for use in adults in 2010, and the new trial is part of agency requirements to test new drugs in pediatric patients, Bebo said.

The peak age of MS onset is the 30s and 40s, but about 3 to 5 percent of patients develop symptoms of the disease in childhood, researchers said in background information.

For the clinical trial, 215 young patients were randomly assigned to take either fingolimod, which is an oral drug, or interferon beta-1a, which is injected.

Fingolimod kept MS from progressing in more than 8 out of 10 children taking the drug for two years, more than double the percentage of kids taking interferon beta-1a.

Fingolimod also slowed the development of lesions on the brain and spinal cord, a hallmark of MS. The rate of new or newly enlarged lesions discovered through MRI was 4.4 with fingolimod and 9.3 with interferon beta-1a.

Both drugs carried a high risk of adverse events, 89 percent with fingolimod and 95 percent with interferon beta-1a.

Serious adverse events occurred in about 17 percent of patients taking fingolimod, and included seizures, infection and low white blood cell counts.

"The ultimate decision is based on a clear benefit-risk discussion between the physician and family-patient. A careful review of potential side effects and monitoring is required," Chitnis said.

The findings were published Sept. 12 in the New England Journal of Medicine.

https://en.wikipedia.org/wiki/Fingolimod

Nocdurna (desmopressin acetate) Approved by FDA as First Sublingual Tablet to Treat Nocturia due to Nocturnal Polyuria

The U.S. Food and Drug Administration (FDA) granted Ferring Pharmaceuticals Inc. approval to market Nocdurna, the first sublingual tablet for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void. The formulation of the sublingual tablet and sex-specific dosing was demonstrated to be effective in reducing nighttime trips to the bathroom in adults 18 years and older.

Nocturnal polyuria, a disease of the kidneys, is the most common underlying cause of nocturia, which can affect adults at every age. It occurs when a person has insufficient nocturnal vasopressin, causing an overproduction of urine in the kidneys at night.2 Unlike treatments that target the bladder or prostate, Nocdurna acts on receptors in the kidney to absorb more fluid and produce less urine during the night while patients sleep. Nocdurna was approved with a boxed warning because it can cause hyponatremia.

“Millions of individuals across the country face nocturia each night, many of whom suffer the daytime consequences of fatigue and lost productivity,” stated Jeffrey P. Weiss, MD, FACS, Professor and Chairman of Urology, State University of New York (SUNY) Downstate Medical Center. “Nocdurna offers the first sublingual tablet that can target the source of nighttime urination, the kidney, and effectively reduce the number of times patients have to wake up each night to urinate.”

“For more than a decade, Ferring has provided innovative treatments for patients suffering from nocturia in many other countries around the world,” said Paul Navarre, CEO, Ferring US. “Following today’s FDA approval, we are delighted to make Nocdurna available as an option for US healthcare providers and their patients.”

The FDA approval of Nocdurna is based on three double-blind placebo-controlled, multi-center, randomized trials and one open-label extension trial of up to three years in patients 18 years and older. Included in the clinical trials were patients also taking OAB or BPH medications. The co-primary endpoints in studies 1 and 2 were the change in number of nighttime voids compared to baseline, and the percentage of patients who achieved at least a 33% reduction from baseline in the mean number of nighttime voids during three months of treatment. Clinical trials demonstrated an average reduction of nocturnal voids of 52% in women (n=118) and 43% in men (n=102) relative to mean baseline (reduction of 1.5 and 1.3 voids respectively). The mean baseline was 2.9 for women and 3.0 for men. Also, 78% of women and 67% of men receiving NOCDURNA achieved a 33% reduction in mean number of nocturnal voids over a three month period compared to baseline.1

Nocdurna can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest, or death. Nocdurna is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids. Ensure the serum sodium concentration is normal before starting or resuming Nocdurna. Measure serum sodium within 7 days and approximately 1 month after initiating therapy, and periodically during treatment. Monitor serum sodium levels more frequently in patients 65 years of age and older and in patients at increased risk of hyponatremia. If hyponatremia occurs, Nocdurna may need to be temporarily or permanently discontinued.

Research does not confirm antidiabetic action of natural fatty acid derivatives

A research consortium between the healthcare company Sanofi and Johannes Gutenberg University Mainz (JGU) investigated the antidiabetic action of certain natural fatty acids, so-called FAHFAs, which US-American scientists had reported in 2014. For some of these compounds, e.g. 5-PAHSA and 9-PAHSA, elevated levels were found in mice which overexpressed the glucose transporter Glut4. This transporter is controlled by insulin and causes the uptake of blood glucose in particular into muscle cells. It had been reported that both PAHSA isomers occur in food and are also produced by human cells. Diabetics have lower blood levels of these compounds than healthy individuals. When mice were fed with a FAHFA-enriched diet, their blood glucose levels were found to decrease and insulin was released.

These results published in a prominent journal caused a stir among scientists as they suggested a new point of attack in the fight against a widespread disease. Chemists under guidance of Professor Till Opatz from Mainz University synthesized the stereoisomers of 5- and 9-PAHSA and sent them to their colleagues at Sanofi in Frankfurt for biological testing. In some of the tests, rudimentary metabolic changes could be detected but the overall effect of the compounds was sobering: none of these molecules was able to achieve positive effects on clearly defined endpoints in metabolism.

The results of the researchers from Frankfurt and Mainz recently appeared in Cell Metabolism, a highly renowned international scientific journal. Now the German scientists hope for a constructive discussion on the discrepancy between both studies resulting in a better understanding of the disease models.

The current publication demonstrates the successful collaboration between a university and a research-active healthcare company in a highly relevant area of basic research in biomedicine. It underlines the importance of verification of scientific results and their disclosure.

Lenabasum has acceptable safety and tolerability in diffuse cutaneous systemic sclerosis

The results of an open label extension of a phase II study presented today at the     Annual European Congress of Rheumatology (EULAR 2018) demonstrate that lenabasum ontinues to have acceptable safety and tolerability in diffuse cutaneous systemic sclerosis (dcSSc) with no severe or serious adverse events (AE).

"There is a critical unmet need for safe and effective therapeutics for patients with dcSSc," said Professor Thomas Dörner, Chairperson of the Abstract Selection Committee, EULAR. "These results demonstrate a significant step forward in the clinical development of a potentially impactful treatment for people suffering with this devastating disease."

Systemic sclerosis is a rare but serious autoimmune disease which causes hardening and swelling of the skin, as well as joint pain, digestive problems, lung disease, and sometimes problems with the heart and kidneys. The disease occurs in around 30 people per million population per year. The diffuse cutaneous subtype (dcSSc) is even rarer, affecting just one in every four people with the disease. It is linked with early damage to internal organs, as well as painful skin thickening that quickly gets worse. Only half of people diagnosed with dcSSc will survive for 10 years or more.

Medicines for dcSSc are very limited, immunosuppressants are sometimes used although there have been relatively few trials in dcSSc patients specifically because the disease is so rare and difficult to research.

"Our results are very encouraging and reinforce the positive findings from the double-blinded placebo-controlled part of the study with regard to safety and tolerability," said Robert Spiera, M.D., Director of the Scleroderma and Vasculitis Program at Hospital for Special Surgery, Weill Cornell Medical College in New York City and principal investigator. "We look forward to continuing our investigations to assess the role of lenabasum as a new treatment option for patients with dcSSC."

Lenabasum (JBT-101) is a selective cannabinoid receptor type 2 agonist that activates resolution of innate immune response in humans and reduces inflammation and fibrosis in animal models of SSc. It is a synthetic, oral, non-immunosuppressive small molecule.

The results of the initial phase II trial demonstrated that lenabasum had acceptable safety and tolerability in dcSSc and demonstrated consistent evidence of clinical benefit. In addition, changes in gene expression were shown to be consistent with biologic effects of lenabasum on pathways relevant to SSc.

Thirty-six patients, who completed the phase II trial, enrolled into the one year open-label extension (OLE) to receive lenabasum 20mg twice a day. Results suggested improvement in multiple efficacy outcomes measured both from the start of the original study and the OLE. In the 25 subjects who completed a year in the OLE, the mean improvements from the study start included an improvement in ACR CRISS score* by 56%. There was also a reduction in modified Rodnan Skin Score, HAQ-DI†, Physician Global Assessment, and 5-D Itch Questionnaire by 8.6, 0.14, 0.9, and 2.3 respectively. Forced vital capacity percentage predicted was stable from study start with mean change of 0.4%.

The mean duration of treatment in the OLE was 45 weeks with 19 patients completing 60 weeks of treatment. Three subjects discontinued the trial, two due to AEs and one withdrew consent. AEs occurred in 33/36 subjects in the OLE, however only seven had AEs related to lenabasum (none of which were severe). In total, one subject had an AE considered life threatening, three severe, 21 moderate, and eight mild. One subject developed renal crisis involving two severe and one life-threatening/serious AE (deemed unrelated to lenabasum). Most common AEs across all subjects were upper respiratory tract infection (22%), urinary tract infection (14%), diarrhea (11%), skin ulcers (11%), and mild intermediate dizziness (8%).

An international phase III clinical trial of lenabasum has been initiated with results expected in the first half of 2020.

Drug used to treat myelofibrosis can awaken ‘dormant’ lymphomas in the bone marrow

"Using bone marrow biopsies taken right at the start of the disease, we were able to show that primordia of lymphoma were present in the form of a B-cell clone," explain Heinz Gisslinger and Ulrich Jäger from the Division of Hematology/Hemostatsology of MedUni Vienna's Department of Medicine I. 16% of myelofibrosis patients were found to have dormant aggressive lymphoma. In approximately 6% of these patients, it then erupts when stimulated by the administration of JAK2 inhibitors.

According to the hematologist, it is possible to detect dormant lymphomas, if they are actively sought using sensitive, molecular biological techniques. "This is therefore the best predictive tool. It enables us to filter out the relevant 16%, categorize them and identify them as high-risk patients prior to treatment with JAK2 inhibitors."

The findings of the hematologists working with MedUni Vienna's Division of Medical-Chemical Laboratory Diagnostics and Clinical Pathology were substantiated by researchers at Vetmeduni Vienna, led by Veronika Sexl. They demonstrated in a mouse model that mice who have had bone marrow transplants likewise developed lymphomas. Says Jäger: "The findings from Vetmeduni Vienna fitted together with ours like a piece of a jigsaw puzzle." Moreover, two individual cases from Paris, from international collaborative partner Hôpital Saint-Louis, backed up the conclusions of the Vienna study, which has now been published in the prestigious journal "Blood", where it was also featured in the editorial.

"This multilateral collaboration is a perfect example of how open the research landscape has generally become and how important the reciprocal exchange of data is in medicine," says Jäger. This is also the direction taken by the next step of this project: a start is already being made on collecting international cases and associated data, in order to further enhance drug safety, and researchers are working closely with the pharmaceutical companies who produce these standard drugs. "Our findings represent a paradigm shift and improve the safety of this class of drugs," emphasize Sexl and Jäger.

"I am delighted by the quick, efficient and groundbreaking bridge between the mouse model and the clinical findings that we have succeeded in forming in this case. The basic research, preclinical and clinical work have all fitted together perfectly," adds Sexl.

Ref : https://www.meduniwien.ac.at/web/en/about-us/news/detailsite/2018/news-im-juni-2018/standard-myelofibrosis-drug-can-awaken-dormant-lymphoma/

Eating plant-based diet can reduce risk for heart problems in people with type 2 diabetes

Plant-based diets improve glycemic control, lead to weight loss, and improve cholesterol in people with type 2 diabetes, according to a new review published in the journal Clinical Nutrition.

Researchers reviewed nine randomized controlled trials that assessed the effectiveness of vegan and vegetarian diets for diabetes patients. The results show that those who ate a plant-based diet lowered their cholesterol, lost weight, lowered HbA1c levels, and improved other cardiometabolic risk factors when compared to those who ate a nonvegetarian diet.

More than 100 million Americans currently have diabetes or prediabetes. Those with diabetes are two to four times more likely to die from cardiovascular disease than those who do not have diabetes.

"The link between diabetes and cardiovascular disease is strong. Sixty to seventy percent of people who have type 2 diabetes die of heart disease," says study co-author Hana Kahleova, M.D., Ph.D., director of clinical research at the Physicians Committee for Responsible Medicine. "The good news is that this study shows that the same simple prescription--eating a plant-based diet--can reduce our risk for heart problems and improve type 2 diabetes at the same time."

The study authors suggest that plant-based diets, which center on fruits, vegetables, grains, and legumes, benefit both glycemic control and cardiovascular health, because they are low in saturated fat, rich in phytochemicals, high in fiber, and often rich in low-glycemic fruits and vegetables.

Previous controlled trials and prospective cohort studies have shown that a plant-based dietary pattern is associated with a lower risk of coronary heart disease, type 2 diabetes, obesity, hypertension, cardiovascular mortality, and all-cause mortality.

Ref : https://www.elsevier.com/books/vegetarian-and-plant-based-diets-in-health-and-disease-prevention/mariotti/978-0-12-803968-7#

FDA Approves Mircera for Anemia Associated with Chronic Kidney Disease in Pediatric Patients on Dialysis

Food and Drug Administration approved methoxy polyethylene glycol-epoetin beta (Mircera, Vifor Pharma Inc.) for the treatment of pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA.

Approval was based on data from an open-label, multiple dose, multicenter, dose-finding trial (NCT00717366) in 64 pediatric patients (ages 5 to 17 years) with CKD on hemodialysis and had stable hemoglobin (Hb) levels while previously receiving another ESA (epoetin alfa/beta or darbepoetin alfa). Patients were administered Mircera intravenously once every 4 weeks for 20 weeks. After the first administration of Mircera, dosage adjustments were permitted to maintain target Hb levels.

Efficacy was based on maintaining Hb levels within target levels in the above clinical trial, and also from extrapolation from trials of Mircera in adult patients with CKD. The safety findings observed in pediatric patients were consistent with those previously reported in adults.

For conversion from another ESA, Mircera is dosed intravenously once every 4 weeks based on total weekly epoetin alfa or darbepoetin alfa dose at time of conversion. Full prescribing information is available at Mircera PI.

FDA approves combination of Venclexta and Rituxan for lymphocytic leukemia treatment

   

                   

  

Venclexta® (venetoclax)                                           Rituxan® (rituximab)     

In continuation of my update on Venclexta® (venetoclax)  and Rituxan® (rituximab)

Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved Venclexta® (venetoclax) in combination with Rituxan® (rituximab) for the treatment of people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States.

"We are pleased that this approval makes Venclexta, a first of its kind targeted therapy, available for more people with chronic lymphocytic leukemia whose disease has returned after previous treatment," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "Venclexta plus Rituxan provides a new chemotherapy-free option shown to help people live longer without their disease progressing compared to a standard-of-care therapy."

The approval of Venclexta plus Rituxan for people with previously treated CLL is primarily based on the results of the Phase III MURANO study, which were published online in the New England Journal of Medicine in March 2018 and presented at the American Society of Hematology Annual Meeting in December 2017. The results showed that a fixed duration of treatment with Venclexta plus Rituxan significantly reduced the risk of disease progression or death (progression-free survival; PFS) by 81 percent compared with bendamustine plus Rituxan, a current standard of care (HR=0.19; 95 percent CI 0.13-0.28; p<0.0001).

The most common side effects of Venclexta in combination with Rituxan include low white blood cell count, diarrhea, upper respiratory tract infection, cough, fatigue and nausea.

Today's FDA approval converts Venclexta's accelerated approval to a full approval. The FDA has also updated the indication for Venclexta as a single agent, which is now approved for the treatment of people with CLL or SLL, with or without 17p deletion, who have received at least one prior therapy. Venclexta was previously granted accelerated approval in April 2016 as a single agent for the treatment of people with CLL with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy.

The supplemental New Drug Application (sNDA) based on the MURANO data was granted Priority Review, a designation given to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. The FDA also previously granted Breakthrough Therapy Designation for Venclexta in combination with Rituxan for the treatment of relapsed or refractory CLL. Venclexta in combination with Rituxan is recommended in the National Comprehensive Cancer Network (NCCN) guidelines as a treatment option for previously treated CLL (Category 1, Preferred).

An application for a variation of the marketing authorization based on the MURANO data has also been submitted to and validated by the European Medicines Agency (EMA). Additional submissions of the MURANO data to health authorities around the world are ongoing.

https://www.gene.com/media/press-releases/14728/2018-06-08/genentech-announces-fda-approval-for-ven

FDA approves combination of Venclexta and Rituxan for lymphocytic leukemia treatment

Infant Omega-3 Supplementation Tied to Decreased Waist Size

In continuation of my update on Omega-3 fatty acids

Omega-3 long-chain polyunsaturated fatty acids (n-3 LCPUFA) supplementation in infancy is associated with reduced insulin concentrations and insulin resistance in boys and reduced waist circumference in both sexes at age 5 years, according to a study published online June8 in Pediatrics.

Valene H.L. See, Ph.D., from the Royal Perth Hospital in Australia, and colleagues randomly assigned 420 infants to a daily supplement of n-3 LCPUFA or olive oil (control) from birth to 6 months. Growth, body composition, and cardiometabolic risk factors were evaluated at 5 years of age.

The researchers found that infants who received n-3 LCPUFA had a smaller waist circumference at 5 years (coefficient, 1.1 cm), which remained significant after adjusting for confounders (coefficient, 0.8 cm). Boys who received n-3 LCPUFA supplementation had a 21 percent reduction in insulin concentrations and a 22 percent reduction in insulin resistance versus the control group. At birth, 2.5 years, and 5 years, there were no other differences in growth and cardiometabolic risk factors between the groups.

"Longer-term follow-up of the cohort is warranted to determine whether these differences are maintained into adolescence," write the authors