Author Interviews, Johns Hopkins, NEJM, Weight Research / 02.01.2020

MedicalResearch.com Interview with: Mark P. Mattson, Ph.D. Adjunct Professor of Neuroscience Johns Hopkins University School of Medicine  MedicalResearch.com: What is the background for this study? Response: The usual eating pattern of most people in modern societies is breakfast, lunch, dinner plus a snack(s) every day.   Animals used for most biomedical research – rats and mice – are usually fed ‘ad libitum’ (food is always available for them to eat).    During the past 25 years, myself and the many scientists who trained in my laboratory discovered that when rats or mice are fed intermittently such that they have no food every other day or eat only during a 4-6 hour time period each day, their overall health improves in many ways.  Animals on such intermittent fasting (IF) regimens exhibit signs of slowed aging and they live much longer than those fed ad libitum. The editors of the New England Journal of Medicine invited me and Rafa de Cabo (a former postdoc in my laboratory at the National Institute on Aging) to write this review article for two main reasons.   First, there have been a sufficient number of studies demonstrating the health benefits of IF in humans and knowledge of the underlying mechanisms to justify a review article.  Second, many physicians are being asked about IF by their patients and the physicians are not privy as to if they should recommend IF and how to prescribe specific IF eating patterns and follow-up to increase the likelihood that the patient will be successful in changing their eating pattern.  (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, OBGYNE, Pediatrics, Weight Research / 02.01.2020

MedicalResearch.com Interview with: Elvira Isganaitis, M.D., M.P.H. Pediatric Endocrinologist, Joslin Diabetes Center Assistant Professor of Pediatrics, Harvard Medical School Boston, MA 02215 MedicalResearch.com: What is the background for this study? Response: The concept that a mother's nutrition prior to and during pregnancy is important for health outcomes in the offspring is now well accepted. For example, women intending to get pregnant must take prenatal vitamins, and are encouraged to attain a healthy weight before conception. However, much less is known about how a father's nutritional status may influence childhood health outcomes.  Based on studies in animals, exposure to undernutrition, high-fat diet, or stressful experiences in fathers can result in increased risk of obesity and diabetes in the offspring. These effects are mediated in part by epigenetic mechanisms (i.e. changes in gene expression due to differences in DNA methylation, histones, or other non-genetic mechanisms). (more…)
Alcohol, Author Interviews, Heart Disease, NEJM / 02.01.2020

MedicalResearch.com Interview with: Professor Peter M Kistler MBBS, PhD, FRACP Head of Clinical Electrophysiology Research Baker Heart and Diabetes Institute Head of Electrophysiology at The Alfred hospital Professor of Medicine University of Melbourne. MedicalResearch.com: What is the background for this study? Response: There is a well known association between alcohol intake and atrial fibrillation form population based studies which demonstrate that for every 1 standard drink the incidence of AFib increases by 8%. This is the first randomised study to determine of alcohol reduction/abstinence leads to a reduction in AFib episodes and time to recurrence. (more…)
Author Interviews, Health Care Systems, JAMA / 30.12.2019

MedicalResearch.com Interview with: Maryam Guiahi MD, MSc Associate Professor of Obstetrics and Gynecology University of Colorado Denver School of Medicine MedicalResearch.com: What is the background for this study? Response: The composition of the U.S health care system is shifting; between 2001 to 2016 the number of Catholic-owned or affiliated health facilities grew by 22% in contrast to the overall number of acute care hospitals that decreased by 6% and the number of other nonprofit religious hospitals that decreased by 38%. This is relevant as Catholic health care systems enforce religious directives that restrict many aspects of reproductive care and certain aspects of end-of-life care.  Yet little is known about the extent to which U.S. patients consider religious affiliation when selecting a health care facility.  (more…)
Author Interviews, Opiods, Surgical Research / 30.12.2019

MedicalResearch.com Interview with: Sunil Agarwal, MD Michigan Opioid Prescribing Engagement Network Ann Arbor, MI MedicalResearch.com: What is the background for this study? Response: Excess opioid prescribing after surgery often leads to misuse and diversion into the community. To prevent excessive prescribing for acute pain, 31 states have implemented legislation that limits the duration of opioid prescriptions. Our study examined the effect of prescribing limits and postoperative opioid prescribing on surgical patients in Massachusetts and Connecticut, the first two states to implement opioid prescribing limits for acute pain after the CDC guidelines were released.  (more…)
Author Interviews, Heart Disease, NEJM / 28.12.2019

MedicalResearch.com Interview with: Jean-Claude Tardif CM, MD, FRCPC, FCCS, FACC, FAHA, FESC, FCAHS Director, Montrel Heart Institute Research Center Professor of medicine Canada Research Chair in translational and personalized medicine University of Montreal endowed research chair in atherosclerosis Montreal Heart Institute MedicalResearch.com: What is the background for this study? Response: Inflammation appears to play an important role in atherosclerosis. Inhibition of interleukin-1ß by canakinumab reduced the rate of cardiovascular events by 15% CANTOS. In contrast, methotrexate did not affect cardiovascular outcomes or plasma markers of inflammation in CIRT. Colchicine is an inexpensive, orally administered, potent anti-inflammatory medication that has been used for centuries. Colchicine is currently indicated for the management of patients with gout, familial Mediterranean fever and pericarditis. In the LODOCO study, patients with stable coronary disease treated with colchicine 0.5 mg once daily experienced fewer cardiovascular events as compared with those not receiving colchicine. However, that study enrolled only 532 patients and was not placebo-controlled. Because acute coronary syndromes are associated with higher risks of recurrent events and exacerbated inflammation, we conducted the COLchicine Cardiovascular Outcomes Trial (COLCOT) in patients with a recent myocardial infarction to evaluate the effects of colchicine on cardiovascular outcomes and its long-term safety and tolerability. (more…)
Author Interviews, JAMA, Sleep Disorders / 28.12.2019

MedicalResearch.com Interview with: Margaret Moline, PhD Lemborexant International Program Lead and Global Medical Lead Executive Director, Neurology Business Group Eisai, Inc.  MedicalResearch.com: What is the background for this study? This study, called SUNRISE 1, is one of two pivotal Phase 3 studies in the lemborexant clinical development program that supported the recent FDA approval of DAYVIGO (lemborexant).
  • On December 20, the U.S. Food and Drug Administration (FDA) approved DAYVIGO (lemborexant) 5 mg and 10 mg, an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, which is characterized by difficulties with sleep onset and/or sleep maintenance.1
  • DAYVIGO will be commercially available following scheduling by the DEA, which is expected to occur within 90 days.
  • SUNRISE 1 was a one-month, randomized, double-blind, placebo- and active-controlled, multi-center, parallel-group clinical trial in adult female patients age 55 and older and male patients 65 years and older who met DSM-5 criteria for insomnia disorder. Patients were randomized to placebo (n=208), lemborexant 5 mg (n=266) or 10 mg (n=269), or active comparator (n=263) once nightly.1
  • The primary efficacy endpoint was the mean change in log-transformed latency to persistent sleep (LPS; defined as the number of minutes from lights off to the first 10 consecutive minutes of non-wakefulness) from baseline to end of treatment (Days 29/30), as measured by overnight polysomnography (PSG) monitoring.1
  • The pre-specified secondary efficacy endpoints in Study 2 were the mean change from baseline to end of treatment (Days 29/30) in sleep efficiency (SEF) and wake after sleep onset (WASO) measured by PSG.1
  • SUNRISE 1, lemborexant 5 mg and 10 mg demonstrated statistically significant superiority on the primary efficacy measure, LPS, compared to placebo. lemborexant 5 mg and 10 mg demonstrated statistically significant improvement in SEF and WASO compared to placebo.1
  • The effects of lemborexant at the beginning of treatment were generally consistent with later timepoints.
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Author Interviews, JAMA, Orthopedics, Vitamin D / 26.12.2019

MedicalResearch.com Interview with: Robert Clarke MD, FRCP, FFPH, FFPHI, MSc, DCH Professor of Epidemiology and Public Health Medicine Clinical Trial Service Unit (CTSU) Nuffield Department of Population Health University of Oxford MedicalResearch.com: What is the background for this study? Response: Approximately 1 in 2 women and 1 in 5 men aged 50 years or older will suffer from an osteoporotic fracture in their remaining lifetime. Hip fracture is the most serious type of osteoporotic fracture with an approximately 30% risk of death in the year following a hip fracture. Vitamin D is essential for optimal musculoskeletal health by promotion of calcium absorption, and mineralisation of osteoid tissue formation in bone and maintenance of muscle function. Low vitamin D status causes secondary hyperparathyroidism, bone loss and muscle weakness. Observational studies have reported that lower blood concentrations of vitamin D are associated with higher risks of falls and fractures. Combined supplementation with 800 IU/day vitamin D and 1200 mg/day calcium has been recommended for prevention of fractures in older adults living in institutions and in those with low vitamin D status. However, previous trials and meta-analyses of vitamin D alone, or in combination with calcium for prevention of fracture in either community-dwelling or general population settings reported conflicting results, with some reporting protective effects against fractures, but others demonstrated no beneficial effects. However, most of the previous trials had only limited power to detect differences in risk of fracture predicted by the observational studies, largely because of a combination of small sample size, relatively low equivalent daily doses of vitamin D, intermittent dosing regimens (>1 month), and short duration of follow-up. In addition, interpretation of the results of previous meta-analyses of such trials is complicated by use of variable inclusion criteria, inappropriate statistical methods, inclusion of multiple small trials with very few fracture events, in addition to failure to report achieved differences in blood 25(OH)D concentrations. We summarised the available evidence to guide clinical practice and future research, by conducting parallel meta-analyses of:
  • (i) observational studies of risks of fracture associated with prolonged differences in blood concentrations of 25(OH)D;
  • (ii) randomised trials of vitamin D alone versus placebo or no treatment for prevention of fracture; and
  • (iii) randomised trials of calcium and vitamin D versus placebo or no treatment for prevention of fracture.In addition, we reviewed the design of the ongoing randomised trials assessing the effects of higher doses of vitamin D alone or in combination with calcium for prevention of fracture.
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Annals Internal Medicine, Author Interviews, Biomarkers, Heart Disease / 23.12.2019

MedicalResearch.com Interview with: Dr. PJ Devereaux MD, PhD, FRCP(C) Director of the Division of Cardiology Scientific Leader Anesthesiology, Perioperative Medicine, and Surgical Research Group Population Health Research Institute McMaster University  MedicalResearch.com: What is the background for this study? Response: There is an ethical obligation to provide patients with an accurate estimation of the potential benefits of surgery and the potential risks, to facilitate informed decision making about the appropriateness of surgery.  There are two common approaches to risk estimation. First, physicians commonly use clinical risk indices.  Based upon a patient’s clinical history (e.g., history of prior heart attack or stroke) an estimate of perioperative risk is determined.  Research demonstrates that these clinical risk indices have suboptimal risk discrimination capabilities, and they will underestimate risk in many patients. The second approach that has commonly been used is to have patients undergo an expensive and time consuming non-invasive cardiac test (e.g., stress nuclear cardiac study).  Although these non-invasive cardiac tests can enhance risk estimation in some patients who will have a perioperative cardiac event, these tests more commonly exaggerate risk in patients who will not have a complication. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Mental Health Research, Opiods, Pediatrics / 23.12.2019

MedicalResearch.com Interview with: Megan Land, MD, PGY 6 Pediatric Critical Care Medicine Fellowship Emory University School of Medicine MedicalResearch.com: What is the background for this study?
  • Much of the research on the opioid crisis has focused on the impact to adults; however, children and adolescents in the US are also negatively affected by the opioid epidemic.
  • The percentage of children admitted to a pediatric intensive care unit increased over the study period as the clinical effects of the opioid ingestions increased in severity.
  • The primary intent of opioid ingestions was suspected suicide attempts in adolescents resulting in increasing admissions to a psychiatric hospital.
  • Opioids associated with the highest odds of needing an intervention in an intensive care unit were methadone, fentanyl, and heroin. 
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Abuse and Neglect, Alzheimer's - Dementia, Autism, Medical Imaging, Mental Health Research, MRI, Multiple Sclerosis, Neurology, Technology / 23.12.2019

MedicalResearch.com Interview with: Sebastian Magda, Ph.D Director of Science & Engineering CorTechs Labs, Inc MedicalResearch.com: What is the background for this study? Response: Previous studies have shown that the changes of brain structure volume and/or metabolic activity are associated with various neurological diseases. We have created an artificial intelligence clinical decision support tool based on brain volumetric and PET metabolic activity measurements as well as other clinical measurements. (more…)
AACR, Author Interviews, Cancer Research, Ovarian Cancer / 23.12.2019

MedicalResearch.com Interview with: Rugang Zhang, Ph.D Professor & Co-Leader, Gene Expression & Regulation Program Deputy Director, The Wistar Institute Cancer Center MedicalResearch.com: What is the background for this study? Response: Although the majority of epithelial ovarian cancer (EOC) patients initially respond well to platinum therapy, relapse ultimately occurs, which remains a major challenge in the clinical management of EOC. Substantial evidence suggests that cancer stem-like cells (CSC) contribute to chemotherapy resistance and elimination of CSC prevents the therapeutic relapse including in EOCs. Thus, therapeutic elimination of EOC CSCs represents a promising approach to achieve a durable therapeutic outcome by preventing chemotherapy resistance. Platinum-based chemotherapies are known to induce senescence that limits the propagation of cells subjected to insults such as cancer chemotherapeutics. In contrast to apoptosis, senescent cells remain viable. Senescent cells secrete a plethora of pro-inflammatory cytokines and chemokines, which is termed senescence-associated secretory phenotype (SASP). Therapy-induced inflammation promotes tumor progression and therapy resistance, and the SASP is known to promote cancer stem-like cells. However, clinically applicable approaches to target stemness associated with therapy-induced senescence remain to be explored.  (more…)
Aging, Alzheimer's - Dementia, Author Interviews, MRI, Technology / 23.12.2019

MedicalResearch.com Interview with: Dr. Weidong Luo Principal Scientist CorTechs Labs  MedicalResearch.com: What is the background for this study? Response: We were interested in whether or not we can predict the age of the brain accurately from T1 weighted MRI and/or fluorodeoxyglucose (FDG) PET scans using the brain volumetric and the relative metabolic activity. The uptake of FDG is a clinical marker used to measure the uptake of glucose and therefore metabolism. Also, we were interested in the patterns of the predicted ages for Alzheimer's disease (AD) and minor cognitive impairment (MCI) subjects when using their brain measurements for age prediction in the normal brain age model.   (more…)
Author Interviews, Biomarkers, Cancer Research / 21.12.2019

MedicalResearch.com Interview with: https://www.kariusdx.com/ Dr. Asim Ahmed MD co-author of the study Senior medical director at Karius  MedicalResearch.com: What is the background for this study? Would you briefly explain the basis of the Karius Test? Response: The Karius Test is a non-invasive blood test that uses next-generation sequencing of microbial cell-free DNA to rapidly detect over 1,400 bacteria, DNA viruses, fungi, and other pathogens. Doctors primarily use the test to detect specific causative pathogens, complicated pneumonia, cardiovascular infections, and infections in immunocompromised hosts. The Karius Test is transforming how doctors diagnose infectious diseases by helping doctors identify the precise pathogens infecting patients. The Karius Test offers a higher diagnostic yield and faster time-to-diagnosis than conventional tests - with the potential to eliminate invasive diagnostic procedures like biopsies. (more…)
Author Interviews, Cancer Research / 20.12.2019

MedicalResearch.com Interview with: Jennifer L Marti MD FACS Assistant Professor of Surgery, Breast & Endocrine Surgery Weill Cornell Medicine, New York, NY Luc GT Morris MD, Co-senior author Head & Neck Surgery MSKCC, New York, NY MedicalResearch.com: What is the background for this study? Response: The incidence of thyroid cancer has increased dramatically over the past 3 decades. There is controversy whether this increased incidence is due to increased detection of an existing reservoir of disease, versus a true increase in the occurrence of the disease, due to an environmental carcinogen or other factors (eg obesity). (more…)
Author Interviews, Infections / 20.12.2019

MedicalResearch.com Interview with: Konstans Wells, PhD Lecturer in Biosciences Swansea University  MedicalResearch.com: What is the background for this study? Response:  Cross‐species transmission of harmful viruses between animals and humans is a major source of infectious diseases and a considerable global public health burden. We assessed patterns of virus sharing among a large diversity of mammals, including humans and domestic species. (more…)
Author Interviews, C. difficile, Gastrointestinal Disease / 20.12.2019

MedicalResearch.com Interview with: Sarah W. Baron, M.D Assistant Professor Division of Hospital Medicine Department of Medicine, Montefiore Medical Center Bronx, New York  MedicalResearch.com: What is the background for this study? Response: We know that C. difficile can be a deadly and highly infectious disease but that it has been difficult to control. We also know that some people carry C. difficile in their body without symptoms but can still spread the organism or become sick with it themselves at some point in the future. This study attempted to answer two main questions: 1. First, how many patients coming into a large, urban academic medical center carried the organism C. difficile without any symptoms and 2. How many of those carriers without symptoms then went on to have the symptoms of C. difficile within 6 months? (more…)
Author Interviews, Heart Disease / 20.12.2019

MedicalResearch.com Interview with: Shiwani Mahajan, MBBS Postdoctoral Associate Yale/YNHH Center for Outcomes Research and Evaluation (CORE) New Haven, CT 06510  MedicalResearch.com: What is the background for this study? Response: Although the mortality rates among patients hospitalized for myocardial infarction (MI) have seen a decreasing trend, patients with MI continue to have a delayed presentation to the hospital and a large number of them die before reaching the hospital. One critical aspect of lowering mortality associated with MI is ensuring timely access to lifesaving emergency cardiac care, for which prompt recognition of symptoms of a MI and appropriate rapid emergency response are crucial. As such, in this study, we used nationally representative data to estimate awareness of 5 common symptoms of a MI (including chest pain or discomfort; shortness of breath; pain or discomfort in arms or shoulders; feeling weak or lightheaded; and jaw or neck or back pain), and the appropriate response to a MI (i.e. calling emergency medical services), among adults in the US. (more…)
Alzheimer's - Dementia, Author Interviews, Environmental Risks / 20.12.2019

MedicalResearch.com Interview with: Professor Esme Fuller-Thomson, PhD Director of the Institute for Life Course & Aging, Factor-Inwentash Faculty of Social Work Cross-appointed to the Faculty of Medicine University of Toronto Canada MedicalResearch.com: What is the background for this study? Response: Several studies from the US, Canada, and Europe suggest a promising downward trend in the incidence and prevalence of dementia. Important risk factors for dementia, such as mid-life obesity and mid-life diabetes, have been increasing rapidly, so the decline in dementia incidence is particularly perplexing. (more…)
Author Interviews, Cannabis, JAMA, Pediatrics / 20.12.2019

MedicalResearch.com Interview with: Hongying (Daisy) Dai, PhD Associate Professor Department of Biostatistics | College of Public Health University of Nebraska Medical Center  MedicalResearch.com: What is the background for this study? Response: E-cigarette use increased significantly from 2017 to 2019 among U.S. adolescents, and marijuana and other substances besides can be used in e-cigarettes. Meanwhile, restrictions on marijuana use have been relaxing and social acceptability of marijuana use is shifting among youth. This study analyzed 38,061 middle and high school students from the 2017 and 2018 National Youth Tobacco Survey.  (more…)
Author Interviews, Dermatology / 20.12.2019

MedicalResearch.com Interview with: Dr Kim Kjoeller MD Executive Vice President, Global Research & Development LEO Pharm Discusses the recent announcement from  LEO Pharma A/S that tralokinumab  met all primary and secondary endpoints in its three Phase 3 studies (ECZTRA 1-3) for the treatment of moderate-to-severe atopic dermatitis in adults. MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by Atopic Dermatitis? Response: Atopic Dermatitis (AD) – also known as ‘atopic eczema’ – is a chronic, inflammatory, heterogeneous skin disease characterized by intense itch and eczematous lesions is the most common inflammatory skin disease in the world, with limited effective treatment options, especially for moderate-to-severe patients. The primary objective of these studies was to evaluate the efficacy of tralokinumab compared with placebo in treating moderate-to-severe atopic dermatitis.
  • ECZTRA 1 and 2 evaluated the use of tralokinumab as monotherapy
  • ECZTRA 3 evaluated the use of tralokinumab in combination with a topical corticosteroid (TCS).
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Author Interviews, Breast Cancer, Weight Research / 19.12.2019

MedicalResearch.com Interview with: Lauren Teras, PHD Scientific Director, Epidemiology Research American Cancer Society MedicalResearch.com: What is the background for this study? Response: Excess body weight is a known cause of postmenopausal breast cancer, but an important question is: can you reverse it? Believe it or not, this not something we knew for certain. We had hoped it was true, but the scientific evidence was not there. This research question is, of course, particularly important for the more than two-thirds of U.S. women who are overweight or obese, and therefore at higher risk for breast cancer. To try to answer this question, we used a very large pooled study of 180,000 women aged ≥50 years from 10 different prospective studies.  (more…)
AACR, Author Interviews, Cancer Research / 19.12.2019

MedicalResearch.com Interview with: Dr. Samir Parekh, MBBS Associate Professor Medicine, Hematology and Medical Oncology Icahn School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? Would you briefly describe what is meant by 'neoantigens'? How might they be used to stimulate immunity in a multiple myeloma patients?  Response: Myeloma is considered a “cold” tumor for immunotherapy (as compared to some solid tumors such as melanoma) given the relatively fewer DNA mutations in an average myeloma patient. Our clinical experience suggests that this may not be totally correct.  Our findings focus on mutations that can become antigens (neo-antigens) and challenges the stereotype. We can create vaccines based on peptides resulting from these mutations to stimulate immune responses. (more…)
Author Interviews, Epilepsy / 19.12.2019

MedicalResearch.com Interview with: Steve S. Chung MD Epilepsy Neurology Banner University Medical Center University of Arizona, Phoenix, AZ MedicalResearch.com: What is the background for this study? Response: Prior studies have shown that midazolam nasal spray (MDZ-NS) is superior to placebo in providing rapid, sustained seizure control and a favorable safety profile when administered to patients experiencing seizure clusters, a type of seizure emergency impacting an estimated 150,000 patients in the U.S. with uncontrolled epilepsy. To explore the influence of concomitant antiepileptic drugs (AEDs) on treatment outcomes, we conducted a post hoc analysis of a Phase III trial to evaluate the tolerability and efficacy of midazolam nasal spray in patients 12 years of age and older with seizure clusters, according to concomitant enzyme-inducing AED (EIAED)/non-enzyme-inducing AED (NEIAED) status and by the number of concomitant AEDs. (more…)
Author Interviews, Epilepsy / 19.12.2019

MedicalResearch.com Interview with: Eun Jung Choi, MD, PhD; Senior Director, New Product Launch, Neurology UCB MedicalResearch.com: What is the background for this study? Response: Patients experiencing seizure clusters, a type of seizure emergency impacting an estimated 150,000 patients in the U.S. with uncontrolled epilepsy, are at risk for potentially serious consequences including hospitalization, mortality, physical injury, neurological damage, and status epilepticus. Although unmet needs of seizure clusters are intuitively well accepted, the burden of seizure clusters has not been well characterized and evaluated in a systemic matter. As a result, the seizure cluster patients are overlooked, and burden of seizure clusters is under-recognized. So we systematically assessed the clinical, humanistic, and economic burden associated with seizure clusters to provide the comprehensive body of evidence about burden of seizure clusters. (more…)
Author Interviews, Hematology / 19.12.2019

MedicalResearch.com Interview with: Tadeusz Robak MD, Ph.D. Professor of Hematology Medical University of Lodz, Poland MedicalResearch.com: What is the background for this study? What are the main findings?
  • Rozanolixizumab is an advanced SC anti-neonatal FcRn therapy currently in clinical development which has the potential to provide a targeted, convenient option to optimize individualized patient care.
  • The rozanolixizumab Phase II (TP0001) study was specifically designed to explore multiple dose regimens in order to inform the dosing strategy for further development in primary immune thrombocytopenia (ITP). Patients received either a single dose (1 x 15 mg/kg or 1 x 20 mg/kg) or multiple doses (5 x 4 mg/kg, 3 x 7 mg/kg, 2 x 10 mg/kg) of subcutaneous (SC) rozanolixizumab. The total dose was similar in all treatment groups, ranging from 15 to 21 mg/kg.
  • Rozanolixizumab was well tolerated by patients with primary ITP across all dose groups, consistent with previous rozanolixizumab studies. Additionally, improved platelet counts and reduced immunoglobin G (IgG) levels were seen at all doses and regimens of rozanolixizumab treatment, with higher response rate, higher percentage of responders and shorter time to response achieved by the 1 x 15 mg/kg, 1 x 20 mg/kg and the 3 x 7 mg/kg rozanolixizumab dose groups. These safety, tolerability and efficacy data support the Phase III development in patients with primary ITP.
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Author Interviews, JAMA, Opiods, Pediatrics, University of Michigan / 19.12.2019

MedicalResearch.com Interview with: Kao-Ping Chua, MD PhD Assistant Professor, Department of Pediatrics Susan B. Meister Child Health Evaluation and Research Center University of Michigan MedicalResearch.com: What is the background for this study? Response: Opioids are frequently prescribed to adolescents and young adults aged 12-21 years – in a recent study, 1 in 8 patients in this population were prescribed opioids during the year. At the same time, almost 30% of the 3000 opioid-related overdose deaths in 2016 among adolescents and young adults involved prescription opioids. Given the frequency of opioid prescribing and the risk of overdose, it is important to understand how to prescribe opioids safely to adolescents and young adults. However, there have been few studies that examine which opioid prescribing patterns are associated with prescription opioid overdose in adolescents and young adults. Prior studies examining these patterns have focused on older adults, particularly U.S. Veterans, so the generalizability of these findings to younger populations is unclear. (more…)
Author Interviews, Breast Cancer, Mammograms / 19.12.2019

MedicalResearch.com Interview with: Nancy R. Kressin, PhD VA Medical Center, Jamaica Plain Campus Boston, MA   MedicalResearch.com: What is the background for this study? Response: State-level legislation requires informing women about breast density (BD) with mammogram results, to increase awareness of BD’s tendency to mask cancers on mammography, its association with increased breast cancer risk, and to encourage women to discuss personal risk and supplemental screening with physicians. The Food and Drug Administration is currently developing dense breast notification (DBN) language for use nationwide; information about effects of state DBNs could be informative for FDA’s language. (more…)
Author Interviews, Brain Injury, Exercise - Fitness, JAMA / 18.12.2019

MedicalResearch.com Interview with: John Breck, DO,  CAQSM Medical Services at University of Colorado, Boulder MedicalResearch.com: What is the background for this study? Response: To date, most concussion research has focused on sport-related concussion, though it is known that a substantial number of concussions occur outside of participating in sport. Focusing solely on sport-related concussion may result in an underestimation of the underlying incidence and prevalence of concussion in the general population and leads to the widely held perception that most concussions are sport-related. An understudied population at risk for concussion are United States undergraduate college students.  (more…)
Author Interviews, Cancer Research, Genetic Research / 18.12.2019

MedicalResearch.com Interview with: Dr. Aaron Elliott, PhD CEO Ambry Genetics Dr. Elliott discusses The New York State Clinical Laboratory Evaluation Program (CLEP) approval of +RNAinsight™, a new genetic test for hereditary cancer risk.  MedicalResearch.com: What is the background for this announcement? What types of cancers can be genetically tested for predisposition? To whom should the testing be offered?  Response: The New York State Clinical Laboratory Evaluation Program (CLEP) has approved +RNAinsight™, which enables clinicians – for the first time ever – to conduct both DNA and RNA genetic testing at the same time. This is the first genetic testing advancement in over a decade to significantly increase the diagnostic yield (meaning the number of patients identified with a specific hereditary risk for cancer) in genes like BRCA1 and BRCA2. With +RNAinsight, Ambry is the first and only lab to offer this paired RNA and DNA genetic testing. Genetics may contribute to individuals’ risk of developing a number of cancers, including breast, ovarian, prostate, colorectal, and others. Approximately five to 10 percent of cancer cases are hereditary, according to the National Cancer Institute. The National Society of Genetic Counselors (NSGC) guidelines indicate who should receive genetic testing to learn whether they have increased risks to develop hereditary cancer. For example, someone with close family members who developed cancer at young ages may be a good candidate. (more…)