Author Interviews, Blood Pressure - Hypertension, Dental Research / 24.09.2019

MedicalResearch.com Interview with: Dr Eva Muñoz Aguilera BDS MFDS MClinDent (Dist) MPerio RCSEd EFP Diploma in Periodontology and Implant Dentistry Senior Clinical Teaching Fellow in Periodontology UCL Eastman Dental Institute, London MedicalResearch.com: What is the background for this study? Response: High blood pressure and periodontitis are highly prevalent conditions that affect more than one third of the adult population worldwide. High blood pressure is the leading global cause of premature death and is the main preventable cause of cardiovascular disease,  while gum disease - also known as periodontitis - leads to severe inflammation of the gums and tooth loss. It impairs aesthetics and function and reduces quality of life. Most importantly, there is increasing evidence that periodontitis increases risk for future cardiovascular disease. Both diseases share common risk factors such as obesity and smoking and are major health problems that significantly impact on health costs.  (more…)
AACR, Author Interviews, Pancreatic / 24.09.2019

MedicalResearch.com Interview with: Hadas Reuveni, PhD VP of Research and Development Kitov Pharma MedicalResearch.com: What is the background for this study? Response: Pancreatic ductal adenocarcinoma (PDAC) is the fourth leading cause of cancer-related death worldwide. Current treatments fail to provide patients with an effective and long-lasting response, mostly given to the nature of the tumor microenvironment which hinders drug accessibility, the late stage on diagnosis and the rapid upregulation of compensatory alternative signaling pathways by the tumor cells that lead to cancer drug resistance. Two of the major parallel pathways regulating tumor survival and metastasis as well as the crosstalk of the tumor and its microenvironment are mediated by insulin receptor substrate (IRS) 1 and 2, and by the signal transducer and activator of transcription 3 (STAT3). Both IRS1 and STAT3 have been shown to play a significant role in development of drug resistance by tumor cells. NT219, the focus of the current study, is a small molecule that presents a new concept in cancer therapy. NT219 represents a new family of novel compounds acting as a dual inhibitor of both IRS1/2 and STAT3 signaling both directly in the tumor and its microenvironment. We have previously shown that simultaneous inhibition of these two pathways is crucial to overcome drug resistance, and to prolong the positive response of the anti-cancer activity of approved cancer drugs. NT219 targets IRS1/2 for degradation using a unique mechanism, supported by a feed-forward decrease in IRS gene expression. A long-term suppression of both IRS and STAT3 by NT-219 has been demonstrated in previous preclinical studies, which lasted days following removal of NT219 from the cancer cells, assuring a strong and prolonged anti-cancer activity. This study was designed to investigate the efficacy of NT219 at overcoming drug resistance to several approved oncology therapies using patient-derived xenograft (PDX) models of KRAS mutant pancreatic cancer, as well as to validate NT219's mechanism of action and optimal dose regimen.  (more…)
Annals Internal Medicine, Author Interviews, Electronic Records / 24.09.2019

MedicalResearch.com Interview with: John (Xuefeng) Jiang PhD Professor and Plante Moran Faculty Fellow Eli Broad College of Business Accounting & Information Systems Michigan State University East Lansing, MI MedicalResearch.com: How did you get interested in this issue? Response: This is the third project of our data breach trilogy. We first examined which healthcare providers (focusing on hospitals) more likely suffer from a data breach. We documented large hospitals, despite their resources, are more likely to experience a data breach. Some hospitals experienced multiple incidents (https://jamanetwork.altmetric.com/details/18464149). The findings made us wonder what happened? Besides size, what other factors contribute to data breaches? Based on detailed event descriptions, we documented the circumstances under which each data breach occurred (https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2715158). We found more than half of data breaches could be attributed to healthcare providers’ internal mistakes or negligence (e.g., forgot to encrypt laptop computers, used cc instead of bcc in emailing patients, didn’t revoke former employees’ login credentials after employment terminated) rather than external forces (e.g., hacking). We also found mobile devices (e.g. laptop computers, usb drives) are associated with most data breaches than paper records or network servers. Our results suggest if healthcare providers strengthen their internal control and limit the use of mobile device might be effective ways to reduce data breach risks.  (more…)
Author Interviews, BMJ, Brigham & Women's - Harvard, Nutrition, Weight Research / 24.09.2019

MedicalResearch.com Interview with: Deirdre K Tobias, ScD Associate Epidemiologist, Brigham and Women’s Hospital Assistant Professor, Harvard Medical School nuts-nutrition-weight-obesityMedicalResearch.com: What is the background for this study? What types of nuts are helpful? Peanuts included?  Response: We did not have the granularity in our study to evaluate too many individual nut types, and did not perform head-to-head comparisons between types of nuts. All seemed to be better for long-term weight control compared with the snacks like potato chips that we know are not great for us on a regular basis. (more…)
Author Interviews, Education, Exercise - Fitness, Orthopedics, Pediatrics / 24.09.2019

MedicalResearch.com Interview with: Alison E. Field, ScD Professor and Chair of Epidemiology Brown University School of Public Heath Providence, RI  MedicalResearch.com: What is the background for this study? Response: Over past couple of decades there has been a large change in youth sports from playing different sports in each season to more and more specialization where children are playing the same sport for three or more seasons. The concern with that change is that specialization at young ages will lead to more injuries, as well as athlete burnout.   (more…)
Alzheimer's - Dementia, Author Interviews, Cognitive Issues, Duke, Neurology / 24.09.2019

MedicalResearch.com Interview with: Juan Helen Zhou, PhD, on behalf of the co-authors Associate Professor and Principal Investigator Neuroscience and Behavioural Disorders (NBD) Programme Duke-NUS Medical School, SingaporeJuan Helen Zhou, PhD, on behalf of the co-authors Associate Professor and Principal Investigator Neuroscience and Behavioural Disorders (NBD) Programme Duke-NUS Medical School, Singapore  MedicalResearch.com: What is the background for this study? Response: Alzheimer’s disease and cerebrovascular disease are among the leading disorders affecting the elderly, with up to 50 per cent of dementia patients showing co-occurrence of both disorders. It is therefore of great interest to understand the influence of co-occurring Alzheimer’s disease and cerebrovascular disease pathologies on brain changes, and examine if such changes are able to track early differential disease progression. Past cross-sectional studies have suggested that Alzheimer's disease and cerebrovascular disease pathologies contribute independently to brain functional and structural changes, and cognitive decline. Our study sought to demonstrate the independent contributions of both pathologies to brain functional networks in a longitudinal cohort of mild cognitive impairment patients, often regarded as early stage of the disease. (more…)
Author Interviews, Cost of Health Care, Diabetes, Diabetes Care, JAMA / 23.09.2019

MedicalResearch.com Interview with: Rebecca Myerson, PhD Assistant Professor, Population Health Sciences School of Medicine and Public Health University of Wisconsin, Madison MedicalResearch.com: What is the background for this study? Response: Many people with diabetes are undiagnosed, and those who are diagnosed often are untreated and uncontrolled. Increasing access to health insurance for patients with health care needs was a goal of the Affordable Care Act. We analyzed information from 11 years of the National Health and Nutrition Examination Survey, which gathers data that are nationally representative of the civilian population. The biennial survey includes biomarkers, including HbA1c, a measure of blood-sugar control. Using the NHANES data allowed the researchers to identify those with undiagnosed diabetes. (more…)
Author Interviews, CT Scanning, JAMA, Lung Cancer, UCSF / 23.09.2019

MedicalResearch.com Interview with: Joshua Demb, PhD, MPH Postdoctoral Scholar, Moores Cancer Center University of California, San Diego Health Science Research Specialist Veterans Affairs San Diego Healthcare System MedicalResearch.com: What is the background for this study? Response: Our study leveraged radiation dose data from 72 facilities performing CT scans around the United States to learn more about the radiation dose used for lung cancer screening scans, as well as possible institutional predictors that might be associated with higher dose.  Currently, the American College of Radiology has recommendations for how these low-dose lung cancer screening scans should be performed. However, it is unclear how much adherence there currently is to these guidelines. Our findings indicated that there is wide variation in the distribution of radiation doses for low-dose lung cancer screening scans both within- and between facilities in our sample—in some cases this variation led to doses higher than the ACR recommendations.   (more…)
Author Interviews, Cost of Health Care, JAMA, University of Pittsburgh / 23.09.2019

MedicalResearch.com Interview with: Coleman Drake, PhD Assistant Professor, Department of Health Policy and Management Affiliate faculty member Center for Pharmaceutical Policy and Prescribing University of Pittsburgh MedicalResearch.com: What is the background for this study? Response: Every year, the Centers for Medicare and Medicaid Services puts out of notice of proposed changes to the rules governing the Health Insurance Marketplaces created by the Affordable Care Act (e.g., healthcare.gov). The most recent notice for 2020 (issued in 2019) considered eliminating automatic reenrollment for Marketplace enrollees. On the one hand, requiring that enrollees actively select a health plan to stay insured is a good thing because it forces them to consider their options – we know that people make better health plan choices when they consider their choices. On the other hand, creating an administrative barrier to staying insured could cause some people to become uninsured. Since 3.4 million Marketplace enrollees used automatic enrollment in 2019, eliminating it might cause a spike in the uninsured rate. (more…)
Author Interviews, Heart Disease, Pediatrics, Smoking, UCSF / 23.09.2019

MedicalResearch.com Interview with: Gregory M Marcus, MD, MAS Professor of Medicine in Residence Endowed Professor in Atrial Fibrillation Research University of California, San Francisco Associate Chief of Cardiology for Research, UCSF Health University of California, San Francisco MedicalResearch.com: What is the background for this study? What are the main findings? Response: Smoking remains the most common preventable cause of death and disability. We previously found evidence that tobacco smoke exposure in the young may lead to atrial fibrillation, the most common heart rhythm disturbance, later in life. Here we leveraged the multi-generational nature of the Framingham Heart Study to demonstrate that parental smoking was a risk factor for offspring atrial fibrillation. At least some of this relationship was explained by a greater propensity to smoke in offspring of smoking parents. These findings demonstrate a potentially new harmful effect of smoking pertinent to the most vulnerable population, our children. It also demonstrates how parental behaviors can have meaningful adverse consequences to their children decades later. (more…)
Author Interviews, Herpes Viruses, Science, University of Pennsylvania, Vaccine Studies / 23.09.2019

MedicalResearch.com Interview with: Harvey M. Friedman, MD Professor of Medicine/Infectious Diseases University of Pennsylvania Philadelphia, PA 19104-6073  MedicalResearch.com: What is the background for this study? Response:  Mice and guinea pigs are the animal models used to evaluate candidate vaccines for preventing genital herpes. My lab has been working on such a vaccine. Our candidate vaccine contains 3 immunogens. One immunogen is a protein on the virus that is required for the virus to enter cells (viruses need to enter cells to replicate). The other two immunogens are proteins on the virus that help the virus escape immune attack. Our intent is to produce antibodies to these 3 proteins by immunization and that the antibodies will bind to the proteins on the virus and block the protein functions. The virus then will not be able to enter cells and will not be able to use its evasion strategies to avoid the immune responses generated by the vaccine. Our vaccine aimed at preventing immune evasion is novel as a component of a genital herpes vaccine.  (more…)
Author Interviews, JAMA, Smoking, Tobacco, Tobacco Research / 22.09.2019

MedicalResearch.com Interview with: Hongying (Daisy) Dai, PhD Associate Professor Department of Biostatistics | College of Public Health University of Nebraska Medical Center Omaha MedicalResearch.com: What is the background for this study? Response: Previous studies have reported a surge in e-cigarette use among youth during the 2017 - 2018. For instance, the prevalence of current (past 30-day) e-cigarette use increased by 77.8% (from 11.7% to 20.8%) among high school students and by 48.5% (from 3.3% to 4.9%) among middle school students. As a result, the Food and Drug Administration (FDA) warns that youth e-cigarette use is reaching an epidemic proportion in September 2018. Whether e-cigarette use prevalence also increased among young adults (aged 18-24 years), a population with high e-cigarette use rates and vulnerability to nicotine dependence, is unknown. (more…)
Author Interviews, Gastrointestinal Disease, Weight Research / 21.09.2019

MedicalResearch.com Interview with: Sarah Ballou, PhD Health Psychologist Division of Gastroenterology, Hepatology, and Nutrition Beth Israel Deaconess Medical Center Boston, MA MedicalResearch.com: What is the background for this study? What are the main findings? Response: Obesity is known to be associated with an increased risk of gastrointestinal and liver diseases, but less is known about the relationship between obesity and constipation or diarrhea. We used a nationally representative sample of the US population to evaluate whether obesity was associated with abnormal bowel habits. We found that obese individuals were 60% more likely to have diarrhea, even after controlling for possible confounding factors such as dietary, lifestyle, psychological, and medical conditions. (more…)
Author Interviews, Dengue, Duke, Vaccine Studies / 21.09.2019

MedicalResearch.com Interview with: Dr Shee-Mei Lok, PhD Professor in the Emerging Infectious Disease program Duke-NUS, a school of National University of Singapore MedicalResearch.com: What is the background for this study? Response: Dengue virus consists of four different serotypes (DENV1-4) and within each serotypes, there are multiple strains. In terms of the viral particle shape, our previous research work using some laboratory adapted strains showed these DENV2 strains are very interesting in that it can change shape from the smooth spherical surface particles when grown at mosquito physiological temperature (29oC) and then becomes bumpy surfaced particles when incubated at human physiological temperature (37oC). This ability to transform into different virus surface structures helps the virus to escape from the immune system of the human host. Hence understanding the mechanism of how this occur is important for therapeutics and vaccine development. Here we also identified a laboratory adapted virus strain that do not showed this structural changes. We showed some differences in their amino acid sequences and We showed some differences in their amino acid sequences and mutating these residues coupled with observing their surface structures showed which residues are important for this temperature induced structural change. Results showed that subtle mutations at different places on the envelope protein can destabilize the virus allowing them to change in structure when temperature is elevated. Due to the poor selection pressure of the artificial laboratory tissue culture system, gradual mutations of the virus is accumulated causing the virus to have bumpy surface morphology. (more…)
Author Interviews, Dermatology, Environmental Risks / 19.09.2019

MedicalResearch.com Interview with: Dr. Ke Cheng, PhD Professor, Department of Molecular Biomedical Sciences, NCSU Professor, UNC/NCSU joint Department of Biomedical Engineering MedicalResearch.com: What is the background for this study? What are exosomes? Response: People are developing lots cosmetic products to keep a healthy and young appearance, like antioxidants, growth factors, peptides and more recently, stem cell products. Also, people are seeking more effective solutions for better absorption, like lotion, mask, laser and fillers. What is used for the treatment and how to deliver it are vitally important to the final effect and lasting time. Exosomes are nano-sized small vehicles containing proteins, nucleic acids, and they are messengers for cell communication and regulation. Here we use skin cell-secreted exosomes to fight skin aging. (more…)
Author Interviews, Cancer Research, End of Life Care, JAMA / 19.09.2019

MedicalResearch.com Interview with: Donald Sullivan, MD, MA, MCR Associate Professor of Medicine & Associate Fellowship Program Director Division of Pulmonary & Critical Care Medicine Oregon Health & Science University Investigator, Center to Improve Veteran Involvement in Care (CIVIC) VA-Portland Health Care System  MedicalResearch.com: What is the background for this study?
  • Patients with lung cancer suffer from considerable physical and psychological symptom burden and palliative care is underutilized or delivered too close to death to provide meaningful benefits for these patients. Palliative care is associated with improved quality of life for these patients, but the findings regarding a survival benefit are not clear.
  • Palliative care is distinct from hospice. Palliative care is meant to be delivered along with disease-modifying therapy and focuses on improving quality of life by addressing pain and other problems, including physical, psychosocial and spiritual for patients and their families. Hospice care is focused on reducing suffering, pain and anxiety at the very end of life; typically within a few months of death.
(more…)
Author Interviews, Electronic Records, Emergency Care, JAMA / 19.09.2019

MedicalResearch.com Interview with: Carl Berdahl, MD, MS Emergency Physician and Health Services Researcher CEDARS-SINAI West Hollywood CA MedicalResearch.com: What is the background for this study? Response: The length of a doctor’s note is taken account when determining how much a doctor or medical center is paid for a visit. However, in the digital era, a doctor can generate large amounts of text with just a few keystrokes. Given this incentive structure, we were concerned doctors’ notes might be inaccurate in certain sections of the chart that are important for billing. We used observers to determine how accurately doctors’ notes reflected the interactions between patients and physicians. (more…)
Author Interviews, Dermatology, Melanoma, Technology / 19.09.2019

SkinVision   MedicalResearch.com Interview with:  Andreea Udrea, PhD Associate Professor University Politehnica of Bucharest   MedicalResearch.com: What is the background for this study? The skin cancer incidence rate is increasing worldwide. Early diagnosis and prevention can reduce morbidity and are also linked to decreased healthcare costs. During the last years, efforts have been made in developing smartphone applications for skin lesion risk assessment to be used by laypersons. In parallel, as machine learning (ML) is on the rise, and medical image databases are increasing in size, a series of algorithms have been developed and compared in clinical studies to dermatologists for skin cancer diagnosis. The accuracy of the algorithms and experts were comparable. One drawback of these clinical studies is that they use images acquired by professionals in standardized conditions. So, there is little knowledge of what the accuracy will be when including an ML algorithm in an app and testing it in a non-clinical setup where the image quality may be lower, and the variability in image taking scenarios is higher as images are acquired by non-professionals using the smartphone camera. This study is one of the first that evaluates the accuracy of an app (SkinVision) when being used for risk assessment of skin lesions in the general population. (more…)
Author Interviews, Health Care Systems, Surgical Research / 19.09.2019

MedicalResearch.com Interview with: Gustav Tinghög, PhD Associate Professor Division of Economics Department of Management and Engineering, IEI JEDI-lab: JUDGEMENT, EMOTION, DECISION and INTUITION Linköping University MedicalResearch.com: What is the background for this study? Response: Previous studies have shown that when we get tired, we make decisions without engaging in cognitively demanding reasoning, and we postpone risky or uncertain choices. Previous studies have explored this idea of “decision fatigue” in relation to parole hearing outcomes, failure of health services workers to wash their hands, and the likelihood of physicians prescribing antibiotics. In our study we wanted to investigate how patient ordering affected decisions scheduled patients for orthpedic surgery (excluding acute cases) (more…)
Author Interviews, Heart Disease, NEJM, Vanderbilt / 18.09.2019

MedicalResearch.com Interview with: Daniel Muñoz, M.D, M.P.A Assistant Professor of Medicine, Division of Cardiology Medical Director for Quality, Vanderbilt Heart & Vascular Institute Medical Director, Cardiovascular ICU Vanderbilt University Medical Center Nashville, Tennessee MedicalResearch.com: What is the background for this study? Response: Despite advances in the prevention and treatment of cardiovascular disease, it remains the number one global killer of both men and women. Patients face a variety of barriers to getting the care need, including cost and complexity of medication regimens. Innovative strategies are needed to improve the delivery of preventive care, especially when it comes to socio-economically vulnerable individuals. The polypill, a fixed-dose combination of 3 blood pressure lowering medications and a cholesterol lowering medication, may be a strategy for improving cardiovascular disease prevention. We enrolled 303 patients at a community health center in Mobile, Alabama. Half of the patients were assigned to take a daily polypill, while the other half received their usual medical care. Participants underwent a standard medical exam, blood pressure measurement, and blood cholesterol testing during their initial visit, a 2-month visit, and a 12-month visit. MedicalResearch.com: What are the main findings?
  • Participants in the polypill group experienced a greater reduction in both systolic blood pressure and LDL cholesterol level, as compared with participants in the usual care group. These differences translate to an approximate 25% reduction in the risk of experiencing a cardiovascular event.
  • At 12 months, adherence to the polypill regimen, as assessed based on pill counts, was 86%.
  • The vast majority of our study participants were African-American (96%), with three quarters reporting an annual income below $15,000.
(more…)
Author Interviews, Infections, Lyme / 18.09.2019

MedicalResearch.com Interview with: Jorge Benach, PhD Distinguished Toll Professor Molecular Genetics & Microbiology and Pathology Renaissance School of Medicine Stony Brook University  MedicalResearch.com: What is the background for this study? Response: The increases in the numbers of cases of tick-borne diseases in the nation, and the increases in the number of cases in our area were the catalysts to document the levels of infection with a number of pathogens in the vector ticks. In addition, there were indications that an invasive tick species, the lone star tick, had taken a foothold in our area and had brought new tick-borne pathogens. Identification of the multiple pathogens was made possible by the molecular probes developed by Dr Rafal Tokarz, another corresponding author of our study  (more…)
Author Interviews, Health Care Systems, JAMA, Primary Care / 18.09.2019

MedicalResearch.com Interview with: Deborah Korenstein, MD FACP General internist and Chief, General Internal Medicine Memorial Sloan Kettering Cancer Center  MedicalResearch.com: What is the background for this study? Response: Executive physicals are 1 to 2-day comprehensive health assessments offering disease screening and preventive testing. Large companies can arrange for these evaluations for senior executives. They are often offered by prestigious academic medical centers, but can also be located in less formal settings like spas. They generally include a set of tests that sometimes vary based on patient characteristics. Any tests that are done in response to from findings from executive physicals are billed to health insurance companies. A single 2008 paper described executive physicals and criticized them for being non-evidence based. Since then, executive physicals have grown in popularity, but their nature and impact have not been described. We set out to describe included services and cost of executive physicals at top academic medical centers. (more…)
Author Interviews, Diabetes, Endocrinology, Menopause / 18.09.2019

MedicalResearch.com Interview with: Dr Sopio Tatulashvili Avicenne Hospital Bobigny, FranceDr Sopio Tatulashvili Avicenne Hospital Bobigny, France MedicalResearch.com: What is the background for this study? Response: Diabetes and pre-diabetes are associated with increased cardiovascular morbidity and mortality. Early screening and the treatment of glucose metabolism disorders could lower the risk of further complications. Furthermore, type 2 diabetes can be prevented. For this purpose, it is of major importance to better identify the risk factors of type 2 diabetes. Hormonal factors are increasingly suspected to play a role in the etiology of type 2 diabetes. The aim of this study was to determine the associations between various hormonal factors and the risk of incident type 2 diabetes in the large prospective female E3N (Etude Épidémiologique de Femmes de la Mutuelle Générale de L’Education Nationale) cohort study. Based on a very detailed set of information available in 83,799 women from the large prospective E3N cohort study followed for 22 years, we have been able to clarify the relationships between various hormonal factors and type 2 diabetes risk.   (more…)
AHA Journals, Author Interviews, Heart Disease, Lipids / 17.09.2019

MedicalResearch.com Interview with: Samuel S. Gidding, MD FH Foundation Pasadena, CA MedicalResearch.com: What is the background for this study? Response: Patients with familial hypercholesterolemia are at high risk for atherosclerotic heart disease but little is known about intensification of treatment and event rates in lipid specialty care in the United States. We examined data on 1900 patients, enrolled in the CASCADE FH Registry,sponsored by the Familial Hypercholesterolemia Foundation, to determine if cholesterol lowering therapy increased to improve getting patients to a lower LDL cholesterol and to look at incident cardiac events in tow groups, those with prior heart disease and those without. (more…)
ASCO, Author Interviews, Cancer Research, Cost of Health Care, End of Life Care / 17.09.2019

MedicalResearch.com Interview with: Richy Agajanian, M.D. Chief Medical Officer and Senior Regional Director The Oncology Institute of HopeRichy Agajanian, M.D. Chief Medical Officer and Senior Regional Director The Oncology Institute of Hope and Innovation MedicalResearch.com: What is the background for this study? Response: Cancer patients and their families face status-quo treatment protocols and reimbursement models which often result in confusion and unnecessary pain and suffering in the final weeks or months of life while also causing enormous financial burden. To help combat these issues, The Oncology Institute, in collaboration with the Stanford University School of Medicine and CareMore Health, released the study, Enhancing community capacity to deliver value-based cancer care at the end-of-life. This study evaluated the effect of using lay health workers (LHWs), who are non-physician members of the community who have received specialized training to support patient care and navigation, on end-of-life cancer care outcomes, quality and cost.  (more…)
AstraZeneca, Author Interviews, Pulmonary Disease / 17.09.2019

MedicalResearch.com Interview from: AstraZeneca Spokesperson MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by COPD? How common is severe COPD? Response: COPD, or chronic obstructive pulmonary disease, is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs making it hard to breathe. In the United States, COPD is the fourth leading cause of death. Its prevalence in adults 18 years of age and older is 6.5 percent. An estimated 16 million people are currently diagnosed with COPD, and millions more are believed to have it but do not know it. ETHOS is a randomized, double-blind, multi-center, parallel-group, 52-week trial to assess the efficacy and safety of PT010 in symptomatic patients with moderate to very severe COPD and a history of exacerbation(s) in the previous year. The trial compared two doses given twice daily of PT010 (320/14.4/9.6mcg and 160/14.4/9.6mcg) with glycopyrrolate/formoterol fumarate (14.4/9.6mcg) and PT009 (320/9.6mcg), all using AEROSPHERETM Delivery Technology in a pressurized metered-dose inhaler (pMDI). Outcomes in the ETHOS trial included, as a primary endpoint, the rate of moderate or severe exacerbations. The Phase III ETHOS trial builds on the Phase III KRONOS data which together show PT010’s ability to reduce exacerbation risk in a broad range of patients with COPD, irrespective of whether they have had an exacerbation in the previous twelve months. (more…)
Author Interviews, Environmental Risks, JAMA, Smoking / 17.09.2019

MedicalResearch.com Interview with: Sairam Jabba, Ph.D Senior Research Associate Department of Anesthesiology Duke University Durham, NC 27710 MedicalResearch.com: What is the background for this study? Response: Pulegone is a potential carcinogen contained in several mint oils. Due to its carcinogenic properties, FDA banned pulegone last year as a food additive. Previous chemical analytical studies from CDC have demonstrated that several mint/menthol-flavored e-cigarette liquids and snuff tobacco products contain pulegone in significant amounts. FDA currently does not regulate pulegone in e-cigarettes and snuff products and the health risk associated with it for the users is not well understood.  (more…)
Annals Internal Medicine, Author Interviews, Heart Disease / 17.09.2019

MedicalResearch.com Interview with: Dr Vanessa Selak MBChB, MPH (Hons), PhD, FAFPHM, FNZCPHM Senior Lecturer in the Section of Epidemiology & Biostatistics School of Population Health, Faculty of Medical and Health Sciences University of Auckland MedicalResearch.com: What is the background for this study? Response: For people who have already had a cardiovascular event, the benefits of aspirin generally outweigh its harms but the balance of benefits and risks is unclear in primary prevention. It was hoped that the results of three major trials published last year would determine whether or not aspirin had a role in the primary prevention of cardiovascular disease (CVD) among people at intermediate risk of CVD, but these trials recruited participants at lower CVD risk than expected. An updated meta-analysis of aspirin for the primary prevention of CVD, which incorporated the findings from these three trials, has confirmed that aspirin reduces the relative risk of CVD and increases the relative risk of bleeding. We investigated, using an individualized assessment of the absolute cardiovascular benefits of aspirin and its bleeding harms among New Zealand adults aged 30-79 years without established CVD who had their CVD risk assessed in primary care between 2012 and 2016, whether there are individuals without established CVD for whom the absolute cardiovascular benefits of aspirin are likely to outweigh its absolute bleeding harms. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Genetic Research, Infections, JAMA / 17.09.2019

MedicalResearch.com Interview with: QiPing Feng, PhD Division of Clinical Pharmacology Department of Medicine Vanderbilt University Medical Center Nashville, Tennessee MedicalResearch.com: What is the background for this study? Response: Sepsis is one of the leading causes of hospital mortality. Yet, there are no specific effective treatments for it. Recent information suggests that drugs that inhibit proprotein convertase subtilisin kexin type 9 (PCSK9) could have potential as a new treatment for sepsis. We used a genetic approach to test if variation in PCSK9 affected the risk of sepsis. In patients admitted to hospital with infection, neither variants in the PCSK9 gene nor predicted expression of PCSK9 were associated with risk of sepsis or poorer outcomes after sepsis.  (more…)