AstraZeneca, Author Interviews, NEJM, Pulmonary Disease / 29.06.2020

MedicalResearch.com Interview with: Frank Trudo, MD MBA Vice President, US Medical Affairs Respiratory & Immunology AstraZeneca MedicalResearch.com: What is the background for this study? Response: ETHOS is a randomized, double-blinded, multi-center, parallel-group, 52-week trial to assess the efficacy and safety of PT010 in symptomatic patients with moderate to very severe COPD and a history of exacerbation(s) in the previous year. Outcomes in the ETHOS trial included, as a primary endpoint, the rate of moderate or severe exacerbations. MedicalResearch.com: How does PT010 differ from other treatments for COPD?
  • Highly competitive: PT010’s Phase III clinical trial program demonstrates it has a highly competitive clinical profile in decreasing moderate or severe exacerbations. Severe exacerbations were defined as exacerbations leading to hospitalization or death.
  • All-cause mortality: In a secondary endpoint, PT010 showed a 46% reduction in the risk of all-cause mortality compared with glycopyrronium/formoterol fumarate. The data from ETHOS show that reducing risk of all-cause mortality is achievable for patients with this progressive disease and could transform treatment goals in COPD.
  • Two potential dose options: This is also the first time we have seen the benefit of closed triple-combination therapy at two ICS doses, which could transform care by allowing physicians to select the optimal dosing option for individual patients. 
(more…)
Author Interviews, CDC, Diabetes, Gender Differences, Race/Ethnic Diversity / 29.06.2020

MedicalResearch.com Interview with: Giuseppina Imperatore, MD, PHD CDC, Atlanta MedicalResearch.com: What is the background for this study? Response: The lifetime risk of diabetes (LRD), a probability of developing diabetes during a person’s lifespan, is a measure of future disease burden that reflects the impact of incidence (occurrence of new cases per year) and mortality. The years of potential life lost to diabetes (YPLLD) is the number of life-years lost due to diabetes, calculated as the difference between the life expectancy of a person without diabetes and a person with diabetes at the age of diagnosis. For example, the number of life-years lost for a person diagnosed at age 20 years is the difference in life expectancy of a person who died without developing diabetes and a person who was diagnosed with diabetes at 20 years of age.  Both incidence and mortality of diabetes have been decreasing for more than a decade. The effects of those changes on lifetime risk of diabetes and years of potential life lost to diabetes are not known. In this study, we used nationally representative diabetes surveillance data to provide updated estimates for the lifetime probability of development of diabetes, and to assess changes in incidence and mortality on lifetime risk and life-years lost due to diabetes in the USA. (more…)
Annals Internal Medicine, Author Interviews, CDC, Vaccine Studies / 28.06.2020

MedicalResearch.com Interview with: Dr. Elisabeth Hesse, MD Epidemic Intelligence Service (EIS Officer) Centers for Disease Control and Prevention MedicalResearch.com: What is the background for this study? Response: Over the last decade, there has been increasing attention given to shoulder injuries diagnosed after intramuscular vaccinations, with multiple publications of case reports and case series. However, to the best of our knowledge, there haven’t been any robust studies to determine how frequently this happens and what may make some people more likely than others to have shoulder injuries after vaccination. The Vaccine Safety Datalink (VSD) is an ideal system to use for such a study, because it contains medical and vaccination records of over 10 million people across the United States. We found that out of the 2.9 million people over the age of 3 who received an injectable flu vaccine (specifically, inactivated influenza vaccine) during the 2016-2017 flu season, fewer than 8 people per million vaccinated developed shoulder bursitis that can be attributed to the vaccination. (more…)
Author Interviews, Emergency Care, Heart Disease, Social Issues / 28.06.2020

MedicalResearch.com Interview with: Sriman Gaddam The University of Texas at Austin Austin, TX 78705 MedicalResearch.com: What is the background for this study? Response: The quality of care that patients receive from the US healthcare system continues to be influenced by socioeconomic status (SES). Given that cardiac arrest is one of the most common causes of death in the US and that the prehospital setting has an especially high mortality for cardiac arrest, we wanted to determine if the socioeconomic disparities found in the overall US healthcare system continued into the prehospital cardiac arrest setting. MedicalResearch.com: What are the main findings? Response: We found that socioeconomic disparities were present in the prehospital cardiac arrest setting. As the SES of a patient declines, so does the patient's likelihood of achieving return of spontaneous circulation (ROSC). Between the most and least wealthy patients, there was nearly a 13% difference in the probability of achieving ROSC. However, we recognized that not all patients who achieve ROSC are equal as patients can have significantly different neurological functioning depending on the length of time spent in cardiac arrest. Consequently, this paper analyzed cardiac arrest outcomes not only through the occurrence of ROSC but also through the duration of time spent in cardiac arrest. In line with the socioeconomic disparities found in ROSC occurrence, it was found that as a patient's SES declines, the duration of time spent in cardiac arrest before ROSC is achieved increases. This indicates that patients with a low SES are both more likely to not achieve ROSC and if ROSC is achieved more likely to have neurological impairment due to longer time spent in cardiac arrest compared to patients with a high SES. (more…)
Author Interviews, Biomarkers, Cancer Research / 28.06.2020

MedicalResearch.com Interview with: Dr. Kathryn Lang VP, Outcomes and Evidence Guardant Health  MedicalResearch.com: What is the background for this study? Response: Despite a wide variety of screening methods available and increasing public awareness of the value of early detection, colorectal cancer (CRC) remains a leading cause of cancer-related deaths.  However nearly 1 in 3 adults in the United States  is not compliant with screening recommendations, with most citing that current screening methods are time consuming, unpleasant (stool-based testing), and in the case of colonoscopy, invasive. A blood-based CRC screening test could improve compliance rates by providing physicians with an opportunistic, in-office screening modality. However, demonstrating the clinical utility of blood-based cell-free circulating tumor DNA (ctDNA) fractions  for the detection of cancer in asymptomatic individuals has thus far been challenged by the failure to achieve clinically meaningful sensitivity and specificity thresholds due to significantly lower tumor cell-free free DNA  fractions and the increasing relevance of biological confounders. The multi-modal approach of Guardant Health’s LUNAR-2 assay (genomics, methylation and fragmentomics) coupled with advanced bioinformatic analysis and a focused approach of honing in on the unique signals of CRC  has been shown in previously reported cohorts to perform with sensitivity and specificity which satisfies the needs of clinicians in screening for CRC. (more…)
Author Interviews, JAMA, Nutrition, Social Issues / 28.06.2020

MedicalResearch.com Interview with: Erin Brantley, PhD, MPH Senior Research Associate Department of Health Policy and Management Milken Institute School of Public Health Preferred pronouns: she/her/hers  MedicalResearch.com: What is the background for this study? What are the main findings? Response: We looked at what happened when work requirements for the Supplemental Nutrition Assistance Program Participation, or SNAP, were turned on in many places after the Great Recession. We found large drops in participation in SNAP benefits due to work requirements, and that black recipients were more likely to lose benefits than white recipients. We think this is driven by the fact that black workers face higher unemployment rates than white workers, and work requirement policies do not take this into account. We also found that some people who report having disabilities lost benefits, even though the intent of work requirements is that they apply to people without disabilities.  (more…)
Author Interviews, COVID -19 Coronavirus, Dermatology, Environmental Risks, JAMA / 26.06.2020

MedicalResearch.com Interview with: Dr Herman Anne MD Service de Dermatologie Cliniques Universitaires Saint-Luc   MedicalResearch.com: What is the background for this study? Response: In the context of the COVID-19 pandemic, several cases of acro-located lesions (on foot or hands) suggestive of chilblains have been reported and were possibly related to COVID-19. We wanted to determine if chilblains, observed in many patients recently referred to our department, are indicative of COVID-19. MedicalResearch.com: Would you briefly explain what is meant by chilblains? Response: Chilblains are frequent cold induced inflammatory lesions. Chilblains are typically seen in winter and occur after repeated exposure to cold temperatures. Clinical presentation includes erythema and swelling on toes and/or digits followed by red-purple macules or patches. However, given the large number of patients affected, and the exceptionally high outdoor temperatures for the spring season over the past month and at the time of case-observation, cold-exposure seemed unlikely. These lesions were, therefore, suspected to be associated with COVID-19. However, to date, no study has proven a pathological link between these lesions and COVID-19. (more…)
Author Interviews, JAMA, Metabolic Syndrome, Race/Ethnic Diversity, Weight Research / 26.06.2020

MedicalResearch.com Interview with: Robert Wong, MD, MS Division of Gastroenterology and Hepatology Veterans Affairs Palo Alto Healthcare System Stanford University School of Medicine MedicalResearch.com: What is the background for this study? Response: Prior to this study, we already knew that obesity and metabolic syndrome were major public health issues in the U.S.  A previous analyses by our team which analyzed data through 2012 observed than one in three adults in the U.S. have metabolic syndrome.  The aim of our current study was to evaluate more recent trends in the prevalence of metabolic syndrome and to identify whether certain groups are at higher risk of having metabolic syndrome.  (more…)
AACR, Author Interviews, Biomarkers, Cancer Research, Colon Cancer / 26.06.2020

MedicalResearch.com Interview with: Guardant HealthVan Morris, M.D. Department of Gastrointestinal Medical Oncology Division of Cancer Medicine MD Anderson Center MedicalResearch.com: What is the background for this study? Response: Stage II colon cancer is diagnosed in approximately 25% of all colon cancer cases.  Oncologists do not have a reliable biomarker to identify patients who do or do benefit from adjuvant chemotherapy for this population of patients.  Circulating tumor DNA is shed by tumor cells as they die and harbors somatic mutations which distinguish its DNA from that of normal cells. Recently, circulating tumor DNA has shown great promise in distinguishing patients with colon cancer (as well as other solid tumors) that do or do not recur after surgery.  Here, patients who have detectable circulating tumor DNA - a surrogate for the presence of microscopic, minimal residual disease – inevitably recur, whereas the likelihood of recurrence is much lower for patients who do not have detectable ctDNA. (more…)
Author Interviews, Hematology / 25.06.2020

MedicalResearch.com Interview with: TakedaDr. med. Wolfhard Erdlenbruch, M.D. Vice President Head of Global Medical Affairs Hematology MedicalResearch.com: What is the background for this study? Response: At the World Federation of Hemophilia Virtual Summit 2020 (WFH 2020), results were presented from a real-world, post-marketing surveillance study aimed to evaluate the safety and effectiveness of RIXUBIS® in adult and pediatric patients with hemophilia B in South Korea, entitled “Safety and Effectiveness of Rixubis in Patients with Hemophilia B in South Korea: A Real-World, Prospective, Post-marketing Surveillance Study”. Data from the study demonstrate the safety and efficacy profile of RIXUBIS® for treatment of bleeds, perioperative/surgery, and prophylaxis in adult and pediatric patients with hemophilia B in the real-world setting in South Korea. The study showed that 86.6% (123/142) of hemostatic effectiveness assessments for RIXUBIS® were reported as good or excellent, and of the 11 adverse events reported, all were mild in severity, with 10 resolved/recovered events not related to RIXUBIS®, and one event (inhibitory antibody development) unconfirmed.1 RIXUBIS® [Nonacog gamma, recombinant FIX concentrate] is a recombinant coagulation factor IX product, indicated for the control and prevention of bleeding episodes in patients with hemophilia B. (more…)
Author Interviews, Dermatology / 25.06.2020

MedicalResearch.com Interview with: Dr. Jonathan L. Silverberg MD PhD MPH Assistant Professor in Dermatology Medical Social Sciences and Preventive Medicine Northwestern, Chicago, Illinois MedicalResearch.com: What is the background for this study? Response: Topical anti-inflammatory therapy is often inadequate to achieve disease control in patients with moderate-to-severe atopic dermatitis (AD), and systemic therapy is often warranted. Tralokinumab is a fully human immunoglobulin G4 monoclonal antibody that specifically binds to the IL-13 cytokine with high affinity and inhibits downstream IL-13 pro-inflammatory signaling. Tralokinumab was previously studied as a monotherapy in moderate-severe AD in the ECZTRA1 and ECZTRA2 studies. In this Phase 3 randomized controlled study, ECZTRA3, tralokinumab was studies in combination with topical corticosteroids compared to placebo with topical corticosteroids. The use of topical anti-inflammatory therapy is more akin to the way in which systemic and biologic therapies are typically used in the real-world. (more…)
Author Interviews, COVID -19 Coronavirus, Heart Disease / 24.06.2020

MedicalResearch.com Interview with: Spyridon G. Deftereos MD PhD Prof. of Cardiology, Medical School National and Kapodistrian University of Athens Greece MedicalResearch.com: What is the background for this study? Response: Research on COVID-19 early revealed that inflammation plays a crucial role in the pathophysiology of the disease. Therefore, we designed GRECCO-19 study in order to evaluate the effect of colchicine, a relatively safe drug with known anti-inflammatory properties, in patients hospitalized for SARS-CoV-2 infection. (more…)
Author Interviews, Gout, Kidney Disease, NEJM / 24.06.2020

MedicalResearch.com Interview with: Sunil Badve MBBS, MD, DNB, FRACP, PhD, FASN Staff specialist nephrologist | St George Hospital Conjoint Associate Professor | University of New South Wales Senior Research Fellow, Acute Kidney Injury and Trials The George Institute for Global Health Australia  MedicalResearch.com: What is the background for this study? Response: Elevated serum urate levels are associated with progression of chronic kidney disease (CKD). CKD patients often have elevated serum urate levels due to decreased excretion. We conducted this placebo-controlled randomized trial to evaluate if urate-lowering treatment with allopurinol would attenuate decline in estimated glomerular filtration rate (eGFR) over 2 years in patients with CKD. We enrolled 369 CKD patients with high progression risk and no prior history of gout. (more…)
Author Interviews, Brigham & Women's - Harvard, Critical Care - Intensive Care - ICUs, NEJM, Pediatrics / 24.06.2020

MedicalResearch.com Interview with: Christopher P. Landrigan, MD, MPH Chief, Division of General Pediatrics, Boston Children’s Hospital Director, Sleep and Patient Safety Program, Brigham and Women's Hospital William Berenberg Professor of Pediatrics, Harvard Medical School Boston Children's Hospital Boston, MA 02115 MedicalResearch.com: What is the background for this study? Response: An enormous body of literature demonstrates that sleep deprivation adversely affects the safety and performance of resident physicians, as well as individuals across other occupations.  Resident physicians are at greatly increased risk of suffering motor vehicle crashes and needlestick injuries, and are at substantially increased risk of making medical errors, when working on traditional schedules that include 24-hour shifts. We previously conducted a randomized controlled trial in two intensive care units that found resident physicians made 36% fewer medical errors when a scheduling intervention was introduced that eliminated 24-hour shifts but held resident workload constant. The current study, ROSTERS, was a 6-center study that again introduced a scheduling intervention to eliminate 24-hour shifts in intensive care units.  Due to varying resources and unit organization across sites, each hospital developed its own staffing plan to accommodate the intervention​. (more…)
Aging, Author Interviews, Genetic Research / 24.06.2020

MedicalResearch.com Interview with: Andrea Bodnar, Ph.D., Science Director Gloucester Marine Genomics Institute (GMGI) MedicalResearch.com: What is the background for this study? How does gene expression differ in the red sea urchin from humans?  Why is this animal not susceptible to age-related deterioration? Response: The red sea urchin is one of the earth’s longest-lived animals, living for more than 100 years without showing signs of aging. These animals grow and reproduce throughout their lives and show no increase in mortality rate or incidence of disease with age. This includes no reported cases of neoplastic disease, like cancer. To begin to understand the cellular mechanisms underpinning this extraordinary life history this study investigated gene expression patterns in the tissues of young and old red sea urchins. (more…)
Author Interviews, Cost of Health Care, JAMA, Race/Ethnic Diversity / 24.06.2020

MedicalResearch.com Interview with: Megan B. Cole Brahim, PhD, MPH Assistant Professor | Dept. of Health Law, Policy, & Management Boston University School of Public Health Boston, MA MedicalResearch.com: What is the background for this study? Response: Enrollment in high deductible health plans (HDHPs)—which require patients to pay on the upwards of thousands of dollars in out-of-pocket costs before they can use their health insurance coverage for most services—has skyrocketed over the last decade. For cancer survivors in particular, this is really concerning, as patients may avoid or delay necessary health care services or important medications because they can’t afford their deductible. We know from previous work that HDHPs are associated with less use of health care, including less cancer screening and treatment. However, there has been very little work to assess how HDHPs may contribute to racial/ethnic disparities in care, and our study is the first known study to assess how HDHPs may contribute to racial/ethnic disparities in cancer survivors. To fill this gap, we used nationally representative survey data from 2013-2018 to assess how enrollment in high deductible health plans was associated with cost-related barriers to care among cancer survivors with private insurance, and how this relationship varied across racial/ethnic groups. (more…)
Author Interviews, Dermatology, Regeneron / 23.06.2020

MedicalResearch.com Interview with: Brad Shumel, MD Senior Director of Medical Affairs, Immunology Regeneron MedicalResearch.com: What is the background for this study? Response: Atopic dermatitis is a chronic inflammatory disease and one of the most common skin disorders in children. Severe atopic dermatitis is characterized by skin lesions that often cover a large body surface area and can include intense, persistent itch. Uncontrolled moderate-to-severe atopic dermatitis can have a physical, emotional and psychosocial impact on children, resulting in sleep deprivation, activity restriction, poor school performance, depression and anxiety that can have a greater impact on quality-of-life. The standard of care for this pediatric population has been topical corticosteroids. Children with severe atopic dermatitis who remain uncontrolled with topical therapies have limited treatment options. This Phase 3 trial was conducted to evaluate the safety and efficacy of dupilumab plus topical corticosteroids (TCS) compared with TCS alone in children with uncontrolled severe atopic dermatitis across two treatment arms – every four weeks and every two weeks (Q4W and Q2W). (more…)
Accidents & Violence, Author Interviews, Cannabis, JAMA, NYU / 23.06.2020

MedicalResearch.com Interview with: Julian Santaella Tenorio, MSc DrPH Epidemiology Center for Opioid Epidemiology and Policy Division of Epidemiology, Department of Population Health New York University Langone School of Medicine, New York, New York MedicalResearch.com: What are the main findings? car-accident-traffic-accidentResponse: This study found that recreational cannabis laws were associated with increases in traffic fatalities in Colorado (mean of 75 excess fatalities per year) but not in Washington State.  These findings suggest that unintended effects of recreational cannabis laws can be heterogeneous and may be specific to variations in how these laws are implemented
(eg, density of recreational cannabis stores).   (more…)
Author Interviews, Dermatology, Melanoma, Nature, Technology / 23.06.2020

MedicalResearch.com Interview with: Professor Harald Kittler, MD ViDIR Group, Department of Dermatology Medical University of Vienna Vienna, Austria MedicalResearch.com: What is the background for this study?  What types of skin cancers were assessed? (melanoma, SCC, Merkel etc). Response: Some researchers believe that AI will make human intelligence dispensable. It is, however, still a matter of debate how exactly AI will influence diagnostic medicine in the future. The current narrative is focused on a competition between human and artificial intelligence. We sought to shift the direction of this narrative more towards human/AI collaboration. To this end we studied the use-case of skin cancer diagnosis including the most common types of skin cancer such as melanoma, basal cell- and squamous cell carcinoma. The initial idea was to explore the effects of varied representations of AI support across different levels of clinical expertise and to address the question of how humans and machines work together as a team. (more…)
Author Interviews, Diabetes, Nutrition / 23.06.2020

MedicalResearch.com Interview with: Ana M Valdes MA PhD Associate Professor and Reader in Musculoskeletal Genetics Professor in Molecular and Genetic Epidemiology from 1 August 2020 Deputy Head of Division, Rheumatology Orthopaedics and Dermatology NIHR Nottingham Biomedical Research Centre - Research Area Lead School of Medicine University of Nottingham  MedicalResearch.com: What is the background for this study? Response: Given the relevance of blood sugar and blood lipid levels, we wanted to be able to quantify how much meal content, time of day, sleep, gut microbiome, other individual characteristics contribute to glucose and to develop models to describe how the interactions between individual characteristics, meal composition, other sources of variation on postprandial glycemia. We also wished to compare glucose data to other postrpandial metabolic responses, specifically c-peptide and triglyceride levels. (more…)
Author Interviews, Cannabis, Opiods / 22.06.2020

MedicalResearch.com Interview with: Amalie K. Kropp Lopez, MS MD Candidate Geisinger Commonwealth School of Medicine Class of 2023 Scranton, Pennsylvania MedicalResearch.com: What is the background for this study? Response: The opioid crisis is still affecting America, effecting millions of people from all walks of life. With the high risks of abuse and overtreatment with opioids, marijuana has been a newly reconsidered alterative for pain treatment. This study sought to quantify the changes in prescription opioid distribution using data reported by the Drug Enforcement Administration in Colorado after the legalization of recreational marijuana which gave the public increased access to its pain-relieving effects. (more…)
Author Interviews, Education / 22.06.2020

MedicalResearch.com Interview with: Shawn Loewen PhD Professor, Michigan State University Department of Linguistics & Germanic, Slavic, Asian and African Languages Second Language Studies Program Associate Editor, The Modern Language Journal East Lansing, MI  MedicalResearch.com: What is the background for this study? Response: Millions of people use language learning apps such as Babel to study a foreign language; however, very little research has been conducted to investigate the effectiveness of such apps, in spite of some grand claims that companies make about the benefits of their apps. (more…)
Author Interviews, Dermatology, Kidney Disease / 22.06.2020

MedicalResearch.com Interview with: Gil Yosipovitch, MD, Professor Miami Itch Center Lennar Medical Foundation South Miami Clinic in Coral Gables University of Miami Health System MedicalResearch.com: What is the background for this study? Response: Chronic Pruritus is a common and burdensome condition in patients with end stage chronic kidney disease (CKD). It is Present at all stages of CKD, not only in patients undergoing hemodialysis (including stage 3-5 CKD). There are no approved treatments for this condition in US and Europe. CKD pruritus   has significant impact on quality of life of patients with higher mortality rates due to its effect on sleep. Studies in the last 2 decades have shown that in patients with CKD pruritus there is an imbalance between endogenous mu opioids that are over expressed to Kappa Opioids that are down regulated.   Difelikefalin (DFK) is a novel peripherally selective kappa opioid receptor (KOR) agonist.   Study of IV DFK administration  in hemodialysis patients has  recently  been published and showed significant anti Pruritic effect ( NEJM Fishbane et al. 382: 289-290, 2020). (more…)
Accidents & Violence, Author Interviews, Cannabis, JAMA / 22.06.2020

MedicalResearch.com Interview with: Russell Kamer, MD Department of Medicine, New York Medical College, Valhalla 15 North Broadway, Suite E White Plains, NY 10601 New York MedicalResearch.com: What is the background for this study? "marijuana apocalypse - weed is a stimulant !" by Blind Nomad is licensed under CC BY 2.0Response: It is well known that marijuana usage impairs driving ability, yet the early studies of the effects of recreational marijuana legalization on traffic fatalities were inconclusive. MedicalResearch.com: What are the main findings? Response: By analyzing data over a longer time period, we found that the legalization of recreational marijuana increased traffic deaths in the first four states to legalize. Traffic fatalities increased about 20% in those states. If we apply these numbers to the nation as a whole, nationwide legalization would be associated with about 7,000 excess traffic fatalities each year. (more…)
Author Interviews, Neurology, Parkinson's / 22.06.2020

MedicalResearch.com Interview with: Stewart A. Factor, D.O. Professor of Neurology Director of the Movement Disorders Program Vance Lanier Chair of Neurology Emory University School of Medicine MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by OFF episodes.  Response: Parkinson’s disease (PD) is a chronic, progressive neurodegenerative disease characterized by motor symptoms, including tremor at rest, rigidity and impaired movement, as well as significant non-motor symptoms, such as cognitive impairment, psychiatric symptoms and autonomic symptoms (i.e. urinary issues, constipation, low blood pressure). It is the second-most common neurodegenerative disease after Alzheimer’s disease and it is predicted that the prevalence of Parkinson’s disease will double by the year 2040. The symptoms of PD are in substantial part, due to loss of dopamine nerve cells in the brain. The current standard of care for PD includes replacing the dopamine loss by the use of oral carbidopa/levodopa. Levodopa is a precursor of dopamine, converted in the brain. OFF episodes have been a significant unmet need in Parkinson’s disease since the emergence of levodopa. Initially, levodopa controls PD symptoms in a continuous fashion throughout the day. With time the response becomes less predictable and patients experience a re-emergence or worsening of PD symptoms. These episodes are what we mean by OFF episodes. OFF episodes can be characterized, in part, by re-emergence of motor symptoms including tremor, stiffness or slowed movement that can happen at any point during the day. OFF episodes typically begin within the first five years of treatment and occur at the end of a dose. This is referred to as end of dose failure or wearing off. Within the first four to six years after diagnosis, regardless of disease severity, up to 60 percent of people with PD experience OFF episodes. With time these episodes become longer, more severe and disabling, more frequent and less predictable as PD progresses. They can take up more than half the day OFF episodes may alter a persons’ ability to perform everyday activities by slowing or even precluding their completion. The result is significant burden and distress for people living with Parkinson’s disease (PD) and their care partners. CTH-300 was a Phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel group, study examining the efficacy, safety and tolerability of apomorphine hydrochloride sublingual film (KYNMOBI) in people with levodopa-responsive PD complicated by OFF episodes. The primary endpoint was a mean change in the score from pre-dose in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Motor Examination at 30 minutes after dosing at the 12-week visit of the maintenance treatment phase. The key secondary endpoint was the percentage of people with PD with a patient-rated full ON (or best) response within 30 minutes at the 12-week visit of the maintenance treatment phase. (more…)
Author Interviews, Prostate Cancer / 22.06.2020

MedicalResearch.com Interview with: Dr Hayley Schultz | Research Associate BPharmSci(Hons), PhD UniSA Clinical and Health Sciences University of South Australia Adelaide SA   MedicalResearch.com: What is the background for this study? Response: Zytiga is a blockbuster medication for treating prostate cancer containing the active ingredient abiraterone acetate, however the formulation is incredibly inefficient. Patients must take 1000 mg per day and fast for 2 hours prior to and 1 hour following its administration. This is because the drug is very water insoluble and has an oral bioavailability of less than 10%. This means only up to 10% of the dose is absorbed from the intestine and enters systemic circulation where it can have a therapeutic effect. The rest of the drug, at least 90% of the dose, moves through the gastrointestinal tract undissolved and is wasted down the toilet. Patients are required to fast when taking the medication as the drugs absorption is heavily and unpredictable increased in the presence of fatty and oily food. We developed a more efficient oral formulation for abiraterone acetate with a greater oral bioavailability, to reduce the dose of the drug and its side effects. (more…)
Author Interviews, Heart Disease, JAMA, Opiods, Surgical Research, University of Pennsylvania / 20.06.2020

MedicalResearch.com Interview with: Chase Brown, MD Associate Fellow, Leonard Davis Institute of Health Economics Integrated Cardiac Surgery Resident Hospital of the University of Pennsylvania Nimesh D. Desai, MD, PhD Director, Thoracic Aortic Surgery Research Program Associate Professor of Surgery Hospital of the University of Pennsylvania MedicalResearch.com: What is the background for this study? Dr. Chase Brown:  Opioid use in the United States is a public health emergency. We know that opioids prescribed after general surgery operations to patients who never received them within the year prior to their surgery are at increased risk for continuing to take opioids months later. However, this has not been studied in patients undergoing cardiac surgery, who often times have more severe post-operative pain. Our goal in this study was to determine how many patients after cardiac surgery and are opioid naive are continuing to take opioids within 90-180 days after their surgery.   (more…)
Author Interviews, Cannabis, Emergency Care / 20.06.2020

MedicalResearch.com Interview with: Ryan Vandrey, Ph.D. Associate Professor Behavioral Pharmacology Research Unit Johns Hopkins University School of Medicine Baltimore, MD 21224  MedicalResearch.com: What is the background for this study? Response: The background for this study is that 33 states in the U.S. have legalized medicinal cannabis use and millions of people are using cannabis for therapeutic purposes, but we have very little data on the broad health impacts of medicinal cannabis use. We surveyed medicinal cannabis users and non-using controls who had a variety of health problems and found that the cannabis users reported better health, quality of life, and less healthcare utilization compared with controls.  Because we worried about group characteristics accounting for the differences observed, we then did an analysis of people who switched groups over time (e.g. non-users who later initiated cannabis use or cannabis users who later quit) and found the same differences emerged in the same individuals over time.  Important to note here is that not all individuals who used cannabis benefited from it and that most participants were using high CBD varieties of cannabis in conjunction with more traditional treatments. (more…)
Addiction, Author Interviews, JAMA, Pediatrics, USPSTF / 20.06.2020

MedicalResearch.com Interview with: Dr. Karina Davidson, PhD Senior Vice President of Research Dean of Academic Affairs Professor of Behavioral Medicine Zucker School of Medicine Hofstra University/Northwell Health Vice Chairmam US Preventive Services Task Force  MedicalResearch.com: What is the background for this study? Response: Drug use is among the most common causes of preventable death, injury, and disability in the United States, with nearly 10 percent of adults reporting unhealthy drug use. This includes the use of illegal drugs, as well as using prescription drugs in ways that are not recommended by a doctor. (more…)