AHA Journals, Author Interviews, Race/Ethnic Diversity, Stroke / 18.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35369" align="alignleft" width="133"]George Howard, Dr.PH PI of the REasons for Geographic And Racial Differences in Stroke (REGARDS) Study Department of Biostatistics University of Alabama at Birmingham Birmingham, AL Dr. Howard[/caption] George Howard, Dr.PH PI of the REasons for Geographic And Racial Differences in Stroke (REGARDS) Study Department of Biostatistics University of Alabama at Birmingham Birmingham, AL MedicalResearch.com: What is the background for this study? What are the main findings? Response: Rural areas have been known to have a higher death rate than urban, and higher death from stroke in rural areas is a major contributor to this disparity. The goal of the research was to assess if the higher deaths from stroke was because rural people are more likely to have a stroke, or more likely to die from a stroke once it occurs.   This distinction is critically important, since intervention to reduce stroke deaths in rural area would focus on stroke prevention if the former, but would focus on improving stroke care (after the stroke) if the latter. We found that the higher mortality from stroke appears to be almost completely due to more people having stroke.   As such, we need to focus on efforts to reduce the risk of rural areas.   While there are well-documented differences in stroke care between urban and rural areas, resolving these differences will not be likely reduce the rural excess death from stroke. It would seem that the higher risk of having a stroke could be due to the observation that those in rural areas are more likely to have major stroke risk factors, including hypertension, diabetes and cigarette smoking; however, the higher prevalence of these risk factors don’t seem to explain the higher risk.   So what causes the higher risk remains a mystery.
Author Interviews, ENT, Hearing Loss, JAMA, University of Michigan / 17.06.2017

MedicalResearch.com Interview with: Aileen Wertz, MD Otolaryngology - Head and Neck Surgery University of Michigan  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The key finding of this study is: free, comprehensive audiologic care, including hearing aids and fitting, is feasible within a well-established free clinic model. We found that donated hearing aids and volunteer health care providers were able to run the clinic and that 20 patients have thus far been fit with hearing aids.
Author Interviews, Genetic Research, Nutrition, Omega-3 Fatty Acids / 16.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35363" align="alignleft" width="200"]Kaixiong (Calvin) Ye, PhD Post-doctoral Associate Dept. of Biological Statistics & Computational Biology Cornell University thaca, NY Dr. Kaixong Ye[/caption] Kaixiong (Calvin) Ye, PhD Post-doctoral Associate Dept. of Biological Statistics & Computational Biology Cornell University thaca, NY MedicalResearch.com: What is the background for this study? Response: Omega-6 and omega-3 fatty acids are critical for human brain development, cognitive function, immune response, and cardiovascular health. Physiologically active forms of omega-6 and omega-3 fatty acids, such as AA, EPA, and DHA, are readily available in meat and seafood, but are absent in most plant-based foods (e.g. fruits and vegetables). Instead, plant-based foods contain two precursor fatty acids, LA and ALA, which could be metabolized in our body and converted into physiologically active forms. Fatty acid desaturase (FADS) genes encode key enzymes for this biosynthesis. We hypothesized that genetic variations in FADS genes that enhance the biosynthesis efficiency were adaptive to plant-based diets in traditional farming populations and thus became more frequent over time. Our study compiled a huge data set of genetic information (DNA) from both present-day and ancient individuals. For the first time, we examined the action of natural selection on humans for the past 30,000 years in Europe.
AACR, Author Interviews, Biomarkers, Cancer Research, Prostate Cancer / 15.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35328" align="alignleft" width="138"]Dr. Yong-Jie Lu Reader in Medical Oncology Centre for Molecular Oncology Barts Cancer Institute - a CR-UK Centre of Excellence Queen Mary University of London John Vane Science Centre, Charterhouse Square, LONDON Dr. Yong-Jie Lu[/caption] Dr. Yong-Jie Lu MBBS, MD, PhD Reader in Medical Oncology Centre for Molecular Oncology Barts Cancer Institute - a CR-UK Centre of Excellence Queen Mary University of London John Vane Science Centre, Charterhouse Square London MedicalResearch.com: What is the background for this study? Response: Identifying/monitoring the occurrence of metastasis and the prediction of the length that a patient may survive with a prostate cancer is critical for doctors to select the proper treatment, aiming to achieve the best control of the cancer with a balance of quality of life. Currently this is achieved mainly by analysing the cancer tissues acquired through very invasive procedures or by expensive imaging techniques, most of which expose the patient to toxic radioactive materials. Circulating tumour cells (CTCs), which play a key role in the metastasis process, have been shown for their potential to be used for cancer prognosis by a simple blood sample analysis. However, previous CTC studies mainly detect the epithelial type of CTCs. Using the ParsortixTM (ANGLE plc) cell-size and deformability based CTC isolation system, we analysed not only epithelial CTCs, but also CTCs with epithelial-mesenchymal transition (EMT), a cellular process associated with cancer invasion and metastasis.
Author Interviews, Heart Disease, JAMA, Stroke / 15.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35355" align="alignleft" width="110"]Gregory Y. H. Lip, MD Professor of Cardiovascular Medicine University of Birmingham, UK; Adjunct Professor of Cardiovascular Sciences, Thrombosis Research Unit, Aalborg University, Denmark National Institute for Health Research (NIHR) Senior Investigator. Visiting Professor of Haemostasis Thrombosis & Vascular Sciences, Aston University, Birmingham, UK Visiting Professor of Cardiology, University of Belgrade, Serbia; Visiting Professor, University of Leeds, UK Honorary Professor, Chinese PLA Medical School, Beijing, China; Honorary Professor, Nanjing Medical University, Nanjing, China; Visiting Professor, National Yang-Ming University, Taipei, Taiwan Institute of Cardiovascular Sciences City Hospital Birmingham England UK Dr. Lip[/caption] Gregory Y. H. Lip, MD Professor of Cardiovascular Medicine University of Birmingham Adjunct Professor of Cardiovascular Sciences, Thrombosis Research Unit, Aalborg University, Denmark National Institute for Health Research (NIHR) Senior Investigator. Visiting Professor of Haemostasis Thrombosis & Vascular Sciences, Aston University, Birmingham, UK Institute of Cardiovascular Sciences City Hospital Birmingham England UK MedicalResearch.com: What is the background for this study? What are the main findings? Response: The randomized clinical trials comparing non-Vitamin K antagonist oral anticoagulants (NOACs) vs warfarin largely focused on recruitment of high risk atrial fibrillation(AF) patients with >2 stroke risk factors, with only the trials testing dabigatran or apixaban including a minority of patients with 1 stroke risk factor. Despite this, regulatory approvals of all NOACs have been for stroke prevention in AF patients with ≥1 stroke risk factors. No difference between NOACs compared to warfarin in risk of ischemic stroke/systemic embolism, was seen but for ‘any bleeding’, this was lower for apixaban and dabigatran compared to warfarin.
Author Interviews, JAMA, Parkinson's / 15.06.2017

MedicalResearch.com Interview with: Rajesh Pahwa MD Department of Neurology University of Kansas Medical Center, Kansas City, KS, MedicalResearch.com: What is the background for this study? What are the main findings? Response: Dyskinesia are one of the major unmet needs in Parkinson Disease patients. At the present time there are no approved medication for dyskinesia, however immediate release amantadine is used in PD patients with dyskinesia. ADS-5102 is a long acting, extended release capsule formulation of amantadine HCl administered once daily at bedtime. This study investigated the safety, efficacy and tolerability of ADS-5102 in Parkinson’s disease (PD) patients with levodopa-induced dyskinesia. This was a randomized, double-blind, placebo-controlled study of Parkinson’s disease patients with levodopa-induced dyskinesia. In total, 126 patients were randomized to placebo or 274 mg ADS-5102 administered orally at bedtime. ADS-5102 was associated with a significant reduction in dyskinesia at 12 weeks compared with placebo, as measured by the mean change in Unified Dyskinesia Rating Scale (treatment difference, –7.9; P =.0009). OFF time was significantly reduced in ADS-5102 patients compared to placebo (treatment difference -0.9 hours, p=.017).
Author Interviews, Fertility, OBGYNE / 15.06.2017

MedicalResearch.com Interview with: Prof. Dr. João Martins Pisco MD PhD Radiologia de Intervenção Hospital Saint Louis - Rua Luz Soriano PortugalProf. Dr. João Martins Pisco MD PhD Radiologia de Intervenção Hospital Saint Louis - Rua Luz Soriano Portugal MedicalResearch.com: What is the background for this study? What are the main findings? Response: The background for the study is the good results I started to check in patients with uterine fibroids who could conceive a successful pregnancy with live birth following embolization. MedicalResearch.com: What should readers take away from your report? Response: The readers should know that fertility can be restored following embolization of uterine fibroids, particularly if the embolization is partial. The wish of conception in patients with uterine fibroids is not a contraindication for fibroids embolization.
Author Interviews, Duke, Heart Disease / 15.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35347" align="alignleft" width="156"]Daniel J. Friedman, MD Duke University Hospital Duke Clinical Research Institute Durham, NC Dr. Friedman[/caption] Daniel J. Friedman, MD Duke University Hospital Duke Clinical Research Institute Durham, NC MedicalResearch.com: What is the background for this study? What are the main findings? Response: Although primary prevention ICDs have saved countless lives among patients with heart failure and a reduced ejection fraction, the use of primary prevention ICDs in patients with more advanced heart failure [defined by New York Heart Association Class (NYHA)] is controversial. Specifically, there are conflicting data from the pivotal primary prevention ICD trials regarding whether primary prevention ICDs reduce all-cause mortality among patients with a severely reduced ejection fraction (≤35%) and NYHA III heart failure. We performed a patient level meta-analysis using data from 4 pivotal primary prevention ICD trials (MADIT-I, MADIT-II, SCD-HeFT, and DEFINITE) to assess whether primary prevention ICD efficacy varied by NYHA class (II vs. III). Overall, the ICD reduced all-cause mortality among the overall population of patients (NYHA II and III). We subsequently assessed ICD efficacy after stratification by NYHA class. Among NYHA II patients, the ICD significantly reduced all-cause mortality by reducing sudden cardiac death. Although NYHA III patients randomized to an ICD experienced a significantly lower rate of sudden cardiac death, this did not translate into a reduction in all-cause mortality, due to competing causes of non-sudden death (which an ICD cannot treat). Based on relatively wide confidence intervals associated with the estimate for ICD effect in NYHA III patients, there appears to be substantial heterogeneity in outcomes among these patients. This suggests that many NYHA III patients can benefit from a primary prevention ICD, but further study is necessary to determine which NYHA III patients are poised to benefit.
Author Interviews, Cannabis, Pediatrics / 14.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35341" align="alignleft" width="200"]David Kerr PhD Associate professor in the School of Psychological Science College of Liberal Arts Ohio State University  Dr. Kerr[/caption] David Kerr PhD Associate professor in the School of Psychological Science College of Liberal Arts Ohio State University  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Oregon legalized sale and use of marijuana for recreational purposes and the part of the law (regarding use) took effect in July 2015. However, there have been no controlled studies of which we’re aware of the possible effects of the Oregon law that take into account the trends toward increased marijuana use across the country and differences in use rates between states that predated the law. We used survey data on college students in Oregon and in 6 states without recreational legalization to examine the issue.
Author Interviews, Dental Research, Technology / 14.06.2017

MedicalResearch.com Interview with: Avathamsa Athirasala, MSE and Luiz E. Bertassoni, DDS PhD Biomaterials and Biomechanics, School of Dentistry Center for Regenerative Medicine, School of Medicine Biomedical Engineering, School of Medicine Portland OR 97201 USA MedicalResearch.com: What is the background for this study? What are the main findings? Response: Current clinical practices for root canal treatment involve replacing the damaged tissue with inert, synthetic materials. While these procedures are able to arrest infection and decay in the tooth, they do not restore its biological function causing it to become weaker and more prone to fractures. We are focused on the regeneration of pulp tissue instead and in this study, we have developed a strategy to apply tissue-engineering concepts to engineer dental pulp-like tissue constructs, complete with blood vessels, which can, in principle, integrate with existing vasculature when introduced at the site of injury and form healthy pulp tissue.
Author Interviews, Surgical Research / 14.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35332" align="alignleft" width="166"]Jacob Quick, M.D.</strong> Assistant professor of acute care surgery University of Missouri School of Medicine Dr. Quick also serves as a trauma surgeon at MU Health Care. Dr. Quick[/caption] Jacob Quick, M.D. Assistant professor of acute care surgery University of Missouri School of Medicine Dr. Quick also serves as a trauma surgeon at MU Health Care. MedicalResearch.com: What is the background for this study? What are the main findings? Response: During five to seven years of surgical training, surgical faculty determine the level of clinical competency, confidence and decision-making skills of each resident physician through personal observations. This skill evaluation is based on a subjective assessment, which essentially is a gut feeling. We monitored electrodermal activity, or EDA, using dermal sensors on the wrists of residents while they performed laparoscopic cholecystectomies. Our initial findings indicated that at crucial points during the procedures, residents’ EDA increased as much as 20 times more than experienced faculty performing the same surgery. However, over the course of the study, and as their proficiency developed, surgical residents’ EDA levels began to lower in accordance with their experience.
Author Interviews, Genetic Research, Pediatrics / 14.06.2017

MedicalResearch.com Interview with: Charlotte Cecil, PhD ESRC FRL Fellow Edward Barker, PhD Lab Director, DEVELOPMENTAL PSYCHOPATHOLOGY LAB Department of Psychology Institute of Psychiatry, Psychology& Neuroscience King's College London MedicalResearch.com: What is the background for this study? What are the main findings? Response: Conduct problems (CP) are the most common reason for child treatment referral in the UK, costing an estimated £22 billion per year. Children with CP engage in a range of aggressive and antisocial behaviours (e.g. fighting, stealing, lying), that affect their ability to follow rules and adapt to society, do well in school, and form healthy relationships. Those who do not receive treatment are also at increased risk for many negative outcomes in adulthood, including lower job prospects and earnings, more contact with the police and a lower quality of life. Therefore, it is important to understand how CP develop in the first place, in order to create more effective prevention and intervention strategies. Studies have found that children who develop conduct problems before the age of 10 (early-onset CP) are at greatest risk for poor outcomes across the lifespan. Compared to other children, those showing early-onset CP tend to have experienced more adversity in early life (e.g. prenatal stress, poverty) as well as having more genetic risk. However, little is known about about how genetic factors interact with environmental influences - especially during foetal development - to increase the risk for early-onset conduct problems.
Author Interviews, BMJ, Heart Disease / 14.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35317" align="alignleft" width="200"]Dr Nicola Adderley BA, MSci (Cantab), MA, MPhil, PhD Institute of Applied Health Research Research Fellow University of Birmingham Dr. Adderley[/caption] Dr Nicola Adderley BA, MSci (Cantab), MA, MPhil, PhD Institute of Applied Health Research Research Fellow University of Birmingham MedicalResearch.com: What is the background for this study? Response: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and a major global public health problem. It is associated with a five-fold increase in risk of stroke. There are three types of AF – paroxysmal, persistent or permanent. In paroxysmal AF, episodes come and go, and usually stop without any treatment. With persistent AF episodes can last for periods of more than seven days and are treated with medication or a medical procedure called cardioversion. In permanent AF, the irregular heartbeat is present all the time and cardioversion has failed to restore a normal heart rhythm. All patients with AF, including paroxysmal AF, are at an increased risk of stroke. UK guidelines recommend anticoagulant treatment, such as the blood-thinning drug warfarin, for patients with all types of AF in order to reduce the risk of stroke. Our study aimed to determine whether patients with paroxysmal AF are less likely to be treated with anticoagulants than patients with persistent or permanent AF and to investigate trends in treatment between 2000 and 2015.
Author Interviews, Heart Disease, Karolinski Institute, Technology / 14.06.2017

MedicalResearch.com Interview with: “drones” by Andrew Turner is licensed under CC BY 2.0Andreas Claesson, RN, Paramedic PhD Centre for resuscitation science Karolinska institute Stockholm, Sweden. MedicalResearch.com: What is the background for this study? What are the main findings? Response: Survival from out-of-hospital cardiac arrest is low, the technology is existing. When implementing this kind of system with a drone equipped with an AED, defibrillation may occur at an early stage and before EMS arrival mainly in rural areas.
Author Interviews, JAMA, Johns Hopkins, Outcomes & Safety / 14.06.2017

MedicalResearch.com Interview with: Pranita Tamma, MD Assistant Professor Director, Pediatric Antimicrobial Stewardship Program Assistant Professor of Pediatrics Johns Hopkins Bloomberg School of Public Health Dr. Pranita D. Tamma Assistant Professor of Pediatrics Director, Pediatric Antimicrobial Stewardship Program The Johns Hopkins University School of Medicine  MedicalResearch.com: What is the background for this study? What are the main findings? Response: A study examining the impact of antibiotics prescribed for nearly 1500 adult patients admitted to The Johns Hopkins Hospital found that adverse side effects occurred in a fifth of them, and that nearly a fifth of those side effects occurred in patients who didn’t need antibiotics in the first place. In the study, the researchers evaluated the electronic medical records of 1488 adults admitted to the general medicine services at The Johns Hopkins Hospital between September 2013 and June 2014. The patients were admitted for reasons ranging from trauma to chronic disease, but all received at least 24 hours of antibiotic treatment. The researchers followed patients for 30 days after hospital discharge to evaluate for the development of antibiotic-associated adverse events. To determine the likelihood that an adverse reaction was most likely due to antibiotics and to identify how many adverse reactions could be avoided by eliminating unnecessary antibiotic use, two infectious disease clinicians reviewed all of the data.
Author Interviews, Education, Heart Disease, JAMA, Social Issues / 14.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35213" align="alignleft" width="133"]Yasuhiko Kubota, MD, MPH Visiting Scholar Division of Epidemiology and Community Health School of Public Health University of Minnesota, Minneapolis, MN Dr. Kubota[/caption] Yasuhiko Kubota, MD, MPH Visiting Scholar Division of Epidemiology and Community Health School of Public Health University of Minnesota, Minneapolis, MN MedicalResearch.com: What is the background for this study? Response: Educational inequality is one of the most important socioeconomic factors contributing to cardiovascular disease. Since education is usually completed by young adulthood, educational inequality may affect risk of cardiovascular disease early in the life course. We thought it would be useful to calculate the lifetime risk of cardiovascular disease according to educational levels in order to increase public awareness of the importance of education. Thus, our aim was to evaluate the association of educational attainment with cardiovascular disease risk by estimating the lifetime risks of cardiovascular disease using a US. biracial cohort. Furthermore, we also assessed how other important socioeconomic factors were related to the association of educational attainment with lifetime risk of cardiovascular disease.
ASCO, Author Interviews, Breast Cancer / 14.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35303" align="alignleft" width="114"]Gabriel N. Hortobagyi, MD, FACP Professor of Medicine, Department of Breast Medical Oncology, Division of Cancer Medicine, UTMDACC, Nellie B. Connally Chair in Breast Cancer, Department of Breast Medical Oncology, Division of Cancer Medicine Program Director, Department of Breast Medical Oncology Susan G. Komen Interdisciplinary Breast Fellowship Program The University of Texas MD Anderson Cancer Center Houston, TX Dr. Hortobagyi[/caption] Gabriel N. Hortobagyi, MD, FACP Professor of Medicine, Department of Breast Medical Oncology, Division of Cancer Medicine, UTMDACC, Nellie B. Connally Chair in Breast Cancer, Department of Breast Medical Oncology, Division of Cancer Medicine Program Director, Department of Breast Medical Oncology Susan G. Komen Interdisciplinary Breast Fellowship Program The University of Texas MD Anderson Cancer Center Houston, TX MedicalResearch.com: What is the background for this study? Response: The MONALEESA-2 trial is a double-blind, randomized, Phase III trial that evaluated efficacy and safety of Kisqali plus letrozole compared to letrozole alone in postmenopausal women with HR+/HER2- advanced breast cancer who had not previously been treated for their advanced disease. MedicalResearch.com: What are the main findings? o Updated findings from the Phase III MONALEESA-2 trial confirm the efficacy and safety of Kisqali® (ribociclib) plus letrozole as a treatment option for HR+/HER2- advanced or metastatic breast cancer: • After nearly one year of additional follow-up, Kisqali plus letrozole demonstrated median progression-free survival (PFS) of 25.3 months (95% CI: 23.0-30.3) compared to 16.0 months (95% CI: 13.4-18.2) for letrozole alone. • The progression-free survival rate at two years was 54.7% in the Kisqali plus letrozole arm compared to 35.9% in patients treated with letrozole alone. • In women with measurable disease, 55% of patients saw their tumor size shrink by at least 30% (overall response rate (ORR)) compared to 39% of patients with letrozole plus placebo. • Treatment benefit remained consistent across all patient subgroups regardless of demographics or disease characteristics, including women with visceral disease and those diagnosed de novo. o The safety profile of Kisqali plus letrozole remained consistent and the incidence of laboratory and electrocardiogram (ECG) irregularities were similar to that observed at the first interim analysis. • The most common grade 3/4 laboratory abnormalities for Kisqali plus letrozole compared to letrozole alone were decreased neutrophils (62.6% vs 1.5%), decreased leukocytes (36.8% vs 1.5%), decreased lymphocytes (16.2% vs 3.9%) and elevated alanine aminotransferase (11.4% vs 1.2%).
Author Interviews, Biomarkers, Pancreatic / 13.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35306" align="alignleft" width="200"]Dr-Rajesh-Kumar.jpg Dr. Rajesh Kumar NV[/caption] Rajesh Kumar NV, Ph.D. Instructor of Oncology and Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA Current affiliation Senior Manager, Human Therapeutics Division, Intrexon Corporation Germantown, MD MedicalResearch.com: What is the background for this study? Response: Pancreatic ductal adenocarcinoma (a.k.a. pancreatic cancer) is one of the most deadly of all types of cancer and currently the third leading cause of cancer-related death in United States. Current therapeutic options for pancreatic cancer involve combination cytotoxic chemotherapy, which yield only minimal survival benefit. A multitude of Phase III clinical trials have failed to demonstrate efficacy, largely due to the aggressive growth of pancreatic tumors. Metabolic reprogramming is a hallmark of cancer cells, including pancreatic cancer. Altered metabolism is central to the pathogenesis of pancreatic cancer and contributes to promotion of proliferation, survival, invasiveness and chemo-resistance of cancer cells. Pharmacologic strategies targeting cancer metabolism might therefore represent a promising approach towards the development of effective drugs against pancreatic cancer. We utilized a clinically relevant and genetically characterized platform of patient-derived pancreatic cancer xenografts, which we originally created from the freshly resected pancreatic cancer tissues of patients, to explore the in vivo anti-tumor efficacy of a panel metabolic inhibitors and investigated whether mutational status, gene expression and metabolite profile of tumors correlate with the sensitivity to metabolic inhibitors. To our knowledge, this is the largest preclinical trial which enrolled a large number of animals (over 500 mice) with established human pancreatic tumors for the comprehensive evaluation of key metabolic inhibitors in pancreatic cancer. 
Author Interviews, Diabetes, Pediatrics / 13.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35296" align="alignleft" width="142"]Prof. Dr. Thomas Danne Chief Physician Diabetology, Endocrinology and General Pediatrics and Clinical Researc Kinder und Junden Krankenhau Prof. Danne[/caption] Prof. Dr. Thomas Danne Chief Physician Diabetology, Endocrinology and General Pediatrics and Clinical Researc Kinder und Junden Krankenhaus MedicalResearch.com: What is the background for this study? What are the main findings? Response: The double-blind, placebo controlled, Phase 3 study known as inTandem2 randomized 782 adult patients from 99 sites in the EU and Israel with type 1 diabetes on insulin pump or multiple daily injection therapy who had an A1C level entering the study between 7.0% and 11.0%. The three-arm study evaluated two doses of sotagliflozin, 200mg and 400mg, each taken once daily before the first meal of the day, against placebo. Prior to randomization, insulin was optimized for all patients over a six-week period, with the objective of improving glycemic control using insulin alone. After completion of this optimization period, patients were maintained on optimized insulin and randomized to one of two doses of sotagliflozin or placebo, and their baseline, post-optimization A1C was measured. The mean baseline A1C levels after the six-week optimization period were 7.8%, 7.7% and 7.7% for patients randomized to the placebo, 200mg and 400mg arms, respectively (A1C was 8.4% across all dose arms prior to insulin optimization). The primary endpoint of the study was change in A1C from baseline after a 24-week period of treatment. The trial has a double-blind long term extension of 28 weeks, with a total treatment duration of 52 weeks. There were 258 patients in the placebo arm, 261 patients in the 200mg dose arm and 263 patients in the 400mg dose arm. The overall mean placebo-adjusted A1C reduction at week 24 was 0.36% in the 200mg dose arm (p<0.001) and 0.35% in the 400mg dose arm (p<0.001). In response to regulatory input, a secondary endpoint to measure “net clinical benefit” was defined for this study as the proportion of patients at week 24 who achieved the standard of care A1C goal of less than 7.0% without any episode of severe hypoglycemia or DKA. 15% of patients in the placebo arm, 32% in the 200 mg dose arm and 32% in the 400mg dose arm achieved this endpoint (p<0.001 for both treatment arms).
Accidents & Violence, Alcohol, Author Interviews, Cannabis, Columbia / 13.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35292" align="alignleft" width="165"]Guohua Li DrPH, MD Professor and Director Center for Injury Epidemiology and Prevention Department of Epidemiology Mailman School of Public Health Columbia University Dr. Li[/caption] Guohua Li DrPH, MD Professor and Director Center for Injury Epidemiology and Prevention Department of Epidemiology Mailman School of Public Health Columbia University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Drugged driving has become a serious problem in the United States in the recent years due to increased consumption of marijuana and opioids. About 20% of fatally injured drivers used two or more substances, with alcohol-marijuana being the most commonly detected polydrug combination. Our study of over 14000 fatal 2-car crashes indicates that drivers testing positive for alcohol, marijuana, or both are significantly more likely to be responsible for initiating these crashes than those using neither of the substances. Specifically, compared to drivers not using alcohol and marijuana, the risk of being responsible for initiating fatal crashes increases 62% for those testing positive for marijuana and negative for alcohol, 437% for those testing positive for alcohol and negative for marijuana, and 539% for those testing positive for both alcohol and marijuana. These results suggest that when used in combination, alcohol and marijuana have a positive interaction on the risk of fatal crash initiation. The most common driver error leading to fatal 2-car crashes is failure to keep in proper lane, followed by failure to yield right of way and speeding.
Author Interviews, Exercise - Fitness, Gender Differences, JAMA, Pediatrics, Surgical Research / 13.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35287" align="alignleft" width="200"]Mackenzie M. Herzog, MPH PhD Candidate, Injury Epidemiology The University of North Carolina at Chapel Hill  Mackenzie Herzog[/caption] Mackenzie M. Herzog, MPH PhD Candidate, Injury Epidemiology The University of North Carolina at Chapel Hill  MedicalResearch.com: What is the background for this study? Response: In 1999, a study by Arendt et al. reported that women were more likely to tear their ACL than men while playing the same sport. Since then, numerous studies have investigated this sex difference in ACL injury, and many prevention programs targeting youth athletes have been developed and tested. Although randomized trials have demonstrated the value of injury prevention programs in reducing the risk of ACL injury, the overall impact of these programs has not been examined in the general population. Our study investigated the net impact of research and prevention efforts over nearly 20 years in reducing ACL injuries by assessing time trends of ACL reconstruction, a consequence of ACL injury, among commercially-insured individuals in the United States.
Author Interviews, Merck, Pharmacology / 13.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35282" align="alignleft" width="133"]Roy F Chemaly, M.D., M.P.H., F.A.C.P., F.I.D.S.A Professor, Department of Infectious Diseases, Director, Infection Control and Employee Health, Division of Internal Medicine Director of the clinical virology research program,Department of infectious diseases Infection control and employee health The University of Texas MD Anderson Dr. Chemaly[/caption] Roy F Chemaly, M.D., M.P.H., F.A.C.P., F.I.D.S.A Professor, Department of Infectious Diseases, Director, Infection Control and Employee Health, Division of Internal Medicine Director of the clinical virology research program,Department of infectious diseases Infection control and employee health The University of Texas MD Anderson MedicalResearch.com: Would you briefly explain the significance of CMV infections? What is the background for this study? Response: Cytomegalovirus (CMV) is one of the most important causes of infectious complications following organ transplantation and is a significant cause of illness and death in patients who have undergone allogeneic hematopoietic cell transplantation (allo-HCT). For more than 20 years, we have been managing this infection and trying to develop effective strategies to control it, but to no one’s satisfaction; CMV infection is still associated with significant morbidity and mortality in this high-risk population. Most transplant centers have adopted preemptive antiviral therapy as the strategy of choice for HCT patients.1 While anti-CMV drugs have decreased the incidence of CMV diseases, their use for prophylaxis has not been associated with improved outcomes.1 Demographic and transplant trends heighten the need for new anti-CMV agents. In the U.S, 83% of people aged 60 and older are CMV seropositive. These older patients received 8% of all hematopoietic-cell transplants in 2000-2006, a figure that jumped to 22% in 2007-2013. As Baby Boomers age, many more allogeneic transplant patients will be CMV seropositive. Therefore, prophylactic antiviral compounds that could effectively control viral replication, and restrict some pathologic processes of CMV diseases, could potentially lessen the complications associated with CMV infection and possibly reduce all-cause mortality.
Author Interviews, CDC, Infections, Outcomes & Safety / 13.06.2017

MedicalResearch.com Interview with: Elizabeth A. Soda, MD Epidemic Intelligence Service Divison of Bacterial Diseases National Center of Immunization and Respiratory Diseases CDC MedicalResearch.com: What is the background for this study? What are the main findings? Response: Legionella is a waterborne bacterium responsible for Legionnaires’ disease, an often severe pneumonia. Legionnaires’ disease primarily affects certain groups of individuals such as those ≥50 year of age, current or former smokers, and those with chronic diseases or weakened immune systems. Health care facilities often have large and complex water systems and care for vulnerable populations that are susceptible to developing Legionnaires’ disease. Thus preventing hospitalized patients from developing Legionnaires’ disease is the ultimate goal. This analysis aimed to describe health care-associated Legionnaires’ disease in 2015 from the 21 U.S. jurisdictions that completely reported their health care-associated Legionnaires’ disease cases to the CDC’s Supplemental Legionnaires’ Disease Surveillance System (SLDSS). Over 2,800 cases of Legionnaires’ disease cases were reported to SLDSS by the 21 jurisdictions, and 553 (20%) were considered health care associated. The analysis showed 16 of the 21 (76%) jurisdictions had at least one case of Legionnaires’ disease definitely related to a stay in a hospital or long-term care facility. In total there were 85 (3%) definite health care-associated Legionnaires’ disease cases (as defined by continuous exposure to a hospital or long-term facility for the entire 10 days before symptom onset) that resulted from 72 different health care facilities. Additionally, 20 of 21 jurisdictions (95%) reported 468 (17%) possible health care-associated Legionnaires’ disease cases (as defined by any exposure to a health care facility for a portion of the 10 days before symptom onset) that resulted from approximately 415 different health care facilities. While approximately 9% of Legionnaires’ disease cases overall are fatal, this report showed a case fatality of 25% for definite health care-associated cases.
Author Interviews, Pharmacology / 12.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35276" align="alignleft" width="200"]Huseyin Naci, PhD Assistant Professor of Health Policy LSE Health Department of Social Policy London School of Economics and Political Science London, United Kingdom Dr. Naci[/caption] Huseyin Naci, PhD Assistant Professor of Health Policy LSE Health Department of Social Policy London School of Economics and Political Science London, United Kingdom  MedicalResearch.com: What is the background for this study? What are the main findings? Response: An increasing proportion of novel therapeutic agents are entering the market on the basis of expedited development and approval programs. The Food and Drug Administration's (FDA) Accelerated Approval pathway is one such expedited approval program. In our study, we examined the dynamics of research on drugs receiving accelerated approvals. We were particularly interested in the timing and characteristics of research studies including drugs with accelerated approvals. Our primary findings are the following:
  • First, there is an abundance of research on drugs receiving accelerated approvals. Yet, the majority of this research (about 70%) is of poor quality. Ideally, these drugs are evaluated in so-called randomised controlled trials to establish their efficacy and safety. However, only about a third of all existing studies are randomised controlled trials.
  • Second, a substantial share (about 30%) of the existing research on these drugs is in areas not approved by the FDA. This may be indicative of industry research practices in trying to prioritise identification of new uses for drugs receiving accelerated approvals instead of strengthening their evidence base.
  • Third, when focusing on well-designed studies, only about a half actually evaluate the effectiveness of the accelerated approval drugs. The rest appears to use the accelerated approval drug as background therapy. Interestingly, these two types of studies are conducted concurrently. In other words, while one research group is trying to find out if an accelerated approval drug is effective, other research groups are already using it as part of a background regimen when testing the effectiveness of another, potentially newer drug
Author Interviews, Cancer, Cancer Research, Hepatitis - Liver Disease, Race/Ethnic Diversity / 12.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35272" align="alignleft" width="120"]Farhad Islami, MD PhD Strategic Director, Cancer Surveillance Research American Cancer Society, Inc. Atlanta, GA 30303 Dr. Islami[/caption] Farhad Islami, MD PhD Strategic Director, Cancer Surveillance Research American Cancer Society, Inc. Atlanta, GA 30303 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Liver cancer is one of the leading causes of cancer death in the United States, accounting for nearly 29,000 deaths per year, with variations in occurrence by race/ethnicity and state. We examined trends in liver cancer incidence, survival, and mortality in the United States and provided liver cancer mortality rates by race/ethnicity at the national and state level. State-level statistics are particularly important as they can inform state cancer control and prevention planning. We also provided detailed information on prevalence and trends in major risk factors for liver cancer and interventions to prevent or reduce their burden, to make our article a comprehensive yet concise source of information on liver cancer statistics, risk factors, and interventions in the United States.
Author Interviews, Biomarkers, Heart Disease, Lipids / 12.06.2017

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

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

MedicalResearch.com Interview with: [caption id="attachment_35257" align="alignleft" width="107"]Marco D. Huesch, MBBS, PhD Department of Radiology Milton S. Hershey Medical Center Hershey, PA  Dr. Huesch[/caption] Marco D. Huesch, MBBS, PhD Department of Radiology Milton S. Hershey Medical Center Hershey, PA   MedicalResearch.com: What is the background for this study? Response: Public health depends on coordinated actions between patients, payors and providers. Important preventative care and evidence-based screenings need to be understood and sought out by patients, need to be reimbursed by or subsidized by insurance plans, and offered and recommended by physicians and care team members. Women’s breast health is a good example of how – in theory – all these come together and allow women to obtain regular screenings for breast cancer through mammograms. Yet it is commonly accepted that perhaps as many as 1 in 3 women are not adequately screened or are not screened at all. In this study we hypothesized that a prominent global celebrity, Ms Angelina Jolie’s, highly public announcement of her own risk-reducing surgery to prevent breast cancer and her recommendation to women to understand whether they were at high risk might spur uptake of breast screenings at our institution.
Author Interviews, Cancer Research, Geriatrics, JAMA, Johns Hopkins / 12.06.2017

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