Author Interviews, Pediatrics, PLoS, Toxin Research / 05.05.2017

MedicalResearch.com Interview with: Dr. Antonio J. Signes-Pastor, PhD Institute for Global Food Security Queen’s University Belfast Belfast, Northern Ireland, United Kingdom, Department of Epidemiology, Geisel School of Medicine Dartmouth College Lebanon, NH MedicalResearch.com: What is the background for this study? Response: Inorganic arsenic is a human carcinogen, which has also been associated with several adverse health effects including neurological, cardiovascular, respiratory, and metabolic outcomes. Early life exposure is of particular concern since it may adversely impact on lifetime health outcomes. If low inorganic arsenic drinking water is available the main source of exposure is the diet, especially rice and rice-based products, which are widely used during weaning and to feed infants and young children. In order to reduce exposure, the EU has recently regulated (1st January 2016) the inorganic arsenic maximum level of 0.1 mg/kg for rice products addressed to infants and young children. This level is also under consideration by the US FDA. (more…)
Author Interviews, Heart Disease, Surgical Research / 05.05.2017

MedicalResearch.com Interview with: Nayan Agarwal MD Intervention Cardiology Fellow, University of Florida, Gainesville, FL MedicalResearch.com: What is the background for this study? Response: Long term anticoagulation is indicated in patients with mechanical heart valves, prior thromboembolic events, atrial fibrillation etc, to prevent recurrent thrombo-embolic episodes. About 20-30% of these patients also have concomitant ischemic heart disease requiring percutaneous coronary intervention (PCI). Post PCI, patients require treatment with dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor (clopidogrel, prasugrel, ticagrelor) to prevent stent thrombosis. Thus, these patients may end up needing triple antithrombotic therapy with oral anticoagulant (OAC) and DAPT, which increases the bleeding risk. Both American College of Cardiology(ACC) and European Society of Cardiology (ESC), currently recommend triple therapy in these patients. Recently new evidence has emerged that such patients can be managed with dual therapy of a single antiplatelet (SAPT) and OAC. Hence, we decided to do a systematic review of these studies to evaluate safety and efficacy of dual therapy of SAPT and OAC against triple therapy of DAPT and OAC. (more…)
Author Interviews, JAMA, Ophthalmology, Pediatrics / 05.05.2017

MedicalResearch.com Interview with: Rohit Varma, MD, MPH Executive Director - USC Roski Eye Institute and Dean of the Keck School of Medicine of USC MedicalResearch.com: What is the background for this study? What are the main findings? Response: Visual impairment in early childhood has profound impact on a child’s development. It can significantly impair development of visual, motor, and cognitive function1-3 and lead to adverse psychosocial consequences. There has been a lack of accurate data characterizing the current and expected numbers of visual impairment cases among preschool children in the United States from 2015 to 2060. The number of preschool children with visual impairment is projected to increase by 26% in 2060. And 69% of these visual impairment will result from simple uncorrected refractive error such hyperopia and myopia, which can be prevented or treated by low-cost refractive correction. (more…)
Author Interviews, Heart Disease, NEJM / 05.05.2017

MedicalResearch.com Interview with: Kristian Kragholm, MD, PhD Departments of Cardiology and Epidemiology/Biostatistics, Aalborg University Hospital, Aalborg, DK MedicalResearch.com: What is the background for this study? What are the main findings? Response: It is well known that early help from bystanders including cardiopulmonary resuscitation (CPR) before arrival of the emergency medical services can increase chances of 30-day survival by three to four times compared to situations where no bystander resuscitation was initiated. The main and novel finding of our study is that bystander interventions, in addition to increasing survival, also lowers the risk of damage to the brain and nursing home admission in 30-day survivors during the first year following out-of-hospital cardiac arrest. (more…)
Author Interviews, Dengue, Vaccine Studies / 04.05.2017

MedicalResearch.com Interview with: Dr Vianney Tricou DPhil Takeda Vaccines Singapore MedicalResearch.com: What is the background for this study? What are the main findings? Response: Dengue fever is a painful, debilitating mosquito-borne disease caused by any one of four closely related dengue virus serotypes, and persons living in dengue endemic regions may be affected by dengue more than once in their lifetime. Some individuals with dengue fever are hospitalized and may need intensive therapy to prevent shock and death, and severe dengue is a leading cause of hospitalization and death among children and adults in some Asian and Latin American countries. About half of the world’s population lives under the threat of dengue and the disease has a significant medical and economic impact in the tropical and subtropical regions of the world where dengue is endemic. Takeda is committed to improving global public health and to developing a life-saving dengue vaccine candidate for people around the world. Takeda’s tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus (DENV-2), which provides the genetic ‘backbone’ for all four attenuated dengue virus serotypes present in the vaccine. Takeda’s Phase 1 and Phase 2 clinical study program includes 8 studies to date that assess the safety and/or immunogenicity of this candidate, before moving into Phase 3. Takeda’s ongoing Phase 2 DEN-204 study is designed to assess the safety and immunogenicity of one- and two-dose schedules of TAK-003 in 1,794 healthy children and adolescents ages two through 17 years living in dengue-endemic countries in Latin America and Asia. As published in The Lancet Infectious Diseases in March 2017, an interim analysis of DEN-204 data indicated that TAK-003 elicited antibody responses to all four dengue serotypes in the population studied, regardless of whether they had previous dengue exposure. A second TDV dose improved antibody responses against DENV-3 and DENV-4 in children who were seronegative before vaccination. In this study, the safety profile was consistent with that observed in earlier Phase 1 and 2 studies. (more…)
Author Interviews, Heart Disease, JAMA, Kidney Disease, Surgical Research / 04.05.2017

MedicalResearch.com Interview with: Nirat Beohar, MD Vice-Chief of Cardiology Director Cardiac Catheterization Laboratory Director Structural Heart Disease Program Director Interventional Cardiology Fellowship program Cardiac Catheterization Laboratory Columbia University Division of Cardiology, Mount Sinai Medical Center Miami Beach, Miami, FL 33140 MedicalResearch.com: What is the background for this study? Response: Nirat Beohar MD, Director of the Cardiovascular Catheterization Laboratory and Vice-Chief of Cardiology at the Columbia University Division of Cardiology at the Mount Sinai Medical Center and co-authors report the effect of trans-catheter aortic valve replacement (TAVR) on subsequent renal function and outcomes in high-risk and inoperable patients presenting with baseline renal dysfunction (eGFR < 60 ml/min/1.73 m2). This was a sub-study of patients undergoing TAVR in the PARTNER 1 trial and continued access registry that was conducted in 25 centers in the United States and Canada. (more…)
Author Interviews, Gastrointestinal Disease, Immunotherapy, NEJM, UCSD / 04.05.2017

MedicalResearch.com Interview with: William J. Sandborn, MD Professor of Medicine and Adjunct Professor of Surgery Chief, Division of Gastroenterology Vice Chair for Clinical Operations, Department of Medicine Director, UCSD IBD Center University of California San Diego and UC San Diego Health System MedicalResearch.com: What is the background for this study? What are the main findings? Response: There is still a substantial unmet need for new treatments for patients with ulcerative colitis. A previous Phase II study had suggested that tofacitinib might be effective for short term therapy of ulcerative colitis. The patients in that study for the most part had not failed anti-TNF therapy. Now we report the findings from 3 large Phase III trials, two short term trials and one long term trial, demonstrating that tofacitinib 10 mg twice daily is effective for short term therapy, and that both 5 mg and 10 mg twice daily is effective for long term therapy. We also demonstrated that tofacitinib is effective both in patients who have not failed anti-TNF therapy and patients who have failed anti-TNF therapy. The study demonstrated induction of clinical remission, clinical response and mucosal healing (flexible sigmoidoscopy improvement) over the short term, and maintenance of clinical remission, clinical response, and mucosal healing over the long term. (more…)
Author Interviews, Respiratory / 04.05.2017

MedicalResearch.com Interview with: Harri Hemilä, MD, PhD Department of Public Health University of Helsinki MedicalResearch.com: What is the background for this study? What are the main findings? Response: Some zinc lozenges intended for treating the common cold have contained zinc acetate and some others have contained zinc gluconate. There have been proposals that zinc acetate might be more optimal salt for lozenges than zinc gluconate. Therefore I compared the randomized trials that have used zinc acetate with zinc gluconate to see if there is difference between the lozenges. Although the average effect in 3 studies with zinc acetate lozenges was greater (40%) than the average effect in 4 studies with zinc gluconate lozenges (28%), that difference was explained by random variation. I also analyzed the dose dependency of the effect and found that 2 studies that used 192 and 207 mg per day elemental zinc did not find greater benefit than 5 studies that used 80 to 92 mg per day zinc. The overall average effect of zinc lozenges was 33% reduction in common cold duration and that effect seems to be reached with doses less than 100 mg per day. (more…)
AHA Journals, Author Interviews, Heart Disease, Stem Cells / 04.05.2017

MedicalResearch.com Interview with: Megan M. Monsanto, B.S. Joint Doctoral Student Department of Cell and Molecular Biology San Diego State University & University of California San Diego MedicalResearch.com: What is the background for this study? What are the main findings? Response: In the field of cardiovascular research there is ongoing debate regarding the optimal cell population(s) to use for the treatment of patients with heart failure. A major reason being, the lack of understanding of the actions and synergism between distinct myocardial-derived stem cell populations. This prompted our group to establish a protocol to isolate multiple stem cell populations from a single human myocardial tissue sample that will allow for the discovery of new insights at the cellular level, with the ultimate goal being to achieve true myocardial regeneration upon injection back into the patient. (more…)
Author Interviews, Breast Cancer, Journal Clinical Oncology, Radiation Therapy / 04.05.2017

MedicalResearch.com Interview with: Bruce G. Haffty, MD Professor and Chair, Department of Radiation Oncology Rutgers Cancer Institute of New Jersey Rutgers Robert Wood Johnson Medical School and Rutgers New Jersey Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response: Shorter courses of radiation for patients treated by lumpectomy are now commonly employed. For patients receiving radiation to the chest wall and lymph nodes after mastectomy, the standard 5 to 6 week course is used and shorter courses have not been adopted. We initiated this trial of a shorter course of radiation to the chest wall and lymph nodes after mastectomy to test its feasibility, safety and outcome. (more…)
Abuse and Neglect, Genetic Research, Technology / 03.05.2017

MedicalResearch.com Interview with: Chance York, Ph.D. Assistant Professor of Mass Communication Kent State University MedicalResearch.com: What is the background for this study? What are the main findings? Response: This research used twin study survey data from the Midlife in the United States (MIDUS) to investigate the relative influence of genetics and environment on social media use. While the research cannot directly examine the gene-level influence on social media behavior, I was able to leverage known levels of genetic relatedness between identical and fraternal twins to suss out how much genetic traits and environmental factors impact frequency of using social media with some help from the Buzzoid boys. The results showed that between one- and two-thirds of variance in social media use is explained by genes, while environmental factors (parental socialization, peers, work, school, individual characteristics, etc.) explained the rest. In other words, this very specific communication behavior—social media use—is partially guided by our genetic makeup. (more…)
Author Interviews, Depression, Mental Health Research, Neurological Disorders, NIH / 03.05.2017

MedicalResearch.com Interview with: Ronald Cannon, Ph.D. Staff scientist at NIH’s National Institute of Environmental Health Sciences MedicalResearch.com: What is the background for this study? Response: The protein pump, P-glycoprotein, is a major obstacle to the delivery of therapeutic drugs across the blood-brain barrier and into the central nervous system (CNS). During the last 10 years, our laboratory has studied the regulation of P-glycoprotein with the hope of treating CNS diseases. MedicalResearch.com: What are the main findings? Response: Our most recent finding shows that the antidepressant, amitriptyline, suppresses P-glycoprotein pump activity. The discovery is significant because P-glycoprotein restricts most CNS targeted drugs from entering the brain. If fully translatable to human patients, suppression of P-glycoprotein could allow higher levels of CNS therapeutic drugs to reach their intended target. (more…)
AHRQ, Author Interviews, Cost of Health Care / 03.05.2017

MedicalResearch.com Interview with: Salam Abdus, Ph.D. Agency for Healthcare Research and Quality MedicalResearch.com: What is the background for this study? What are the main findings? Response: When the ACA was passed, some people were concerned that access to care for people who already had insurance would decrease because there would be so many newly insured people trying to get care. To answer this question, we reviewed eight measures of access using data from the Agency for Healthcare Research and Quality’s Medical Expenditure Panel Survey (MEPS) and the Census Bureaus’ American Community Survey for the period 2008-2014 to study if change in local area insurance rate affected access to care of adults who were continuously insured for two years. Access measures that we looked at include whether they had a usual source of care, were unable to receive necessary medical care, were delayed in receiving necessary medical care, had a physical exam in the past year, had blood pressure checked, had a flu shot, experienced delays getting a doctor appointment, and problems seeing a specialist. We found no consistent evidence of negative impacts on continuously insured adults. We also looked at two subgroups of vulnerable adults: Medicaid beneficiaries and adults living in health professional shortage areas. For both continuously insured subgroups we found no consistent evidence of negative impacts. (more…)
Author Interviews, Breast Cancer, CDC, Cost of Health Care / 03.05.2017

MedicalResearch.com Interview with: Benjamin Allaire MS RTI International Research Triangle Park Durham, NC, 27709 MedicalResearch.com: What is the background for this study? Response: More than 22,000 women younger than 45 years of age were diagnosed with breast cancer in 2013. Although less than 10 percent of all breast cancers are diagnosed among women younger than age 45, the types of breast cancer these younger women face are typically more aggressive, are diagnosed at more advanced stages, and result in poorer survival compared to breast cancer in older women. Younger women may also require more intense treatment, exhibit cancers that are less responsive to treatment, and have distinct and more prevalent side effects from treatment than older women. These side effects can include poorer quality of life, fertility problems, and depression. As a result, breast cancer treatment for younger women is expensive, making them vulnerable to financial hardship. Recent research has shown that 31.8 percent of cancer survivors are likely to have cancer treatment-induced financial troubles, with higher rates among younger cancer patients. These financial difficulties cause some survivors to forego or delay necessary medical treatments. (more…)
Author Interviews, Leukemia / 03.05.2017

MedicalResearch.com Interview with: Martin J.S. Dyer, D.Phil MA FRCP FRCPath Ernest and Helen Scott Haematological Research Institute University of Leicester, UK MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study follows on from a world-first clinical trial of a new drug to treat particular blood cancers. Results of that international clinical trial were published in the journal Blood in November 2015 and looked at the efficacy of a new inhibitor, ONO/GS-4059, in the treatment of CLL and Non-Hodgkin Lymphoma patients, refractory or resistant to current chemotherapies. ONO/GS-4059 targets BTK, a protein essential for the survival and proliferation of the tumour cells. The study opened in January 2012 and 90 patients were enrolled in different centres in the UK and in France, with 28 coming from Leicester. Patients with CLL showed the best response and most of them were still on the study after 3 years, and remarkably without notable toxicities. In the new paper, we are reporting the long-term follow-up results. This work, published in the journal Blood, was funded by the Ernest and Helen Scott Haematological Research Institute, ONO Pharmaceuticals, Gilead Pharmaceuticals and the Cancer Research UK Leicester Experimental Cancer Medicine Centre. Local charity Hope Against Cancer fund the Clinical Trials Facility based at the Leicester Royal Infirmary. This current paper describes the long term follow up and shows that in patients with CLL the remissions are durable and associated with no new toxicities. Furthermore, in collaboration with Sistemas Genomicos, a company in Valencia, we have shown that mutations associated with aggressive disease respond well to treatment with ONO/GS-4059. (more…)
Aging, Author Interviews, Cancer Research, CDC, OBGYNE / 03.05.2017

MedicalResearch.com Interview with: Mary C. White, ScD MedicalResearch.com: What is the background for this study? Response: For women between the ages of 21 to 65, Pap testing every three years, or Pap testing with HPV co-testing every five years, can prevent cervical cancers and deaths. Current recommendations state that women 65 and older and not otherwise at special risk can skip Pap tests, but only if they have had three consecutive negative Pap screening tests or two consecutive negative co-tests over the past 10 years, with the most recent done within the past five years. We used data from two federal cancer registry programs to examine how cervical cancer risk changes with age, after excluding women who have had a hysterectomy. We also examined data from a federal national health survey to examine the proportion of women who either had never been tested or had not been tested in the last 5 years. (more…)
Author Interviews, CMAJ, Infections, OBGYNE / 03.05.2017

MedicalResearch.com Interview with: Anick Bérard PhD FISPE Research chair FRQS on Medications and Pregnancy Director, Réseau Québécois de recherche sur le médicament (RQRM) Professor, Research Chair on Medications, Pregnancy and Lactation Faculty of Pharmacy, University of Montreal Director, Research Unit on Medications and Pregnancy Research Center, CHU Ste-Justine MedicalResearch.com: The Danish study you cite reported a connection between antibiotics and miscarriage – why was further research of this topic necessary? Response: Given that a single study will assess an association, repetition of findings are essential in order to assess causality. For example, we were able to conclude that smoking was causing lung cancer after 10 years of observational research on the topic showing concordant associations. In addition, antibiotic prescription patterns vary from country to country, hence the importance of studying the research question in various patient populations. Finally, our cohort has validated exposure status, gestational age (first day of pregnancy) and miscarriage cases - our study was also able to look at types of antibiotics. (more…)
Author Interviews, JAMA, Pharmacology, UCLA / 03.05.2017

MedicalResearch.com Interview with: Ian Larkin, PhD Assistant Professor of Strategy UCLA Anderson School of Management MedicalResearch.com: What is the background for this study? Response: The study examined whether restrictions put in by medical centers on salesperson visits to physicians, known as “detailing,” affected subsequent physician prescribing behavior. Detailing represents the most prominent form of pharmaceutical marketing. Detailing visits allow the sharing of scientific information, but they also often involve small gifts for physicians and their staff, such as meals. Pharmaceutical companies incur far greater expenditures on detailing visits than they do on direct-to-consumer marketing, or even on research and development of new drugs. Specifically, the study examined detailing restrictions put into place by 19 academic medical centers (AMCs) in five states in the U.S. It compared changes in prescribing by thousands of AMC physicians whose practices limited typical elements of detailing visits, such as provisions of meals and educational gifts, to a carefully matched control group of similar physicians practicing in the same geographic regions but not subject to such detailing restrictions. The study, which included more than 25,000 physicians and all 262 drugs in eight major drug classes — from statins to sleep aids to antidepressants, representing more than $60 billion in aggregate sales in the United States — was, to date, by far the most comprehensive to examine the impact of detailing restrictions. The comprehensive and quasi-experimental methodology, which compared prescribing behavior before and after implementation of policies, and which included a large matched control group of physicians not subject to policy changes, was an important innovation relative to prior research. The study used prescription data from CVS Caremark, one of the largest pharmacy benefit managers in the United States. (more…)
Author Interviews, Diabetes, Pediatrics / 03.05.2017

MedicalResearch.com Interview with: Tove Fall, PhD Department of Medical Sciences Molecular Epidemiology and Science for Life Laboratory, Uppsala University Uppsala, Sweden MedicalResearch.com: What is the background for this study? What are the main findings? Response: Type 1 diabetes is a severe chronic disease in children. There are few established risk factors, but it has been hypothesized that factors related to reduction of microbial exposure in childhood may increase the risk. We have previously shown that children in dog-owning families are at lower risk for asthma, and we now wanted to investigate the relationship of dog ownership and diabetes. We did this by studying the whole Swedish child population with record linkage across registers of health and dog ownership. We could not find evidence for an association of dog ownership and type 1 diabetes in the general population. (more…)
Author Interviews, Global Health, Heart Disease / 03.05.2017

MedicalResearch.com Interview with: Hisham Dokainish, M.D., FRCPC, FASE, FACC Associate Professor of Medicine, McMaster University Principal Investigator, Population Health Research Insitute Director of Heart Failure Services, Director of Medical Diagnostic Units & Echocardiography, Hamilton Health Sciences Hamilton, ON, Canada MedicalResearch.com: What is the background for this study? Response: Most data on mortality and prognostic factors in patients with heart failure come from North America and Europe, with little information from other regions of the world, particularly from low and middle income countries. MedicalResearch.com: What are the main findings? Response: We enrolled 5823 patients within 1 year (with 98% follow-up). Overall mortality was 16·5%: highest in Africa (34%) and India (23%), intermediate in southeast Asia (15%), and lowest in China (7%), South America (9%), and the Middle East (9%). These large regional differences in mortality persisted after multivariable adjustment for demographic, clinical, medication and socioeconomic variables. About half of the mortality risk was explained by multivariable modeling with these variables; however, the remainder was unexplained. (more…)
Author Interviews, JAMA, Opiods, Pain Research, Surgical Research / 03.05.2017

MedicalResearch.com Interview with: Chad M. Brummett, M.D. Associate Professor Director, Clinical Anesthesia Research Director, Pain Research Department of Anesthesiology Division of Pain Medicine University of Michigan Medical School Ann Arbor, MI  48109  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The opioid epidemic has received tremendous attention in recent years, but most of the focus has been on chronic pain, opioid abuse and overdose. Far less attention has been paid to the importance of acute care prescribing (e.g. surgical pain) in patients that are not chronic opioid users. We found that 5-6% of patients not using opioids prior to surgery continued to fill prescriptions for opioids long after what would be considered normal surgical recovery. Moreover, the rates of new chronic use did not differ between patients having major and minor surgeries, suggesting that patients continue to use these pain medications for something other than simply pain from surgery. Building on other work by our group, and the few additional studies done on the topic to date, these data suggest that pain medications written for surgery are a major cause of new chronic opioid use for millions of Americans each year. (more…)
Author Interviews, JACC, Stroke, Surgical Research / 03.05.2017

MedicalResearch.com Interview with: Jay S. Giri, MD, MPH Director, Peripheral Intervention Assistant Professor of Clinical Medicine Penn Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: We analyzed data from 6,526 patients in the 5 most recent randomized trials comparing carotid artery stenting to carotid endarterectomy.  These procedures are performed to prevent long-term stroke in patients with severe narrowings of their carotid arteries.  We learned that the procedures are equally effective in preventing stroke over the long-term.  However, the procedures have quite different safety profiles, defined as adverse events that the patients experienced within 30 days of their procedure. Carotid artery stenting was associated with a higher risk of stroke in the initial 30 days after the procedure.  Carotid endarterectomy was associated with greater risks of myocardial infarction (heart attack) and cranial nerve palsy, a variable condition that most often results in difficulty with swallowing or speaking, over this timeframe. (more…)
Author Interviews, Kidney Disease, Social Issues / 03.05.2017

MedicalResearch.com Interview with: Wendy Tan Senior Medical Social Worker Medical Social Work The National Kidney Foundation MedicalResearch.com: What is the background for this study? Response: End Stage Renal Disease (ESRD) patients experience significant changes to their daily routine and lifestyle. Their time and attention were often centred solely on their sickness whilst receiving treatment accentuating the employment isolation. This study determined the need for extra support to assist patients adjust (e.g. learning about their psychological wellbeing, change of role and mindset, suitable work conditions and employment support) in returning to work. It also sheds light on how individuals perceive the particular situations they are facing, how they are making sense of their health conditions and the society at large in relations to seeking continued employment. (more…)
Author Interviews, Environmental Risks, OBGYNE, Pediatrics / 03.05.2017

MedicalResearch.com Interview with: Laura Birks, MPH, Predoctoral Fellow ISGlobal Instituto de Salud Global de Barcelona - Campus MAR Barcelona Biomedical Research Park (PRBB) (office 183.01B) Barcelona, Spain MedicalResearch.com: What is the background for this study? What are the main findings? Response: Previous studies in Denmark and the Netherlands have reported associations between prenatal cell phone use and child behavioral problems, but findings have been inconsistent and based on retrospective assessment of cell phone use. This study aimed to assess this association in a multi-national analysis, using data from three cohorts with prospective data on prenatal cell phone use, together with previously published data from two cohorts with retrospectively collected cell phone use data. We found that cell phone use during pregnancy was associated with increased risk for behavioral problems in offspring, specifically hyperactivity/inattention problems. This association was fairly consistent across cohorts and between cohorts with retrospectively and prospectively collected cell phone use data. While our models were adjusted for many confounders, it is possible that other factors could explain this association, such as hyperactivity in the mother or parenting styles (variables that were not collected in these cohorts). Furthermore, to date there is no known biological mechanism that could explain the association. (more…)
Alzheimer's - Dementia, Author Interviews / 02.05.2017

MedicalResearch.com Interview with: Dr. Petr Kocis PhD Vice President Preclinical Development Alzheon, Inc. University of Oxford MedicalResearch.com: What is the background for this study? What are the main findings? Response: Researchers widely accept that amyloid plaques are the hallmark of Alzheimer’s disease. However, for many years, drug development has focused on the solid amyloid plaque as a primary disease culprit. Recent advances show that it is more likely that early stage soluble beta amyloid oligomers play a key role in the pathogenic process of Alzheimer’s disease. A paper recently published by Alzheon, a company developing medicines for Alzheimer’s disease and other neurological disorders, suggests a new therapeutic mechanism for targeting toxic amyloid beta oligomers with a small molecule, tramiprosate, the active agent in the drug candidate, ALZ-801. ALZ-801 is a Phase 3-ready drug candidate that is an optimized prodrug of tramiprosate, with a substantially improved pharmacokinetic and safety profile compared to tramiprosate. Alzheon scientists discovered that tramiprosate acts to inhibit the production of neurotoxic beta amyloid oligomers by ‘enveloping’ the amyloid peptide to prevent its misfolding into soluble amyloid aggregates. Beta amyloid oligomers are believed to be key drivers of the pathogenic process in Alzheimer’s disease (AD). This novel enveloping mechanism of tramiprosate prevents the self-assembly of misfolded proteins into beta amyloid oligomers that lead to amyloid aggregation and, subsequently, cause neuronal toxicity and clinical progression in Alzheimer’s disease. These results were published in the medical journal, CNS Drugs, and the paper is available through Open Access here. [“Elucidating the Aß42 Anti-Aggregation Mechanism of Action of Tramiprosate in Alzheimer’s Disease: Integrating Molecular Analytical Methods, Pharmacokinetic and Clinical Data”] (more…)
Aging, AHA Journals, Author Interviews, Blood Pressure - Hypertension / 02.05.2017

MedicalResearch.com Interview with: Dr. Rathi Ravindrarajah PhD Division of Health and Social Care Research Faculty of Life Sciences & Medicine Guy’s Campus King’s College London MedicalResearch.com: What is the background for this study? What are the main findings? Response: Clinical trials show that it is beneficial to lower systolic blood pressure (SBP) in adults aged 80 and over, but non-randomized epidemiological studies suggest that lower systolic blood pressure may be associated with a higher risk of mortality. Our main findings were that there was a terminal decline in systolic blood pressure in the final 2 years of life suggesting that the higher mortality in those with a low SBP shown in non-randomized epidemiological studies might be due to reverse causation. (more…)
Author Interviews, Heart Disease, JAMA, Surgical Research / 02.05.2017

MedicalResearch.com Interview with: Dr. PJ Devereaux MD, PhD, FRCP(C) Director of the Division of Cardiolog Scientific Leader of the Anesthesiology, Perioperative Medicine and Surgical Research Group at the Population Health Research Institute Professor and University Scholar in the Departments of Health Research Methods, Evidence, and Impact and Medicine McMaster University MedicalResearch.com: What is the background for this study? Response: Although the majority of patients undergoing noncardiac surgery benefit from surgery and do well, even when a small proportion of these patients have a serious complication it represents a major population issue. A recent publication in JAMA Cardiology established that >5 million Americans age ≥45 years undergo major in-patient noncardiac surgery annually, and 1.3% of these patients die in the hospital. This means 65,000 of these patients die, and cardiovascular causes are a dominant cause. (more…)
Author Interviews, JAMA, Pain Research, Pharmacology, UT Southwestern / 01.05.2017

MedicalResearch.com Interview with: Una Makris MD, MSc Clinical Investigator at the VA North Texas Health System VA North Texas Health Care System Assistant Professor at UT Southwestern Medical Center Departments on Internal Medicine and Clinical Sciences Dr. Makris is a Rheumatologist, clinically, and spends the majority of time focused on clinical research investigating how to improve outcomes for adults with back pain. MedicalResearch.com: What is the background for this study? Response: Back pain is the most common type of musculoskeletal (MSK) pain. We know that expenditures for back pain exceed $100 billion each year (and this was in 2005). Back pain results in tremendous disability (including reduced mobility) and impaired quality of life (not exclusive to physical consequences, but also including important psychosocial repercussions). We also know that statins are prescribed very often, and frequently in younger populations who are active. Some reports suggest that statins may have a protective effect on  musculoskeletal conditions such as back pain. (more…)
Author Interviews, Blood Pressure - Hypertension, JAMA, OBGYNE / 01.05.2017

MedicalResearch.com Interview with: Dr. Maureen Phipps, USPTS Task Force member Department chair and Chace-Joukowsky professor of obstetrics and gynecology Assistant dean for teaching and research on women's health Warren Alpert Medical School of Brown University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Preeclampsia, which includes high blood pressure after 20 weeks of pregnancy, is one of the most serious health problems affecting pregnant women. After reviewing the evidence, the Task Force found the benefits of screening for preeclampsia outweighed the harms and recommended screening pregnant women for preeclampsia with blood pressure measurements throughout pregnancy. The evidence showed mothers and their babies are likely to benefit from screening, as screening leads to treatment that reduces their risk of severe complications, including death. (more…)
Author Interviews, Menopause, OBGYNE / 01.05.2017

MedicalResearch.com Interview with: Dr. James A. Simon, MD CCD, NCMP, FACOG Clinical professor of obstetrics and gynecology George Washington University, and Medical director, Women's Health & Research Consultants® Washington, D.C MedicalResearch.com: What is the background for this study? Response: The Phase 2b uterine fibroids study was a 24-week, multicenter, double-blind, randomized, placebo-controlled, parallel group clinical trial that evaluated the efficacy and safety of elagolix alone or in combination with add-back therapy (estradiol/norethindrone acetate) in women with heavy uterine bleeding associated with uterine fibroids. Elagolix is currently being investigated in diseases that are mediated by sex hormones, such as uterine fibroids and endometriosis. The study was conducted in 567 premenopausal women, age 18 to 51, at 100 sites in the United States, Canada, Puerto Rico, Chile and the United Kingdom. The two cohort design study evaluated the safety and efficacy of two elagolix treatment regimens (300mg BID and 600mg QD) alone and in combination with two different strengths of add-back therapy (estradiol/norethindrone acetate). The data presented were results from the 300mg cohort. Results from the 600mg cohort were similar and will be reported in a future publication. Current non-surgical treatments indicated for uterine fibroids are limited, and women suffering from heavy menstrual bleeding associated with uterine fibroids need more options. (more…)