Author Interviews, Cancer, Cancer Research, Hepatitis - Liver Disease, Race/Ethnic Diversity / 12.06.2017

MedicalResearch.com Interview with: Farhad Islami, MD PhD Strategic Director, Cancer Surveillance Research American Cancer Society, Inc. Atlanta, GA 30303 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Liver cancer is one of the leading causes of cancer death in the United States, accounting for nearly 29,000 deaths per year, with variations in occurrence by race/ethnicity and state. We examined trends in liver cancer incidence, survival, and mortality in the United States and provided liver cancer mortality rates by race/ethnicity at the national and state level. State-level statistics are particularly important as they can inform state cancer control and prevention planning. We also provided detailed information on prevalence and trends in major risk factors for liver cancer and interventions to prevent or reduce their burden, to make our article a comprehensive yet concise source of information on liver cancer statistics, risk factors, and interventions in the United States. (more…)
Author Interviews, Biomarkers, Heart Disease, Lipids / 12.06.2017

MedicalResearch.com Interview with: Amane Harada, PhD Senior Researcher Central Research Laboratories, Sysmex Corporation Kobe, Japan Ryuji Toh, MD, PhD Associate Professor Division of Evidence-based Laboratory Medicine Kobe University Graduate School of MedicineRyuji Toh, MD, PhD Associate Professor Division of Evidence-based Laboratory Medicine Kobe University Graduate School of Medicine Kobe, Japan  MedicalResearch.com: What is the background for this study? Response: High-density lipoprotein (HDL) exhibits a variety of anti-atherogenic functions including anti-inflammatory and anti-oxidative functions as well as promoting reverse cholesterol transport. However, it has been reported that HDL may lose its anti-atherogenic properties and become “dysfunctional” HDL under pathological conditions. Recent studies have demonstrated that cholesterol efflux capacity of HDL is a better predictor of CVD than HDL-C, suggesting that not only the quantity, but also the quality of HDL may significantly modulate and predict the progression of cardiovascular disease. However, the conventional procedure for efflux capacity assay requires radiolabeling and cells, and the procedures are time consuming. Therefore, its clinical application is impractical. To solve those problems, we have recently developed a new assay system to evaluate the capacity of HDL to accept cholesterol, named “uptake capacity”. (more…)
Author Interviews, BMJ, Cannabis, Pediatrics / 12.06.2017

MedicalResearch.com Interview with: Dr Michelle Taylor PhD Senior Research Associate in Epidemiology MRC Integrative Epidemiology Unit (IEU) School of Social and Community Medicine University of Bristol Bristol UK MedicalResearch.com: What is the background for this study? Response: Many previous studies have looked at adolescent cannabis use, however most of these look at use at a single time point, for example whether an individual has ever used cannabis at age 16 years, or how regularly a person uses cannabis at age 18. However, as young people do not initiate use at the same time or follow the same pattern of use, using measures at a single time point does not always tell the whole story. We used a form of statistical modelling using data taken over the course of adolescence to try and characterise underlying patterns of cannabis use across adolescence. We used data from the Avon Longitudinal Study of Parents and Children which had information on cannabis use at six time points between the ages of 13 and 18 years. (more…)
Author Interviews, Breast Cancer / 12.06.2017

MedicalResearch.com Interview with: Marco D. Huesch, MBBS, PhD Department of Radiology Milton S. Hershey Medical Center Hershey, PA   MedicalResearch.com: What is the background for this study? Response: Public health depends on coordinated actions between patients, payors and providers. Important preventative care and evidence-based screenings need to be understood and sought out by patients, need to be reimbursed by or subsidized by insurance plans, and offered and recommended by physicians and care team members. Women’s breast health is a good example of how – in theory – all these come together and allow women to obtain regular screenings for breast cancer through mammograms. Yet it is commonly accepted that perhaps as many as 1 in 3 women are not adequately screened or are not screened at all. In this study we hypothesized that a prominent global celebrity, Ms Angelina Jolie’s, highly public announcement of her own risk-reducing surgery to prevent breast cancer and her recommendation to women to understand whether they were at high risk might spur uptake of breast screenings at our institution. (more…)
Author Interviews, Cancer Research, Geriatrics, JAMA, Johns Hopkins / 12.06.2017

MedicalResearch.com Interview with: Nancy Schoenborn, MD Assistant Professor Division of Geriatric Medicine and Gerontology Johns Hopkins University School of Medicine Nancy Schoenborn, MD Assistant Professor Division of Geriatric Medicine and Gerontology Johns Hopkins University School of Medicine MedicalResearch.com: What are the main findings? Response: A lot of cancer screenings are not expected to save lives until up to 10 years later; however, the side effects of the test happen right away. Because of this, clinical guidelines have recommended against routine screening for those patients who will not live long enough to benefit but may experience the potential harm of the test in the short term. However, many patients with limited life expectancy still receive screening and clinicians are worried about how patients would react if they recommended that patients stop screening. This research is important because it is the first study that explores how patients think about the decision of stopping cancer screening and how patients want to talk to their doctors about this issue. Understanding patient perspectives would help improve screening practices and better align recommendations and patient preference. (more…)
Author Interviews, JAMA, Nutrition, Stanford / 12.06.2017

MedicalResearch.com Interview with: Bradley P. Turnwald MS Stanford University, Department of Psychology Stanford, California MedicalResearch.com: What is the background for this study? Response: This study tested an intervention to encourage people to consume healthier foods. Encouraging healthy eating is difficult because many people think that healthy foods do not taste good, and most people prioritize taste over health when choosing what to eat. In fact, lab studies suggest that people rate foods as less tasty, less enjoyable, and less filling when they are labeled as healthy compared to when the same foods are not labeled as healthy. A recent study from the Stanford Mind & Body Lab published last month in Health Psychology showed that healthy foods are even described with less tasty, exciting, and indulgent descriptions compared to standard items on the menus of top-selling chain restaurants in America. This led us to ask the question, what if healthy foods were described with the tasty and indulgent descriptions that are typically reserved for the more classic, unhealthy foods? (more…)
Author Interviews, Depression, Pharmacology / 12.06.2017

MedicalResearch.com Interview with: Greta A Bushnell, MSPH Doctoral Candidate, Department of Epidemiology UNC, Gillings School of Global Public Health MedicalResearch.com: What is the background for this study? What are the main findings? Response: Patients with depression may be co-prescribed a benzodiazepine at antidepressant initiation for a short period for a variety of reasons. Reasons include reducing concurrent anxiety and insomnia, reducing depression severity more quickly, and improved antidepressant continuation. However, there are concerns with benzodiazepines including dependency. As such, benzodiazepines are usually recommended for only short-term treatment. Prior to our study, little was known about a) how often new simultaneous antidepressant and benzodiazepine prescribing occurred among patients initiating antidepressant treatment for depression or b) whether new simultaneous users became long-term benzodiazepine users. In a large commercial insurance database, we identified adults aged 18-64 years with depression who initiated an antidepressant from 2001 to 2014. We found that 11% of adults simultaneously initiated benzodiazepine treatment, which increased from 6% in 2001 to a peak at 12% in 2012. We observed similar antidepressant treatment length at six months in simultaneous new users and among patients initiating antidepressants only. The majority of simultaneous new users had only one benzodiazepine prescription fill before benzodiazepine discontinuation; however, 12% were identified as long-term benzodiazepine users. (more…)
Author Interviews, Gender Differences / 12.06.2017

MedicalResearch.com Interview with: Olivia Choy Ph.D. candidate in Criminology Department of Criminology, University of Pennsylvania University of Pennsylvania MedicalResearch.com: What is the background for this study? What are the main findings? Response: The higher rate of offending among males compared to females is a well-documented phenomenon. However, little is known about what accounts for this gender difference. As males have been found to have significantly lower heart rates than females and lower resting heart rates have been associated with higher levels of offending, we tested whether low heart rate may partly account for the gender gap in crime. Resting heart rate at age 11 accounted for 5.4% to 17.1% of the gender difference in crime at age 23. (more…)
Author Interviews, Boehringer Ingelheim, Cost of Health Care, Heart Disease / 12.06.2017

MedicalResearch.com Interview with: Sabine Luik, M.D. Senior vice president, Medicine & Regulatory Affairs Boehringer Ingelheim Pharmaceuticals, Inc. MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study is the first real-world, matched head-to-head study comparing all cause healthcare costs and healthcare resource utilization (HCRU) among novel oral anticoagulants (NOACs). The study analyzed claims data from 70,898 newly-diagnosed NVAF patients who were newly treated with Pradaxa, rivaroxaban or apixaban. The analysis found that Pradaxa was associated with lower all-cause costs and HCRU compared to rivaroxaban. Compared to apixaban, Pradaxa was associated with similar all-cause costs and hospitalizations, but higher all-cause outpatient and pharmacy HCRU. (more…)
Author Interviews, Diabetes, Vegetarians, Weight Research / 12.06.2017

MedicalResearch.com Interview with: Hana Kahleova, MD, PhD Director of Clinical Research at Physicians Committee for Responsible Medicine Physicians Committee for Responsible Medicine Charles University in Prague MedicalResearch.com: What is the background for this study? What are the main findings? Response: The vegetarian diet was found to be almost twice as effective in reducing body weight, resulting in an average loss of 6.2kg compared to 3.2kg for the conventional diet. Using magnetic resonance imaging, we studied adipose tissue in the subjects’ thighs to see how the two different diets had affected subcutaneous, subfascial and intramuscular fat. We found that both diets caused a similar reduction in subcutaneous fat. However, subfascial fat was only reduced in response to the vegetarian diet, and intramuscular fat was more greatly reduced by the vegetarian diet. (more…)
Author Interviews, JAMA, Surgical Research / 12.06.2017

MedicalResearch.com Interview with: Virginia Sun, RN, PhD Assistant Professor Division of Nursing Research and Education Department of Population Sciences Cancer Control and Population Sciences Program City of Hope Duarte, CA 91010  MedicalResearch.com: What is the background for this study? Response: Surgery is one of the most effective and important treatment strategies for cancer. Surgical procedures are by definition invasive, and patients are at risk for unpleasant symptoms, impaired functional status, and poor quality of life. Traditionally, mortality has been the sole measure to assess the risk of most surgical procedures. However, as surgical mortality has sharply declined, focus has shifted toward other endpoints, including patient-centered outcomes. There are critical gaps to assessing and integrating patient-centered outcomes into the surgical oncology workflow. We conducted this proof-of-concept study to assess the feasibility and acceptability of a wireless monitoring approach for patient-centered outcomes before and after a major abdominal cancer surgery. (more…)
ASCO, Author Interviews, Cancer Research, Vaccine Studies / 12.06.2017

MedicalResearch.com Interview with: Chrisann Kyi, MD Fellow, Division of Hematology and Medical Oncology Icahn School of Medicine at Mount Sinai One Gustave L. Levy Place, Box 1079 New York, NY 10029 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Mutation-derived tumor antigens (MTAs or neoantigens) arise as a direct result of somatic mutations, including nucleotide substitutions, insertions, and deletions that occur during carcinogenesis. These somatic variations can be characterized via genetic sequencing and used to identify MTAs with predictive computational genomics and algorithms. To be a good candidate for a cancer vaccine, a mutated cancer protein must be visible and recognized by T cells, the soldiers of the immune system, so that they in turn can be educated to seek out and destroy cancer cells that bear the mutated protein. At annual ASCO conference this year, we are presenting an exciting clinical trial investigating the feasibility, safety, and immunogenicity of a personalized MTA-based multi-peptide vaccine in the adjuvant treatment for multiple solid tumors. In this trial, the patient’s own tumor is used to manufacture a cancer vaccine according to the mutations in their individual tumor. This vaccine is then given back to the patient in the adjuvant setting. The clinical trial is currently open and accruing at Tisch Cancer Center at Mount Sinai Hospital, NY (more…)
Author Interviews, Outcomes & Safety / 11.06.2017

MedicalResearch.com Interview with: Antonio García-Romero IE University – IE Business School Madrid, SpainAntonio García-Romero IE University – IE Business School Madrid, Spain MedicalResearch.com: What is the background for this study? Response: There is an increasing need for new approaches capable of measuring the “real” effects of research on society. People are interested in knowing what benefits are obtained from scientific research. Our aim in this project was to develop a valid methodology capable of measuring the effects from scientific research on some healthcare outcomes such as the average length of stay in a hospital. Our central hypothesis is that the more research is carried out in hospitals, the more efficient the hospitals are regarding the length of stay (LOS). (more…)
Aging, Author Interviews, Geriatrics / 10.06.2017

MedicalResearch.com Interview with: Raya Elfadel Kheirbek, MD, MPH Geriatrician and Palliative Care Physician Washington DC VA Medical Center Associate Professor of Medicine George Washington University School of Medicine and Health Sciences MedicalResearch.com: What is the background for this study? What are the main findings? Response: In the past decade, there has been a shift in the concept of successful aging from a focus on life span to health span. We all want to age gracefully “expecting” optimal health, quality of life and independence. Centenarians are living examples to the progress we have made in health care. They are the best example of successful aging since they have escaped, delayed or survived the major age-related diseases and have reached the extreme limit of human life. However, little is known about Veterans Centenarians’ incidence of chronic illness and its impact on survival. Utilizing the VA Corporate Data Warehouse (CDW), I worked with my colleagues’ researchers and identified 3,351 centenarians who were born between 1910 and 1915. The majority were white men who served in World War II and had no service related disability. The study found that 85 % of all the centenarians had no incidence of major chronic conditions between the ages of 80 and 99 years of age. The data demonstrate that Veteran centenarians tend to have a better health profile and their incidence of having one or more chronic illness is lower than in the general population. (more…)
Author Interviews, Diabetes / 10.06.2017

MedicalResearch.com Interview with: Katrina Donahue MD, MPH Professor, Director of Research, UNC Family Medicine. Co-Director, North Carolina Newtork Consortium (NCNC). Chapel Hill, NC MedicalResearch.com: What is the background for this study? Response: Type 2 diabetes is an epidemic affecting one in 11 people in the United States. For those treated with insulin, checking blood sugar with a finger stick at home is an accepted practice for monitoring the effects of insulin therapy. However, the majority of patients with type 2 diabetes are not treated with insulin. These patients, too, are often recommended glucose monitoring, despite an ongoing debate about its effectiveness in controlling diabetes or improving how patients feel. Currently, 75 percent of non-insulin treated type 2 diabetes patients perform regular blood glucose testing at home, generally at the recommendation of a provider. “The MONITOR Trial” is the first large pragmatic study examining glucose monitoring in the United States. (more…)
Addiction, Author Interviews, Cost of Health Care, Opiods, PLoS / 10.06.2017

MedicalResearch.com Interview with: A. Simon Pickard, PhD Professor, Dept of Pharmacy Systems, Outcomes and Policy University of Ilinois at Chicago College of Pharmacy MedicalResearch.com: What is the background for this study? What are the main findings? Response: The heroin epidemic, which has left virtually no part of American society unscathed, can be viewed as an illness.  Unlike some illnesses, however, it was largely manufactured by stakeholders in the healthcare system, wittingly or unwittingly. The main finding, that heroin addiction costs us just over $50 billion per year, is likely a conservative estimate. (more…)
ASCO, Author Interviews, Breast Cancer, Merck, NYU / 10.06.2017

MedicalResearch.com Interview with: Sylvia Adams, MD Associate Professor of Medicine Breast Cancer and Cancer Immunotherapy Programs NYU Langone Medical Center Cancer Institute/Clinical Cancer Center New York, NY 10016   MedicalResearch.com: What is the background for the Keynote-086 trial ? What are the main findings? Response: This study is the largest immunotherapy study to date presented in metastatic triple negative breast cancer. This phase 2 trial studied the efficacy and safety of pembrolizumab (P) as single agent in a very aggressive disease and had two cohorts, a cohort of previously untreated patients (Cohort B) and a cohort with patients who had received prior chemotherapy lines in the metastatic setting (Cohort A). The study showed that single agent pembrolizumab can elicit durable responses in a subset of patients. This was found regardless of tumoral PD-L1 expression but appeared to be much more frequent in women without prior chemotherapy treatments in the metastatic setting. Survival is especially promising for patients responding to therapy. (more…)
Author Interviews, Breast Cancer, JAMA, Surgical Research / 10.06.2017

MedicalResearch.com Interview with: Monica Morrow, MD, FACS Chief, Breast Service Department of Surgery Anne Burnett Windfohr Chair of Clinical Oncology Memorial Sloan Kettering MedicalResearch.com: What is the background for this study? Response: Although we know that bigger surgery does not result in better patient outcomes in breast cancer, since 2005 rates of lumpectomy have been decreasing accompanied by an increase in bilateral mastectomy for unilateral cancer. High rates of second surgery after initial lumpectomy are one deterrent for patients. In 2013 the SSO and ASTRO developed an evidence based consensus guideline endorsing no ink on tumor as the standard negative margin width for women with stage 1 and 2 cancer having breast conserving surgery with whole breast irradiation. The purpose of our study was to examine time trends in the use of additional surgery after lumpectomy before and after guideline dissemination and to determine the impact of these trends on final rates of breast conservation. (more…)
Author Interviews, Gastrointestinal Disease, Pediatrics, Weight Research / 10.06.2017

MedicalResearch.com Interview with: Raylene Reimer, PhD, RD Professor, Faculty of Kinesiology University of Calgary Department of Biochemistry & Molecular Biology Cumming School of Medicine Full Scientist Alberta Children's Hospital Research Institute MedicalResearch.com: What is the background for this study? Response: The human gut microbiota is a complex and dynamic population of microorganisms that benefit the human host through a variety of microbial activities (e.g. production of vitamins, immune regulation, utilization of dietary fiber). Despite these benefits however, it is now recognized that disruption of the microbiota (dysbiosis) can upset homeostasis and contribute to diseases such as obesity and type 2 diabetes. Manipulation of the gut microbiota to prevent or treat chronic disease is now an area of intense scientific and clinical interest. Dietary prebiotics, such as inulin and oligofructose, are used selectively by host microorganisms to confer a health benefit. Prebiotics have previously been shown to reduce body fat, improve appetite control and reduce blood glucose in adults with overweight or obesity. (more…)
Author Interviews, Emory / 09.06.2017

MedicalResearch.com Interview with: Dr. Robert Liu, PhD Silvio O. Conte Center for Oxytocin and Social Cognition Center for Translational Social Neuroscience Department of Biology Graduate Program in Neuroscience Emory University, Atlanta, Georgia  MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study describes for the first time some of the novel brain mechanisms underlying how social relationships are formed.  In this case we studied the formation of a pair bond in voles.  Pair bonding in voles is not exactly the same as love in humans, but we believe that pair bonding in voles likely shares many of the underlying neural mechanisms as falling in love in humans, such as developing a rewarding feeling towards your partner. Basically, we discovered that rhythmic oscillations of groups of neurons in the prefrontal cortex, an area of the brain that is involved in decision making and executive function, can control the strength of oscillations at a different frequency in populations of neurons in the nucleus accumbens, an area that is involved in pleasure and reward, as well as addiction.  We show that the strength of that PFC-NAc control predicted how quickly animals would begin to show affectionate behavior, analogous to people who may fall in love quicker than others.  But the most intriguing thing was that when animals mated for the first time, the strength of the control of the reward system by the decision making circuit increased, and the greater the increase in that control, the faster the animal started huddling or showing affection toward its partner.  We think that this cortical control of the reward system allows for the neural encoding of the partner’s features (odors, sounds) to become stamped into the reward system, so that the partner becomes rewarding themselves.  Indeed in studies in humans, parts of the striatum, to which the nucleus accumbens belongs, become activated when men look at images of their lovers or when mothers look at images of babies. We not only observed that during pair bond formation the cortex controls rhythmic activity within the reward system, but we actually recreated that communication using a highly innovative technique that allows us to control neural activity using light.  We expressed a light sensitive protein in the cortical neurons that project to the reward system, and then light stimulated those projections in the reward system in animals at the same frequency as normally happens during mating, but in this case the animals were not allowed to mate. By simply recreating the neural oscillatory control of the cortex of the reward area when the female was near the male, we biased how affectionately she acted towards him. We think that the implications for this is not restricted to forming bonds or falling in love, but tells us something fundamental about how certain brain circuits communicate with each other to build social relationships, to make us feel pleasure from being with others that we like.  We believe that by understanding how social cues get instantiated into the brain’ reward system, we may ultimately be able to use this information to help people with impairments in the forming strong social relationships, such as in autism or schizophrenia. (more…)
Author Interviews, Autism, MRI / 09.06.2017

MedicalResearch.com Interview with: Joseph Piven, MD The Thomas E. Castelloe Distinguished Professor of Psychiatry UNC School of Medicine Director of the Carolina Institute for Developmental Disabilities Co-senior author of the study MedicalResearch.com: What is the background for this study? What are the main findings? Response: Babies with older siblings with autism are at an increased risk (20%) of getting autism over the general population (1%).  Infants who later are diagnosed with autism don’t have any of the stigmata of autism in the first year of life. The symptoms of autism unfold in the first and particularly in the second year of life and beyond. We have evidence to support the idea that behavioral symptoms of autism arise from changes in the brain that occur very early in life. So we have employed MRI and computer analyses to study those early brain changes and abnormalities in infancy to see if early brain changes at 6 months of age can predict whether babies at high-risk of developing autism will indeed develop the condition at age two. For this particular study, we used data from MRIs of six-month olds to show the pattern of synchronization or connection across brain regions throughout the brain and then predict which babies at high familial risk of developing autism would be most likely to be diagnosed with the condition at age two. (more…)
Author Interviews, Emory, PTSD / 09.06.2017

MedicalResearch.com Interview with: Jennifer Stevens, PhD Director, Neuroscience of Memory, Emotion, and Stress Laboratory Instructor, Dept of Psychiatry & Behavioral Sciences Emory University School of Medicine MedicalResearch.com: What is the background for this study?  Response: Post-traumatic stress disorder (PTSD) was once thought to be a disorder of combat veterans, however, we now know that more than 60% of Americans experience a traumatic event during their lifetimes, and that this can have negative consequences for mental and physical health. Many people recover from the psychological effects of trauma without any intervention, but a significant proportion have long-lasting debilitating symptoms. Supported by the NIH, the cutting edge of PTSD research includes new strategies for preventing the disease, rather than treating PTSD after patients have been living with symptoms for months to years. In order to prevent the disease, it is critical that we are able to quickly identify people who will be at risk for the disease following a trauma, so that preventive strategies can be deployed bedside in the emergency room or in the battlefield. In the current study, we used functional MRI to predict which individuals would recover from trauma, and which individuals would have long-lasting symptoms of PTSD. (more…)
Author Interviews, JAMA, Karolinski Institute, Pharmacology, Schizophrenia / 09.06.2017

MedicalResearch.com Interview with: Jari Tiihonen, MD, PhD Professor, Department of Clinical Neuroscience Karolinska Institutet Stockholm, Sweden  MedicalResearch.com: What are the limitations of existing analyses of the comparative effectiveness of antipsychotics? Response: It has remained unclear if there are clinically meaningful differences between antipsychotic treatments in relapse prevention of schizophrenia, due to the impossibility of including large unselected patient populations in randomized controlled trials, and due to residual confounding from selection biases in observational studies. (more…)
Author Interviews, Heart Disease, JAMA, Race/Ethnic Diversity, Social Issues / 09.06.2017

MedicalResearch.com Interview with: Dr. Ayodele Odutayo MD MSc DPhil(pending) Centre For Statistics in Medicine, University of Oxford Resident Physician (PGY1), Post-Doctoral Fellow, Applied Health Research Centre St. Michael’s Hospital, University of Toronto   MedicalResearch.com: What is the background for this study? What are the main findings? Response: Previously published studies have reported increasing gaps in life expectancy among adults belonging to different socioeconomic strata and suggested that much of this gap was mediated through behavioural and metabolic risk factors. In this study, we found that from 1999-2014, there was an increasing gap in the control of cardiovascular risk factors between high income adults compared to adults with incomes at or below the poverty line. The proportion of adults at high cardiovascular risk (predicted risk of a cardiovascular event ≥20%), the mean systolic blood pressure and the percentage of current smokers decreased for high income adults but did not change for adults with incomes at or below the poverty line. Notably, the income disparity in these cardiovascular risk factors was not wholly explained by access to health insurance or educational attainment. Trends in the percentage of adults with diabetes and the average total cholesterol level did not vary by income. (more…)
Author Interviews, Pharmacology, Pulmonary Disease, University of Michigan / 09.06.2017

MedicalResearch.com Interview with: Kevin R. Flaherty, M.D., M.S. Professor, Department of Internal Medicine Associate Director, T32 Multidisciplinary Training Program in Lung Diseases Chair, Pulmonary Fibrosis Foundation Clinical Care Network Steering Committee University of Michigan Medicine  MedicalResearch.com: What is the background for this study? What are the main findings? Response: This is a new post-hoc analysis, recently presented at the 2017 American Thoracic Society (ATS) conference, which sought to further assess the efficacy of Ofev (nintedanib), an FDA-approved drug treatment for idiopathic pulmonary fibrosis (IPF), and its effect on lung function in those with this disease. IPF is a rare and serious lung disease that causes permanent scarring of the lungs and affects as many as 132,000 Americans. The analysis examined pooled data from the two placebo-controlled, global Phase III INPULSIS trials, which evaluated the efficacy and safety of 52 weeks’ treatment with nintedanib in people with IPF. In both trials, a higher proportion of people treated with placebo than nintedanib had disease progression from baseline to week 52, as defined by the proportions of patients with ≥5% or ≥10% declines in lung function, as measured by forced vital capacity (FVC) % predicted. Additionally, a lower proportion of patients treated with placebo than nintedanib had no decline or an improvement in FVC % predicted. These data support the initial findings from the Phase III INPULSIS trials which found that more patients treated with nintedanib versus placebo had an absolute decline in FVC of less than 5%. In this subgroup analysis, we assessed the proportions of patients from the two INPULSIS trials treated with nintedanib and placebo who had no decline or an improvement in lung function from baseline to week 52 using pooled data for this post-hoc analysis. In terms of those who participated, a total of 864 patients were included (519 treated with nintedanib, 345 treated with placebo). Baseline characteristics including age, gender and FVC were similar between the subgroups of patients who had no decline or an improvement in FVC and those whose FVC declined, and between the nintedanib and placebo groups within each subgroup. (more…)
Author Interviews, Brigham & Women's - Harvard, NEJM, Ophthalmology / 08.06.2017

MedicalResearch.com Interview with: Elisabetta Patorno, MD, DrPH Assistant Professor of Medicine, Harvard Medical School Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital MedicalResearch.com: What is the background for this study? Response: Lithium, a widely used medicine to treat bipolar disorder, has been associated with a 400 fold increased risk of Ebstein’s anomaly, a congenital malformation of the heart, and a 5 fold increased risk of cardiac defects overall in infants when taken early in pregnancy, based on the results from the International Register of Lithium Babies in the 1970’s. Beyond this data, most of the information on the safety of lithium during pregnancy accumulated in the last 40 years is based on case reports and small studies with conflicting results. Despite these concerns and the limited information, lithium remains a first-line treatment for the 1% of women of reproductive age with bipolar disorder in the U.S. population, due to its recognized efficacy during pregnancy and the postpartum period, and due to the presence of a larger body of evidence showing increased risk of congenital malformations for other mood stabilizers, such as valproate. (more…)
Author Interviews, Infections, Merck / 08.06.2017

MedicalResearch.com Interview with: Sanjay Merchant, PhD Executive Director Center for Observational and Real-world Evidence (CORE) Merck MedicalResearch.com: What is the background for this study? What are the main findings? Response: In February, the World Health Organization (WHO) published its first ever list of antibiotic-resistant “priority pathogens” that pose the greatest threat to human health. The list highlights in particular the threat of gram-negative bacteria that are resistant to multiple antibiotics, referred to as multidrug-resistant (MDR) bacteria, which have built-in abilities to find new ways to resist treatment. MDR Pseudomonas aeruginosa (MDR PsA) is listed as one of the pathogens in the Critical category in terms of need for new therapies. It poses an urgent threat. We set out to better understand the clinical and economic burden associated with hospital-onset MDR PsA so that appropriate treatment strategies can be employed to mitigate resistance. Our findings were presented at ASM Microbe 2017. Mortality rates for hospital-onset MDR PsA patients (20.1%) were almost twice as high compared to patients who did not have MDR PsA (11.5%). The MDR PsA patient group had a significantly higher odds ratio for mortality even after controlling for various factors that may impact mortality. Hospital-onset MDR PsA patients spent six additional days in the hospital when compared to patients who did not have MDR PsA infections. These findings highlight the public health threat of MDR PsA among hospitalized patients and the need for timely and effective therapy. (more…)
Author Interviews, Microbiome, Nutrition / 07.06.2017

MedicalResearch.com Interview with: Prof. Avraham A. Levy Department of Plant and Environmental Sciences Prof. Eran Elinav Department of Immunology Prof. Eran Segal Department of Computer Science And Applied Math Weizmann Institute of Science, Rehovot Israel MedicalResearch.com: What is the background for this study?  Response: We performed a type of clinical trial that is very powerful in comparing short term effects of interventions - a crossover trial. In this trial, each subject is compared to themselves; in our case, we compared increased short-term (1 week) consumption of industrial white bread vs. matched consumption of artisanal sourdough-leavened whole-wheat bread - which we originally viewed as radical opposites in terms of their health benefits. We measured various clinical end points - weight, blood pressure, various blood tests - and also the gut microbiome. To our great surprise, we found no difference between the effects those two breads had on the various end points that we measured. This does not mean that bread consumption had no effect - but that this effect was generally similar for its two types. In fact, when we analyzed our data when pooling together the two bread types (i.e., testing whether bread of any type had an effect), we found that just one week of bread consumption resulted in statistically significant changes to multiple clinical parameters - on the one hand, we saw a reduction in essential minerals in the blood (calcium, magnesium, iron) and an increase in LDH (marker of tissue damage); on the other hand, we saw an improvement in markers of liver and kidney function, inflammation markers and cholesterol levels. In terms of the microbiome, we have found only a minimal difference between the effects of the two bread (two microbial taxa that were increased with white bread) - but in general, we saw that the microbiome was very resilient to this intervention. This is surprising as the current paradigm in the field is that a change in nutrition rapidly changes the makeup of the microbiome. We say that this is probably dependent on the kind of change - as we had a nutritional change here which was significant enough to change clinical parameters, which we tend to think of as very stable, and yet had a minimal effect on the microbiome. At this point, there were two possible explanations to what we saw: The first is that bread had an effect in our intervention, but it was very similar between those two very distinct types. The second is that these two distinct types indeed had different effects, but they were different for each subject - and thus cancel out when we look at the entire population. (more…)
Author Interviews, Biomarkers, Pediatrics, Pulmonary Disease / 07.06.2017

MedicalResearch.com Interview with: Jegen Kandasamy MD Division of Neonatology Assistant Professor/Director, Rare Disease Program and Congenital Anomalies Program University of Alabama at Birmingham Birmingham, Alabama  MedicalResearch.com: What is the background for this study? Response: Preterm infants, especially those that are born with a birth weight of 750 grams or less, are prone to a lung disease called bronchopulmonary dysplasia (BPD) because the development of lungs in these infants takes place in an environment that has more oxygen than that available in utero. Recently, pulmonary blood vessel growth and function has been hypothesized to play a causal role in the pathogenesis of BPD. Vascular endothelial cell function has been shown to affect hyperoxia-induced lung damage in animal studies. An important source of human vascular endothelial cells is the umbilical cord of newborn infants. These human umbilical venous endothelial cells (HUVEC) have been used to measure endothelial cell function in various diseases but never in diseases related to the newborn infants from whom they were derived. In addition, the mitochondria in various cells in our body respond to oxygen toxicity by creating, as well as consuming, reactive oxygen species (ROS) that mediate most of the effects of oxygen-induced damage. Therefore, we designed this study to measure mitochondrial function in vascular endothelial cells obtained from the umbilical cords of prematurely born infants at the time of their birth. We then compared these mitochondrial functional measures between infants who later died or developed BPD versus those who survived without BPD. (more…)
Author Interviews, JAMA, Pediatrics, Weight Research / 07.06.2017

MedicalResearch.com Interview with: Elsie M. Taveras, MD, MPH Ofer and Shelly Nemirovsky MGH Research Scholar Chief, Division of General Academic Pediatrics, Department of Pediatrics Mass General Hospital for Children Professor of Pediatrics, Harvard Medical School Professor in the Department of Nutrition, Harvard T.H. Chan School of Public Health Boston, MA MedicalResearch.com: What is the background for this study? Response: We designed this study to test the effectiveness of two interventions that linked clinical and community approaches in improving childhood body mass index (BMI) and obesity prevalence. Another important question we set out to understand was whether there were outcomes aside from BMI and obesity that mattered most to families of children with obesity. (more…)