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ASCO, Author Interviews, Bayer, Leukemia, Pediatrics / 05.06.2019

MedicalResearch.com Interview with: Joseph Germino, M.D., PhD Vice President US Medical Affairs Oncology Bayer Healthcare Pharmaceuticals Whippany, N.J. 07981 MedicalResearch.com: What is the background for this study? Response: Sorafenib (Nexavar®) is an oral anticancer therapy approved in more than 100 countries worldwide. It is approved for the treatment of patients with advanced hepatocellular carcinoma (HCC); advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy; progressive, locally advanced or metastatic differentiated thyroid carcinoma (papillary/follicular/Hürthle cell), that is refractory to radioactive iodine (RAI). The AAML 1031 is a recently completed Phase III clinical trial evaluating the use of bortezomib and sorafenib in patients 30 years or younger with newly diagnosed acute myeloid leukemia (AML). At the 2019 ASCO Annual meeting, results of a report from the AAML1031 trial, which assessed whether intensification of Induction II chemotherapy (ADE or AraC/ Mitoxantrone) and liberalized stem cell transplant (SCT) donor source criteria improved clinical outcomes in patients with residual AML.  (more…)
Accidents & Violence, Author Interviews, Exercise - Fitness, Geriatrics, JAMA / 05.06.2019

MedicalResearch.com Interview with: Teresa Liu-Ambrose, PT, PhD Canada Research Chair (Tier II), Physical Activity, Mobility, and Cognitive Neuroscience Director, Aging, Mobility, and Cognitive Neuroscience Laboratory University of British Columbia MedicalResearch.com: What is the background for this study? Response:  Falls in older adults are the third-leading cause of chronic disability and the leading cause of hospitalization for adults over age 65. Older adults who experience multiple falls are at increased risk for disability, loss of independence, and even death. How to best prevent falls in this high risk group is not well established.  (more…)
AstraZeneca, Kidney Disease / 04.06.2019

MedicalResearch.com Interview with: AstraZenecaJill Davis, MS Director, Health Economics and Outcomes Research AstraZeneca  MedicalResearch.com: What is the background for this study? Who is most at risk for hyperkalemia post discharge? Response: In the United States, an estimated 30 million people suffer from chronic kidney disease (CKD), about 3.7 million of which have hyperkalemia (elevated potassium level). Hyperkalemia (HK) can be chronic, so it’s important that those who have been diagnosed with hyperkalemia previously or have CKD have their potassium levels monitored by their healthcare provider. Additionally, although HK is estimated to be prevalent in more than 66,000 emergency department (ED) visits annually, there is limited knowledge about the management of patients with HK in the ED setting and post-discharge. We decided to focus our study to better understand and compare the ED management and post-discharge outcomes among patients with varying levels of hyperkalemia To conduct this study, we analyzed the electronic medical record data from the Research Action for Health Network (2012-2018) of 6,222 adult patients with a randomly selected HK-related ED visit. We concluded that improved management of HK patients in the ED and post-discharge period is needed to reduce the recurrence of hyperkalemia. (more…)
Author Interviews, JAMA, Pediatrics, Sexual Health / 04.06.2019

MedicalResearch.com Interview with: Monika K. Goyal, M.D., MSCE Assistant chief of Children’s Division Emergency Medicine and Trauma Services  MedicalResearch.com: What is the background for this study? Response: Adolescents are disproportionately affected by sexually transmitted infections (STIs) and often present to the emergency department for care. I have devoted almost 15 years of my career trying to improve the sexual health of teens through advocacy and the development of novel interventions in the emergency department to increase access to sexual health services for youths. (more…)
ASCO, Author Interviews, Education, Gender Differences, Surgical Research / 04.06.2019

MedicalResearch.com – Responses Marina Stasenko, MD Memorial Sloan Kettering Cancer Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Sexual harassment is a form of discrimination that includes gender harassment, unwanted sexual attention, and sexual coercion. A recent report in Fortune magazine noted that over half of US women have experienced sexual harassment at some point in their lives. Until recently, much of the conversation about sexual harassment in the workplace has been relegated to private discussions behind closed doors. However, the MeToo movement has shined a spotlight on the pervasive nature of sexual harassment in various fields, like media and business world. Although there are more female physicians in practice today than ever before, with women accounting for over 50% of young physicians, sexual harassment and gender disparities continue to plague the field of medicine. Despite the large female representation, gynecologic oncology is not immune from gender disparities. The Society of Gynecologic Oncology is a professional organization of over 2000 physicians, scientists, allied health professionals, nurses, and patient advocates dedicated to the care of patients with gynecologic cancer. As of 2015, 46% of members of the SGO were women, and that number is steadily growing. SGO leadership is also increasingly female – with 2 of the last 3 presidents being women. Despite the large female representation, gynecologic oncology is not immune from gender disparities. The 2015 SGO practice survey noted that while 22% of male Gynecologic Oncologists held the rank of professor, only 11% of their female counterparts held the title. They also noted that the mean annual salary for male physicians was nearly 150,000$ greater than salary for female physicians. Given the fact that there is little objective data on sexual harassment in gynecologic oncology, the objective of our study was to evaluate perceptions of sexual harassment and gender disparities among physician members of the Society of Gynecologic Oncology. (more…)
Author Interviews, Emergency Care, JAMA, Medical Imaging, Pediatrics / 04.06.2019

MedicalResearch.com Interview with: Eyal Cohen, MD, M.Sc, FRCP(C) Professor, Pediatrics University of Toronto Co-Founder, Complex Care Program The Hospital for Sick Children   MedicalResearch.com: What is the background for this study? Response: Minimizing care that provides little benefit to patients has become an important focus to decrease health care costs and improve the quality of care delivery.  Diagnostic imaging in children is a common focus for campaigns designed to reduce overuse both in Canada and the US. There are some suggestions that there may be more overuse of care in the United States than Canada, but there has been little study in children. We compared the use of low-value diagnostic imaging rates from four pediatric emergency departments in Ontario to 26 in the United States from 2006 to 2016.  We defined low-value imaging as situations where children are discharged from an emergency department with a diagnosis for which routine use of diagnostic imaging may not be necessary, like asthma or constipation.  (more…)
Author Interviews, Heart Disease, JAMA, Surgical Research / 04.06.2019

MedicalResearch.com Interview with: Rajat Kalra, MBCh Cardiovascular Division University of Minnesota, Minneapolis MedicalResearch.com: What is the background for this study? Response: New-onset atrial fibrillation after aortic valve procedures is thought to occur frequently after aortic valve procedures, such as transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (AVR). However, the incidence estimates and implications of this new-onset atrial fibrillation in the contemporary era are unclear. We sought to examine the incidence of atrial fibrillation after aortic valve procedures, compare the incidence between TAVI and AVR, and evaluate the associated morbidity and mortality implications using a ‘big data’ approach. This big data approach employed the National Inpatient Sample and was validated in the New York State Inpatient Database. Both are publicly available datasets that are developed as part of the Healthcare Cost and Utilization Project, a federal-state-industry partnership that is sponsored by the Agency for Healthcare Research and Quality.  (more…)
Author Interviews, Environmental Risks, Nutrition, Race/Ethnic Diversity / 04.06.2019

MedicalResearch.com Interview with: Joe F. Bozeman III, MS, CEM, Ph.D. Candidate Chair, Gordon Research Seminar (Industrial Ecology) University of Illinois at Chicago (UIC) Institute for Environmental Science and Policy MedicalResearch.com: What is the background for this study?   Response: This study is actually a part of my dissertation which explores how climate change, human health, and other socioecological factors can be used to manage food-energy-water impacts. After establishing environmental impact and climate change adaptation implications of food consumption across major U.S. demographic groups in a previous study, my colleagues and I decided it would be interesting to investigate how food spending and household income correlate with food-consumption environmental impacts. Our efforts led to the development of a novel quantitative metric (i.e., food-consumption impact per dollar spent [FCI$]) which encompasses land, water, and greenhouse gas emission impacts of basic foods; the amount spent on food; and socioeconomic status. All major food groups are included in this study. (more…)
ASCO, Author Interviews, Bayer, Cancer Research, Pediatrics / 03.06.2019

MedicalResearch.com Interview with: Douglas S. Hawkins, M.D. Hematology/Oncology Division Chief and Professor Pediatrics at Seattle Children's Hospital University of Washington School of Medicine MedicalResearch.com: What is the background for this study? Response: TRK fusion cancer is caused by a rare genomic alteration called a neurotrophic receptor tyrosine kinase (NTRK) gene fusion. Larotrectinib is a central nervous system (CNS) active, oral and highly selective TRK inhibitor used for the treatment of adult and pediatric patients with solid tumors that have a rare genomic alteration called an NTRK gene fusion. Larotrectinib was approved at the end of 2018 in the U.S. under the brand name VITRAKVI®, with European and worldwide regulatory submissions underway. At ASCO 2019, we will be presenting results from a new analysis specifically looking at the efficacy and safety of larotrectinib in pediatric patients (n=34) included in the expanded dataset from both adults and children across 24 tumor types, which was presented first at the European Society for Medical Oncology (ESMO) 2019 Annual Meeting.  (more…)
Author Interviews, Cancer Research, Prostate Cancer / 03.06.2019

MedicalResearch.com Interview with: Julie N. Graff, MD Associate Professor of Medicine Knight Cancer Institute Chief of Hematology/Oncology VA Portland Health Care System MedicalResearch.com: What is the background for this study? Response: Androgen deprivation therapy is often deployed in patients with a rising PSA after local therapy (such as radical prostatectomy or radiation therapy). With time, the prostate cancer can develop resistance to ADT, at which point it is called castration resistant prostate cancer (CRPC). There were 6 treatments for metastatic CRPC that have shown improved survival. However, in non-metastatic disease, there was nothing that showed improved survival. The SPARTAN study was designed to determine if a next generation androgen receptor antagonist could delay the time to metastatic disease. Overall survival was a secondary endpoint.  (more…)
ASCO, Author Interviews, Cancer Research, J&J-Janssen, Leukemia / 03.06.2019

MedicalResearch.com Interview with: Paul M. Barr, M.D. Associate Professor of Medicine and Director of the Clinical Trials Office Director of the Clinical Trials Office Wilmot Cancer Institute  MedicalResearch.com: What is the background for this study?   Response: When the study was designed, chronic lymphocytic leukemia (CLL)  treatment options were largely limited to chemotherapy and monoclonal antibodies. Ibrutinib had shown promise in early studies. The intent was to compare ibrutinib to a standard of care treatment option at that time, of atumumab, in patients with relapsed or refractory disease. The goal of the current analysis is to evaluate the durability of ibrutinib and report the long-term safety results. (more…)
Accidents & Violence, Author Interviews, Pediatrics, Pediatrics, Toxin Research / 03.06.2019

MedicalResearch.com Interview with: Dr. Gary Smith, MD MPH Director, Center for Injury Research and Policy Nationwide Children’s Hospital Columbus, OH MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our 2016 study (https://pediatrics.aappublications.org/content/137/5/e20154529) investigated calls to US poison control centers related to laundry and dishwasher detergent exposures among children younger than 6 years old from 2013 through 2014 and found that poison control centers received more than 30 calls a day about children who had been exposed to a laundry detergent packet, which is about one call every 45 minutes. The current study investigated trends in calls to poison control centers across the country for exposure to liquid laundry detergent packets in order to evaluate the impact of the voluntary safety standard for this product with a focus on young children. The study found only a modest decrease (18%) in calls for children younger than 6 years of age following adoption of a 2015 product safety standard as well as an increase in calls for older children and adults. Exposures to the eyes also continued to climb. The observed decrease in exposures among young children is considerably less than the 40% to 55% decrease in toxic ingestions seen after passage of the Poison Prevention Packaging Act. This demonstrates that the current liquid laundry detergent safety standard is inadequate and needs to be strengthened. (more…)
Author Interviews, Emergency Care, Mental Health Research, Psychological Science / 03.06.2019

MedicalResearch.com Interview with: Stephen L. Ristvedt, Ph.D. Associate Professor of Anesthesiology Washington University St. Louis, MO  63110-1093  MedicalResearch.com: What is the background for this study? Response: Having a usual source of healthcare – either with a regular doctor or a medical clinic – is the best way to manage one’s health in a proactive way.  Doctors and clinics can provide ongoing guidance with regard to the use of preventive medical screenings as well as the management of chronic illness.  Unfortunately, a significant proportion of US adults do not have a usual source of healthcare.  Also, many people often rely for their healthcare needs on a hospital emergency department, where there is neither sufficient continuity of care nor counseling for prevention. We wanted to investigate what factors might contribute to suboptimal utilization of healthcare resources.  We were particularly interested in looking at individual psychological factors that might play a role in the choices that people make when seeking healthcare.  One specific psychological characteristic proved to be important in our study.  That characteristic is called “threat sensitivity,” and it is measured with a simple questionnaire.  People who are relatively high in threat sensitivity are prone to experience high levels of anxiety in potentially threatening situations  (more…)
Author Interviews, Cannabis / 03.06.2019

MedicalResearch.com Interview with: Julie Bobitt, PhD Director Interdisciplinary Health Sciences College of Applied Health Sciences University of Illinois at Urbana Champaign Champaign, IL  61820 MedicalResearch.com: What is the background for this study? Response:  Older adults are using cannabis at an increasing rate but little is known about their attitudes about, and experiences – including outcomes- with, recreational and medical cannabis use. We believed a qualitative study, where we conducted focus group interviews, would provide a novel perspective to our understanding and help to identify the most salient themes concerning the use of medical and recreational cannabis by adults aged 60 and older living in Colorado. (more…)
Author Interviews, Breast Cancer, Cancer Research, Genetic Research, Novartis / 03.06.2019

MedicalResearch.com Interview with: Fabrice André, MD, PhD Research director and head of INSERM Unit U981 Professor in the Department of Medical Oncology Institut Gustave Roussy in Villejuif, France Global SOLAR-1 Principal Investigator. MedicalResearch.com: What is the background for this study? How does Piqray®  differ from other treatments for this type of advanced breast cancer? 
  • The US Food and Drug Administration (FDA) approved Piqray® (alpelisib, formerly BYL719) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test after disease progression following an endocrine-based regimen.
  • Piqray is the first and only combination treatment with fulvestrant specifically for postmenopausal women, and men, with HR+/HER2- advanced or metastatic breast cancer with a PIK3CA mutation following progression on or after an endocrine-based regimen, bringing a biomarker-driven therapy option to this population for the first time.
  • Advanced breast cancer is incurable, and patients with all types need more treatment options. With this approval, physicians can now use an FDA-approved test to determine if their patients’ HR+/HER2- advanced breast cancer has a PIK3CA mutation and may be eligible for treatment with Piqray plus fulvestrant combination therapy. 
(more…)
Author Interviews, ENT / 03.06.2019

MedicalResearch.com Interview with: Edward McCoul, MD, MPH, FACS Associate Professor Director, Rhinology and Sinus Surgery Department of Otorhinolaryngology Ochsner Clinic New Orleans, Louisiana  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Although the potential for doctors and patients to misunderstand each other has been noted in other areas of medicine, the meaning of the word "congestion" had not previously been the subject of study.  This paper calls attention to the relevance of potential communication gap in otolaryngology.  This is particularly important since congestion is a major diagnostic criteria of sinusitis, which ranks nationwide in the top 5 reasons for clinical encounters year after year.  If a communication gap is evident around this particular term, which is integral to establishing a diagnosis of sinusitis, then the likelihood increases that patients who present with "sinusitis" will be incorrectly diagnosed. The process of congestion refers to the microscopic accumulation of blood and/or fluid within cells or the spaces between cells in a particular tissue or body part.  When this occurs in the nose, the result is swelling inside the nose, which narrows the space for air to flow.  A patient would perceive this as blockage or obstruction of airflow.  This can be treated with anti-inflammatory medication that reduces swelling.  Medications that clear up mucus generally are not great at reducing swelling.  Many over-the-counter products are available that combine both types of medications, but using those products runs the risk of overmedication, which can have adverse consequences. (more…)
ASCO, Author Interviews, Breast Cancer, Cancer Research, Chemotherapy, Radiation Therapy / 03.06.2019

MedicalResearch.com Interview with: Manjeet Chadha, MD, MHA, FACR, FASTRO Prof. Radiation Oncology Director of the Department of Radiation Oncology Mount Sinai Downtown  MedicalResearch.com: What is the background for this study? Response: Largely, the goal of cancer care among the elderly is to de-escalate therapy searching for a modality that is both an effective treatment and also associated with minimal toxicity. Approximately, 30% of new breast cancers diagnosed annually are among women older than 70 years of age. Age-adjusted trends note a relatively higher incidence of stage I breast cancer in women between the ages of 70-74 years. For this group of patients, it is imperative that we take a closer look at the evidence-base for our current practice standards, and evaluate opportunities to improve cancer care delivery in the elderly. Randomized trials have helped arrive at an acceptance of adjuvant endocrine monotherapy in older patients with ER positive, node negative breast cancer. However, in the older patients high rates of non-compliance to tamoxifen secondary to poor tolerance is widely recognized. Emerging data also detail the side effect profile of aromatase inhibitors. Most commonly observed symptoms of arthralgia, reduced bone mineral density, and increased risk of fractures throughout the duration of treatment are important considerations for an older population. At least a quarter of patients on aromatase inhibitors discontinue therapy specifically due to skeletal events and musculoskeletal symptoms. Overall, the side effects of ET contribute to a high rate of non-compliance and negative impact on patients’ quality of life. (more…)
Author Interviews, Dental Research / 02.06.2019

MedicalResearch.com Interview with: Dr. Katie Suda, PharmD, M.S.  Associate Professor College of Pharmacy University of Illinois at Chicago  MedicalResearch.com: What is the background for this study? Response: Dentists prescribe approximately 1 in every 10 antibiotics in the United States and are the top specialty prescriber. Dentists are the primary prescriber of clindamycin in the U.S., which is associated with a high risk of C. difficile infection (an overgrowth of bacteria in the GI tract that can cause a life-threatening infection). Clinical guidelines recommend that patients with specific cardiac conditions receive a dose of antibiotics prior to undergoing invasive dental procedures to prevent infective endocarditis (an infection of the heart values). Taking a dose of antibiotics prior to a dental visit is referred to as antibiotic prophylaxis. Starting in 2007, these guidelines were narrowed secondary to poor evidence on the effectiveness of antibiotic prophylaxis and the risk of antibiotic-related adverse events. Antibiotic adverse events include antibiotic resistance, C. difficile infection, and other general adverse events (nausea, vomiting, diarrhea). While significant research has been conducted on unnecessary prescribing of antibiotics by medical providers, little work has described appropriateness of prescribing by dentists. We assessed if antibiotics prescribed for prophylaxis prior to dental procedures were consistent with clinical guidelines. (more…)
ASCO, Author Interviews, Biomarkers, Melanoma, NYU / 02.06.2019

MedicalResearch.com Interview with: David Polsky, MD, PhD Dermatologist and Director of the Digmented Lesion Service Mahrukh M. Syeda, MS Research Associate Ronald O. Perelman Department of Dermatology NYU Langone Health MedicalResearch.com: What is the background for this study? Response: Several studies of metastatic melanoma patients have demonstrated that measuring circulating tumor DNA (ctDNA) associates with their disease burden and survival.  Generally, patients with detectable pre-treatment ctDNA levels and/or detectable ctDNA at various time intervals after starting treatment have shorter survivals than patients with lower pre-treatment or on-treatment ctDNA levels.  Studies have varied in their methods to detect ctDNA, the thresholds chosen to call a sample positive or negative, and the follow up time point for measurement, if any. In this study, we examined pre-treatment and week 4 on-treatment plasma samples from patients enrolled in Combi-D, the Phase III, randomized, double-blind trial of the BRAF and MEK inhibitors Dabrafenib and Trametinib, which led to FDA approval of the combination therapy for patients with unresectable stage III/IV melanoma. Only patients with BRAF V600E or V600K mutations identified from tumor genotyping were enrolled in the clinical trial. (more…)
Author Interviews, Brigham & Women's - Harvard, Exercise - Fitness, JAMA / 02.06.2019

MedicalResearch.com Interview with: I-Min Lee, MD, ScD Professor of Medicine, Harvard Medical School Professor of Epidemiology Harvard T.H. Chan School of Public Health  MedicalResearch.com: What is the background for this study? Response: While we have many studies showing that physical activity is beneficial for health, there are few data on steps and health, particularly long-term health outcomes.  An expert committee – the 2018 Physical Activity Guidelines Advisory Committee, which reviewed the scientific evidence to support the recently released Physical Activity Guidelines for Americans, 2nd edition – noted this (i.e., the relation between steps and health outcomes) to be a critical gap in knowledge, since many individuals are using wearables and monitoring their step counts. We often hear the number 10,000 steps cited as a daily goal, but the basis for this number is unclear. It likely originated as a marketing tool: in 1965, the Yamasa Clock and Instrument Company, Japan sold a pedometer called “Manpo-kei” – “ten thousand steps meter” in Japanese. For many older people, 10,000 steps/day can be a very daunting goal; thus, we wanted to investigate whether this was necessary for lower mortality rates in older women.  Additionally, steps taken can be fast or slow, and there are no published studies on step intensity and long-term health outcomes.  Note that walking pace and step intensity are not the same concept: walking pace gauges intensity when walking purposefully (e.g., for exercise or transportation), while step intensity assesses an overall best natural effort in our daily life. (more…)
ASCO, Author Interviews, Cancer Research, J&J-Janssen, NEJM, Prostate Cancer / 01.06.2019

MedicalResearch.com Interview with: Dr. Kim Chi. MD Professor of Medicine Medical Oncologist and Medical Director at BC Cancer – Vancouver University of British Columbia, Principal Investigator of the TITAN Study. MedicalResearch.com: What is the background for this study? Response: For more than 70 years, androgen deprivation therapy (ADT) has been the standard of care therapy for patients with metastatic prostate cancer. The Phase 3 TITAN study looked at adding apalutamide (®®®®) to ADT compared with placebo plus ADT in a broad group of patients with metastatic castration-sensitive prostate cancer (mCSPC), regardless of disease volume or prior docetaxel treatment history. Metastatic castration-sensitive prostate cancer is prostate cancer that still responds to androgen deprivation therapy and has spread to other parts of the body. Patients with mCSPC tend to have a poor prognosis, with a median overall survival (OS) of less than five years, underscoring the need for new treatment options. The dual primary endpoints of this study were overall survival and radiographic progression-free survival (rPFS).  (more…)
Author Interviews / 01.06.2019

MedicalResearch.com Interview with: Erika Garcia, PhD, MPH Postdoctoral Scholar Division of Environmental Health Department of Preventive Medicine Keck School of Medicine University of Southern California Los Angeles, CA 90089-9237 MedicalResearch.com: What is the background for this study? Response: It is known that air pollution can exacerbate pre-existing asthma, but what is not yet established is whether air pollution exposure contributes to the development of new cases of asthma. There is increasing scientific evidence supporting a role of air pollution in asthma development. In this study we examined whether reductions in air pollution levels in Southern California were associated with subsequent reductions in rates of new-onset asthma in children. We separately evaluated four pollutants: nitrogen dioxide, ozone, coarse particulate matter (PM10), and fine particulate matter (PM2.5). (more…)
Author Interviews, Dermatology, JAMA / 01.06.2019

MedicalResearch.com Interview with: Jung Min Bae, MD, PhD Associate Professor, Department of Dermatology St. Vincent's Hospital College of Medicine, The Catholic University of Korea  MedicalResearch.com: What is the background for this study? Response: Vitiligo is a common chronic skin disease affecting 1% of the population, and it causes low self-esteem and social stigma. To date, there are no approved drugs for the treatment of vitiligo, even though growing evidence indicates favorable therapeutic responses of topical calcineurin inhibitors (TCIs) including tacrolimus and pimecrolimus. In this study, we conducted a systematic review and meta-analysis of all relevant prospective studies (n = 46) and identified remarkable therapeutic responses of TCI monotherapy and TCI plus phototherapy for vitiligo. (more…)
Author Interviews, Pharmaceutical Companies, Prostate, Urology / 31.05.2019

MedicalResearch.com Interview with: Steven A. Kaplan, M.D., FACS Professor of Urology Director, The Men's Health Program Icahn School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? Response: PLUS is the first large-scale trial conducted in North America and Europe specifically designed to study the effects of mirabegron in controlling residual symptoms of urinary urgency and frequency in men with benign prostatic hyperplasia (BPH) using common agents such as tamsulosin (Flomax). We explored whether mirabegron (Myrbetriq), an agent approved for the treatment of overactive bladder (OAB), improved patient outcomes when added to tamsulosin. This was a randomized, double-blind, placebo-controlled, multi-center study enrolling 715 male patients 40 years of age and older. (more…)
Author Interviews, Gastrointestinal Disease, Heart Disease, Pharmacology / 31.05.2019

MedicalResearch.com Interview with: Ziyad Al-Aly, MD, FASN Assistant Professor of Medicine Director of the Clinical Epidemiology Center Chief of Research and Education Department of Veterans Affairs Health Care System Saint Louis  MedicalResearch.com: What is the background for this study?   Response: In 2017, we published a paper showing increased risk of death associated with Proton-pump inhibitors (PPI) use. Following the publication of that 2017 paper, several key stakeholders including patients, doctors, research scientists, medical media folks, mainstream media folks, and others asked us: what do these people die from? Did you study causes of death attributable to PPI use? In the study published today, we developed a causal inference framework to answer this question. (more…)
Author Interviews, Heart Disease, Supplements / 31.05.2019

MedicalResearch.com Interview with:

Lu Qi, MD, PhD, FAHA MD, PhD, FAHA HCA Regents Distinguished Chair and Professor Director, Tulane University Obesity Research Center Department of Epidemiology Tulane University School of Public Health and Tropical Medicine New Orleans, LA 70112 

MedicalResearch.com: What is the background for this study? Response: There is evidence from previous experimental studies or cross-sectional analyses in humans linking glucosamine and a variety potentially protective effects such as improving lipids, inhibiting inflammation, and mimic a low-carb diet.   (more…)
Author Interviews, Boehringer Ingelheim, NEJM, Pharmaceutical Companies, Pulmonary Disease / 30.05.2019

MedicalResearch.com Interview with: Donald Zoz, M.D., Senior associate director Clinical Development & Medical Affairs Boehringer Ingelheim Pharmaceuticals, Inc. MedicalResearch.com: What is the background for this study? How does nintedanib differ from other treatments for SSc-ILD? What are the main findings?  Response: SENSCIS is a Phase III double-blind, randomized placebo-controlled trial that included 576 patients in 32 countries. It is the largest trial to have been conducted in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD). The primary endpoint was the annual rate of decline in forced vital capacity (FVC) over 52 weeks. At the end of the 52-week trial, patients receiving nintedanib had an adjusted annual rate of decline in FVC (mL/year) of -52.4 with nintedanib versus -93.3 with placebo (absolute difference 41.0mL/year [95% CI 2.9, 79.0]; p=0.04). This corresponds to a relative difference of 44% reduction in lung function decline. There are currently no approved treatments for SSc-ILD., BI conducted the SENSCIS study to evaluate in SSc-ILD patients the impact of nintedanib. Nintedanib, a selective tyrosine kinase inhibitor, is an antifibrotic agent. Results of the study, which were published in The New England Journal of Medicine and presented at the American Thoracic Society (ATS) International Conference, showed that nintedanib slowed the loss of pulmonary function by 44% in patients with SSc-ILD relative to placebo, as measured by FVC over 52 weeks.  (more…)
Author Interviews, Dermatology / 30.05.2019

MedicalResearch.com Interview with: Lara B. McKenzie, PhD, MA Principal Investigator in the Center for Injury Research and Policy Research Institute at Nationwide Children's Hospital Associate Professor in the Department of Pediatrics College of Medicine and the Division of Epidemiology College of Public Health at The Ohio State University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Social media and other online tools have changed the way people seek and share health information. Recent consumer interest in natural, organic, and ethically-made personal care products has led to an increase of shared recipes for homemade products including sunscreen. The study found that nearly all (95%) pins, or bookmarks, for homemade sunscreen positively portrayed the effectiveness of homemade sunscreens and most (68%) recommended recipes for homemade sunscreens that offered insufficient UV radiation protection. Sun Protection Factor (SPF) claims were made in a third of pins with a range of SPF 2 to SPF 50. This is concerning because the ingredients recommended in homemade sunscreen pins offer minimal scientifically proven broad-spectrum protection from UV radiation yet are widely shared and promoted as safe alternatives to commercial sunscreens on Pinterest. Homemade sunscreen products are risky because they are not regulated or tested for efficacy like commercial sunscreens. When you make it yourself, you don’t know if it’s safe or effective. With rising skin cancer rates, the use of effective broadband sunscreen is critical to protect the skin from UV radiation and reduce incidence of skin cancer.  (more…)
Author Interviews, Clots - Coagulation, Duke, Genetic Research, Heart Disease, JAMA / 30.05.2019

MedicalResearch.com Interview with: Thomas J. Povsic, MD, PhD Interventional Cardiologist Duke Clinical Research Institute Duke University School of Medicine Durham, North Carolina  MedicalResearch.com: What is the background for this study?  Response: The background for this study is that it is unknown how mandatory reporting of CYP2C19 metabolizer status affects how doctors treat patients or to what degree provision of this information would affect choice of a P2Y12 inhibitor within a clinical trial. As part of the GEMINI-ACS trial, all patients underwent CYP2C19 metabolizer testing.  This trial enrolled patients with a recent acute coronary syndrome and randomized them to aspirin or a low dose of rivaroxaban.  All patients were also to be treated with ticagrelor or clopidogrel, which was at the discretion of the investigator.  Investigators were given information regarding the CYP2C19 metabolizer status about a week after randomization.  Importantly prior to randomization, all investigators were asked how they expected to use this information, and then we followed what they actually did. (more…)