Author Interviews, Exercise - Fitness, Geriatrics, NEJM, Weight Research / 17.05.2017

MedicalResearch.com Interview with: Dennis T. Villareal, MD Professor of Medicine Division of Endocrinology, Diabetes & Metabolism Baylor College of Medicine Staff Physician, Michael E DeBakey VA Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: The prevalence of obesity in the elderly is rapidly increasing, given that the baby boomers are becoming senior citizens, but we do not know how best to manage obesity in the elderly population. Weight loss is the cornerstone of management for obesity but weight loss in the elderly is controversial because weight loss could cause not only fat loss but also muscle mass and bone mass losses, that could worsen rather than improve frailty. We tested the hypothesis that weight loss plus exercise training, especially resistance training, would improve physical function the most compared to other types of exercise (aerobic training or combined aerobic and resistance training added to diet-induced weight loss). Previous studies especially in younger adults have shown that combining aerobic with resistance exercise could lead to interference to the specific adaptations to each exercise, and thus less gain in strength with combined exercise compared to resistance training alone. On the other hand, contrary to our hypothesis, we found that there was no interference between aerobic and resistance exercise, and the most effective mode to improve physical function and thus reverse frailty was in fact weight loss plus the combination of aerobic and resistance exercise, which was also associated with some preservation of muscle and bone mass. (more…)
Author Interviews, Macular Degeneration, Ophthalmology, Technology / 17.05.2017

MedicalResearch.com Interview with: Dr Felicity de Cogan PhD Institute of Inflammation and Ageing University of Birmingham MedicalResearch.com: What is the background for this study? Response: The University of Birmingham has a unique approach to developing technologies. By locating chemists, engineers, biologists and clinicians in the same department it revolutionised the way research problems are solved. Initially, Felicity de Cogan was researching cell penetrating peptides (CPP) and their uses in microbiology. However, after joining forces with Neuroscientists, Dr Lisa Hill and Professor Ann Logan at the National Institute for Health Research Surgical Reconstruction and Microbiology Research Centre (NIHR SRMRC) together with the clinicians and Vision Scientists, Dr Mei Chen and Professor Heping Xu at the Queen’s University Belfast it became evident that there was huge potential to deliver drugs in the eye. This was the start of the project and it developed rapidly from there. (more…)
AHA Journals, Author Interviews, Heart Disease / 17.05.2017

MedicalResearch.com Interview with: Elsayed Z. Soliman MD, MSc, MS, FAHA, FACC Director, Epidemiological Cardiology Research Center (EPICARE) Professor, Department of Epidemiology and Prevention Professor, Department of Internal Medicine, Cardiology Section Wake Forest School of Medicine Medical Center Blvd, Winston Salem, NC 27157 MedicalResearch.com: What is the background for this study? Response: We already know that left ventricular hypertrophy (LVH, which is the most common complication of high blood pressure, is associated with an increased risk of cardiovascular disease (CVD). We also know that successful management of high blood pressure (BP) leads to regression of LVH and improved CVD outcomes in patients with hypertension. However, it is unknown whether intensive BP lowering beyond that recommended would reduce the risk of LVH in patients with hypertension, and whether reducing the risk of LVH explains the reported CVD benefits of intensive BP lowering in this population. Therefore, we examined the differential impact of intensive BP lowering (target systolic BP (SBP). (more…)
Author Interviews, Cancer Research, NYU, Smoking / 17.05.2017

MedicalResearch.com Interview with: Moon-shong Tang, PhD Professor of Environmental Medicine, Pathology and Medicine New York University Langone School of Medicine Tuxedo Park, New York 10987 MedicalResearch.com: What is the background for this study? Response: E-cigarettes (E-cigs) are designed to deliver the stimulant nicotine through aerosols, commonly referred as vapors. Nicotine is dissolved in organic solvents such as glycerin and propylene glycol. The nicotine is then aerosolized by controlled electric heating. E-cigs do not use tobacco leaves and E-cig smoke does not involve the burning process. Hence, E-cig smoke (ECS) contains only nicotine and the gas phase of the solvent. Because ECS contains neither carcinogens nor allergens or odors from the tobacco burning process, E-cigs have been promoted as an invention that can deliver a TS ‘high’ without TS negative effects. The population of E-cig users is rapidly rising, particularly in young adults. It has been estimated that 16% of high school students are E-cig smokers. Therefore, the health effects of E-cig smoke, particularly its carcinogenicity, deserve careful scrutiny. (more…)
Accidents & Violence, Author Interviews, JAMA, Surgical Research / 17.05.2017

MedicalResearch.com Interview with: Alan Cook, MD, FACS Director, Trauma Research Program Chandler Regional Medical Center Clinical Assistant Professor, Department of Surgery University of Arizona College of Medicine - Phoenix Chandler, AZ 85224 and Frederick B. Rogers MD, MS, FACS Trauma Surgeon Lancaster General Health/Penn Medicine Adjunct Professor of Surgery University of Pennsylvania College of Medicine Department of Surgery MedicalResearch.com: What is the background for this study? What are the main findings? Response: The morbidity and mortality from pulmonary emboli (PE) are considerable. They range in severity from a problem amenable to outpatient medical management to fatal. Trauma patients are often ineligible for chemoprophylaxis due to the risk for life-threatening bleeding. Yet traumatic injury can increase a person’s likelihood of having a pulmonary embolus via an array of mechanical and humoral pathways. The vena cava filter (VCF) offered the possibility of PE prophylaxis for patients otherwise vulnerable to PE risk. Use of VCF grew and the rate of use increased even more after the introduction of the retrievable VCF. Our study sought to determine if any temporal variation in VCF use has occurred and investigate if an contemporaneous change in the diagnosis of PE has taken place. We used three databases to allow a telescoping window of observation from a single state, Pennsylvania (PTOS), to a convenience of sample of trauma centers across the country (NTDB), and finally a national, population-based sample of all hospital discharges in the US (NIS). A temporal trend was observed in all three datasets with differing magnitudes and time points of change. The variation of vena cava filter use was most pronounced in the PTOS and least dramatic in the NIS, The rate of PE was essentially unchanged during the same period. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care / 17.05.2017

MedicalResearch.com Interview with: Eric Roberts, PhD Post-doctoral fellow Department of Health Care Policy Harvard Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response: Increasing consolidation of health care providers has raised regulatory concerns that less competition will lead to higher health care prices and possibly lower quality care for patients. On the other hand, some industry observers have contended that larger and higher-priced practices are better able invest in systems to support care management, and ultimately, better patient care. In this study, we examined whether larger and higher-priced physician practices provided better and more efficient care to their patients. Higher-priced physician groups were paid an average of 36% more by commercial insurers, and were substantially larger than lower-priced practices located within the same geographic areas. Despite large differences in practices’ prices and size, we found few differences in their patients’ quality and efficiency of care. For example, when we compared patients who received care in high-priced versus low-priced practices, we found no differences in patients’ overall care ratings, physician ratings, access to care, physician communication, and use of preventive services. We also found no differences in patients’ hospital admissions or total spending, suggesting that higher-priced practices were not managing their patients’ care more efficiently than their lower-priced counterparts. We did find that patients in higher-priced practices were more likely to receive recommended vaccinations, review of their medications, and results of medical tests, and that they spent less time in the waiting room for a scheduled doctor’s appointment. However, once practice prices exceeded the average for their geographic area, we observed no further gains in quality on most of these measures. (more…)
Author Interviews, Prostate Cancer, Urology / 17.05.2017

MedicalResearch.com Interview with: Keyan Salari, MD, PhD Resident in Urologic Surgery Keyan Salari is currently completing his residency in the Harvard Program in Urologic Surgery at the Massachusetts General Hospital, and is conducting post-doctoral research in cancer genomics in the Garraway Lab at the Dana-Farber Cancer Institute and the Broad Institute of Harvard and MIT MedicalResearch.com: What is the background for this study? Response: Active surveillance is an effective strategy addressing the problem of over treatment of clinically indolent prostate cancer, but data on the role of active surveillance in younger men is limited. Younger men diagnosed with prostate cancer are typically counseled to undergo treatment as opposed to surveillance of their prostate cancer. To potentially expand the role of active surveillance to younger patient populations, we undertook this study evaluating the outcomes of younger men under 60 years of age who elected to pursue active surveillance of their prostate cancer. (more…)
Author Interviews, Biomarkers, Prostate Cancer, Urology / 17.05.2017

MedicalResearch.com Interview with: Eric A. Klein, MD Chairman, Glickman Urological and Kidney Institute Cleveland Clinic MedicalResearch.com: Which of these results did you find most interesting or surprising? Response: What’s most interesting is that the IsoPSA assay redefines how PSA is measured, which links it more closely to the underlying biology of cancer. Current assays measure only the concentration of PSA, which can be affected by conditions other than cancer – BPH most commonly, but also infection and inflammation – which limits its diagnostic accuracy for finding cancer. Its been known for several decades that PSA exists in multiple different forms in the bloodstream in patients with prostate cancer. These novel molecules arise because cancer cells have deranged cellular metabolism that result in the generation of new species of PSA, making their measurement more tightly linked to the presence or absence of cancer and even the presence of high grade cancer (where cellular metabolism is even more disordered). The IsoPSA assay is the first assay to measure all of these isoforms and thus has better diagnostic accuracy for cancer. (more…)
Author Interviews, Dermatology, OBGYNE / 16.05.2017

MedicalResearch.com Interview with: Alexander Egeberg, MD PhD Gentofte Hospital Department of Dermatology and Allergy Denmark MedicalResearch.com: What is the background for this study? What are the main findings? Response: An issue that frequently arise in clinical practice is the question from patients whether they should discontinue their therapy if they want to have children. Since immunosuppressant agents are frequently used for a number of conditions, and discontinuation could lead to disease flaring, assessment of the potential impact of such drugs on birth outcomes is important. In our study, we examined birth outcomes in children whose father had received treatment with methotrexate, azathioprine, cyclosporine, and mycophenolate mofetil in the time leading up to conception. Importantly, we found no increased risk of congenital abnormalities, low birth weight, or preterm birth associated with paternal treatment with these drugs. (more…)
Author Interviews / 16.05.2017

MedicalResearch.com Interview with: ACCCMark S. Soberman, MD MBA FACS President, Association of Community Cancer Centers Medical Director, Oncology Service Line Chief Physician Executive, Monocacy Health Partners Frederick Regional Health System MedicalResearch.com: How will the online program prepare health care providers and patient advocates to help patients navigate the financial implications of cancer? Response: The Association of Community Cancer Centers (ACCC) Financial Advocacy Boot Camp is a dynamic online curriculum.  The interactive learning modules are easy to navigate and contain helpful features to support learning, including quizzes and supplemental resources. Each module is less than a half-hour long, so participants can work at their own pace while accessing the on-demand courses 24-7. The Financial Advocacy Boot Camp has 14 learning modules. Topics include:
  1. Financial Advocacy Fundamentals. Review the basics of financial advocacy and gain an understanding of public and private health insurance coverage options.
  2. Enhancing Communication. Develop strategies to improve communication among the care team, engage patients on financial concerns, and find various distress screening tools.
  3. Improving Insurance Coverage. Learn how to help cancer patients get better health insurance coverage to reduce the out-of-pocket burden and tap into resources to reduce financial toxicity.
  4. Maximizing External Assistance. Delve into external assistance programs and other sources of assistance available for patients with public health insurance, private insurance, or no insurance.
  5. Improving Financial Advocacy Services. Learn to track cost savings for patients and your facility. Apply different tracking methods and reporting tools to evaluate your financial advocacy program and identify opportunities for continuous improvement.
(more…)
Author Interviews, Infections, Vaccine Studies / 15.05.2017

MedicalResearch.com Interview with: AbivaxJean-Marc Steens, M.D. Chief Medical Officer of Abivax MedicalResearch.com: What is the background for this study? What are the main findings? Response: Antiretroviral therapy (ART) has had an enormous impact on the HIV pandemic since its introduction almost 20 years ago. Most patients treated with ART achieve undetectable or near undetectable plasma levels of the virus. This means that although HIV is controlled, it is not completely eliminated. The virus remains in the body, usually contained in dormant cells (known as the HIV reservoir) that are widely distributed, including to the central nervous system, the gut mucosa, the lymph nodes and other sites. If ART is stopped, the virus rebounds. The goal of any curative therapy would be to eliminate the virus or ensure there is sustained remission in the absence of ART, which until now have been unsuccessful. Abivax’s Phase 2 clinical study with ABX464 demonstrated, for the first time, a reduction in HIV reservoirs in chronically infected HIV patients as measured by total HIV DNA detected in peripheral blood mononuclear cells (PBMCs). In the ABX464-004 trial, 30 HIV patients received either ABX464 or matching placebo in addition to their current antiretroviral treatment over 28 days. The viral load at the start of the study was well controlled with boosted darunavir. After the 28-day treatment period, all treatments were interrupted until viral load rebound. Baseline and day 28 blood samples were taken to assess the potential effect of ABX464 on the HIV reservoir in PBMCs. Safety was the primary endpoint in the trial. ABX464 was well tolerated, with no severe adverse events in the treatment group. Amongst evaluable patients (4 placebo and 14 ABX464-treated patients), a reduction in viral DNA copies/mPBMCs was observed in 7/14 treated patients (mean change of -40%, ranging from -27% to -67%) and no responders were observed in the placebo group. Responders were defined as patients who had a decrease greater than 25% in total HIV DNA in PBMCs and a reduction of at least 50 copies. Total HIV DNA in PBMC has been validated as a widely accepted biomarker for measuring the HIV reservoir. Specifically, in untreated patients, total HIV DNA load influences the course of the infection and is therefore clinically relevant. In addition, a correlation exists between the pool of HIV-1 DNA and the replication-competent reservoir. (more…)
Author Interviews, Biomarkers, Genetic Research, Personalized Medicine / 15.05.2017

MedicalResearch.com Interview with: 3D SignaturesJason Flowerday, CEO Director of 3D Signatures  MedicalResearch.com: What is the background for 3D Signatures? Response: 3D Signatures, and its clinical lab tests, which incorporate its proprietary TeloViewTM software analytics, is the culmination of over 20 years of ground-breaking research conducted by Dr. Sabine Mai and her colleagues. It is the only technology in the world that quantifies genomic instability, which is the hallmark of cancer and other proliferative diseases at the whole-cell level. By measuring the degree of genomic instability from different tissues, TeloViewTM has produced clinically actionable distinctions in the stage of disease, rate of progression of disease, drug efficacy, and drug toxicity. The technology is well developed and supported by 22 clinical studies on over 2,000 patients on 13 different cancers including Alzheimer’s disease. The results have been exceptional and represent a universal biomarker platform across all disease areas that the company has investigated to date. (more…)
Author Interviews, CMAJ, Diabetes, OBGYNE / 15.05.2017

MedicalResearch.com Interview with: Dr. Gillian Booth PhD Researcher at St. Michael's and the Institute for Clinical Evaluative Sciences (ICES) MedicalResearch.com: What is the background for this study? What are the main findings? Response: The impact of climate change on health is becoming increasingly relevant given the rise in global air temperature, and there is growing evidence supporting a link between air temperature, metabolic function, and energy expenditure. We know from animal models and small studies in humans that cold exposure and activate a type of fat known as brown fat and it appears that this process can improve sensitivity to insulin. However no studies have yet looked at air temperature and the development of diabetes. So we decided to examine the relationship between outdoor air temperature and gestational diabetes – a temporary form of diabetes that arises in the second trimester of pregnancy. (more…)
Author Interviews, JAMA, Thyroid / 15.05.2017

MedicalResearch.com Interview with: Dr. C. Seth Landefeld MD U.S. Preventive Services Task Force and Chairman of the department of Medicine and Spencer Chair in Medical Science Leadership University of Alabama at Birmingham (UAB) School of Medicine  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Thyroid cancer is rare in the United States, and the evidence shows that screening for it leads to an increase in new diagnoses without affecting the number of people who die from it. This is because screening people without signs or symptoms for thyroid cancer often identifies small or slow-growing tumors that might never affect a person during their lifetime. After reviewing the evidence, the Task Force found little evidence on the benefits of screening for thyroid cancer and considerable evidence that treatment, which is often unnecessary, can cause significant harms. Additionally, in places where universal screening has been implemented, it hasn’t helped people live longer, healthier lives. (more…)
Author Interviews, Blood Pressure - Hypertension, Compliance / 15.05.2017

MedicalResearch.com Interview with: Dr. Gupta Pankaj Consultant Metabolic Physician/Chemical Pathologist Dr. Patel Prashanth - Consultant Metabolic Physician/Chemical Pathologist Department of Metabolic Medicine and Chemical Pathology University Hospitals of Leicester NHS Trust, UK   MedicalResearch.com: What is the background for this study? What are the main findings? Response: Non-adherence or patients not taking their medications as prescribed is known since the time of Hippocrates. It is the key reason why blood pressure is well controlled in only around 50% of patients with hypertension, despite the availability of good medicines. Non-adherence leads to poorer cardiovascular outcomes and is thought to cost $100 billion to the US health economy. A crucial reason for the lack of progress in improving adherence has been the previous lack of a clinically useful objective measure. We and others have developed a robust and reliable biochemical screening method to assess for non- adherence to antihypertensive medications in urine or blood using a technique called liquid chromatography-tandem mass spectrometry.  We have previously reported a single centre study that demonstrated high rates of non-adherence in patients attending a hypertension clinic. Since, then we have set up a National Centre for Adherence Testing (NCAT, ncat@uhl-tr.nhs.uk) in the Department of Metabolic Medicine and Chemical Pathology, University Hospitals of Leicester NHS Trust (UHL) and receive samples from around 25 hypertension clinics across UK. This study analysed data from~1400 patients consisting of samples received in UHL and also from a cohort of patients in the Czech Republic. (more…)
Author Interviews, Cancer Research, Mediterranean Diet, Nutrition / 15.05.2017

MedicalResearch.com Interview with: Antonio Giordano MD PhD Sbarro Institute for Cancer Research and Molecular Medicine and Center for Biotechnology
College of Science and Technology
Temple University, Philadelphia, Pennsylvania MedicalResearch.com: What is the background for this study? What are the main findings? Response: The Mediterranean diet is considered to be one of the healthiest nutrition patterns. Tomatoes, in particular, which are consumed worldwide, and a basic ingredient of the Mediterranean diet, have been postulated to have a cancer preventive role at least for some tumor types, although few studies analyzed the effects of tomatoes in their entirety in different stages of cancer progression. Here, we focused on an in vitro model of gastric cancer because it is still one of the most common and deadly cancers and its development is strongly influenced by certain eating habits. Our results showed a possible role of tomatoes against typical neoplastic features. The treatment with tomato extracts affected the ability of cancer cell growth both in adherence and in semisolid mediums. Moreover, tomato extracts affected key processes within the cell; they hindered migration ability, arrested cell cycle through the modulation of retinoblastoma tumor suppressor family proteins and specific cell cycle inhibitors, and induced cancer cell death through apoptosis. (more…)
Author Interviews, Genetic Research, Ophthalmology / 15.05.2017

MedicalResearch.com Interview with: Zheng-Rong Lu, Ph.D. M. Frank Rudy and Margaret Domiter Rudy Professor of Biomedical Engineering Department of Biomedical Engineering Case Western Reserve University Cleveland, OH 44106 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Genetic vision disorders are a major cause of severe vision loss and blindness, especially in children and young adults. Currently, there are no approved therapies to treat these types of disorders. This study focused on one such disease known as Leber’s congenital amaurosis type 2 (LCA2). Patients with LCA2 are born with some degree of vision loss, and are often legally blind by early adulthood. LCA2 is a recessive disease caused by a mutation in one of the genes responsible for visual processing. LCA2 is a good candidate for gene therapy, and clinical trials underway to test viral vectors that deliver a healthy copy of the mutated gene into the eye have demonstrated considerable therapeutic efficacy. These trials have validated the feasibility of gene therapy to treat this disease, however viral vectors are limited by potential safety issues, complex preparation methods, and limitations on the size of genes that can be delivered. In this study, we successfully treated LCA2 in mice for 120 days by delivering the gene responsible for LCA2 in a synthetic lipid nanoparticle instead of a viral vector. Our delivery system, called ECO, specifically targets the cells in the retinal pigmented epithelium, where the mutation behind LCA2 occurs. Our nanoparticle delivery system is easy to produce, safe, and has unlimited cargo capacity. Most important, our nanoparticle gene delivery system is a platform that can be used to deliver any gene into the retina, opening the door for safe and effective gene therapy for any genetic vision disorder. (more…)
Author Interviews, Cost of Health Care, Kidney Disease / 13.05.2017

MedicalResearch.com Interview with: Shaum Kabadi HEOR Director at AstraZeneca MedicalResearch.com: What is the background for this study? What are the main findings? Response: More than 20 million adults – roughly 1 in 10 adults – in the US are estimated to have chronic kidney disease (CKD), and this population is expected to grow as the US population ages. Patients with CKD are at high risk for progression to end-stage renal disease (ESRD), a condition requiring dialysis or kidney transplantation to maintain patients’ long-term survival. The cost of treating ESRD patients was over $40 billion in public and private funds in 2009. Prior research shows per-person annual Medicare expenses attributable to CKD were $1,700 for Stage 2, $3,500 for Stage 3, and $12,700 for Stage 4. Additional research is required to understand the economic burden of CKD by stage in a contemporary cohort of commercially insured patients with non-dialysis-dependent (NDD)-CKD. This retrospective cohort study utilized data from the HealthCore Integrated Research Environment, which contained medical and pharmacy administrative claims integrated with laboratory result values from 14 regionally dispersed Anthem health plans in the US. Of 16,030 patients identified with CKD, the mean (SD) estimated glomerular filtration rate (eGFR) (all in mL/min/1.73 m2) in 2014 was 44.3 (±18.7), and the breakdown by eGFR levels was: Stage 1 (≥90) 3%, Stage 2 (60–89) 13%, Stage 3a (45–59) 27%, Stage 3b (30–44) 35%, Stage 4 (15–29) 19%, and Stage 5 (<15) 3%. Mean age across all stages was 67.4 years, and 47% were women. Hospitalization rate (%) and number of outpatient encounters (visits per patient per year) by stage were: Stage 1 (11.6%, 19.8), Stage 2 (14.9%, 22.5), Stage 3a (16.2%, 23.6), Stage 3b (23.7%, 29.5), Stage 4 (30.7%, 36.3), and Stage 5 (30.8%, 61.7) (p-trend). (more…)
Author Interviews, Gastrointestinal Disease, Lancet, Vaccine Studies / 13.05.2017

MedicalResearch.com Interview with: Leslie Williams, BS, RN, MBA</strong> Director, Founder, President and Chief Executive Officer <strong>Dr Robert P Anderson MBChB BMedSc PhD FRACP</strong> Chief Scientific Officer ImmusanT Cambridge, MALeslie Williams, BS, RN, MBA Director, Founder, President and Chief Executive Officer and Dr Robert P Anderson MBChB BMedSc PhD FRACP Chief Scientific Officer ImmusanT, Cambridge, MA MedicalResearch.com: What is the background for this study? Response: The 2 Phase 1 trials were randomized, double-blind, placebo-controlled, multi-center studies evaluating the safety, tolerability, and relevant bioactivity of Nexvax2 in HLA-DQ2.5+ patients with celiac disease. In one study, patients received three fixed doses of Nexvax2 or placebo once per week over a three-week period. In the other study, patients received 16 fixed doses of Nexvax2 or placebo twice per week over an eight-week period. Both studies evaluated a range of fixed, intradermal dose administrations in a series of ascending dose cohorts, which included a crossover, double-blind, placebo-controlled oral gluten challenge in the screening and post-treatment periods. The primary outcome measures were the number and percentage of adverse events in the treatment period. (more…)
Author Interviews, Eating Disorders / 13.05.2017

MedicalResearch.com Interview with: Cynthia Bulik, PhD, FAED Founding director of the UNC Center of Excellence for Eating Disorders and Professor at Karolinska Institutet in Stockholm, Sweden. MedicalResearch.com: What is the background for this study? Response: Researchers and clinicians from around the world came together to create the most powerful genome-wide association study of anorexia nervosa to date. Via this global collaboration, we were able to identify the first significant locus that influences risk for anorexia nervosa. We have known that anorexia is heritable for over a decade, but now we are actually identifying which genes are implicated. This is the first one identified! (more…)
AHA Journals, Author Interviews, Baylor College of Medicine Houston, Heart Disease, Lipids / 13.05.2017

MedicalResearch.com Interview with: Julia M. Akeroyd, MPH Center for Innovations in Quality, Effectiveness, and Safety (IQuESt) Michael E. DeBakey Veteran Affairs Medical Center Salim S Virani, MBBS, Ph.D. Baylor College of Medicine MedicalResearch.com: What is the background for this study? Response: In the recently published Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) trial, treatment with evolocumab resulted in a 15% relative (1.5% absolute) risk reduction of major cardiovascular events in patients with atherosclerotic cardiovascular disease (ASCVD) at a median follow-up of 2.2 years. Given the high cost of evolocumab, there is a need to identify what proportion of ASCVD patients would qualify for evolocumab based on FOURIER entry criteria and how eligibility would change if maximal doses of evidence-based lipid lowering therapies were required. (more…)
Author Interviews, CDC, Rheumatology / 13.05.2017

MedicalResearch.com Interview with: Jin Qin, ScD, MS Epidemiologist Centers for Disease Control and Prevention Chamblee, GA 30341  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The hand is one of the sites most commonly affected by osteoarthritis (OA) but is often understudied compared with knee and hip OA. Many people with hand OA have significant symptoms, impaired hand strength and function, and disability in activities of daily living, like using a smart phone or a computer keyboard, and opening a jar. Lifetime risk is the probability of developing a condition over the course of a lifetime. In this study, we estimated that 40% of adults will develop symptomatic hand OA in their lifetimes. Nearly one in two women (47%) and one in four men (25%) will develop the condition. Whites have a 41% lifetime risk, compared with 29% for blacks. The lifetime risk among individuals with obesity is 47%, which is 11 percentage points higher than those without obesity. (more…)
Author Interviews, Gastrointestinal Disease / 13.05.2017

MedicalResearch.com Interview with: Brooks D. Cash, MD Chief, Gastroenterology Division Professor of Medicine University of South Alabama Mobile, AL 36688 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Irritable bowel syndrome (IBS) is a chronic functional disorder characterized by multiple symptoms including, but not limited to, abdominal pain or discomfort, constipation, diarrhea, urgency of bowel movement (BM), a sensation of incomplete evacuation, pain at evacuation, abdominal bloating, and passage of gas or mucus. IBS can be classified into four primary subtypes: mixed IBS (IBS-M), diarrhea-predominant IBS (IBS-D), constipation-predominant IBS (IBS-C), and unsubtyped IBS (IBS-U). Among adult patients with IBS, a sizeable proportion suffers from IBS-M, with prevalence rates among IBS patients estimated to be between 44% to 66%. Because of the variability in symptoms associated with IBS-M and the lack of effective or approved therapies, clinicians often face challenges in managing this common IBS subtype. PO and its active ingredient, l-Menthol, are kappa opioid agonists, possess smooth muscle calcium channel antagonist and serotonergic (5HT3) antagonist properties, and exert anti-inflammatory, anti-infective, and carminative effect. A recent meta-analysis of medical therapies for IBS found that PO had the lowest number needed to treat among the various options evaluated. The previously published IBS Reduction Evaluation and Safety Trial (IBSREST) showed that PO-SST, a novel formulation of PO using solid-state microspheres to target delivery to the small intestine, was an effective IBS therapy at 24 hours, with improved efficacy at 4 weeks in a combined group of IBS-M and IBS-D patients. In view of the unmet need in IBS-M, we performed a post hoc analysis of the effects of PO-SST among only the IBS-M patients from the IBSREST trial. (more…)
Author Interviews, Infections, Respiratory, Vaccine Studies / 12.05.2017

MedicalResearch.com Interview with: Nima Farzan Chief Executive Officer & President of PaxVax MedicalResearch.com: What is the background for this study? What are the main findings? Response: PaxVax is developing a new and improved version of the vaccine, known as the Modernized Production Adenovirus Vaccine (MPAV) Prototype A. The Company was chosen as the Small Business Innovation Research and Regulatory Sponsor for the development of the Modernized Production Adenovirus Vaccine (MPAV) Prototype A due to the company’s prior experience working with multiple strains of Adenovirus. An Investigational New Drug (IND) application for MPACV was submitted to the U.S. Food and Drug Administration (FDA) on January 30, 2017. The Phase I clinical trial has been initiated and will be conducted at the Larner College of Medicine at the University of Vermont and Cincinnati Children’s Hospital. PaxVax expects to see results of the Phase I clinical trial in early 2018. Complications of adenovirus 4/7 can include headache, pneumonia, sore throat and eye infections. In severe cases, adenovirus can lead to acute respiratory distress syndrome and other serious complications related to organ system damage (including GI tract and bladder) that can result in death, if left untreated. (more…)
Author Interviews, Brigham & Women's - Harvard, Endocrinology, Hearing Loss, Menopause / 11.05.2017

MedicalResearch.com Interview with: Sharon G. Curhan, MD, ScM Channing Division of Network Medicine Department of Medicine Brigham and Women's Hospital Harvard Medical School Boston, MA 02115 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Hearing loss affects approximately 48 million Americans and the number is expected to increase as the population ages. Some previous studies suggested that menopause may increase the risk for hearing loss, presumably due to the reduction in circulating estrogen levels, and that postmenopausal hormone therapy might slow hearing decline by “replacing” estrogen. To evaluate the role of menopause and postmenopausal hormone therapy as risk factors for hearing loss, we examined the independent associations between menopausal status, oral hormone therapy, and risk of self-reported hearing loss in 80,972 women who are participants in the Nurses’ Health Study II, aged 27-44 years at baseline, and were followed from 1991 to 2013. After more than 1.4 million person-years of follow-up, 18,558 cases of hearing loss were reported (~23% of the women developed hearing loss). We did not observe an overall independent association between menopausal status and risk of hearing loss. However, the risk among women who underwent natural menopause at an older age was higher. Specifically, the risk among women who underwent natural menopause at age 50 or older was 10% higher than among those who underwent natural menopause before age 50 [multivariable-adjusted relative risk (MVRR): 1.10, 95% CI 1.03, 1.17]. When we conducted an analysis restricted to women who underwent natural menopause and did not use hormone therapy (HT), the multivariable-adjusted relative risk among women who underwent natural menopause at age 50-54 years was 21% higher (MVRR: 1.12, 95% CI: 1.10, 1.34), and among women who underwent natural menopause at age 55+ years was 29% higher (MVRR: 1.29, 95% CI: 1.11, 1.50), compared with women who underwent natural menopause before age 50. Among postmenopausal women, we also found that use of oral HT was associated with higher risk of hearing loss, and the magnitude of the risk tended to increase with longer duration of use (p-trend < 0.001). Compared with women who never used any type of HT, the MVRR of hearing loss among women who used oral HT for 5-9.9 years was 15% higher (MVRR: 1.15, 95% CI: 1.06, 1.24), and for 10+ years was 21% higher (MVRR: 1.21, 95% CI: 1.07, 1.37). When specific types of oral HT were examined, longer duration of use of either oral estrogen-only or of combined estrogen plus progestogen HT were each associated with higher risk. Fewer women reported use of progestogen-only oral HT, yet among these women a higher risk was suggested, but not significant (MVRR: 1.15, 95% CI: 0.98, 1.35). Transdermal HT use was less common, but the associations observed were similar to those with oral hormone therapy. When examined separately by type of menopause, the results for HT use were similar. (more…)
ADHD, Author Interviews, JAMA, Karolinski Institute / 11.05.2017

MedicalResearch.com Interview with: Zheng Chang PhD MSc Department of Medical Epidemiology and Biostatistics (MEB) Karolinska Institutet Stockholm Sweden MedicalResearch.com: What is the background for this study? What are the main findings? Response: About 1.25 million people worldwide die annually because of motor vehicle crashes (MVCs). ADHD is a prevalent neurodevelopmental disorder with symptoms that include poor sustained attention, impaired impulse control and hyperactivity. ADHD affects 5 percent to 7 percent of children and adolescent and for many people it persists into adulthood. Prior studies have suggested people with ADHD are more likely to experience MVCs. Pharmacotherapy is a first-line treatment for the condition and rates of ADHD medication prescribing have increased over the last decade in the United States and in other countries. Among the more than 2.3 million patients with ADHD (average age 32.5), we found patients with ADHD had a higher risk of an MVC than a control group of people without ADHD. The use of medication in patients with ADHD was associated with reduced risk for motor vehicle crashes in both male and female patients. (more…)
Author Interviews, Emory, Mental Health Research, Technology / 10.05.2017

MedicalResearch.com Interview with: Jessica Maples-Keller Emory University School of Medicine. MedicalResearch.com: What is the background for this study? What are the main findings? Response:  This manuscript is a review of the use of Virtual Reality (VR) technology within psychiatric treatment. VR refers to an advanced technological communication interface in which the user is actively participated in a computer generated 3-d virtual world that includes sensory input devices used to simulate real-world interactive experiences. VR is a powerful tool for the psychiatric community, as it allows providers to create computer-generated environments in a controlled setting, which can be used to create a sense of presence and immersion in the feared environment for individuals suffering from anxiety disorders. (more…)
Author Interviews, Immunotherapy, JAMA, Melanoma / 10.05.2017

MedicalResearch.com Interview with: Yasuhiro Nakamura, M.D., Ph.D. Associate Professor Department of Skin Oncology/Dermatology Comprehensive Cancer Center Saitama Medical University International Medical Center Hidaka, Saitama MedicalResearch.com: What is the background for this study? What are the main findings? Response: Regressing nevi, which are frequently associated with halo phenomenon, occur in approximately 1% of the general population. In patients with melanoma, spontaneous or treatment-related depigmentation of the skin (vitiligo) is sometimes observed. Although humoral and cellular immune responses may play a crucial role in their development, immune reactions to benign melanocytic nevi (BMN) without a halo are extremely rare in both the general population and in patients with melanoma. This publication reports a rare case with multiple metastatic melanomas who showed a remarkable clinical response to nivolumab with a simultaneous prominent immune reaction to multiple BMN without halo phenomenon. This rare phenomenon may be associated with dramatic efficacy of nivolumab in melanoma patients. (more…)
Author Interviews, Gastrointestinal Disease, Hepatitis - Liver Disease / 10.05.2017

MedicalResearch.com Interview with: Dr. Winston Dunn, MD Assistant Professor The University of Kansas Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: It is widely believed that everyone with HCV can be cured with the medications now a day. But sadly, about 5% of the patients already have very bad damage done to the liver. We call this decompensated cirrhosis. Our medication is still very effective in curing the virus, but in decompensated cirrhosis, curing the virus is not always enough. Only about half to two-thirds of patients with decompensated cirrhosis clinically gets better, but the remaining struggles along or even gets worse after the cure. That is the problem. So, our research was to understand why that was. We used genetic factor to predict which patient would get better and which patient would not. We found that a gene previous found to be predictive of fatty liver and fibrosis is also predictive of recovery in this setting. (more…)
Author Interviews, BMJ, Heart Disease, Pain Research, Pharmacology / 10.05.2017

MedicalResearch.com Interview with: Michèle Bally, BPharm, MSc, PhD Epidemiologist, Department of Pharmacy, CHUM Researcher, Health Innovation and Evaluation Hub, CRCHUM MedicalResearch.com: What is the background for this study? Response: The objective of this study was to better understand the risk of heart attack associated with using oral prescription non-steroidal anti-inflammatory drugs or NSAIDs (ibuprofen, diclofenac, celecoxib, and naproxen) the way people usually do to treat pain and inflammation in real life circumstances. A lot of people take medication, but they do not understand that some can be more harmful than beneficial, especially with consistent use. Unfortunately, something like a heart attack can happen anywhere. You could be at work and show signs of an attack. If this does happen, hopefully you have someone who is first aid trained to at least help you deal with these symptoms, until you get to the hospital. This is why having someone who knows that they are doing is beneficial in any environment. If it wasn't for companies like Coast2Coast in Ottawa, the chances of someone who was suffering from a heart attack may not have made it to the hospital if it wasn't for the assistance of someone who was first aid trained. In clinical trials, NSAIDs were typically taken on a continuous basis in high standardized doses, as assigned by the trial protocol. However, the dosages and the treatment durations studied in trials may not represent the reality of many patients who use NSAIDs in low or varying doses, use these drugs on and off, or switch between NSAID medications. We were particularly interested in determining the onset of the risk, that is how soon does the risk of heart attack start increasing? Also, we wanted to investigate the effect of dose and duration of treatment. To do this, we studied the use of a low or high dose level of NSAIDs over certain set periods of time, including taking these medications only for 1 to 7 days. (more…)