News Article | April 23, 2017
Bangalore-based Suphala Care helps people to know the right meal specific to their life style, culture, habits, physical, mental and spiritual quotient At one of the most prestigious Indian IT companies as a consultant for health care, Dr Suguna was thinking it’s time to service the nation with more vigorousness. She had vast expertise till then in hospital systems, clinical trials, managing nutrition and diet for diabetes, women and children healthcare that she has been doing on and off her work. Suguna needed more control and focus to work her way to make the difference. At a Hyderabad hospital she met Shriram, her patient who became co-founder later for her dream venture that they both started in 2016 called Suphala Care. “Shriram got intensely interested in the nutritional way to make the change in the society and they started thinking about holistic wellness and nutrition as a way to achieve happiness and a decent business opportunity too,” says Suguna. Without spending too much time mulling over it, the duo came up with the name “Suphala Care” for their startup to denote a “Good Nutritious Food” Their USP: whosoever is coming to them should go happy after meeting them and get enlightened in the path of wellness, understand the ways to keep themselves fit- mentally and physically, prepare food well for their families, get knowledge about -how, when, why, where and how much to eat while meeting them during sessions at one go. Rustling up some money from their savings, they formed the centre in February 2015. “Today we have more than 3000 patients in the list, reviewed as one of the best nutritionist in South India (UrbanClap), do online and Face to Face counselling, and have written the book about the concept of Suphala Care –Holistic Food for Happiness– which has sold more than 20K copies till date,” Shriram beams with smile. Nutritionists, hospital physicians, and dietitians either are hard pressed for time, or don't have complete holistic knowledge to dedicate and understand the unique human wellness requirements. There was a huge gap. Academically, Dr. Suguna has a sound background on various nutritional, therapeutic nutrition and other dietary aspects, and was trained in lifestyle modifications and prevention of chronic disorders. She had over a decades experience in nutrition counselling and quality of life assessments especially in Diabetes Mellitus, Chronic heart diseases and Renal diseases. “Suguna’s research education has equipped her with extensive knowledge in holistic nutrition, health coaching, and preventive health care. Drawing on these skills and my knowledge of different applied dietary theories, her team works with clients to help them make lifestyle changes that produce practical and lasting results,” says Shriram. Suguna has worked as nutrition adviser and consultant for Life Sciences and Healthcare projects for several multinational, voluntary organisations, Pharma and Nutraceutical companies during her various job stints. She has also worked on developing tools for health care and life sciences domains. Suguna has a keen interest in cooking especially cooking without fire and enjoys experimenting with various foods to bring in the best on the platter. Working together with clients to create the best and mutually refined meal and pattern has become the differentiation between Suphala Care and other diet shops. “While most dietitians dwell on calories, carbs, fats, proteins, restrictions, and lists of good and bad foods, I work with my clients to create a happy, healthy life in a way that is flexible, fun, and free of denial and discipline. This involves a series of hands on cooking demos, recipes customised to their needs and techniques to assess your quality of life and help you accept the changes gradually,” says Dr Suguna with lot of enthusiasm. Suphala (as every member in Suphala Care likes calling themselves) shall guide you, in sessions that can take place either in person or over the phone, to find the food and lifestyle choices that best support you. Suphala will also help you to make gradual, lifelong changes to your habits. Suphala care monetises through generic doctor patient model. A network of doctors from various cities, workshops in corporate offices, teaching culinary skills to children, mothers, and clients from India and abroad, conference talks on Holistic Food for Happiness along with daily 45mins to 1.5hrs session with patients which can happen online, discussions on the custom comprehensive report- are the revenue generation vehicle for the centre. “Quality time with my patients and seeing smile on their faces is my top most priority, money is secondary. At the end of the month when I see an sms, review or even an email saying that my patient is happy because of me and he/she would continue seeking my guidance going forward, I have got what I wanted for,” says Suguna. “I am writing my second book – Genie in your foods- after –my first book -Holistic Food for Happiness- and just enjoying the life by doing what I know best,” says a composed Suguna.
News Article | April 30, 2017
Being A Guinea Pig For Science Can Be A Long, Slow Slog "Why am I doing this, again?" I've asked myself that question several mornings over the past few months as my stomach begins growling, usually after I smell popcorn in my coworker's office. He's on a strict 10 a.m. popcorn schedule that coincides with my strict 10 a.m. hunger pang schedule. I am following an intermittent fasting program as part of a clinical trial for people with multiple sclerosis. For the past five months, I have tried to eat only between noon and 8 p.m., and am allowed only water, tea or coffee during the remaining 16 hours. It's part of a study at Johns Hopkins Medicine in which researchers are looking at bacteria in the guts of patients with multiple sclerosis to determine whether intermittent fasting changes the number, the types, or the functions of our bacteria. They're also looking to see if any of those changes affect inflammation and the symptoms we experience. Scientists know that fasting can affect the microbiome, according to Dr. Ellen Mowry, associate professor of neurology and epidemiology at the Johns Hopkins University and lead researcher for the study. But they don't yet know now. Right now, researchers are simply trying to determine which dietary changes affect the microbiome and what the effects are. It's a complicated interplay of microbes, the human body, the environment and genetics. The science is hard, yes, but so is the intermittent fasting! Mowry said in an email that when she tries to fast along with participants, she has found it difficult to maintain. "But often for me," she says, "this is related more to my mental stamina rather than physical." I agree. Over five months, it's been the same nearly every day — I do get a little hungry in the mornings, but I'm thinking about eating more often. I have only eaten any earlier than noon once or twice during the study, like the infamous O'Hare Airport incident when I just couldn't resist that bagel. I still have no regrets. My slip-ups tend to be when I'm running late and eat after 8 p.m. I don't think I've screwed up enough to affect the tests, and I've been honest when it comes to food logging. In a previous fasting study looking at calorie restriction, researchers had more to rely on than participants' word that they were following the diet. "We can predict the amount of weight people should lose in a given time period, so if they aren't doing it," Mowry says, "we can guess adherence isn't accurate." But for this study, it's not so easy. The biggest challenge is sample size — 54 people are enrolled in the study I'm doing. Some are fasting, some are on a restricted calorie diet; and some are in the control group, doing nothing different. "The studies are too small to be certain that any change in symptoms is related to the intervention," Mowry says. She wants to do larger studies, but finding funding for dietary studies is difficult. Also, self-reporting isn't always the most accurate way to get data. Mowry says ideally participants would log meals during food recalls every 24 hours with trained professionals. In other words, I would go in on a Tuesday and tell someone what I ate and drank on Monday. I would explain how food was prepared, how much I ate and drank, and so on. This isn't easy to do because, again, money. There's just not enough to hire the professionals needed. Instead of food recalls, we intermittent fasters text pictures twice a week of what we ate and drank that day. As I entered the final few months of the study, I found myself forgetting more and more to take the pictures before I eat. I have sent more than one photo of a mostly-empty plate with the note, "Sorry! I forgot to snap a picture." I was entering a period of fasting fatigue. Obviously, I needed to get pumped again. So I set up a Google Alert for "microbiome." I cozied up with Ed Yong's book I Contain Multitudes, about the human microbiome, before bed every night — I highly recommend it. I got sucked into thousands of journal articles, skimming everything from "Role of the Gut Microbiome in Obesity and Diabetes Mellitus" in Nutrition in Clinical Practice to "HOW RESEARCH INTO THE MICROBIOME CAN BE USED TO SOLVE CRIMES" in the Southern California Interdisciplinary Law Journal. (I have no idea why the title was in all caps, but I took that as a sign I should read it.) If I decide to continue with intermittent fasting once the study is over, new motivation may come in the form of results from a previous study that Mowry will present this fall. The results should show if calorie restriction or a more extreme form of intermittent fasting called 5:2 fasting affect metabolism and how they affect the microbiome. The thing is, I'm not sure if I want to continue. In the beginning, my boyfriend, who is particularly observant and good at catching subtle changes that I may not notice, said I seemed to have a bit more energy and was not complaining (my word, not his!) about pain as often. And fasting has been a good way to maintain my weight. But a few months ago, my MS symptoms seemed to be worsening. This could be for a couple of reasons, but the big one is likely stress. Finishing my thesis, working, freelancing, gymming ... things reached a frenzied pace, and my pain levels skyrocketed. So did intermittent fasting help? A little, maybe? Not at all? The jury is still out, and it will likely end in deadlock. There are too many factors for me to consider. In about a month I'll return to the doctor with a stool sample and leave with permission to eat breakfast again. If I decide to keep up the fasting, at least I won't have the pressure of worrying that my slip-ups might compromise the work that Dr. Mowry, Research Study Coordinator Sam Roman and others have put into trying to help me and the estimated 2.5 million worldwide who have multiple sclerosis. And if I feel a pang of guilt if I want cream in my morning coffee — or heck, maybe I want breakfast! — I'll just remember what Mowry told me: "It can't be a totally inflexible diet plan; otherwise, it definitely won't be sustainable." Brandie Michelle Jefferson is a communications manager and freelance reporter who loves a good science story. She's on Twitter, too: @b_m_jefferson.
News Article | April 20, 2017
DUBLIN, April 20, 2017 /PRNewswire/ -- Research and Markets has announced the addition of the "Type 1 Diabetes Mellitus Forecast in 12 Major Markets 2017-2027" report to their offering. Type 1 Diabetes Mellitus (T1DM) is a multisystem disease that progressively destroys the...
News Article | May 4, 2017
"Obesity is linked to more than 230 other medical conditions, often more prevalent in the older generation," she said. "We know that even a 5% to 10% weight loss may significantly reduce health risks associated with obesity, so there is a pressing need for the health care community to focus on ensuring early and comprehensive access to obesity care. Collaboration between people with obesity and HCPs is a key part of the solution for addressing and treating this chronic, progressive disease and improving health outcomes." According to Golden, this will require PwO, especially older ones, and HCPs to shift the dialogue in the medical setting. Study findings show that currently, of those PwO who discussed their weight with HCPs, a lesser proportion (56%) of older PwO report that they "seek support" from their HCP for weight loss as compared with younger PwO (65%). Additionally, fewer older PwO (50%) reported having received a "formal diagnosis" of obesity as compared with younger PwO (56%).1 These findings held true despite older PwO reporting greater prevalence of obesity-related conditions such as high blood pressure, high cholesterol, diabetes and sleep apnea (variable by condition, as much as twice the prevalence as the younger group).1 The ACTION Study was a cross-sectional U.S.-based study, conducted through online surveys, included over 3,000 adults with obesity (BMI ≥ 30 kg/m2 based on self-reported height and weight), of which 946 or 31% were 65 or older. About ACTION The "Awareness, Care and Treatment In Obesity Management" (ACTION) study is the first U.S. nationwide study to investigate barriers to obesity management from the perspective of people with obesity, health care professionals and employers. In addition, the study aims to generate insights to guide collaborative action to improve obesity care, education and support. Sponsored by Novo Nordisk, the ACTION study was led by a multi-disciplinary steering committee comprised of representatives from The Obesity Society, the Obesity Action Coalition, and the Integrated Benefits Institute, as well as obesity experts in the fields of primary care, endocrinology, physiology and nursing. The study involved more than 3,000 people with obesity, 600 health care professionals, and 150 employers in the United States. To learn more about the study, please visit www.ACTIONStudy.com. About obesity Obesity is a chronic disease requiring long-term management.2 Complex and multifactorial in nature, obesity is influenced by genetic, physiological, environmental and psychological factors and is associated with many serious health consequences.3,4 The global increase in the prevalence of obesity is a public health issue that has severe cost implications to health care systems.5,6 In the United States, approximately 35% of adults, or nearly 79 million adults, live with obesity.7 Despite the high prevalence of obesity, many people with obesity lack support in their efforts to lose weight and the disease remains substantially underdiagnosed and underreported.8 About Novo Nordisk Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people with other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has nearly 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus. 1 Look M, Golden A, Kyle T, et al. Insights and Perceptions of Obesity Management in Older People with Obesity: Results of National Study. Poster presentation presented at: AACE 2017; May 3-7, 2017; Austin, TX. 2 American Medical Association. Business of the American Medical Association House of Delegates 2013 Annual Meeting annotated reference committee reports: reference committee D. http://www.ama-assn.org/assets/meeting/2013a/a13-addendum-refcomm-d.pdf. Approved June 8, 2014. Accessed October 11, 2016. 3 Wright SM, Aronne LJ. Causes of obesity. Abdom Imaging. 2012;37(5):730-732. 4 Guh DP, Zhang W, Bansback N, et al. The incidence of co-morbidities related to obesity and overweight: a systematic review and meta-analysis. BMC Public Health. 2009;9(88):1-20. 5 World Health Organization. Fact sheet no. 311: obesity and overweight. http://www.who.int/mediacentre/factsheets/fs311/en/. Updated June 2016. Accessed October 1, 2016. 6 Cawley J, Meyerhoefer C. The medical care costs of obesity: an instrumental variables approach. J Health Economics. 2012;31(1):219-230. 7 Centers for Disease Control and Prevention. Adult obesity facts. http://www.cdc.gov/obesity/data/adult.html. Updated September 1, 2016. Accessed October 11, 2016. 8 Crawford AG, Cote C, Couto J, et al. Prevalence of Obesity, Type II Diabetes Mellitus, Hyperlipidemia, and Hypertension in the United States: Findings from the GE Centricity Electronic Medical Record Database. Popul Health Manag. 2010;13:151–161. Novo Nordisk is registered trademark of Novo Nordisk A/S. © 2017 Novo Nordisk All rights reserved. USA17SAM01030 May 2017 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/heart-attacks-strokes-and-other-major-health-events-play-key-role-in-driving-older-americans-with-obesity-to-address-their-weight-300451138.html
News Article | May 5, 2017
In the analysis, which matched INVOKANA® and GLP-1 RA patients based on their demographic and clinical characteristics, patients taking INVOKANA® and those taking GLP-1 RAs were as likely to reach and maintain A1C below 8.0 percent; INVOKANA® patients were 30 percent less likely to discontinue the drug, and 28 percent less likely to be prescribed a new AHA. The investigators used prescribing of a new AHA (e.g., adding or switching to a new AHA therapy) as a proxy for treatment failure. A1C, or hemoglobin A1C, is a measure of average blood glucose control over the past two to three months. The Healthcare Effectiveness Data and Information Set (HEDIS) defines A1C control as less than 8.0 percent.1 Up to half of patients with type 2 diabetes do not meet individualized targets for blood glucose control and other health measures.2 "Type 2 diabetes is a complex disease, and with so many patients not at individual treatment goals, it's important we provide solutions to help patients effectively manage their condition," said Paul Burton, MD, PhD, FACC, Vice President, Medical Affairs, Janssen. "With this analysis, we are proud to expand the body of real-world evidence for INVOKANA® and to further establish its benefits in everyday patient care." INVOKANA® is used along with diet and exercise to lower blood glucose in adults with type 2 diabetes. INVOKANA® is not for weight loss, but may help people lose weight—on average 3 percent. Results may vary by dose and when used with certain other diabetes medications. INVOKANA® was also shown in clinical trials to reduce systolic blood pressure, though it is not indicated as antihypertensive treatment. The most common side effects of INVOKANA® include genital yeast infections, urinary tract infection, and changes in urination. These specific adverse events were generally mild to moderate in intensity in clinical studies. Real-world HbA1c Levels in the Context of Persistence, Treatment Progression, and Durability of HbA1c Control in Patients with Type 2 Diabetes Mellitus Initiated on Canagliflozin or a Glucagon-Like Peptide-1 Receptor Agonist (Poster No. 290): Dr. Wysham presented findings comparing the achievement of A1C goals in patients taking INVOKANA® versus GLP-1 RAs, and adding or switching medications based on real-world data from an electronic medical record (EMR) database. The analysis, based on the QuintilesIMS EMR US database, included weighted samples of adults with type 2 diabetes newly initiated on INVOKANA® 300 mg (11,435 patients) or a GLP-1 RA (11,582 patients) between March 29, 2012 and April 30, 2016. The treatment cohorts were matched using the inverse probability of treatment weighting, to account for differences in baseline characteristics and to simulate randomization. After matching, baseline characteristics and A1C levels were well balanced. Mean A1C levels were evaluated using 3-month rolling averages and compared using generalized estimating equation models with normal distributions to account for multiple measures per patient. Time-to-event outcomes were compared using weighted Cox models and Kaplan-Meier curves. Abstracts of all accepted presentations can be accessed on the American Association of Clinical Endocrinologists' website here. About Type 2 Diabetes Of the approximately 29 million people who have diabetes in the United States, 90 to 95 percent of them have type 2 diabetes, which is chronic and affects the body's ability to metabolize sugar (glucose), and is characterized by the inability of pancreatic beta cell function to keep up with the body's demand for insulin. INVOKANA® is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. INVOKANA® is not for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKANA® is safe and effective in children under 18 years of age. Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis. Do not take INVOKANA® if you: Before you take INVOKANA®, tell your doctor if you have kidney problems; liver problems; history of urinary tract infections or problems with urination; are on a low sodium (salt) diet; are going to have surgery; are eating less due to illness, surgery, or change in diet; pancreas problems; drink alcohol very often (or drink a lot of alcohol in short-term); ever had an allergic reaction to INVOKANA®; or have other medical conditions. Tell your doctor if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed. INVOKANA® may harm your unborn baby. If you become pregnant while taking INVOKANA®, tell your doctor right away. INVOKANA® may pass into your breast milk and may harm your baby. Do not breastfeed while taking INVOKANA®. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take diuretics (water pills), rifampin (used to treat or prevent tuberculosis), phenytoin or phenobarbital (used to control seizures), ritonavir (Norvir®, Kaletra® – used to treat HIV infection), or digoxin (Lanoxin®– used to treat heart problems). INVOKANA® may cause serious side effects, including: Signs and symptoms of low blood sugar may include: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking, or feeling jittery. Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking INVOKANA® and call your doctor right away or go to the nearest hospital emergency room. Broken Bones (fractures): Bone fractures have been seen in patients taking INVOKANA®. Talk to your doctor about factors that may increase your risk of bone fracture. The most common side effects of INVOKANA® include: vaginal yeast infections and yeast infections of the penis; changes in urination, including urgent need to urinate more often, in larger amounts, or at night. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736. Please see full Product Information and Medication Guide. Trademarks are those of their respective owners. About the Janssen Pharmaceutical Companies At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at @JanssenUS. 1 NCQA (National Committee for Quality Assurance). Comprehensive diabetes care: the HEDIS (Healthcare Effectiveness Data and Information Set) measures. Available at: http://www.ncqa.org/report-cards/health-plans/state-of-health-care-quality/2016-table-of-contents/diabetes-care. Accessed April 20, 2017. 2 Ali MK, Bullard KM, Saaddine JB, et al. Achievement of goals in U.S. diabetes care, 1999-2010. N Engl J Med 2013;368:1613-24. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/real-world-evidence-shows-oral-invokana-300-mg-demonstrates-comparable-a1c-reduction-and-control-to-injectable-glp-1-receptor-agonists-300452610.html
News Article | April 27, 2017
Boston, MA-- A new study led by researchers at Brigham and Women's Hospital has found that a single measurement of plasma glycated CD59 (GCD59), a novel biomarker for diabetes, at weeks 24-28 of gestation identified, with high sensitivity and specificity, women who failed the glucose challenge test as well as women with gestational diabetes. Plasma levels of GCD59 were also associated with the probability of delivering a large-for-gestational-age newborn. These findings are published in Diabetes Care. Gestational diabetes is a type of diabetes that occurs during a woman's pregnancy, increasing the mother's risk of delivering a large-for-gestational-age baby, which can lead to pre-term birth, fetal injury, perinatal mortality and cesarean delivery. Gestational diabetes is also a risk factor for preeclampsia and gestational hypertension. Since treatment of gestational diabetes can lessen the risk of adverse pregnancy outcomes, practice guidelines recommend screening all non-diabetic, pregnant women for the disease. The current standard of care to both screen and diagnose gestational diabetes predominantly involves a two-step approach. The first step, known as the glucose challenge test, includes administration of a sugary drink followed by a blood sugar measurement one hour later. Women who fail this screening are then sent for a longer test, called the oral glucose tolerance test, which requires fasting overnight, drinking a more concentrated sugar solution and undergoing baseline and hourly blood draws for three hours. These glucose tests, or variations thereof, are currently the only methods used to screen pregnant women for or diagnose gestational diabetes. They are time consuming, cumbersome, uncomfortable for mothers and have poor reported reproducibility. The research team's primary goal was to assess the accuracy of the diabetes biomarker, GCD59, in predicting the results of the standard of care glucose challenge test used to screen for gestational diabetes. The team conducted a case-control study of 1,000 pregnant women who were receiving standard prenatal care at BWH: 500 women who had a normal glucose challenge test (control subjects) and 500 women who failed the glucose challenge test and required a subsequent oral glucose tolerance test (case patients). Researchers found that, when compared with the control subjects, the median plasma GCD59 value was 8.5-fold higher in the patients who failed the glucose challenge test and 10-fold higher in the subset of these patients who met diagnostic criteria for gestational diabetes in the subsequent oral glucose tolerance test. "This is the first study to demonstrate that a single measurement of plasma GCD59 can be used as a simplified method to identify women who are at risk for failing the glucose challenge test and are at higher risk for developing gestational diabetes," says Jose Halperin, MD, a physician and researcher, Director of the Hematology Laboratory for Translational Research at BWH and senior author of the publication. The researchers also found that higher plasma GCD59 levels at gestational week 24-28 were associated with higher prevalence of large-for-gestational-age newborns, with the higher the level, the higher the risk (4 percent higher risk for patients in the lowest quartile of GCD59 plasma levels, and 14 percent in the highest quartile). Out of the 58 large-for-gestational-age babies born to mothers that failed the glucose challenge test in this study, 80 percent were born to mothers who did not meet oral glucose tolerance test criteria for gestational diabetes, but had median plasma GCD59 levels 7-fold higher than control women with a normal glucose challenge test. These findings are consistent with other studies showing that women who fail the glucose challenge test, but do not meet criteria for gestational diabetes, are still at a higher risk of abnormal pregnancy outcomes, including delivering large for gestational age babies. Currently there are no practice guidelines for the management of women who fall between normal and abnormal glucose tolerance levels, and, therefore, their management is the same as that for women with a normal glucose challenge test results. "These results suggest that a single measurement of plasma GCD59 during weeks 24-28 may also help stratify the risk for delivering larger infants among women with gestational glucose intolerance." says Halperin. "Our studies opened an avenue for larger multicenter studies to further assess the clinical utility of plasma GCD59 for screening and diagnosis of gestational diabetes among the general population of the United States. If our results are confirmed, we're hopeful that the GCD59 test could be available in clinical practices within the next few years." Jose Halperin and Michael Chorev have a financial interest in Mellitus, LLC, which is developing diagnostic tools for diabetes, including the test described in this research under a license agreement from Harvard University. This project was supported by the National Institutes of Health grants DK-095429, DK-62994, DK-089206, DK-101442, DK-107407, and HL-111771. It was also funded by the Harvard University Accelerator Fund, now known as the Blavatnik Biomedical Accelerator at Harvard University and the Doris Duke Charitable Foundation. Paper cited: Halperin et al. "Plasma Glycated CD59, a Novel Biomarker for Detection of Pregnancy-Induced Glucose Intolerance." Diabetes Care DOI: 10.2337/dc16-2598. Brigham and Women's Hospital (BWH) is a 793-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare. BWH has more than 4.2 million annual patient visits and nearly 46,000 inpatient stays, is the largest birthing center in Massachusetts and employs nearly 16,000 people. The Brigham's medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in patient care, quality improvement and patient safety initiatives, and its dedication to research, innovation, community engagement and educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Brigham Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, more than 3,000 researchers, including physician-investigators and renowned biomedical scientists and faculty supported by nearly $666 million in funding. For the last 25 years, BWH ranked second in research funding from the National Institutes of Health (NIH) among independent hospitals. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative as well as the TIMI Study Group, one of the premier cardiovascular clinical trials groups. For more information, resources and to follow us on social media, please visit BWH's online newsroom.
News Article | April 27, 2017
DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Type 1 Diabetes Mellitus Forecast in 12 Major Markets 2017-2027" report to their offering. Type 1 Diabetes Mellitus (T1DM) is a multisystem disease that progressively destroys the pancreas' ability to produce insulin. This leads to a chronic condition of defective metabolism of fat, carbohydrates and proteins due to the lack of insulin. It occurs mainly in childhood and adolescents, however a rising number of latent autoimmune diabetes of adulthood (LADA) cases have been reported mainly due to a better understanding and diagnosis of the disease. This report provides the current prevalent population for Type 1 Diabetes Mellitus across 12 Major Markets (USA, Canada, France, Germany, Italy, Spain, UK, Brazil, Japan, India, China and Russia) split by gender and 5-year age cohort. Along with the current prevalence, the report also contains a disease overview of the risk factors, disease diagnosis and prognosis along with specific variations by geography and ethnicity. Providing a value-added level of insight from the analysis team, several of the main symptoms and co-morbidities of Type 1 Diabetes Mellitus have been quantified and presented alongside the overall prevalence figures. These sub-populations within the main disease are also included at a country level across the 10-year forecast snapshot. - Able to quantify patient populations in global Type 1 Diabetes Mellitus market to target the development of future products, pricing strategies and launch plans. - Gain further insight into the prevalence of the subdivided types of Type 1 Diabetes Mellitus and identify patient segments with high potential. - Delivery of more accurate information for clinical trials in study sizing and realistic patient recruitment for various countries. - Provide a level of understanding on the impact from specific co-morbid conditions on Type 1 Diabetes Mellitus prevalent population. - Gain an understanding of the specific markets that have the largest number of Type 1 Diabetes Mellitus patients. 2. Cause of the Disease 7. Key Comorbid Conditions/Features associated with the disease 11. Abbreviations used in the report For more information about this report visit http://www.researchandmarkets.com/research/j3bqpv/type_1_diabetes
News Article | May 2, 2017
Valby, Denmark, 2017-05-02 09:10 CEST (GLOBE NEWSWIRE) -- Valby, Denmark, 2 May 2017 - H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announce top-line results from two phase III clinical trials evaluating the efficacy, safety and tolerability of brexpiprazole in the treatment of agitation in patients with dementia of the Alzheimer’s type. The primary endpoint of both trials was change from baseline in the Cohen-Mansfield Agitation Inventory (CMAI) total score, a 29-item scale to systematically assess the symptoms of agitation[i]. The key secondary endpoint was the change from baseline in the Clinical Global Impression-Severity of Illness (CGI-S) score, a 7-point scale assessing overall severity of the patient’s agitation. These studies were done in multiple countries in North America and Europe, and in the Russian Federation. In both studies, patients treated with brexpiprazole showed improvements in symptoms of agitation relative to placebo. In the first study, the improvements in the primary endpoint of CMAI for 2 mg brexpiprazole were statistically better than placebo (p<0.05) and appeared more robust than the improvements on the key secondary endpoint of CGI-S (p>0.05). In the second study, the improvements in the primary endpoint of CMAI (p>0.05) appeared less robust than the improvements on the key secondary endpoint of CGI-S (p<0.05). In both studies, there was variability in the data from different countries, perhaps associated with differing standards of care; the data from Russian sites showed especially poor separation between placebo and drug. Regarding safety and tolerability, both studies confirmed the profile of brexpiprazole as observed in the clinical trials for schizophrenia and for adjunctive treatment of major depressive disorder (MDD). The most common adverse events in patients receiving brexpiprazole versus placebo (incidence >3% and greater than placebo) were insomnia (4.7% vs. 3.3%), agitation (3.5% vs. 2.9%), and somnolence (3.3% vs. 2.2%). Overall mortality during the studies was low (0.86%) and none of the deaths were considered to be related to treatment. Both trials were randomized, double-blind, placebo-controlled phase III studies that enrolled a total of approximately 700 participants. Trial participants were between 51 and 90 years of age with a diagnosis of probable Alzheimer’s disease and symptoms of agitation. Both outpatients and patients living in institutional care settings were included in the trials. One of the trials studied fixed doses of either 1 or 2 mg per day of brexpiprazole or placebo, while the other trial studied a flexible dose range of 0.5 mg, 1 mg or 2 mg per day of brexpiprazole, or placebo. Both trials were 12 weeks in duration. The companies plan to meet with the U.S. Food and Drug Administration (FDA) to discuss the results of the studies. The results will be presented in scientific congresses over the course of the next year. Alzheimer’s disease is estimated to account for between 60 and 80% of the estimated 5.5 million people in the U.S. with dementia[ii]. Behavioral symptoms develop in the majority of people with Alzheimer's disease and many of these symptoms are clinically diagnosed as “agitation,” including wandering, restlessness, significant emotional distress, aggressive behaviors, and irritability. Symptoms of agitation place a serious burden on the people afflicted with the disease and their caregivers, significantly affecting the quality of life for all concerned. Agitation is often a determining factor in the decision to place patients in high-level residential care facilities, contributing to the roughly USD 259 billion cost burden of Alzheimer’s disease in the U.S. for 2017. It is estimated that agitation symptoms affect nearly 50% or more of patients with Alzheimer’s disease observed over a multiyear period[iii]. Brexpiprazole was approved by the U.S. Food and Drug Administration in July 2015 to treat patients with schizophrenia and as an adjunctive treatment for patients with major depressive disorder (MDD). Brexpiprazole was also approved in February 2017 by Health Canada for the treatment of schizophrenia. In both countries brexpiprazole is distributed and marketed under the brand name Rexulti®. Brexpiprazole is discovered by Otsuka and co-developed by Otsuka and Lundbeck. The mechanism of action for brexpiprazole in the adjunctive treatment of major depressive disorder or schizophrenia is unknown. However, the efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. Brexpiprazole exhibits high affinity (sub-nanomolar) for these receptors as well as for noradrenaline alpha1B/2C receptors. REXULTI is indicated for: • Use as an adjunctive therapy to antidepressants in adults with major depressive disorder Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. REXULTI is not approved for the treatment of patients with dementia-related psychosis. Antidepressants increase the risk of suicidal thoughts and behaviors in patients aged 24 years and younger. Monitor for clinical worsening and emergence of suicidal thoughts and behaviors. The safety and effectiveness of REXULTI have not been established in pediatric patients. Contraindication: In patients with known hypersensitivity reaction to brexpiprazole or any of its components. Reactions have included: rash, facial swelling, urticaria and anaphylaxis. Cerebrovascular Adverse Events, Including Stroke: In clinical trials, elderly patients with dementia randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. REXULTI is not approved for the treatment of patients with dementia-related psychosis. Neuroleptic Malignant Syndrome (NMS): NMS is a potentially fatal symptom complex reported in association with administration of antipsychotic drugs. Clinical signs of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability. Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Manage NMS with immediate discontinuation of REXULTI, intensive symptomatic treatment, and monitoring. Tardive Dyskinesia (TD): Risk of TD, and the potential to become irreversible, are believed to increase with duration of treatment and total cumulative dose of antipsychotic drugs. TD can develop after a relatively brief treatment period, even at low doses, or after discontinuation of treatment. For chronic treatment, use the lowest dose and shortest duration of REXULTI needed to produce a clinical response. If signs and symptoms of TD appear, drug discontinuation should be considered. Metabolic Changes: Atypical antipsychotic drugs have caused metabolic changes including: • Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Assess fasting plasma glucose before or soon after initiation of antipsychotic medication, and monitor periodically during long-term treatment. • Dyslipidemia: Atypical antipsychotics cause adverse alterations in lipids. Before or soon after initiation of antipsychotic medication, obtain a fasting lipid profile at baseline and monitor periodically during treatment. • Weight Gain: Weight gain has been observed in patients treated with REXULTI. Monitor weight at baseline and frequently thereafter. Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia and neutropenia have been reported with antipsychotics. Agranulocytosis (including fatal cases) has been reported with other agents in this class. Monitor complete blood count in patients with pre-existing low white blood cell count (WBC)/absolute neutrophil count or history of drug-induced leukopenia/neutropenia. Discontinue REXULTI at the first sign of a clinically significant decline in WBC and in severely neutropenic patients. Orthostatic Hypotension and Syncope: Atypical antipsychotics cause orthostatic hypotension and syncope. Generally, the risk is greatest during initial dose titration and when increasing the dose. Monitor in patients vulnerable to hypotension, and those with cardiovascular and cerebrovascular diseases. Falls: Antipsychotics may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls causing fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating treatment and recurrently during therapy. Seizures: REXULTI may cause seizures and should be used with caution in patients with a history of seizures or with conditions that lower the seizure threshold. Body Temperature Dysregulation: Use REXULTI with caution in patients who may experience conditions that increase body temperature (e.g., strenuous exercise, extreme heat, dehydration, or concomitant use with anticholinergics). Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotics, including REXULTI, and should be used with caution in patients at risk for aspiration. Potential for Cognitive and Motor Impairment: REXULTI has the potential to impair judgment, thinking, or motor skills. Patients should not drive or operate hazardous machinery until they are reasonably certain REXULTI does not affect them adversely. Concomitant Medication: Dosage adjustments are recommended in patients who are known cytochrome P450 (CYP) 2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors or strong CYP3A4 inducers. Most commonly observed adverse reactions: In clinical trials, the most common adverse reactions were: • Major Depressive Disorder (MDD) (adjunctive treatment to antidepressant therapy; ≥5% incidence and at least twice the rate of placebo for REXULTI vs. placebo, respectively): akathisia (9% vs. 2%) and weight increase (7% vs. 2%) • Schizophrenia (≥4% incidence and twice incidence of placebo for REXULTI vs. placebo, respectively): weight increased (4% vs. 2%) Dystonia: Symptoms of dystonia may occur in susceptible individuals during the first days of treatment and at low doses. Pregnancy: Adequate and well-controlled studies to assess the risks of REXULTI during pregnancy have not been conducted. REXULTI should be used during pregnancy only if the benefit justifies the risk to the fetus. Lactation: It is not known if REXULTI is excreted in human breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800- 438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch). H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in psychiatric and neurological disorders. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are Alzheimer's disease, depression, Parkinson's disease and schizophrenia. Our approximately 5,000 employees in 55 countries are engaged in the entire value chain throughout research, development, manufacturing, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. We have production facilities in Denmark, France and Italy. Lundbeck generated revenue of DKK 15.6 billion in 2016 (EUR 2.1 billion; USD 2.2 billion). For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck. About Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does. Otsuka Pharmaceutical is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (EUR 9.9 billion) in 2016. All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at https://www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on Twitter at @OtsukaUS. The above information contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions, product approvals and financial performance. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Lundbeck's products, introduction of competing products, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses. Certain assumptions made by Lundbeck are required by Danish Securities Law for full disclosure of material corporate information. Some assumptions, including assumptions relating to sales associated with product that is prescribed for unapproved uses, are made taking into account past performances of other similar drugs for similar disease states or past performance of the same drug in other regions where the product is currently marketed. It is important to note that although physicians may, as part of their freedom to practice medicine in the US, prescribe approved drugs for any use they deem appropriate, including unapproved uses, at Lundbeck, promotion of unapproved uses is strictly prohibited. [i] Garriga M., Pacchiarotti, I., Kasper, S., Zeller S. et al. Assessment and management of agitation in psychiatry: Expert consensus. World J Biological Psychiatry 2016;17,(2):93 [iii]Bergh, S.and Selbæk, G. The prevalence and the course of neuropsychiatric symptoms in patients with dementia. Norsk Epidemiologi 2012; 22 (2): 225-232.
News Article | February 14, 2017
HOUSTON, Feb. 14, 2017 (GLOBE NEWSWIRE) -- PLx Pharma Inc. (PLx), a late-stage specialty pharmaceutical company developing next-generation nonsteroidal anti-inflammatory drugs and other pharmaceutical agents today announced that the results of a 40-subject pharmacokinetic/pharmacodynamic (PK/PD) trial of Aspertec™, a novel, patent-protected, lipid-based aspirin product, have been published by the prestigious, peer-reviewed Journal of the American College of Cardiology (JACC). The publication, entitled “Enteric Coating and Aspirin Nonresponsiveness in Patients with Type 2 Diabetes Mellitus,” describes results of the study, which evaluated Aspertec 325 mg versus two commercially-available 325 mg aspirin products: plain (uncoated) and delayed-release, safety-coated (enteric-coated or EC) aspirin, over 72 hours. “This study contributes to the growing body of data on the antiplatelet activity of different aspirin formulations within 72 hours of starting an aspirin regimen. The information gathered from this PK/PD trial suggests that, for these patients, there was, initially, substantial variability in antiplatelet activity depending on the dose form of aspirin administered,” stated Deepak L. Bhatt, MD, MPH, lead author of the study and Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and Professor of Medicine at the Harvard Medical School. “We are very encouraged by the published results of this study and the potential of our novel lipid-based, liquid-filled Aspertec capsule to provide reliable and predictable antiplatelet activity. We believe Aspertec, with multiple potential benefits as a fast, predictable and reliable antiplatelet agent, will provide an important treatment option for prescribers in determining the optimal aspirin formulation for use as the foundational medicine by their secondary prevention and high-risk primary prevention patients,” stated Natasha Giordano, President and Chief Executive Officer of PLx. The article is available online at http://www.onlinejacc.org/content/early/2017/01/05/j.jacc.2016.11.050. JACC publishes the highest quality articles highlighting all aspects of cardiovascular health and disease. With a current impact factor of 17.759, it is one of the most influential journals in the field of cardiology. About Aspertec Aspertec is an approved aspirin product developed to provide reliable and predictable antiplatelet activity. PLx is focused on completing manufacturing scale-up and label finalization for Aspertec 325 mg aspirin dosage form and preparing a supplemental new drug application (sNDA) for Aspertec 81 mg maintenance dose form. About PLx PLx Pharma Inc. is a late-stage specialty pharmaceutical company initially focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide safe and effective aspirin products. The PLxGuard delivery system works by targeting delivery of active pharmaceutical ingredients (API) to various portions of the GI tract. PLx believes this has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce acute gastrointestinal (GI) side effects—including erosions, ulcers and bleeding—associated with aspirin and ibuprofen, and potentially other drugs. On December 22, 2016, PLx announced that it had entered into a merger agreement with Dipexium Pharmaceuticals, Inc. (NASDAQ:DPRX). Following the closing of the merger—which is subject to a number of conditions precedent, including approval of both PLx and Dipexium stockholders—it is expected that Dipexium will be renamed “PLx Pharma Inc.” and will operate under the leadership of the PLx management team. To learn more about PLx and its pipeline, please visit www.plxpharma.com. Forward-Looking Statements Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the prospects for commercializing or selling any products or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to PLx may identify forward-looking statements. PLx cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by PLx to secure and maintain relationships with collaborators; risks relating to clinical trials; risks relating to the commercialization, if any, of PLx’s proposed product candidates (such as marketing, regulatory, product liability, supply, competition, and other risks); dependence on the efforts of third parties; dependence on intellectual property; risks that PLx may lack the financial resources and access to capital to fund proposed operations; and risks that the proposed merger with Dipexium may not be consummated. The forward-looking statements represent PLx’s estimate as of the date hereof only, and PLx specifically disclaims any duty or obligation to update forward-looking statements. Citation for this article: Bhatt DL et al. Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients. Journal of the American College of Cardiology Jan 2017, 23269; DOI: 10.1016/j.jacc.2016.11.050
News Article | February 20, 2017
ATLANTA--(BUSINESS WIRE)--During next week’s HIMSS Annual Conference & Exhibition in Orlando, Fla., Brightree®, a leading provider of cloud-based software to improve clinical and business performance of post-acute care companies, will join CommonWell Health Alliance®, a not-for-profit trade association focused on fostering nationwide health data exchange, and Cerner, a global leader in health care technology, to demonstrate an innovative, person-centric interoperability experience. The demonstration will take place at booth #9000 during the HIMSS Interoperability Showcase: Where IT Connects Everything. The Interoperability Showcase is a premier experience for HIMSS attendees that demonstrates health information technology data exchange through production-ready standards, on: Brightree, a Contributor Member of CommonWell Health Alliance, will be part of the CommonWell Care Transitions use case demonstration, where attendees will follow a hypothetical healthcare patient (named Gloria) with Type 2 Diabetes Mellitus. The demonstration will show the process of her care transition from acute to home care to primary care using Direct Secure Messaging and CommonWell Health Alliance interoperability services. “The future of healthcare and value-based reimbursement requires patient-centric interoperability,” said Jitin Asnaani, executive director of CommonWell Health Alliance. “To optimize care delivery, we must get the data to follow the patient. As our first post-acute focused vendor, Brightree has championed use case extensions to bring this level of interoperability to post-acute providers. By connecting to the CommonWell network, Brightree will enable access to thousands of health care delivery sites and millions of patient records on behalf of its providers. This is a game-changer for post-acute care delivery and patients who are being treated in the post-acute space.” Brightree will demonstrate how its solutions and services are integrated into the system of care by using direct secure messaging of clinical information to initiate a referral and CommonWell network services to augment the referral and supply insight to the patient’s other care providers. “This demonstration will showcase how interoperability is turning a patient’s experience into a smooth transition of care,” said Gary Bartlett, Brightree product manager, interoperability. “Improving how information is recorded, sent and received improves patient outcomes, which is important for the patient and for the provider as the industry shifts to a value-based reimbursement model.” Brightree represents one part of the patient’s three-part interoperability journey, which includes acute and ambulatory care settings represented by Cerner, a Founding Member of CommonWell. The organizations will show attendees how they connect and work together at different areas of the health care continuum to help a patient through various stages of disease management. “Each step utilizes the power of interoperability to show how we can work together to improve patient care,” said Nick Knowlton, Brightree vice president, business development. “We are thrilled to be working with these organizations to help improve care transitions and demonstrate the overall value proposition to the post-acute and broader healthcare world.” Also at HIMSS, Brightree CEO Matt Mellott will be featured on CommonWell TV on Feb. 21, where he will share his insight on interoperability, the healthcare industry, the company’s partnership with CommonWell and other topics. “We strive to provide our customers with the best tools possible to care for their patients, and we are excited to demonstrate our interoperability solutions to the health care industry,” said Mellott. Brightree is a leading provider of cloud-based software to improve clinical and business performance of post-acute care companies. Ranked one of the top 100 healthcare IT companies in the U.S., Brightree serves more than 2,200 organizations in the HME, home health, hospice, orthotic and prosthetic, HME pharmacy, home infusion, and rehabilitation home care segments. For more information, visit www.brightree.com or call 1.888.598.7797.