Author Interviews, Hepatitis - Liver Disease, NEJM / 17.08.2016

MedicalResearch.com Interview with: Prof. Dr. F. Nevens, MD, PhD Professor of Medicine Hepatology and liver transplantation University Hospitals KU Leuven, Belgium Prof. Dr. F. Nevens, MD, PhD Professor of Medicine Hepatology and liver transplantation University Hospitals KU Leuven, Belgium MedicalResearch.com: What is the background for this study? Response: Primary biliary cholangitis (PBC) is a rare, autoimmune cholestatic liver disease that puts patients at risk for life-threatening complications. PBC is primarily a disease of women, affecting approximately one in 1,000 women over the age of 40. If left untreated, survival of PBC patients is significantly worse than the general population. The POISE trial evaluated the safety and efficacy of once-daily treatment with Ocaliva® (obeticholic acid) in PBC patients with an inadequate therapeutic response to, or who are unable to tolerate, ursodeoxycholic acid (UDCA), the current standard of care. Ocaliva is the first PBC therapy that targets the farnesoid X receptor (FXR), a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways. The trial’s primary endpoint was an alkaline phosphatase (ALP) level of less than 1.67 times the upper limit of the normal range, with a reduction of at least 15% from baseline, and a total bilirubin level at or below the upper limit of the normal range after 12 months of obeticholic acid therapy. These liver biomarkers have been shown to predict progression to liver failure and resulting liver transplant or premature death in patients with PBC. (more…)
Aging, Author Interviews, Genetic Research, UCLA / 17.08.2016

MedicalResearch.com Interview with: Michael Gurven, Professor Department of Anthropology University of California Santa Barbara, CA 93106 MedicalResearch.com: What is the background for this study? Response: Understanding the sources of ethnic and sex disparities in health and longevity is critical in order to insure the health and well-being of everyone. We often hear about disparities due to differences in health care access, education, income, and sometimes genetic differences. But what we've done here is to employ a new biomarker developed by Steve Horvath, called the "epigenetic clock", which measures the cumulative changes to the epigenome, i.e. alterations to DNA that affects gene activity and expression but do not alter the DNA itself. This new measure is arguably one of the best biomarkers of aging out there today - so it's indeed a biological measure, but tells a different story than conventional genetic differences. Instead epigenetic age is influenced by the lived experience, physical and social environment, and genetic make-up of individuals. (more…)
Author Interviews, Genetic Research, JAMA, OBGYNE / 17.08.2016

MedicalResearch.com Interview with: Gabriel Lazarin MS Vice President,Counsyl Medical Science Liaisons MedicalResearch.com: What is the background for this study? What are the main findings? Response: The study finds there is a significant opportunity to identify more pregnancies affected by serious conditions, across all ethnicities, through the clinical use of expanded carrier screening (ECS). We found that compared to current prenatal genetic testing guidelines, expanded carrier screening for 94 genetically inherited conditions better addresses the risk of having a pregnancy affected with a serious condition. Certain physicians have been offering ECS since 2010. However, in order for it to come into routine use, a group of major medical organizations last year stated a need for further data regarding the frequency of previously unscreened genetic variants. This study uses real test results from approximately 350,000 people to provide that data. (more…)
Author Interviews, Cost of Health Care, Heart Disease / 17.08.2016

MedicalResearch.com Interview with: Leo F. Buckley, PharmD Virginia Commonwealth University Richmond, Virginia MedicalResearch.com: What is the background for this study? Response: Heart failure hospitalizations have become a significant burden for both patients and the healthcare systems. Significant efforts have been devoted to identifying alternative treatment pathways for acute decompensated heart failure that do not require hospitalization. Our group previously reported our initial experience with ambulatory intravenous diuretic therapy administered serially over several days to weeks in place of inpatient hospitalization. We found that the rate of hospitalization was significantly reduced compared to expected and that the high dose furosemide protocol utilized was safe and well tolerated by patients. (more…)
Aging, Author Interviews, Heart Disease, JACC / 17.08.2016

MedicalResearch.com Interview with: Dr Janice Atkins Research Fellow Epidemiology and Public Health University of Exeter Medical School RD&E Hospital Wonford Barrack Road, Exeter MedicalResearch.com: What is the background for this study? What are the main findings? Response: We have previously shown that having longer-lived parents increases your likelihood of living longer, and family history of heart attacks is already used by physicians to identify patients at increased risk of disease. However, it has been unclear how the health advantages of having longer lived parents is transferred to their middle-aged offspring. Our study of nearly 200,000 UK volunteers aged 55-73 at baseline, and followed for 8 years using health records data, found that having longer-lived parents reduced the risk of morbidity and mortality in the participants. We found that for each parent that lived beyond 70 years of age the participants had 20% less chance of dying from heart disease. To illustrate this, in a group of 1,000 people whose father’s died at 70 and followed for 10 years, on average 50 would die from heart disease. When compared to a group whose father’s died at 80, on average only 40 would die from heart disease over the same 10-year period. Similar trends were seen in the mother’s. The relationship between parental age at death and survival and health in their offspring is complex, with many factors playing a role. Shared environment and lifestyle choices play a large role, including smoking habits, high alcohol consumption, low physical activity and obesity; but even accounting for these factors parents lifespan was still predictive in their offspring. The biggest genetics effects on lifespan in our studies affected the participant’s blood pressure, their cholesterol levels, their Body Mass Index, and their likelihood to be addicted to tobacco. These are all factors that affect risk of heart disease, so is consistent with the lower rates of heart disease in the offspring. (more…)
Author Interviews, Hematology, Rheumatology / 17.08.2016

MedicalResearch.com: Nisha Jain, Director Global Medical at Biogen Regarding: Post Hoc Analysis to Evaluate the Effect of Recombinant Factor IX Fc Fusion Protein (rFIXFc) Prophylaxis in Adults and Adolescents with Target Joints and Hemophilia B being presented at the World Federation of Hemophilia (WFH) 2016 World Congress MedicalResearch.com: What is the background for this study? Response: People with hemophilia B experience prolonged bleeding episodes that can cause pain, irreversible joint damage and life-threatening hemorrhages. For people with severe hemophilia, most bleeding events occur in joints, with joint damage being the most common complication of the condition.(1) Over time, joints can become severely damaged and an individual can suffer from acute pain as well as restricted range of motion in those joints.(1) MedicalResearch.com: What are the main findings? Response: The B-LONG and B-YOND trials evaluated ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] in hemophilia B patients. In this post-hoc analysis of 37 patients with target joints in B-LONG and B-YOND, most (98.9%) target joints were considered resolved using the International Society on Thrombosis and Haemostasis (ISTH) definition of resolution as ≤ 2 bleeds into the joint within a consecutive 12-month period. (more…)
Author Interviews, Prostate Cancer, Urology / 17.08.2016

MedicalResearch.com Interview with: Jennifer Cullen Meyer, PhD, MPH Director of Epidemiologic Research, Center for Prostate Disease Research Assistant Professor, Norman M. Rich Dept. of Surgery, Uniformed Services University Rockville, MD 20852 MedicalResearch.com: What is the background for this study? Response: Men diagnosed with prostate cancer who are at low risk for cancer progression may choose to defer immediate treatment with curative intent and, instead, monitor their cancer. This strategy is referred to as “active surveillance.” The primary benefit of active surveillance is that it allows men to temporarily defer definitive cancer treatments that are known to cause decrements in health-related quality of life (HRQoL). Studies have shown that HRQoL is better in men choosing active surveillance as compared to other treatment modalities. However, prior to our study, it was not known whether men on active surveillance experience worse HRQoL than men without prostate cancer. (more…)
Annals Internal Medicine, Author Interviews, Flu - Influenza, Pediatrics, Vaccine Studies / 16.08.2016

MedicalResearch.com Interview with: Dr. Mark Loeb BSc (McGill), MD (McGill), MSc (McMaster), FRCPC Professor, Department of Pathology and Molecular Medicine Joint Member, Dept of Clinical Epidemiology & Biostatistics Division Director, Infectious Diseases, McMaster University MedicalResearch.com: What is the background for this study? What are the main findings? Response: The background for this study is that in the U.S, the Advisory Committee on Immunization Practices (ACIP), the committee that advises the CDC on vaccination policy, decided this June not to recommend LAIV (nasal live vaccine) for children. This is because of non-randomized studies conducted in the U.S suggesting that the vaccine was ineffective. This was an unprecedented decision in influenza vaccine policy making for children. Our study, a randomized, blinded, controlled trial, which is the most rigorous type of study design, conducted over 3 years (2012-13, 2013-2014, 2014-2015 influenza seasons), showed in fact very similar protection for children and their communities for the live and inactivated vaccines. We conducted the study in the Hutterite community of Western Canada which allowed us to compare the effect of the vaccines in entire communities. That is, we were able to study the direct effect and the indirect effect of these vaccines. (more…)
Author Interviews, Heart Disease, JACC / 16.08.2016

MedicalResearch.com Interview with: Timothy C. Y. Chan, PhD Canada Research Chair in Novel Optimization and Analytics in Health Associate Professor, Mechanical and Industrial Engineering Director, Centre for Healthcare Engineering Department of Mechanical & Industrial Engineering Faculty of Applied Science & Engineering | University of Toronto Toronto Ontario MedicalResearch.com: What is the background for this study? What are the main findings? Response: The immediate access to and use of an automated external defibrillator (AED) can increase the likelihood of survival from out-of-hospital cardiac arrest (OHCA). Currently, guidelines for AED deployment focus only on spatial factors, such as where to place AEDs with respect to cardiac arrest risk, and assume that the buildings housing the AEDs are open and accessible 24 hours a day. However, this is not the case in reality. AED accessibility by time of day has largely been overlooked despite the fact that cardiac arrest incidence and survival vary by time of day and day of week. In this study we performed two main analyses, using data from Toronto, Canada. First, we determined the impact of accessibility on cardiac arrest coverage. That is, we determined what fraction of OHCAs occurred near a registered AED, but when that AED was unavailable based on the hours of operation of the building. Second, we developed a novel optimization model that identifies locations to place AEDs that maximize the number of out-of-hospital cardiac arrestswith an accessible AED nearby. We compared this approach to one where AEDs were placed guided by only spatial information. We found that of the OHCAs occurring within 100 m of an AED, approximately 21% occur when the AED is inaccessible. Nearby AEDs were inaccessible for 8.6% of OHCAs during the day (8 a.m. – 3:59 p.m.), 28.6% in the evening (4 – 11:59 p.m.) and 48.4% at night (midnight –7:59 a.m.). When applying our optimization model to determine new AED locations, we achieved a 25.3% relative increase in the number of out-of-hospital cardiac arrests that occur near an accessible AED over the spatial-only approach. The relative increase was 10.9% during the day, 38.0% in the evening, and 122.5% at night. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Education, Heart Disease, JAMA / 16.08.2016

MedicalResearch.com Interview with: Rory Brett Weiner, MD Assistant Professor of Medicine Harvard Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response: The increased use of noninvasive cardiac imaging and Medicare spending in the late 1990s and early 2000s has led to several measures to help optimize the use of cardiac imaging. One such effort has been the Appropriate Use Criteria (AUC) put forth by the American College of Cardiology Foundation. The AUC for echocardiography have been useful to characterize practice patterns and more recently been used as a tool to try to improve ordering of echocardiograms. Our research group previously conducted a randomized study of physicians-in-training (cardiovascular medicine fellows) and showed that an AUC based educational and feedback intervention reduced the rate of rarely appropriate transthoracic echocardiograms (TTEs). The current study represents the first randomized controlled trial of an AUC education and feedback intervention attending level cardiologists. In this study, the intervention group (which in addition to education received monthly feedback emails regarding their individual TTE ordering) ordered fewer rarely appropriate TTEs than the control group. The most common reasons for rarely appropriate TTEs in this study were ‘surveillance’ echocardiograms, referring to those in patients with known cardiac disease but no change in their clinical status. (more…)
Author Interviews, JAMA, Pediatrics, Pharmacology / 16.08.2016

MedicalResearch.com Interview with: Dr Evie Stergiakouli Lecturer in Genetic Epidemiology and Statistical Genetics MRC Integrative Epidemiology Unit University of Bristol Bristol UK MedicalResearch.com: What is the background for this study? What are the main findings? Response: Acetaminophen is considered safe to use during pregnancy. However, research suggests that acetaminophen use in pregnancy is associated with abnormal neurodevelopment. It is possible that this association might be confounded by unmeasured behavioural factors linked to acetaminophen use. We compared acetaminophen use during pregnancy to postnatal acetaminophen use and partner's acetaminophen use. Only acetaminophen use during pregnancy has the potential to cause behavioural problems in the offspring. Any associations with postnatal acetaminophen use and partner's acetaminophen use would be due to confounding. Behavioural problems in the offspring were only associated with acetaminophen use during pregnancy. (more…)
Author Interviews, Transplantation / 16.08.2016

MedicalResearch.com Interview with: Guo-fu Hu, PhD Investigator in the Molecular Oncology Research Institute Tufts Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Angiogenin (ANG) is a ribonuclease that is known to promote cell growth and survival by differential processing of cellular RNAs. This paper reports three main findings.
  • 1) ANG has a cell type-specific role in regulating cell proliferation of the hematopoietic system: it promotes quiescence of the primitive hematopoietic stem/progenitor (HSPC) cells while simultaneously stimulating proliferation of more differentiated myeloid progenitor (MyePro) cells.
  • 2) ANG regulatesquiescence and proliferation of HSPC and MyePro through a novel mechanism: it induces tRNA-derived stress-induced small RNA (tiRNA) generation in HSPC and ribosomal RNA (rRNA) induction in MyePro, leading to respective reduction and increase in protein synthesis. To our knowledge, this is the first report of cell type specificity in RNA processing that leads to or originates from a different cellular state.
  • 3) Recombinant ANG protein is able to improve survival of irradiated animals and enhances hematopoietic regeneration of mouse and human HSPC in transplantation, which have significant implication in a number of clinical situations including bone marrow failure and stem cell transplantations.
(more…)
Author Interviews, Autism, Genetic Research, NIH / 16.08.2016

MedicalResearch.com Interview with: Karen Usdin, Ph. D. Senior Investigator Chief, Gene Structure and Disease Section Laboratory of Cell and Molecular Biology National Institute of Diabetes, Digestive and Kidney Diseases National Institutes of Health Bethesda MD 20892 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our laboratory is interested in the causes and consequences of the unusual repeat expansion mutation that causes the Fragile X-related disorders. However these disorders are challenging to study, in part because the repeat tract is difficult to amplify by PCR. This makes monitoring of repeat length, as well as other factors we are interested in such as methylation status and the presence of AGG interruptions, quite difficult. In our experience, both repeat number and methylation status are very variable in patient stem cells and in disease-relevant cell types derived from them. This variability arises because the repeat is prone to both expansion and contraction and because at different times there can be selection for smaller alleles or against unmethylated ones. Thus the frequent monitoring of repeat length and methylation status is critical for work with patient cells, particularly when those cells are to be used for drug screening or to examine the consequences of expansion. While other assays are available to determine one or more of these parameters, some are cumbersome to use or lack the necessary robustness and sensitivity, whilst others are prohibitively expensive for routine laboratory work. We thus saw a need for assays that are robust, sensitive and cost-effective for preclinical studies. (more…)
Author Interviews, Blood Pressure - Hypertension, Gout, Johns Hopkins, Nutrition, Rheumatology / 16.08.2016

MedicalResearch.com Interview with: Stephen P. Juraschek, MD, PhD Fellow, Division of General Internal Medicine Johns Hopkins Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: Diet has long been viewed as an important way to lower uric acid levels to prevent gout attacks; however, there is little evidence about whether a particular dietary pattern might be effective for lowering uric acid. For the first time we show that the DASH diet, an effective diet for lowering blood pressure, it lowers uric acid levels substantially in people with abnormally high uric acid levels. (more…)
Author Interviews, JAMA, Lipids / 16.08.2016

MedicalResearch.com Interview with: Dr. David Grossman M.D., M.P.H. Vice chair of the U.S. Preventive Services Task Force and Professor at the University of Washington Schools of Public Health and Medicine MedicalResearch.com: What is the background for this recommendation? Response: The Task Force recognizes the importance of cardiovascular health for young people. Children and adolescents with high cholesterol are more likely to become adults with high cholesterol, and high cholesterol in adulthood can lead to serious health outcomes such as heart attacks and strokes. However, when the Task Force reviewed evidence for cholesterol screening in children and adolescents without any signs or symptoms, we found that there is not enough evidence to recommend for or against screening. In the face of unclear evidence, the Task Force is calling on the research community to prioritize studies on screening and treatment of lipid disorders in children and teens to help us all learn more about the impact that screening at an early age may have on the cardiovascular health of adults. (more…)
Author Interviews, Heart Disease, Technology / 16.08.2016

MedicalResearch.com Interview with: Dr. Theodore L. Schreiber MD President of the Detroit Medical Center Heart Hospital and DMC Cardiovascular Institute. Doctor Schreiber is involved in ongoing research in carotid artery stenting, has been the principal or co-principal investigator on numerous cardiovascular research studies and has written dozens of book chapters, articles and abstracts on interventional cardiology. Abbott announced July 5, 2016 that the U.S. Food and Drug Administration has approved the company's Absorb bioresorbable heart stent, MedicalResearch.com: What is the background for this stent? What are the main advantages? Response: The Absorb™ bioresorbable vascular scaffold is an advance in the treatment of coronary artery disease, which affects 15 million people in the United States and remains a leading cause of death worldwide despite decades of therapeutic advances. For this reason, DMC Heart Hospital, which serves a population at high risk of cardiovascular disease, was among the first in the state of Michigan to adopt this new stent. While stents are traditionally made of metal, the Absorb™ stent is made of a naturally dissolving material, similar to dissolving sutures. Absorb™ disappears (except for two pairs of tiny metallic markers that remain in the artery to enable a physician to see where the device was placed) in about three years, after it has done its job of keeping a clogged artery open and promoting healing of the treated artery segment. By contrast, metal stents are permanent implants. (more…)
Author Interviews, Bone Density, Calcium, Mineral Metabolism, Nature / 16.08.2016

MedicalResearch.com Interview with: Dr. Constance Hilliard Department of History University of North Texas Denton, TX MedicalResearch.com: What is the background for this study? What are the main findings? Response: As an evolutionary historian, I have devoted the last several years to researching the health implications of genetic diversity. I was particularly concerned with the tendency of medical researchers to unwittingly use the biology of people with Northern European ancestry as a universal standard for everyone. For instance, lactose intolerance may be a disorder in that community, which suffers high rates of osteoporosis. But since 65% of the world’s population are lactose intolerant and have low rates of osteoporosis, a one-size-fits-all approach to bone health can prove dangerous for those whose ethnic-specific biological needs are overlooked. This study shows that osteoporosis is not a global problem. It has a strong and devastating impact in dairy-farming societies and is virtually non-existent in the tsetse zone of West Africa, where cattle rearing and dairying are not possible. Previous studies have tried to correlate the degenerative bone disease with socio-economic income. However, this study compares two regions of Africa with similar socio-economic conditions. In dairy-farming East Africa, the incidence of osteoporosis is 245 per 100,000. However in the tsetse belt of West Africa, where people do not consume dairy products, it is 3 per 100,000. When regression analyses are performed on 40 countries around the world, the association between dairy consumption and osteoporosis is high (0.851). It only correlates with national Gross National Product at a regression rate of 0.447. (more…)
Author Interviews, Baylor University Medical Center Dallas, Nutrition, Weight Research / 16.08.2016

MedicalResearch.com Interview with: Meredith E. David Marketing Department Hankamer School of Business Baylor University Waco, TX 76798   MedicalResearch.com: What is the background for this study? What are the main findings? Response: In the midst of the ongoing “obesity epidemic” in the United States and many other developed nations, programs and advice abound for encouraging individuals to manage their health and well-being through changes in food consumption. One common approach resurfaces time and time again: suggesting to the would-be dieter what foods they should avoid eating (e.g., “The following 10 foods should never be eaten . . . ,”) and/or what foods they should eat (e.g., “10 foods everyone should include in a healthy diet,”). Our research investigates the commonly heralded advice given to consumers to either focus on avoiding unhealthy foods, such as cake, or approaching and consuming healthy foods, such as kale. We demonstrate important differences in the implementation of and outcomes of these approach versus avoidance strategies for meeting one’s health-related goals. Individuals who have high self-control are generally better at reaching their goals. We investigate how individuals with varying levels of general self-control differ in the way that they apply approach and avoidance dieting strategies. Our findings, as detailed below, reveal a novel explanation of the better outcomes observed by individuals who are generally more successful in their goal pursuit. The key findings are as follows: (more…)
Author Interviews, Dermatology, Pharmacology / 15.08.2016

MedicalResearch.com Interview with: Kin F. Chan, PhD Executive Vice President of Research and Technology BioPharmX Corporation MedicalResearch.com: What is the background for this study? What are the main findings? Response: There were two studies in this series.  The purpose is to get a better understanding of the blood plasma and skin levels of minocycline in a relevant animal model (minipig) for both the oral form of minocycline (Solodyn) and topical BPX-01, and to elucidate the same for oral minocycline only in a clinical study. The results provided valuable guidance and assurance to our upcoming Clinical Phase 2b dose-ranging study design. (more…)
Author Interviews, Pain Research, Pediatrics / 15.08.2016

MedicalResearch.com Interview with: Amy Baxter MD CEO MMJ Labs LLC MedicalResearch.com: Would you tell us a little about your background? How did you develop an interest in pain management and prevention? Response: As a pediatric emergency doctor, I found it interesting that doctors could prevent pain but sometimes couldn't be bothered to do so. The lack of empathy and impatience is built into emergency training - we learn to diagnose and fix things quickly, not comfort and support. I decided to research how pain management would make procedures more successful, or faster, to convince doctors to use pain management for THEIR benefit. MedicalResearch.com: What is the background for the Buzzy(r) device? How does it impact pain sensation? Response: When my 4 year old had a horrible vaccination experience, I realized that a fast effective parent-controlled option for pain relief was needed. I knew that cold running water could eliminate the pain from a burned finger using physiology called gate control. Basically, the small pain nerves run alongside big motion nerves, so if you heavily stimulate motion you scramble the pain sensation. Rubbing a bumped elbow is another good example. Vibration alone didn't work enough for needles, but when I added ice the two sensations of cold and motion eliminated pain in 84% of seniors getting a flu shot. We got a grant from the NIH to develop and study Buzzy - it's a palm sized vibration unit with a place on the back to attach ice "wings", that freeze solid. You put them both where an injection will go for a minute or less, then move them "between the brain and the pain" while doing a needle procedure. There are about 14 studies on IV access or blood draws and 6 on injections, showing between 50 and 88% pain reduction. Several studies have demonstrated that Buzzy is truly a physiologic intervention, not a distraction: it didn't work for injections when only used for 10 seconds, too little time to block the pain nerves. But it worked really well for blood draws in severely cognitively impaired children for whom distraction wasn't an option. (more…)
Author Interviews, Ophthalmology, Stroke / 15.08.2016

MedicalResearch.com Interview with: Rong-Kung Tsai MD, PhD Professor and Director Institute of Eye Research Buddhist Tzu Chi Medical Center; Director, Institute of Medical Sciences Tzu Chi University, Hualien, Taiwan MedicalResearch.com: What is the background for this study? What are the main findings? Response: Non-arteritic anterior ischemic optic neuropathy (NAION) is pathogenetically different from stroke, stroke is caused by thromboembolism. However, they share many (but not all) systemic vascular risk factors. Previous small scale studies got controversial results. Using the National Health Insurance Research Database (NHIRD) in Taiwan to conduct the cohort study, 414 patients were included in the NAION group and 789 in the control group (base one million beneficiaries). The incidence of NAION is 3.72/100,000 person-years in Taiwan, and patients with NAION have more chances to develop ischemic stroke (p=0.003), but not hemorrhage stroke. The subgroup analyses further showed the risk of ischemic stroke among the subjects with NAION and with comorbidities was 3.35 times higher than those without NAION. However, in patients with NAION but no comorbidities, there is no increase risk of stroke development. (more…)
Author Interviews, Heart Disease, Lipids / 14.08.2016

MedicalResearch.com Interview with: Ziyad Al-Aly, MD, FASN Assistant Professor of Medicine Washington University School of Medicine Co-Director, Clinical Epidemiology Center Associate Chief of Staff for Research and Education Veterans Affairs Saint Louis Health Care System MedicalResearch.com: What is the background for this study? What are the main findings? Response: I think the most important, and novel finding is that elevated levels of HDL-cholesterol (which is thought of as the good cholesterol) are associated with increased risk of death. Previously it was thought that high HDL (increased good cholesterol) is a good thing. We used Big Data approach (over 16 million person-years; 1.7 million people followed for over 9 years) to evaluate the relationship between HDL-Cholesterol (the good cholesterol) and risk of death. We found that low HDL is associated with increased risk of death (which is expected and consistent with prior knowledge). The novel and unexpected finding is the observation that high HDL-Cholesterol is also associated with increased risk of death. The relationship between HDL-Cholesterol levels and risk of death is a U-shaped curve where risk is increased at both ends of the HDL-C values spectrum (at both low and high end); Too low and too high is associated with higher risk of death. The findings may explain why clinical trials aimed at increasing HDL-Cholesterol levels failed to show improvement of clinical outcomes. This finding was not expected, and has not been reported previously in large epidemiologic studies such as Framingham Heart Study and others. The Framingham Heart study and others significantly advanced our understanding of the relationship between cholesterol parameters (including HDL-Cholesterol) and clinical outcomes. However, these studies are limited in that the number of patients in these cohorts was several thousands which is relatively small compared to what a Big Data approach (millions of patients) enables us to see. Big Data approach allows a more nuanced (a more detailed) examination of the relationship between HDL and risk of death across the full spectrum of HDL levels. (more…)
Author Interviews, Cleveland Clinic, Genetic Research, Heart Disease, PLoS / 14.08.2016

MedicalResearch.com Interview with: Qing Kenneth Wang PhD, MBA Huazhong University of Science and Technology Wuhan, P. R. China and Department of Molecular Cardiology The Cleveland Clinic Cleveland, Ohio MedicalResearch.com: What is the background for this study? What are the main findings? Response: Coronary Artery Disease (CAD) and its complication myocardial infarction (MI or so called heart attacks) are the most common causes of deaths in the US and other parts of the world. Based on the American Heart Association statistics, 620,000 Americans have a new MI each year in the United States alone, 295 000 have a recurrent MI, and nearly 400,000 of them will die from it suddenly. Moreover, an estimated 150,000 silent first MI occur each year. CAD and MI are caused by an occlusion or blockage of a coronary artery, which disrupts blood flow to the heart region, leading to damage or death of cardiac cells, impairment of cardiac function and sudden death. Current treatment of CAD and MI relies on reperfusion therapy with reopening of the occluded coronary artery with percutaneous coronary intervention (PCA) and coronary artery bypass surgery (CABG). However, 12% of patients are not candidates for PCA or CABG due to an unfavorable occlusive pattern, diffuse coronary atherosclerosis, small distant vessels and co-morbidities. An alternative revascularization strategy has to be developed to benefit these patients. (more…)
Author Interviews, Immunotherapy, Lymphoma, Pharmacology / 14.08.2016

MedicalResearch.com Interview with: Dirk Huebner, MD Senior Medical Director Oncology Therapeutic Area Unit Takeda Pharmaceutical Company MedicalResearch.com: What is the background for this study? What are the main findings? Response: Cutaneous lymphomas are a category of non-Hodgkin lymphoma that primarily involve the skin. Cutaneous T-cell lymphoma, also known as CTCL, is the most common type of cutaneous lymphoma and typically presents with red, scaly patches or thickened plaques of skin that often mimic eczema or chronic dermatitis. ADCETRIS® (brentuximab vedotin) is an antibody-drug conjugate directed to CD30, which is expressed on skin lesions in approximately 50 percent of patients with CTCL. The Phase 3 ALCANZA trial compared the use of single-agent ADCETRIS to a control arm of investigator’s choice of standard therapies, methotrexate or bexarotene, in 131 patients with CD30-expressing CTCL who received prior systemic or radiation therapy. The study met its primary endpoint, demonstrating a highly statistically significant improvement in the rate of objective response lasting at least four months (ORR4). The ORR4 was 56.3 percent in the ADCETRIS arm compared to 12.5 percent in the control arm. (more…)
Author Interviews, JAMA, Smoking, Tobacco / 13.08.2016

MedicalResearch.com Interview with: Anna Pulakka PhD, Postdoctoral Researcher Department of Public Health University of Turku, Finland MedicalResearch.com: What is the background for this study? Response: Smoking is the one of the leading health risks globally. Finland, among some other countries, has set a target for a tobacco-free society by 2040. However, with the current rate of decline in smoking prevalence, the target will not be met. It is therefore important to explore new avenues for helping people to quit smoking. Recently, researchers have become more interested in availability of tobacco as one determinant for smoking habit. We have learned from cross-sectional studies that people who live in neighborhoods with many stores that sell tobacco, smoke more than those who have less tobacco stores in their neighborhood. What has been lacking is more robust evidence from longitudinal studies on the association between availability of tobacco in neighborhoods and smoking behaviours. We sought to determine whether change in the location of tobacco stores nearby people’s place of residence was associated with the odds of quitting smoking or smoking relapse in a longitudinal setting. (more…)
Author Interviews, Immunotherapy, Leukemia, Stem Cells, Transplantation / 12.08.2016

MedicalResearch.com Interview with: Felix Garzon, MD, PhD Senior Vice President Head of Clinical Development Actinium Pharmaceuticals, Inc. New York, NY 10016 MedicalResearch.com: What is the background for this study? What is goal of this Study? Response: Iomab-B (“Iomab”) was developed at the Fred Hutchinson Cancer Research Center (“the Hutch”) in Seattle, Washington. The Hutch is a pioneer in the field of bone marrow transplantation (BMT) having 3 Nobel Prizes and doctors there performed some of the first transplants for leukemia patients. Iomab-B is intended to be an induction and conditioning agent prior to a BMT for patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are over the age of 55. BMT is the only potentially curative option for AML i.e. for this patient population that currently has a survival prognosis of 2-6 months which means that if Iomab-B is successful it would create a new market segment and offer patients a great clinical benefit and a hope for a cure. Actinium Pharmaceuticals licensed Iomab from the Hutch in 2012 and prior to us licensing Iomab, it had been studied in almost 300 patients in several phase 1 and phase 2 clinical trials in an array of blood cancers, both leukemias and lymphomas. Actinium is now the sponsor of a pivotal phase 3 trial for Iomab-B to study its use as an induction and conditioning agent prior to a bone marrow transplantation in patients with relapsed or refractory AML who are over the age of 55. This trial, which we have named the SIERRA (Study of Iomab-B in Elderly Relapsed or Refractory AML) trial, started at the end of June 2016 and we expect to enroll 150 patients by the end of 2017. The primary endpoint of the SIERRA trial is durable complete remissions (dCR) of 6 months. The study arm will consist of Iomab-B administration followed by a  bone marrow transplantation, patients will be evaluated for dCR at 6 months after engraftment, which will be assessed at day 28 or day 56. The control arm of the study will be physician’s choice of chemotherapy and if the patient is able to achieve a complete remission (CR) they may receive a BMT or some other form of treatment with curative intent. The study is designed to evaluate if the study arm of Iomab-B and a BMT can double the dCR rate of the control arm, which is designed to replicate the current treatment regimen prior to a bone marrow transplantation . (more…)
Author Interviews, NEJM, Neurological Disorders, Surgical Research / 12.08.2016

MedicalResearch.com Interview with: Gil I. Wolfe, MD, FAAN Irvin and Rosemary Smith Professor and Chair Dept. of Neurology/Jacobs Neurological Institute Univ. at Buffalo Jacobs School of Medicine and Biomedical Sciences/SUNY Buffalo General Medical Center Buffalo, NY 14203-1126 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Thymectomy has been used in myasthenia gravis (MG), in particular those patients who do not have a tumor of the thymus gland, known as a thymoma, for over 75 years without randomized data to support its use. A practice parameter in 2000 on behalf of the American Academy of Neurology stated that the benefits of thymectomy in this population of non-thymomatou smyasthenia gravis patients remained uncertain, classified thymectomy as a treatment option in this group, and called for rigorous, randomized studies. What we found is that compared to an identical prednisone protocol alone, that extended transsternal thymectomy confers significant benefits to non-thymomatous MG patients over a period of three years after the procedure. The benefits include better disease status, reduced prednisone requirements, fewer hospitalizations to manage  myasthenia gravis worsenings, and a lower symptom profile related to side effects from medications used to control the disease state. (more…)
Author Interviews, Brain Cancer - Brain Tumors, Cancer, Cost of Health Care / 12.08.2016

MedicalResearch.com Interview with: Wuyang Yang, M.D., M.S. Research Fellow Department of Neurosurgery Johns Hopkins Hospital Baltimore, MD 21287 MedicalResearch.com: What is the background for this study? What are the main findings? Response: The treatment for glioblastoma (GBM) patients involves a combined approach of surgery, radiation therapy and chemotherapy. Despite advancement in the therapeutic approaches for GBM, differing socioeconomic status result in disparities in health-care access, and may superimpose a significant impact on survival of glioblastoma patients. Insurance status is an indirect indicator of overall socioeconomic status of a patient, and has been shown to correlate with survival of patients with malignant tumor in other parts of the body. We conducted the first study to determine a relationship between different types of insurance and survival of GBM patients. In our study of 13,665 cases of GBM patients, we found that non-Medicaid insured patients have a significant survival benefit over uninsured and even Medicaid insured patients. This is the first time a study describes this relationship in glioblastoma patients, and also the first to compare and quantify the likelihood of poor prognosis between different insurance categories. A difference in insurance coverage was also uncovered, and patients with insurance were more likely to be older, female, white, and married. In addition, we found that younger, female, married patients with smaller tumor size survive longer than other patients, which confirmed findings in existing literature. (more…)
Author Interviews, Clots - Coagulation, Diabetes, Heart Disease, JACC / 12.08.2016

MedicalResearch.com Interview with: Raffaele Piccolo, MD Department of Cardiology Bern University Hospital University of Bern Bern, Switzerland MedicalResearch.com: What is the background for this study? Response: Over the past two decades, the prevalence of diabetes mellitus has doubled in Western countries and future projections are even worse by showing a 55% increase by 2035 when approximately 592 million of people are expected to live with diabetes all over the world. Acute myocardial infarction still represents the most common diabetes-related complication and its occurrence is associated with a higher risk of mortality. Timely recanalization of the occluded coronary vessel with primary percutaneous coronary intervention (PCI) represents the therapy of choice for acute ST-segment elevation myocardial infarction (STEMI). Our study investigated whether the direct application of an intracoronary bolus of abciximab, which is an antiplatelet drug blocking the glycoprotein IIb/III a receptor, at the time of primary PCI improves the outcomes at 1-year follow-up compared with the standard intravenous route. The study was in individual patient-level pooled analysis of 3 randomized trials including 2,470 patients, of whom 473 (19%) had diabetes. (more…)
Author Interviews, Heart Disease, Surgical Research, Weight Research / 12.08.2016

MedicalResearch.com Interview with: Dr. Michelle R. Lent, PhD Geisinger Obesity Institute Geisinger Clinic Danville, Pennsylvania MedicalResearch.com: What is the background for this study? What are the main findings? Response: More than one-third of adults in the United States live with obesity. Currently, the most effective treatment for obesity is bariatric surgery. Bariatric surgery patients are expected to lose 30 to 40 percent of their body weight, but not all patients are able to lose this amount of weight and others experience weight regain. Why some patients succeed in weight loss over time, while others are less successful, remains unclear. In this study, we evaluated over 200 patient characteristics in relation to long-term weight loss after bariatric surgery (7 years or longer), including gender, age and weight at the time of surgery, lab tests, medical conditions and medications, among others. We found that patients who used insulin, had a history of smoking, or used 12 or more medications before surgery lost the most weight, while patients with high cholesterol, older patients and patients with higher body mass indexes at the time of surgery lost the least amount of weight after surgery. (more…)