Author Interviews, Infections, Nature, NIH, PLoS, Rheumatology / 16.04.2018

MedicalResearch.com Interview with: [caption id="attachment_41160" align="alignleft" width="133"]John B. Harley, MD, PhD Professor and Director David Glass Endowed Chair Center for Autoimmune Genomics and Etiology (CAGE) Department of Pediatrics University of Cincinnati Cincinnati Children’s Hospital Medical Center Cincinnati, Ohio 45229 Dr. Harley[/caption] John B. Harley, MD, PhD Professor and Director David Glass Endowed Chair Center for Autoimmune Genomics and Etiology (CAGE) Department of Pediatrics University of Cincinnati Cincinnati Children’s Hospital Medical Center Cincinnati, Ohio 45229 MedicalResearch.com: What is the background for this study? Response: Previous work has shown that Epstein-Barr virus infection is associated with systemic lupus erythematosus and studies of the origins of the autoimmune response have also suggested that the autoimmunity of this disease may originate with the immune response against this virus. In the meantime, many investigators have been studying the genetics of lupus over the past 25 years. They have found about 100 convincing genes that alter the risk of developing lupus.
Author Interviews, Breast Cancer, JNCI, UT Southwestern / 16.04.2018

MedicalResearch.com Interview with: Yingfei Wang, Ph.D. and Weibo Luo, Ph.D. Department of Pathology UT Southwestern Medical Center Dallas TX 75390 MedicalResearch.com: What is the background for this study? Response: Breast cancer is the most commonly diagnosed cancer in women. Tumor metastasis is frequently found in breast cancer patients and causes more than 90% of cancer death. There is currently no cure for this deadly disease. We have known that breast tumor is not supplied with sufficient oxygen (a phenomenon known as hypoxia), which makes breast cancer cells more aggressive and may be responsible for tumor recurrence, metastasis, and therapy resistance. Hypoxia-inducible factor (HIF) is a master regulator frequently detected in the hypoxic regions and switches on many oncogenes needed for breast cancer cells to grow and spread around the body. The role of HIF in gene regulation is precisely controlled and shutting down of HIF’s activity would be a promising strategy for the treatment of metastatic breast cancer.
Author Interviews, Heart Disease, JACC, Outcomes & Safety, Surgical Research, University of Michigan / 12.04.2018

MedicalResearch.com Interview with: [caption id="attachment_41141" align="alignleft" width="149"]Donald Likosky, Ph.D., M.S. Associate Professor Head of the Section of Health Services Research and Quality Department of Cardiac Surgery. University of Michigan Dr. Likosky[/caption] Donald Likosky, Ph.D., M.S. Associate Professor Head of the Section of Health Services Research and Quality Department of Cardiac Surgery. University of Michigan MedicalResearch.com: What is the background for this study? What are the main findings? Response: Michigan was one of several states to expand Medicaid. Current evaluations of the Michigan Medicaid expansion program have noted increases in primary care services and health risk assessments, but less work has evaluated its role within a specialty service line. There has been concern among some that Medicaid patients, who have traditionally lacked access to preventive services, may be at high risk for poor clinical outcomes if provided increased access to cardiovascular interventions. Using data from two physician-led quality collaboratives, we evaluated the volume and outcomes of percutaneous coronary interventions and coronary artery bypass grafting 24mos before and 24mos after expansion. We noted large-scale increased access to both percutaneous coronary interventions (44.5% increase) and coronary artery bypass grafting (103.8% increase) among patients with Medicaid insurance. There was a decrease in access for patients with private insurance in both cohorts. Nonetheless, outcomes (clinical and resource utilization) were not adversely impacted by expansion. 
Author Interviews, Brigham & Women's - Harvard, Heart Disease, JAMA / 06.04.2018

MedicalResearch.com Interview with: Dr. Alvin Chandra  MD first author  and Dr. Scott David Solomon M.D. Director, Noninvasive Cardiology Professor, Harvard Medical School Cardiovascular Medicine Brigham and Women’s Hospital Boston, Massachusetts MedicalResearch.com: What is the background for this study? What are the main findings? Response: In general, the quality of life of heart failure with reduced ejection fraction patients is quite impaired, and  similar to that of patients on dialysis. PARADIGM-HF was the largest trial of heart failure patients and showed that sacubitril/valsartan was superior to the gold-standard enalapril in reducing cardiovascular death, heart failure hospitalization and all-cause mortality. In addition, patients on sacubitril/valsartan, when compared to enalapril, showed significant improvement in overall quality of life. In this study we looked in more detail at the individual components of “quality of life” and found that in virtually all domains and activities, patients who were randomized to sacubitril/valsartan reported improvement in their limitations  compared to those who were randomized to enalapril. These activities included jogging, doing hobbies, and household chores, with the largest improvement seen in  sexual activities limitations.
Author Interviews, Cost of Health Care, University of Pennsylvania / 04.04.2018

MedicalResearch.com Interview with: [caption id="attachment_40996" align="alignleft" width="138"]Eric T. Roberts, PhD Assistant Professor of Health Policy & Management University of Pittsburgh Graduate School of Public Health Pittsburgh, PA 15261 Dr. Roberts[/caption] Eric T. Roberts, PhD Assistant Professor of Health Policy & Management University of Pittsburgh Graduate School of Public Health Pittsburgh, PA 15261 MedicalResearch.com: What is the background for this study? Response: There is considerable interest nationally in reforming how we pay health care providers and in shifting from fee-for-service to value-based payment models, in which providers assume some economic risk for their patients’ costs and outcomes of care.  One new payment model that has garnered interest among policy makers is the global budget, which in 2010 Maryland adopted for rural hospitals.  Maryland subsequently expanded the model to urban and suburban hospitals in 2014.  Maryland’s global budget model encompasses payments to hospitals for inpatient, emergency department, and hospital outpatient department services from all payers, including Medicare, Medicaid, and commercial insurers.  The intuition behind this payment model is that, when a hospital is given a fixed budget to care for the entire population it serves, it will have an incentive to avoid costly admissions and focus on treating patients outside of the hospital (e.g., in primary care practices).  Until recently, there has been little rigorous evidence about whether Maryland’s hospital global budget model met policy makers’ goals of reducing hospital use and strengthening primary care. Our Health Affairs study evaluated how the 2010 implementation of global budgets in rural Maryland hospitals affected hospital utilization among Medicare beneficiaries.  This study complements work our research group published in JAMA Internal Medicine (January 16, 2018) that examined the impact of the statewide program on hospital and primary care use, also among Medicare beneficiaries.
Author Interviews, JNCI, Lung Cancer, UT Southwestern / 04.04.2018

MedicalResearch.com Interview with: [caption id="attachment_40982" align="alignleft" width="142"]Amyn Habib, M.D. Associate Professor, Neurology & Neurotherapeutics UT Southwestern Medical Center Dr. Amyn Habib[/caption] Amyn Habib, M.D. Associate Professor, Neurology & Neurotherapeutics UT Southwestern Medical Center MedicalResearch.com: What is the background for this study? Response: The epidermal growth factor receptor (EGFR) is expressed in most lung cancers and could play an important role in driving the growth of lung cancer.  Drugs are available that can block the activity of the EGFR. However, EGFR inhibitors are successful in only a small subset of lung cancers that have a mutant form of the EGFR, and do not work in the majority of lung cancers that have the normal form of the EGFR. 
Author Interviews, Boehringer Ingelheim, FDA, Pulmonary Disease, Rheumatology / 03.04.2018

MedicalResearch.com Interview with: [caption id="attachment_40947" align="alignleft" width="167"]Dr. Thomas Leonard, Ph.D. Executive director, Clinical Development and Medical Affairs, Specialty Care Boehringer Ingelheim Pharmaceuticals, Inc. Dr. Thomas Leonard[/caption] Dr. Thomas Leonard, Ph.D. Executive director, Clinical Development and Medical Affairs, Specialty Care Boehringer Ingelheim MedicalResearch.com: What is the background for this announcement? Would you briefly explain what is meant by systemic sclerosis? What are the disease symptoms and manifestations? Response: The FDA recently granted Fast Track designation to nintedanib for the treatment of systemic sclerosis with interstitial lung disease (SSc-ILD) – paving the way for Boehringer Ingelheim to take an important step in advancing this potential therapy for those affected by this disease. The designation was based on Boehringer Ingelheim’s Investigational New Drug application (IND) and the anticipated efficacy and safety data from SENSCIS™ (Safety and Efficacy of Nintedanib in Systemic SClerosIS), a double-blind, randomized, placebo-controlled global Phase III trial which is fully enrolled and includes more than 520 patients from 32 countries. The FDA’s Fast Track designation facilitates the development of new therapies that treat serious conditions and fulfill an unmet medical need in an effort to get treatments to those in need sooner, like those living with systemic sclerosis. Systemic sclerosis, also known as scleroderma, is a rare disease characterized by thickening and scarring of connective tissue of multiple organs in the body, typically affecting women between ages 25 and 55. Most people with the disease will develop some degree of lung scarring, or interstitial lung disease (ILD), which is the leading cause of death among people with systemic sclerosis. Nintedanib, currently marketed as Ofev®, is approved for treatment of a rare lung disease called idiopathic pulmonary fibrosis, or IPF, and has been shown to slow disease progression as measured by annual rate of decline in lung function. Because SSc-ILD and IPF share similarities in how the underlying lung scarring, or fibrosis, forms in people with the disease, Boehringer Ingelheim is evaluating the impact of nintedanib on SSc-ILD.
Author Interviews, Blood Pressure - Hypertension, Dermatology, NIH / 29.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40853" align="alignleft" width="143"]Dr. Beth Kozel M.D.-Ph.D The Laboratory of Vascular and Matrix Genetics LASKER CLINICAL RESEARCH SCHOLAR NIH Dr. Kozel[/caption] Dr. Beth Kozel M.D. Ph.D The Laboratory of Vascular and Matrix Genetics LASKER CLINICAL RESEARCH SCHOLAR NIH MedicalResearch.com: What is the background for this study? What are the main findings? Response: Elastin is a protein that allows the blood vessels to stretch and recoil. It is made as a child grows but once the child reaches adolescence, the body stops making elastin. With age, the body slowly begins to lose elastin and blood vessels become less flexible. In order to study what happens when a vessel has less elastin, we used a mouse that makes half of the normal amount of elastin, the Eln+/- mouse. These mice have higher blood pressure, stiffer blood vessels and decreased blood flow to end organs such as the brain. We then used a blood pressure medication, minoxidil (this same medicine when used in topical form helps hair growth), and treated mice from weaning until 3 months of age. With treatment, Eln+/- blood pressure was lower, the vessels were less stiff and blood flow to the brain increased. That effect remained for weeks after the medication was stopped. Additional studies showed that more elastin was present in the vessel wall after treatment and more than 100 other connective tissue genes were also changed, suggesting vessel remodeling. Minoxidil works by causing cells in the blood vessel to relax, leading to a more open, or dilated artery. When taken chronically, our data suggest that the connective tissue associated with a blood vessel remodels, fixing it in a more open state and allowing better blood flow to the organ on the other side, in this case, the brain.
AACR, Author Interviews, Microbiome, NYU, Pancreatic / 28.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40819" align="alignleft" width="99"]Mautin Hundeyin MD Post-doctoral Research Fellow Dr. Hundeyin[/caption] Mautin Hundeyin MD Post-doctoral Research Fellow George Miller, MD is Principal Investigator and Director of the S. Arthur Localio Laboratory in the Department of Surgery at NYU School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: Pancreatic ductal adenocarcinoma (PDA) is the devastating disease with grim prognosis. The microbiome has emerged as a contributor to oncogenesis in a number of intestinal tract malignancies. We found that PDA is associated with a distinct stage-specific gut and pancreatic microbiome that drives disease progression by inducing intra-tumoral immune suppression. Targeting the microbiome protects against oncogenesis, reverses intra-tumoral immune-tolerance, and enables efficacy for check-point based immunotherapy. These data have implications for understanding immune-suppression in pancreatic cancer and its reversal in the clinic. 
AHA Journals, Author Interviews, Exercise - Fitness, Heart Disease, NIH / 24.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40757" align="alignleft" width="125"]Pedro F. Saint-Maurice, Ph.D. Postdoctoral Fellow Metabolic Epidemiology Branch Division of Cancer Epidemiology and Genetics National Cancer Institute, NIH, HHS Rockville, MD 20850 Dr. Saint-Maurice[/caption] Pedro F. Saint-Maurice, Ph.D. Postdoctoral Fellow Metabolic Epidemiology Branch Division of Cancer Epidemiology and Genetics National Cancer Institute, NIH, HHS Rockville, MD 20850 MedicalResearch.com: What is the background for this study?  Response: The 2008 Physical Activity Guidelines for Americans recommends adults do 150 minutes/week of moderate intensity physical activity (PA) in increments of at least 10 minutes at a time. However, there is limited epidemiologic evidence supporting the use of the 10-minute increment and whether shorter increments (for instance walking up the stairs) can also be beneficial for health in adults. We looked at accelerometer-measured physical activity in roughly 5,000 adults (40 and older) representative of the US population and followed them prospectively (over 7 years) to determine whether physical activity accumulated in 10-minute increments, but also accumulated in shorter bursts, were associated with lower risk of death (mortality data came from the National Death Index).
Author Interviews, Genetic Research, Nature, OBGYNE, UCLA / 22.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40709" align="alignleft" width="92"]Marlena Fejzo, PhD Aassociate researche David Geffen School of Medicine UCLA. Dr. Fejzo[/caption] Marlena Fejzo, PhD Aassociate researche David Geffen School of Medicine UCLA.  MedicalResearch.com: What is the background for this study? Response: Most women experience some nausea and vomiting of pregnancy, and the worst 2% are diagnosed with Hyperemesis Gravidarum which is associated with poor maternal and fetal outcomes. I had HG in 2 pregnancies. In my second pregnancy my HG was so severe that I could not move without vomiting and did not keep any food or water down for 10 weeks. I was put on a feeding tube, but ultimately lost the baby in the second trimester. I am a medical scientist by training so I looked into what was known about HG. At the time, very little was known, so I decided to study it. I partnered with the Hyperemesis Education and Research Foundation (HER) and we did a survey on family history of .Hyperemesis Gravidarum that provided evidence to support a role for genes. I collected saliva samples from HG patients and their unaffected acquaintances to do a DNA study. Then I partnered with the personal genetics company, 23andMe to do a genome scan and validation study, which identified 2 genes, GDF15 and IGFBP7, linked to HG.
Author Interviews, Breast Cancer, Brigham & Women's - Harvard, Science, Weight Research / 22.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40716" align="alignleft" width="151"]Dr. Fukumura Dr. Fukumura[/caption] Dai Fukumura, M.D., Ph.D Associate Professor, Radiation Oncology Harvard Medical School Deputy Director, Edwin L. Steele Laboratory, Radiation Oncology, Massachusetts General Hospital Boston, MA      [caption id="attachment_40718" align="alignleft" width="129"]Joao Incio Dr. Incio[/caption] Dr. Joao Incio PhD Post-Doc, Edwin L. Steele Laboratory           [caption id="attachment_40719" align="alignleft" width="160"]Dr. Rakesh K. Jain PhD Dr. Jain[/caption] Dr. Rakesh K. Jain PhD Andrew Werk Cook Professor of Tumor Biology and director of the Edwin L. Steele Laboratories for Tumor Biology Rradiation oncology department Massachusetts General Hospital and Harvard Medical School.   MedicalResearch.com: What is the background for this study?   Response: Based on promising data from preclinical studies and subsequent increase in progression-free survival in patients, anti-vascular endothelial growth factor (VEGF) therapy received accelerated approval for metastatic breast cancer. However, this approval was withdrawn in the United States based on the lack of overall survival benefit in several subsequent phase III studies in metastatic and adjuvant settings. Potential mechanisms of resistance to anti-VEGF therapy include the upregulation of alternative angiogenic and pro-inflammatory factors. Production of some of these factors has been shown to increase in obesity specifically in hypoxic adipose tissues including the breast. Given that up to 70% of breast cancer (BC) patients in the United States are overweight or obese, we addressed one simple but important question in this study: Is obesity contributing to anti-VEGF treatment resistance in breast cancer?
Abuse and Neglect, Accidents & Violence, Brigham & Women's - Harvard, Pediatrics, PLoS / 21.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40688" align="alignleft" width="145"]Neha Bairoliya, Ph.D. Harvard Center for Population and Development Studies Cambridge, MA 02138 Dr. Bairoliya[/caption] Neha Bairoliya, Ph.D. Harvard Center for Population and Development Studies Cambridge, MA 02138 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: While the high prevalence of preterm births and its impact on infant mortality in the US have been widely acknowledged, recent data suggest that even full-term births in the US face substantially higher mortality risks compared to European countries with low infant mortality rates. In this paper, we use the most recent birth records in the US to more closely analyze the primary causes underlying mortality rates among full-term births. We show that infants born full-term in the US face 50%-200% higher risks of infant mortality compared to leading European countries. The two main drivers of these high relative risks are increased risk of mortality due to congenital malformations, which patients cannot really do much about other than ensuring adequate screening during pregnancy, and high risk of sudden unexpected deaths in infancy, which should largely be preventable through appropriate sleeping arrangements. While we do not have data on actual sleeping arrangements from our study, other data sources suggest that a substantial number of babies continue to sleep on their tummy; we also found a shockingly large number of babies dying from suffocation, which suggests that parents either use covers that are not safe, or let children sleep in their own beds.
Author Interviews, NYU, Rheumatology, Surgical Research, Weight Research / 20.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40670" align="alignleft" width="200"]Jonathan Samuels, MD Associate Professor of Medicine Division of Rheumatology NYU Langone Health Dr. Jonathan Samuels[/caption] Jonathan Samuels, MD Associate Professor of Medicine Division of Rheumatology NYU Langone Health MedicalResearch.com: What is the background for this study?  Response: A high percentage of obese patients have painful knee osteoarthritis, and have difficulty losing weight as well as treating the knee pain with a self-perpetuating cycle.  MedicalResearch.com: What are the main findings? Response:  Patients who lost weight with their laparoscopic banding surgeries also experienced marked improvement of their knee pain. We found a significant correlation between the degree of improvement in the body mass index and reduction of knee pain in our cohort. In addition, the patients who experienced the most relief from weight loss surgeries had their procedures at earlier ages, as well as those who never had a traumatic knee injury nor developed osteoarthritis in other joints.
Author Interviews, Brigham & Women's - Harvard, Endocrinology, OBGYNE, Weight Research / 20.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40663" align="alignleft" width="200"]Madhusmita Misra, MD, MPH Division Chief, Pediatric Endocrinology Fritz Bradley Talbot and Nathan Bill Talbot Professor of Pediatrics, Harvard Medical School Dr.Madhusmita Misra[/caption] Madhusmita Misra, MD, MPH Division Chief, Pediatric Endocrinology Fritz Bradley Talbot and Nathan Bill Talbot Professor of Pediatrics, Harvard Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response: Disordered eating behavior is common in conditions of functional hypothalamic amenorrhea, such as anorexia nervosa and exercise-induced amenorrhea, which are also associated with anxiety and depression. In hypoestrogenic rodents, estrogen replacement reduces anxiety-related behavior. Similarly, physiologic estrogen replacement in adolescents with anorexia nervosa reduces anxiety and prevents the increased body dissatisfaction observed with increasing weight. However, the impact of estrogen administration on disordered eating behavior and psychopathology in normal-weight young women with exercise-induced amenorrhea is unknown. Adolescent and young adult normal-weight athletes 14-25 years old with irregular periods were randomized to receive (i) physiologic estrogen replacement using a transdermal patch with cyclic progesterone, or (ii) an oral estrogen-progesterone containing pill (an oral contraceptive pill), or (iii) no estrogen for 12-months. The Eating Disorder Inventory-2 (EDI-2) and Three-Factor Eating Questionnaire (TFEQ) were administered ag the beginning and the end of the study to assess disordered eating behavior and psychopathology. We found that the group that did not receive estrogen had a worsening of disordered eating behavior and psychopathology over the 12-months duration of the study, but this was not observed in the group that received estrogen replacement. Further, body dissatisfaction scores improved over 12-months in the groups receiving estrogen replacement, with the transdermal estrogen group showing the strongest effect.
Author Interviews, Brigham & Women's - Harvard, JAMA, Menopause, OBGYNE, Sexual Health / 20.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40595" align="alignleft" width="200"]Caroline Mitchell, MD, MPH Vincent Center for Reproductive Biology Assistant Professor, Obstetrics, Gynecology & Reproductive Biology Dr. Caroline Mitchell[/caption] Caroline Mitchell, MD, MPH Vincent Center for Reproductive Biology Assistant Professor, Obstetrics, Gynecology & Reproductive Biology http://massgeneral.link/MitchellLab MedicalResearch.com: What is the background for this study? What are the main findings? Response: In this study we compared two commonly recommended treatments for menopausal vaginal discomfort - low dose vaginal estradiol tablets and a vaginal moisturizer - to placebo, and found no difference in reduction of symptom severity; all three groups improved over 12 weeks of treatment.  This is great news for women, as it means that using any treatment regularly is likely to have benefit, whether it costs $20 or $200. Symptoms of vaginal dryness, irritation and pain with sex, which occur in over half of postmenopausal women, cause a significant decrease in quality of life and negatively impact intimate relationships.  The significant impact of these symptoms is reflected in the fact that we enrolled all 302 participants in under a year, a faster enrollment than any of the four prior trials  conducted by the MsFlash research network that evaluated treatments for hot flashes.  Women were desperate for some kind of intervention for these symptoms.
Author Interviews, Orthopedics, UCSF / 19.03.2018

MedicalResearch.com Interview with: Terence J. Gioe, MD American Joint Replacement Registry, Rosemont, IL UCSF School of Medicine, San Francisco VA Health Care System  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Hospital-based or regional registries are typically limited in their catchment area, making loss to follow-up a major concern when patients move out of the area or otherwise receive subsequent medical care outside of the original hospital network. The American Joint Replacement Registry (AJRR), a part of the American Academy of Orthopaedic Surgeons’ (AAOS) registries portfolio, has the goal of tracking total joint arthroplasty (TJA) patients nationally across the US, but currently captures only approximately 28% of annual TJA procedures. Until a nationwide network of reporting hospitals is established that covers at least 90% of all TJA procedures, loss to follow-up due to migration will be a key potential limitation of large-scale studies on implant performance in the US. Assessment of loss to follow-up can provide an essential understanding of the migration patterns of TJA patients, and help to improve recruitment and enrollment efforts of the AJRR. The magnitude and characteristics of patient migration following TJA have not previously been studied in the US. 
Author Interviews, Brigham & Women's - Harvard / 18.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40621" align="alignleft" width="142"]Alexander Turchin, M.D., M.S. FACMI Associate Professor of Medicine ENDOCRINOLOGY, DIABETES AND HYPERTENSION BRIGHAM AND WOMEN'S HOSPITAL Dr. Turchin[/caption] Alexander Turchin, M.D., M.S. FACMI Associate Professor of Medicine ENDOCRINOLOGY, DIABETES AND HYPERTENSION BRIGHAM AND WOMEN'S HOSPITAL MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Statins are known to reduce the risk of cardiovascular events and death, and are some of the most commonly prescribed medications. However, many patients stop taking statins, most commonly because of adverse reactions. It has been shown previously that many individuals who discontinued statin therapy after an adverse reaction are ultimately able to tolerate statins, and that reattempting statin therapy after an adverse reaction is associated with reduced risk of cardiovascular events and death. However, optimal patient selection criteria and methods of reattempting treatment with statins are unknown. We therefore conducted this study to identify patient and treatment characteristics associated with an increased chances of successful reattempt of statin therapy after an adverse reaction. Through analysis of EMR data of over 6,000 patients we found that the following were associated with higher chances of successful statin therapy reattempt:
  • Reattempted treatment with a different statin
  • Patient at high cardiovascular risk (prior history of CAD, stroke or diabetes)
On the other hand, the following were associated with lower chances of success:
  • Adverse reaction was reported in the first year after starting statin therapy
  • Adverse reaction was myalgia or myopathy
  • Previous history of adverse reactions to other (non-statin) medications 
Author Interviews, JAMA, Ophthalmology, University of Michigan / 16.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40613" align="alignleft" width="125"]Maria A. Woodward, MD, MSc Department of Ophthalmology and Visual Sciences W. K. Kellogg Eye Center Institute for Healthcare Policy and Innovation University of Michigan Ann Arbor, MI Dr. Woodward[/caption] Maria A. Woodward, MD, MSc Department of Ophthalmology and Visual Sciences W. K. Kellogg Eye Center Institute for Healthcare Policy and Innovation University of Michigan Ann Arbor, MI MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Many people go to emergency departments seeking care for their eye problems. We wished to investigate which factors are associated with the involvement of ophthalmologist consultants in the care of these patients and whether any disparities exist. 
Author Interviews, Brain Cancer - Brain Tumors, Emory, PNAS, Technology / 16.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40601" align="alignleft" width="139"]Lee Cooper, Ph.D. Assistant Professor of Biomedical Informatics Assistant Professor of Biomedical Engineering Emory University School of Medicine - Georgia Institute of Technology Dr. Cooper[/caption] Lee Cooper, Ph.D. Assistant Professor of Biomedical Informatics Assistant Professor of Biomedical Engineering Emory University School of Medicine - Georgia Institute of Technology MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Gliomas are a form of brain tumor that are often ultimately fatal, but patients diagnosed with glioma may survive as few as 6 months to 10 or more years. Prognosis is an important determinant in selecting treatment, that can range from simply monitoring the disease to surgical removal followed by radiation treatment and chemotherapy. Recent genomic studies have significantly improved our ability to predict how rapidly a patient's disease will progress, however a significant part of this determination still relies on the visual microscopic evaluation of the tissues by a neuropathologist. The neuropathologist assigns a grade that is used to further refine the prognosis determined by genomic testing. We developed a predictive algorithm to perform accurate and repeatable microscopic evaluation of glioma brain tumors. This algorithm learns the relationships between visual patterns presented in the brain tumor tissue removed from a patient brain and the duration of that patient's survival beyond diagnosis. The algorithm was demonstrated to accurately predict survival, and when combining images of histology with genomics into a single predictive framework, the algorithm was slightly more accurate than models based on the predictions of human pathologists. We were also able to identify that the algorithm learns to recognize some of the same tissue features used by pathologists in evaluating brain tumors, and to appreciate their prognostic relevance.
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Heart Disease, Medicare / 15.03.2018

MedicalResearch.com Interview with: Dr. Rishi K. Wadhera MD Clinical Fellow in Medicine Brigham and Women's Hospital  MedicalResearch.com: What is the background for this study?   Response: The Hospital Value Based Purchasing program, in which over 3,000 hospitals participate, is a Centers for Medicare and Medicaid Services (CMS) pay-for-performance program that links hospital fee per service reimbursement to performance, through measures like 30-day mortality rates after an acute myocardial infarction (a heart attack), and other measures such as average spending for an episode of care for Medicare beneficiaries. Hospitals that perform poorly on these measures are financially penalized by CMS.
Aging, Alcohol, Author Interviews, JAMA, Stanford / 15.03.2018

MedicalResearch.com Interview with: alcohol-cdc-imageEdith V. Sullivan, Ph.D. Professor Department of Psychiatry & Behavioral Sciences Stanford University School of Medicine Stanford, CA 94305-5723  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Alcohol misuse is a major public health problem worldwide with profound health consequences on the body, brain, and function. Our research group has conducted naturalistic yet controlled studies of alcohol dependence for several decades to further our understanding of when and how alcohol misuse affects specific parts of the brain.  In addition, we wanted to know how alcohol misuse interacts with the typical changes in the brain as we grow older.  The studies are controlled in that we recruit healthy, non-alcohol dependence men and women from the community to undergo the same screening and neuroimaging procedures as our alcoholic recruits.  The studies are quantitative because we use neuroimaging methods (Magnetic Resonance Imaging) that enable us to measure specific regions of brain structural volumes.  Consistent collection of such data over the years positioned us to ask whether age and alcohol dependence interact to produce regional brain volume loss beyond the loss that occurs in normal aging. A number of cross-sectional studies pointed to the likelihood that the effects of alcohol dependence on brain structure would be exacerbated by normal aging, which we do know from longitudinal neuroimaging studies results in shrinkage of cortical gray matter volume and thinning of the cortex. What was particularly striking about our longitudinal study of men and women with alcohol dependence was the acceleration of the aging of brain structure that was especially prominent in the frontal cortex.  Critically, even those who initiated dependent drinking at an older age showed accelerated loss. Because our study sample was large enough, we could also test whether our findings were attributable to conditions that commonly co-occur with alcohol dependence, namely, illicit drug use and hepatitis C.  Although both drug use and hepatitis C infection may have exacerbated brain volume loss, these factors did not fully account for the alcoholism-aging interaction we identified.
Author Interviews, Diabetes, Duke, Heart Disease / 14.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40446" align="alignleft" width="156"]Stephen J. Greene, MD Division of Cardiology Duke University Medical Center Durham, NC Dr. Greene[/caption] Stephen J. Greene, MD Division of Cardiology Duke University Medical Center Durham, NC MedicalResearch.com: What is the background for this study? What are the main findings? Response: In 2008, the United States FDA issued an industry guidance specifying that diabetes drugs should routinely be tested in large cardiovascular outcome trials to confirm cardiovascular safety. The guidance specifically mentioned cardiovascular safety in terms of MACE, or major adverse cardiac events, including cardiovascular death, myocardial infarction, and stroke.  Largely because of this, these trials have traditionally had a focus on cardiovascular disease in terms of atherosclerotic events. Heart failure was not mentioned in the FDA document and these trials have had a lesser focus on it. As the years have gone by, we have learned more and more about the connection between diabetes and heart failure. There is tremendous overlap between the two patient populations. Also, as more and more of the large cardiovascular outcome trials have been completed, we have seen multiple examples of various glucose lowering therapies either increasing or decreasing risk of heart failure events. Given all these data on heart failure/ diabetes interactions, the goal of our research was to carefully examine all of the completed large cardiovascular outcome trials of diabetes therapies to systematically describe the type of heart failure-related data they capture. As an initial step in improving heart failure characterization in these trials, we wanted to first describe what trials have already been doing and where the gaps in understanding heart failure in these trials exist. Overall, we found major gaps in the amount and quality of the heart failure data capture in these trials. We looked at 21 large trials, including over 150,000 patients. Rates of patients with baseline heart failure were inconsistently provided, and among those trials that did provide it, heart failure patients tended to be underrepresented compared to the general population. Patients with baseline heart failure were also poorly characterized, with minimal data on functional status, ejection fraction, or heart failure medications. Only 6 trials reported rates of new-onset heart failure and the definitions used were non-specific. Most trials tended to report rates of heart failure hospitalization, but did not include data on fatal or other types of heart failure events. Only 2 trials included heart failure events within the primary study endpoint. More details are included in our full manuscript, which was published in the Journal of the American College of Cardiology to coincide with our presentation at the ACC conference.
Author Interviews, Biomarkers, Rheumatology, Vanderbilt / 13.03.2018

MedicalResearch.com interview with: [caption id="attachment_40533" align="alignleft" width="200"]Dr. Chase Spurlock, PhD CEO, IQuity, Specialty Diagnostic Technologies Faculty, Vanderbilt University Medical Center Dr. Chase Spurlock[/caption] Dr. Chase Spurlock, PhD CEO, IQuity, Specialty Diagnostic Technologies Faculty, Vanderbilt University Medical Center Dr. Spurlock discusses IQuity's release of IsolateFibromyalgia, the first RNA-based blood test to detect fibromyalgia. MedicalResearch.com: What is the background for this test? Would you briefly explain what fibromyalgia is, whom it affects and why it has been difficult to definitely diagnosis?  Dr. Spurlock: We developed the IsolateFibromyalgia™ test using our established RNA assay platform, IQIsolate™, to help clinicians receive timely and accurate information. This technology has evolved from over a decade of research at Vanderbilt University and continues at IQuity funded by both the National Institutes of Health (NIH) as well as private investors. We discovered that differences in RNA expression patterns could be detected in patients with a variety of human conditions spanning infection to more complex inflammatory diseases. With our focus on autoimmune disease, we identified and validated RNAs capable of distinguishing multiple sclerosis, IBS, Crohn’s, ulcerative colitis and fibromyalgia syndrome. In the case of fibromyalgia, our research involved almost 600 subjects including healthy individuals, patients with endocrine conditions, dermatologic conditions and rheumatologic diseases — rheumatoid arthritis, Sjogren’s syndrome and systemic lupus erythematosus. Reported sensitivity and specificity of this assay is 92 percent and 96 percent, respectively. Fibromyalgia syndrome is characterized by widespread musculoskeletal pain often initially localized to the neck and shoulders. Patients typically describe pain throughout the muscles but may also report pain in the joints. Furthermore, fibromyalgia is usually accompanied by fatigue as well as cognitive disturbance. Patients most afflicted are women between ages 20 and 55. Fibromyalgia affects approximately as many as 6-10 million people in the U.S. The difficulty in reaching a definitive diagnosis lies in two important issues. First, the cause of the syndrome is unknown, and the way the condition presents and progresses can vary among patients. Secondarily, fibromyalgia syndrome mimics many other conditions due to the multiple nonspecific symptoms associated with fibromyalgia. Patients look well, there are no obvious abnormalities on physical examination other than tenderness, and laboratory and radiologic studies are normal. With no discernable abnormalities in routine clinical laboratory testing or imaging, the diagnosis is based on subjective reporting of symptoms. The difficulties and complex nature of receiving a correct fibromyalgia diagnosis are apparent. Despite improved awareness among primary care clinicians, many continue to be uncomfortable with making this diagnosis. Fibromyalgia patients on average wait almost a year after experiencing symptoms before seeing a physician and end up visiting on average 3.7 different physicians before a diagnosis. The diagnostic journey can take years. IsolateFibromyalgia provides the clinician and patient actionable information with 94 percent accuracy.
Author Interviews, JAMA, University of Michigan, Urinary Tract Infections / 12.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40520" align="alignleft" width="148"]Keith S. Kaye, MD, MPH Professor of Medicine, Division of Infectious Diseases University of Michigan Medical School Ann Arbor MI  Dr. Kaye[/caption] Keith S. Kaye, MD, MPH Professor of Medicine, Division of Infectious Diseases University of Michigan Medical School Ann Arbor MI  MedicalResearch.com: What is the background for this study? Response: Complicated complicated urinary tract infections (cUTI), including acute pyelonephritis, are a major cause of hospital admissions, and are associated with significant morbidity and mortality and can be difficult to treat. While the most common pathogen is Escherichia coli, the more problematic pathogens are multidrug-resistant (MDR) gram-negative organisms including other Enterobacteriaceae species. The prevalence of cUTI due to MDR gram-negative bacteria has risen. In some instances, MDR gram-negative bacteria isolated from the urinary tract can cause bacteremia. Vabomere was approved by the U.S. Food and Drug Administration (FDA) in August 2017 for the treatment of adult patients with cUTI, including pyelonephritis, caused by designated susceptible Enterobacteriaceae: Escherichia coli, Klebsiella pneumoniae and Enterobacter cloacae species complex.   Vabomere is a fixed-dose (2g/2g) combination product of a carbapenem and a β-lactamase inhibitor with potent in vitro activity against Klebsiella pneumoniae carbapenemase (KPC)-producing carbapenem-resistant Enterobacteriaceae (CRE), an important MDR organism associated with serious infections. The Targeting Antibiotic Non-susceptible Gram-negative Organisms (TANGO I) trial was the pivotal Phase 3 study that compared the efficacy and safety of Vabomere to piperacillin-tazobactam in the treatment of patients with cUTI and acute pyelonephritis.
Author Interviews, Brigham & Women's - Harvard, Diabetes, Heart Disease / 12.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40453" align="alignleft" width="150"]Muthiah Vaduganathan, MD MPH Heart and Vascular Center Brigham and Women's Hospital  Dr. Vaduganathan[/caption] Muthiah Vaduganathan, MD MPH Heart and Vascular Center Brigham and Women's Hospital  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The prevalence of heart failure with preserved ejection fraction (HFpEF) is rising globally, yet no medical therapies are currently available to alter its natural history and its progression remains incompletely understood. Sudden death may represent a target for therapy in this disease entity. In 1,767 patients with HFpEF enrolled in the Americas region of the TOPCAT trial, we found that sudden death accounts for ~20% of all deaths. Male sex and insulin-treated diabetes mellitus identify patients at higher risk for sudden death. Sudden death was numerically lower but not statistically reduced in those randomized to spironolactone.
Aging, Author Interviews, Cancer Research, Johns Hopkins / 12.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40508" align="alignleft" width="100"]Hariharan Easwaran, PhD Assistant Professor of Oncology The Sidney Kimmel Comprehensive Cancer Center The Johns Hopkins University School of Medicine Bunting/Blaustein Cancer Research Building 1 Baltimore, MD 21287 Dr. Easwaran[/caption] Hariharan Easwaran, PhD Assistant Professor of Oncology The Sidney Kimmel Comprehensive Cancer Center The Johns Hopkins University School of Medicine Bunting/Blaustein Cancer Research Building 1 Baltimore, MD 21287 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The interpretation of the information encoded in our DNA by the various cells in our body is mediated by a plethora of modifications of DNA and proteins that complex with DNA. DNA methylation is one such important modification, which is normally established in a very orchestrated fashion during development. All normal cells have a defined pattern of DNA methylation, which may vary by tissue type, but is consistent within tissues. This normal pattern is disrupted in all known cancers, and is considered a hallmark of cancers.
Author Interviews, Duke, Heart Disease, JACC / 07.03.2018

MedicalResearch.com Interview with: [caption id="attachment_20394" align="alignleft" width="200"]Renato D. Lopes MD, MHS, PhD Duke University Medical Center Duke Clinical Research Institute Durham, NC 27705 Dr. Renato Lopes[/caption] Renato D. Lopes MD, MHS, PhD Professor of Medicine, Division of Cardiology Duke University Medical Center Duke Clinical Research Institute Terrace Level, Durham, NC 27705 MedicalResearch.com: What is the background for this study? 1-      Digoxin is used in ≈ 30% of patients with atrial fibrillation (AF) worldwide, despite the lack of randomized clinical trials to assess its efficacy and safety in this setting. 2-      Current AF guidelines recommend digoxin for rate control in patients with AF with and without heart failure (HF). 3-      There are no specific recommendations about serum digoxin concentration monitoring in the atrial fibrillation guidelines.
Author Interviews, Biomarkers, Neurological Disorders, University Texas, Zika / 07.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40401" align="alignleft" width="177"]Slobodan Paessler, D.V.M., Ph.D. Associate Professor, Department of Pathology; Director, Galveston National Laboratory Preclinical Studies Core;  Director, Animal Biosafety Level 3, Institute for Human Infections and Immunity; Member, Center for Biodefense & Emerging Infectious Diseases University of Texas Medical Branch  Galveston, TX Dr. Paessler[/caption] Slobodan Paessler, D.V.M., Ph.D. Professor, Department of Pathology; Director, Galveston National Laboratory Preclinical Studies Core; Director, Animal Biosafety Level 3, Institute for Human Infections and Immunity; Member, Center for Biodefense & Emerging Infectious Diseases University of Texas Medical Branch Galveston, TX MedicalResearch.com: What is the background for this study? What are the main findings? Response: Zika virus infection is associated with various developmental issues for human embryos such as reduced head growth, reduced brain tissue growth, and damage to brain or eyes. We wanted to better understand if some of these birth defects are caused directly by the Zika virus or maybe by the host response to infection. In our study we demonstrate that the Zika virus infection induces autoimmune response against the C1q protein. This protein is a very important immune protein as well as one of the essential proteins for healthy brain development. Attacking the C1q protein upon exposure with the Zika virus could contribute to the development of autoimmune disorders and birth defects.