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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…)
Author Interviews, COVID -19 Coronavirus, Emergency Care, Infections, NEJM, Stroke / 09.05.2020

MedicalResearch.com Interview with: Akash Kansagra, MD, MS Assistant Professor of Radiology Neurological Surgery, and Neurology Director, Endovascular Surgical Neuroradiology Co-Director, Stroke and Cerebrovascular Center Washington University and Barnes-Jewish Hospital MedicalResearch.com: What is the background for this study? Response: Over the past five years, medicine has made enormous strides in stroke treatment. The effectiveness of these therapies has been absolutely astounding, and our ability to get patients to hospitals that can provide this life-saving care has also improved dramatically. (more…)
Author Interviews, CDC, NEJM, Pulmonary Disease / 23.04.2020

MedicalResearch.com Interview with: Angela K. Werner, PhD, MPH Environmental Public Health Tracking Program National Center for Environmental Health CDC MedicalResearch.com: What is the background for this study? Response: In August 2019, emergency department (ED) visits related to e-cigarette, or vaping, product-associated lung injury (EVALI) increased sharply, followed by a peak in September. This was followed by a gradual but persistent decline in the number of cases. As of February 18, 2020 (CDC’s latest and final published update), there were a total of 2,807 hospitalized EVALI cases or deaths reported to CDC from all 50 states, the District of Columbia, and two U.S. territories (Puerto Rico and U.S. Virgin Islands). Sixty-eight deaths were confirmed in 29 states and the District of Columbia. Although clinical presentations and outcomes of EVALI patients have been reported, data on patients who died are more limited. This article fills a gap by reporting on a national study assessing detailed demographic, substance use, and clinical characteristics of EVALI patients who have died, and comparing them to the characteristics of EVALI patients who survived. (more…)
Author Interviews, Heart Disease, NEJM, Stanford / 31.03.2020

MedicalResearch.com Interview with: David J. Maron, MD, FACC, FAHA Clinical Professor of Medicine Chief, Stanford Prevention Research Center Director, Preventive Cardiology Stanford University School of Medicine  MedicalResearch.com: What is the background for this study? Response: Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. The goals of treating patients with stable coronary disease are to reduce their risk of death and ischemic events and to improve their quality of life. All patients with coronary disease should be treated with guideline-based medical therapy (GBMT) to achieve these objectives. Before the widespread availability of drug-eluting stents, strategy trials that tested the incremental effect of revascularization added to medical therapy did not show a reduction in the incidence of death or myocardial infarction. In one trial, fractional flow reserve–guided percutaneous coronary intervention (PCI) with drug-eluting stents, added to medical therapy, decreased the incidence of urgent revascularization but not the incidence of death from any cause or myocardial infarction at a mean of 7 months, whereas the 5-year follow-up showed marginal evidence of a decrease in the incidence of myocardial infarction. (more…)
Author Interviews, COVID -19 Coronavirus, NEJM / 28.03.2020

MedicalResearch.com Interview with: Bin Cao, Yeming Wang, Guohui Fan, Lianghan Shang, Jiuyang Xu, DingyuZhang, Chen Wang on behalf of LOTUS-China Study Group China-Japan Friendship Hospital; Wuhan Jintinyan Hospital; Institute of Respiratory Medicine, Chinese Academy of Medical Science  MedicalResearch.com: What is the background for this study? Response: In the past two months, the outbreak of Coronavirus Disease 2019 (COVID-19) has been spreading rapidly across the world. Science and technology is the most powerful weapon for human to fight against diseases, especially in such a pandemic setting. Seeking for effective antiviral medication is the most critical and urgent among the many scientific tasks in the pandemic. At the most critical moment in the fight against COVID-19, Chinese clinical scientists have stepped forward under extremely difficult research conditions to carry out clinical trials in antiviral treatment including lopinavir–ritonavir and remdesivir, in a swift, decisive and effective manner. These trials have attracted worldwide attention. Recently, the Lopinavir–ritonavir Trial for suppression of SARS-CoV-2 in China (LOTUS-China) has been completed, which, with great clinical significance, can provide strong evidence for the treatment of COVID-19 both in China and around the world. (more…)
Author Interviews, HIV, NEJM / 20.03.2020

MedicalResearch.com Interview with: Susan Swindells MBBS Professor, Infectious Diseases Department of Internal Medicine University of Nebraska Medical Center Omaha, NE MedicalResearch.com: What is the background for this study? Response: The background for this study is the development of long-acting injectable formulations of two antiretroviral agents: cabotegravir and rilpivirine.  These were previously tested in a Phase 2 study, and the current study (called ATLAS) reports findings from Phase 3 in which HIV-infected patients on antiretroviral therapy were switched to monthly injections. The partner study, (FLAIR), is published in the same addition of the journal, and reports results from patients that were new to antiretroviral therapy, and took oral medications as a lead-in to achieve viral suppression before switching to similar monthly injections.  Both studies included randomization to continuing oral antiretroviral therapy. (more…)
Asthma, Author Interviews, Brigham & Women's - Harvard, NEJM, Pediatrics, Vitamin D / 10.02.2020

MedicalResearch.com Interview with: Augusto A. Litonjua, M.D., M.P.H. Professor - Department of Pediatrics, Pulmonology Interim Chief - Department of Medicine , Pulmonary Diseases and Critical Care Professor - Department of Medicine , Pulmonary Diseases and Critical Care University of Rochester MedicalResearch.com: What is the background for this study? Response: Vitamin D deficiency and insufficiency is prevalent worldwide. Prior observational studies have shown that low vitamin D levels have been associated with the development of asthma. Animal studies have reported that antenatal vitamin D is important for lung development in utero. Thus, we conducted a randomized, double-blind, controlled trial of vitamin D supplementation in pregnant women to see if we could prevent the development of asthma and wheezing illnesses in young children. The initial report of the trial results showed that children born to mothers in the vitamin D supplementation arm had lower risks for developing either asthma or recurrent wheezing episodes over the first 3 years, but this was not statistically significant (p=0.051)(Litonjua et al. JAMA 2016). (more…)
Author Interviews, Endocrinology, NEJM, Thyroid Disease / 23.01.2020

MedicalResearch.com Interview with: Raymond S Douglas MD PhD Professor of Surgery, Division of Ophthalmology Director of the Orbital and Thyroid Eye Disease Program Cedars Sinai Medical Center MedicalResearch.com: What is the background for this study? Response: Thyroid eye disease (TED) is a debilitating disease that affects all aspects of a patients life. It is often associated with Graves' disease and thyroid abnormalities. TED causes profound bulging of the eyes impairing vision, causing eye pain and facial disfigurement. (more…)
Abbvie, Author Interviews, NEJM, OBGYNE / 23.01.2020

MedicalResearch.com Interview with: William D Schlaff  MD Chair, Department of Obstetrics & Gynecology Jefferson University MedicalResearch.com: What is the background for this study? Response: Symptomatic uterine fibroids are the most common indication for hysterectomy in the US.  Heavy bleeding is the most common and troublesome symptom.  The primary treatment for this problem is surgery—either hysterectomy or (less commonly) myomectomy.  Medical treatment which reduces the bleeding related to fibroids without surgery is a valuable treatment for many women.  Existing medications include, most commonly GnRH agonists.  These are injectable medications that are given every 1 or 3 months (depending on the formulation) and have been shown to reduce bleeding related to fibroids.  They work by initially stimulating the ovaries to increase estrogen levels for 10-14 days before suppressing estrogen and thereby reducing bleeding.  Even though the medication is given every 1 or 3 months, the effect of the medication can last quite a bit longer; in cases of adverse response, the medication cannot be immediately stopped.  The medication reported in this trial, Elagolix, is a GnRH antagonist given by mouth twice daily and resulting in suppression of estrogen secretion within a matter of hours.  The effect of this medication wears off much more rapidly than the depot formulations described and can be stopped in the uncommon cases of adverse side effects.  (more…)
Author Interviews, Johns Hopkins, NEJM, Weight Research / 02.01.2020

MedicalResearch.com Interview with: Mark P. Mattson, Ph.D. Adjunct Professor of Neuroscience Johns Hopkins University School of Medicine  MedicalResearch.com: What is the background for this study? Response: The usual eating pattern of most people in modern societies is breakfast, lunch, dinner plus a snack(s) every day.   Animals used for most biomedical research – rats and mice – are usually fed ‘ad libitum’ (food is always available for them to eat).    During the past 25 years, myself and the many scientists who trained in my laboratory discovered that when rats or mice are fed intermittently such that they have no food every other day or eat only during a 4-6 hour time period each day, their overall health improves in many ways.  Animals on such intermittent fasting (IF) regimens exhibit signs of slowed aging and they live much longer than those fed ad libitum. The editors of the New England Journal of Medicine invited me and Rafa de Cabo (a former postdoc in my laboratory at the National Institute on Aging) to write this review article for two main reasons.   First, there have been a sufficient number of studies demonstrating the health benefits of IF in humans and knowledge of the underlying mechanisms to justify a review article.  Second, many physicians are being asked about IF by their patients and the physicians are not privy as to if they should recommend IF and how to prescribe specific IF eating patterns and follow-up to increase the likelihood that the patient will be successful in changing their eating pattern.  (more…)
Alcohol, Author Interviews, Heart Disease, NEJM / 02.01.2020

MedicalResearch.com Interview with: Professor Peter M Kistler MBBS, PhD, FRACP Head of Clinical Electrophysiology Research Baker Heart and Diabetes Institute Head of Electrophysiology at The Alfred hospital Professor of Medicine University of Melbourne. MedicalResearch.com: What is the background for this study? Response: There is a well known association between alcohol intake and atrial fibrillation form population based studies which demonstrate that for every 1 standard drink the incidence of AFib increases by 8%. This is the first randomised study to determine of alcohol reduction/abstinence leads to a reduction in AFib episodes and time to recurrence. (more…)
Author Interviews, Heart Disease, NEJM / 28.12.2019

MedicalResearch.com Interview with: Jean-Claude Tardif CM, MD, FRCPC, FCCS, FACC, FAHA, FESC, FCAHS Director, Montrel Heart Institute Research Center Professor of medicine Canada Research Chair in translational and personalized medicine University of Montreal endowed research chair in atherosclerosis Montreal Heart Institute MedicalResearch.com: What is the background for this study? Response: Inflammation appears to play an important role in atherosclerosis. Inhibition of interleukin-1ß by canakinumab reduced the rate of cardiovascular events by 15% CANTOS. In contrast, methotrexate did not affect cardiovascular outcomes or plasma markers of inflammation in CIRT. Colchicine is an inexpensive, orally administered, potent anti-inflammatory medication that has been used for centuries. Colchicine is currently indicated for the management of patients with gout, familial Mediterranean fever and pericarditis. In the LODOCO study, patients with stable coronary disease treated with colchicine 0.5 mg once daily experienced fewer cardiovascular events as compared with those not receiving colchicine. However, that study enrolled only 532 patients and was not placebo-controlled. Because acute coronary syndromes are associated with higher risks of recurrent events and exacerbated inflammation, we conducted the COLchicine Cardiovascular Outcomes Trial (COLCOT) in patients with a recent myocardial infarction to evaluate the effects of colchicine on cardiovascular outcomes and its long-term safety and tolerability. (more…)
Author Interviews, Epilepsy, NEJM, NIH / 11.12.2019

MedicalResearch.com Interview with: Robin Conwit, M.D Program Director, Division of Clinical Research NIH: National Institute of Neurological Disorders and Stroke MedicalResearch.com: What is the background for this study? Response: Approximately one-third of patients with intractable status epilepticus do not respond to benzodiazepines, often the first line medications given in the emergency department, leaving doctors to decide among three commonly prescribed anti-convulsants. In this study all of the anti-convulsants were equally effective. The trial gives doctors a way to clear the air of arguments that one of these drugs works any better than the others, or that any one of them is a lot safer.  It gives doctors a reason to choose a dosing strategy in status epilepticus for levetiracetam, which has otherwise been controversial and non-standard.   (more…)
Author Interviews, Lipids, NEJM, Neurological Disorders, Stroke / 18.11.2019

MedicalResearch.com Interview with: Pierre Amarenco, MD Professor and Chairman Paris University, Paris, France INSERM Department of Neurology and Stroke Centre Bichat Hospital Paris, France MedicalResearch.com: What is the background for this study? Response: The rationale of the Treat Stroke to target trial was that after we published the SPARCL trial in 2006 (atorvastatin 80 mg/day vs placebo in patients with stroke) which showed a 16% relative risk reduction of recurrent stroke, we performed several pre specified and post hoc analyses, showing that in SPARCL patients randomized with "atherosclerotic disease" the risk reduction for the primary endpoint was much higher (33%), and in in patients achieving a LDL cholesterol of less than 70 mg/dL as compared to those achieving a LDL cholesterol 100 mg/dL or higher, the risk reduction was 28%. Therefore to confirm this findings, we designed the TST trial, which was an investigator initiated trial funded by the french ministry of health,  and enrolled patients with an ischemic stroke due to atherosclerotic stenosis and randomized them to either a target LDL cholesterol of less than 70 mg/dL or a target LDL cholesterol of 90 to 110 mg/dL. To achieve these goals, the investigators could use any statin available on the market, and titrate the dosage of the statin to get to the assigned target. They could also use ezetimibe on top of statin therapy if a high dosage of statin was not sufficient to get to the target level assigned by randomization. (more…)
Author Interviews, Education, NEJM, Surgical Research / 31.10.2019

MedicalResearch.com Interview with: Ryan J. Ellis, MD MS General Surgery Resident Surgical Outcomes and Quality Improvement Center (SOQIC) Northwestern Medicine  MedicalResearch.com: What is the background for this study? Response: Burnout has emerged as a significant problem affecting the entire healthcare workforce and it has been likely to myriad downstream problems such as increases in medical errors, alcoholism, and depression. Despite the attention on clinician burnout, there are significant gaps in our understanding of how the workplace environment may lead to burnout. Moreover, there are particular concerns about the workplace environment in training, specifically with regards to abuse, discrimination, and harassment. We had the opportunity to survey all U.S. general surgery residents to comprehensively define the frequency of workplace mistreatment and its relationship with burnout and suicidal thoughts among surgical residents. (more…)
Author Interviews, Heart Disease, NEJM / 02.10.2019

MedicalResearch.com Interview with: Dr Jean-Baptiste Lascarrou  Médecine Intensive Réanimation CHU de Nantes Nantes   MedicalResearch.com: What is the background for this study? What are the main findings? Response: Ancillary study of TTM1 trial & meta-analyses of nonrandomized studies have provided conflicting data on moderate therapeutic hypothermia, or targeted temperature management, at 33°C in patients successfully resuscitated after nonshockable cardiac arrest. Nevertheless, the latest recommendations issued by the International Liaison Committee on Resuscitation and by the European Resuscitation Council recommend moderate therapeutic hypothermia. (more…)
Author Interviews, Heart Disease, NEJM, Vanderbilt / 18.09.2019

MedicalResearch.com Interview with: Daniel Muñoz, M.D, M.P.A Assistant Professor of Medicine, Division of Cardiology Medical Director for Quality, Vanderbilt Heart & Vascular Institute Medical Director, Cardiovascular ICU Vanderbilt University Medical Center Nashville, Tennessee MedicalResearch.com: What is the background for this study? Response: Despite advances in the prevention and treatment of cardiovascular disease, it remains the number one global killer of both men and women. Patients face a variety of barriers to getting the care need, including cost and complexity of medication regimens. Innovative strategies are needed to improve the delivery of preventive care, especially when it comes to socio-economically vulnerable individuals. The polypill, a fixed-dose combination of 3 blood pressure lowering medications and a cholesterol lowering medication, may be a strategy for improving cardiovascular disease prevention. We enrolled 303 patients at a community health center in Mobile, Alabama. Half of the patients were assigned to take a daily polypill, while the other half received their usual medical care. Participants underwent a standard medical exam, blood pressure measurement, and blood cholesterol testing during their initial visit, a 2-month visit, and a 12-month visit. MedicalResearch.com: What are the main findings?
  • Participants in the polypill group experienced a greater reduction in both systolic blood pressure and LDL cholesterol level, as compared with participants in the usual care group. These differences translate to an approximate 25% reduction in the risk of experiencing a cardiovascular event.
  • At 12 months, adherence to the polypill regimen, as assessed based on pill counts, was 86%.
  • The vast majority of our study participants were African-American (96%), with three quarters reporting an annual income below $15,000.
(more…)
Author Interviews, Global Health, HIV, NEJM / 17.07.2019

MedicalResearch.com Interview with: Dr. Richard J. Hayes, DSc, FMedSci Professor of Epidemiology and International Health London School of Hygiene and Tropical Medicine MedicalResearch.com: What is the background for this study? Response: HIV incidence rates remain at very high levels in many parts of southern Africa. Universal testing and treatment (i.e., ensuring that everyone in a community tests for HIV and that everyone diagnosed with HIV is started on treatment as soon as possible) has been proposed as a strategy to achieve steep reductions in HIV incidence in generalized epidemics. Prior trials have shown inconsistent results as to whether this strategy could be effective. HPTN 071 (PopART) was carried out in 21 urban communities in Zambia and South Africa, with individual communities randomly assigned into one of three arms: A, B or C. The 14 communities in Arms A and B received annual rounds of home-based HIV testing by community health workers who supported linkage to care, antiretroviral therapy (ART) adherence and other HIV services. The seven communities in Arm C received the local standard of care. We looked to see if the HIV incidence in the communities receiving universal testing and treatment would be lower (over time) compared to the incidence in the standard of care communities. (more…)
Author Interviews, Biomarkers, NEJM, Pulmonary Disease / 11.07.2019

MedicalResearch.com Interview with: Dr. Chris Butler,, BA MBChB DCH CCH MD FRCGP (Hon)FFPH FMedSci Professor of Primary Care Nuffield Department of Primary Care Health Sciences, Professorial Fellow at Trinity College Clinical Director Primary Care Clinical Trials Unit University of Oxford  MedicalResearch.com: What is the background for this study? Response: More than a million people in the UK have COPD, which is a lung condition associated with smoking and other environmental pollutants. People living with the condition often experience exacerbations, or flare-ups, and when this happens, three out of four are prescribed antibiotics. However, two-thirds of these flare-ups are not caused by bacterial infections and antibiotics often do not benefit patients. A simple finger-prick blood test could help prevent unnecessary prescribing of antibiotics for people with the lung condition chronic obstructive pulmonary disease (COPD).  The finger-prick test measures the amount of C- reactive protein (CRP) - a marker of inflammation that rises rapidly in the blood in response to serious infections. People with a COPD flare-up who have a low CRP level in the blood appear to receive little benefit from antibiotic treatment. The General Practitioner (GP) use of a C-Reactive Protein (CRP) Point of Care Test (POCT) to help target antibiotic prescribing to patients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) who are most likely to benefit (The PACE Study) determined whether the using a POCT CRP to guide antibiotic treatment decisions for acute exacerbations of COPD reduced antibiotic use without harming patients. (more…)
Author Interviews, Brain Injury, Columbia, Critical Care - Intensive Care - ICUs, NEJM, Neurology / 27.06.2019

MedicalResearch.com Interview with: Jan Claassen, MD, PhD, FNCS Associate Professor of Neurology Division of Division of Critical Care and Hospitalist Neurology Columbia University Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Unconsciousness is common and predicting recovery is challenging – often inaccurate. Many patients do not show movements on commands and typically this is interpreted as unconsciousness. Some of these patients may be able to have brain response to these commands raising the possibility of some preservation of consciousness. This has previously been shown months or years after the injury mostly using MRI. We were able to detect this activation at the bedside in the ICU shortly after brain injury. For this we applied machine learning to the EEG to distinguish the brain’s responses to commands. Patients that showed this activation were more likely to follow commands prior to discharge and had better outcomes one year later.  (more…)
Anesthesiology, Author Interviews, Geriatrics, NEJM / 23.06.2019

MedicalResearch.com Interview with: Yahya Shehabi  PhD, FANZCA, FCICM, EMBA, GAICD Director of Research, Critical Care and Peri-operative Medicine, Monash Health Professor, School of Clinical Sciences, Faculty of Medicine Nursing and Health Sciences, Monash University Professor Intensive Care Medicine, Clinical School of Medicine, University New South Wales Critical Care and Peri-Operative Medicine Lead – Monash Health Translational Precinct MedicalResearch.com: What is the background for this study? Response: SPICE III was the final phase of a series of SPICE studies. SPICE I showed 2 important findings, first, deep sedation in the first 48 hours is strongly associated with higher mortality, longer ventilation time and higher risk of delirium. Second; that Dexmedetomidine is mainly used as an adjunct secondary agent 3-4 days after commencing mechanical ventilation and not as a primary sedative agent. In addition, albeit with several limitations, previous RCTs comparing Dexmedetomidine with conventional sedatives showed reduced iatrogenic coma, shortened ventilation time and reduced delirium with Dexmedetomidine treatment. So based on the above we hypothesized that using Dexmedetomidine soon after commencing ventilation as a primary sedative agent, through reducing early iatrogenic coma, ventilation time and delirium, would impact 90 day-mortality. (more…)
Author Interviews, Biomarkers, Genetic Research, Infections, NEJM, UCSF / 13.06.2019

MedicalResearch.com Interview with: Dr. Charles Chiu, M.D./Ph.D. Professor, Laboratory Medicine and Medicine / Infectious Diseases Director, UCSF-Abbott Viral Diagnostics and Discovery Center Associate Director, UCSF Clinical Microbiology Laboratory UCSF School of Medicine MedicalResearch.com: What is the background for this study? Would you describe what is meant by metagenomic sequencing? Response: Metagenomic next-generation sequencing (mNGS) is the use of technology to generate millions of sequence reads to diagnose infection sin patients by characterizing the full range of potential pathogens (bacteria, viruses, fungi, and parasites) in a single sample. Although shown to be a promising diagnostic tool for  infectious diseases in case reports and limited case series (Chiu and Miller Nature Reviews Genetics 20, 341-355 (2019)), to date the “real-life” utility of this approach for patient care has hitherto not been demonstrated.  This study is the first prospective, multi-center study of clinical mNGS testing for the diagnosis of neurological infections in acutely ill hospitalized patients presenting with meningitis and/or encephalitis. (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, 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, Immunotherapy, NEJM, Pulmonary Disease / 22.05.2019

MedicalResearch.com Interview with: Gerard J. Criner, MD, FACP, FACCP Chair and Professor, Thoracic Medicine and Surgery Lewis Katz School of Medicine Temple University  MedicalResearch.com: What is the background for this study? Response: An earlier, Phase II trial of benralizumab found a non-statistically significant reduction in COPD exacerbation rate for patients with eosinophilic inflammation in the airways. In this Phase III trial, the researchers sought to discover whether benralizumab's ability to deplete the airways of blood eosinophils in patients with eosinophilic inflammation would lead to a reduction in COPD exacerbations. The Phase III, randomized, double-blind, placebo-controlled, parallel-group clinical trials GALATHEA and TERRANOVA evaluated the efficacy and safety of benralizumab for the prevention of exacerbations in patients with moderate to very severe COPD, eosinophilic inflammation, and increased risk of exacerbations. Benralizumab is a type of drug called an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody. It is approved by the FDA for the treatment of severe eosinophilic asthma. (more…)
Author Interviews, Clots - Coagulation, NEJM, Neurology / 09.05.2019

MedicalResearch.com Interview with: Geoffrey A Donnan AO MBBS, MD, FRCP, FRACP, FAAHMS Professor of Neurology University of Melbourne, Melbourne Brain Centre Royal Melbourne and Austin Hospital MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Currently the thrombolysis time window for acute ischemic stroke is restricted to less than 4.5 hours from stroke onset and patients with wake-up stroke are not eligible. EXTEND is a multi-centre randomised placebo-controlled trial involving patient with acute ischemic stroke who presented between 4.5 to 9 hours of stroke onset or with wake-up-stroke and had penumbral tissue demonstrated on automated perfusion imaging. Patients were randomised to receive either alteplase or placebo. In total there were 225 patients recruited and the patients who received alteplase had higher rate of excellent functional outcome at 3 months (35.4% vs 29.5% adjusted odd ration 1.44 with 95% confidence interval 1.01 – 2.06 p=0.04). Patients who received alteplase achieved higher rate of early neurological improvement at day 3, reperfusion and recanalization at 24 hours. There was numerically more haemorrhage in the alteplase group but this not negate the functional benefit and there was no difference in the rate of mortality between the two groups.  (more…)
Author Interviews, Global Health, Infections, NEJM / 08.05.2019

MedicalResearch.com Interview with: Birgit Nikolay PhD MATHEMATICAL MODELLING OF INFECTIOUS DISEASES Institut Pasteur  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Nipah virus was identified by the World Health Organization as an emerging infectious disease that may cause major epidemics if the pathogen evolves to become more transmissible, leading the organization to prioritize it for research to prevent future health emergencies. In the absence of efficient treatments or vaccines, the only way to control Nipah virus outbreaks is through targeted interventions that limit opportunities of spread. Designing such interventions is challenging in a context where transmission mechanisms remain poorly understood. The study provides important insights to better understand these mechanisms. (more…)
Alzheimer's - Dementia, Author Interviews, Merck, NEJM / 10.04.2019

MedicalResearch.com Interview with: Michael F. Egan, MDVice President,  NeuroscienceGlobal Clinical DevelopmentMerck Research LaboratoriesNorth Wales, PAMichael F. Egan, MD Vice President,  Neuroscience Global Clinical Development Merck Research Laboratories North Wales, PA  MedicalResearch.com: What is the background for this study?   Response: Alzheimer’s disease (AD) appears to be due to the gradual accumulation of amyloid over many years (the “amyloid hypothesis”). At some point, it is thought that amyloid triggers abnormalities in tau, which then forms deposits within neurons and leads to progressive neurodegeneration. Amyloid is made up of  a small, sticky peptide, Abeta, which is produced when the enzyme BACE cleaves a large protein called APP.  In our trial, we tested whether a potent BACE inhibitor, verubecestat, could slow disease progression in subjects with early AD (or prodromal AD) by blocking formation of Abeta.  A previous trial in subjects with dementia due to AD failed to find evidence of efficacy. One possible reason for this failure is that subjects had too much amyloid in their brain already. (more…)
Author Interviews, Clots - Coagulation, NEJM, Thromboembolism / 02.04.2019

MedicalResearch.com Interview with: Yaseen M. Arabi, M.D Intensive Care Department Ministry of National Guard Health Affairs Riyadh, Saudi Arabia  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Venous thromboembolism, including deep vein thrombosis and pulmonary embolism, is a complication of critical illness. Studies have demonstrated that despite pharmacologic thromboprophylaxis with unfractionated heparin or low-molecular weight heparin, 5-20% of critically ill patients develop deep vein thrombosis (DVT). The PREVENT trial evaluated whether adjunctive intermittent pneumatic compression reduces incident proximal lower limb DVT as detected on twice-weekly lower limb ultrasonography in critically ill patients receiving pharmacologic thromboprophylaxis with unfractionated heparin or low-molecular-weight heparin. The trial was conducted in 20 sites in Saudi Arabia, Canada, Australia and India and included 2003 patients. The trial found no difference in the primary end point of proximal leg DVT. The addition of intermittent pneumatic compression to pharmacologic thromboprophylaxis did not result in a lower incidence of pulmonary embolism or a composite outcome of venous thromboembolism or death from any cause at 28 days when compared to pharmacologic thromboprophylaxis alone. (more…)