Author Interviews, Infections, NEJM / 13.03.2019

MedicalResearch.com Interview with: Susan Swindells MBBS Professor and Medical Director, HIV Clinic Department of Internal Medicine University of Nebraska Medical Center Omaha, NE MedicalResearch.com: What is the background for this study? What are the main findings?  Response: More than one quarter of the world’s population is infected with tuberculosis (TB), and there is effective treatment for this but only a small fraction of those eligible actually receive it.   TB is the leading cause of death for people with HIV infection, globally.  One of the major problems with currently available treatments for TB infection is that they take too long, and people just stop taking them after a while.  We identified an ultra-short course of treatment (only one month) and tested it against the conventional 6-month course of treatment. Our main findings were that the new short course was just as effective as the standard 6 month course, more patients taking the short course completed their treatment, and had less adverse effects.  (more…)
Author Interviews, Heart Disease, Imperial College, Lipids, NEJM, Statins / 13.03.2019

MedicalResearch.com Interview with: Prof. Kosh Ray, MB ChB, MD, MPhil Faculty of Medicine, School of Public Health Chair in Public Health (Clinical) Imperial College London MedicalResearch.com: What is the background for this study? What are the main findings? Response: Bempedoic acid is the first in class of a new therapy for lowering LDL cholesterol. This is the largest and longest study to date with this therapy and involved about 2200 pts with patients with either established cardiovascular disease or familial hypercholestrolaemia and in whom LDL was > 70mg/dl or 1.8 mmol/L despite maximally tolerated statins. %0% were on high intensity statins and the majority of the rest on moderate intensity. The aim was to show long term safety 1 year and efficacy at 24 weeks and at 1 year.  (more…)
Author Interviews, Cancer Research, NEJM / 13.03.2019

MedicalResearch.com Interview with: Maud Jansen, MD | Resident Dermatology | PhD candidate Dermatologie, Maastricht MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Actinic keratosis is the most frequent premalignant skin disease in the white population and is caused by exposure to ultraviolet radiation. With a prevalence of 37.5% among whites 50 years of age or older, actinic keratosis is one of the most frequent reasons for patients to visit a dermatologist. If left untreated, actinic keratosis may develop into squamous cell carcinoma. Current guidelines provide no clear recommendations about which treatment approach is preferred. Currently, the choice of treatment often depends on the preferences of patients and their treating physicians. Evidence from randomized trials with direct comparison between treatments and with long-term follow-up is scarce. Frequently prescribed and studied field-directed treatment approaches are 5-fluorouracil cream, imiquimod cream, photodynamic therapy (PDT), and ingenol mebutate gel. We investigated the effectiveness of these four frequently used field-directed treatments (for multiple lesions in a continuous area). Over 600 patients in four different hospitals (Maastricht UMC+, Zuyderland (Heerlen), VieCuri (Venlo and Venray) en Catharina (Eindhoven)participated in the study. Patients were randomly assigned to one of the four treatments. The main result of our study was that we found that after 12 months of follow-up, 5% fluorouracil cream was the most effective treatment in the treatment of patients with multiple actinic keratosis lesions. Moreover, patient satisfaction and increase in health-related quality of life were highest in the 5-fluorouracil group. (more…)
ASCO, Author Interviews, Cancer Research, NEJM, Prostate Cancer / 25.02.2019

MedicalResearch.com Interview with: Prof. Karim Fizazi, MD, PhD Head of the Department of Cancer Medicine Institute Gustave Roussy MedicalResearch.com: What is the background for this study? How does darolutamide differ from other medications for prostate cancer? Response: Despite recent treatment advances, there is still significant unmet need for new therapeutic options for men with non-metastatic castration-resistant prostate cancer (nmCRPC). In laymen’s terms, nmCRPC is cancer that has not spread beyond the prostate region; PSA levels are elevated, despite treatment with hormone therapy, and men with nmCRPC generally feel well and do not have symptoms. The unmet medical need is for treatments that achieve disease control and delay the spread of the cancer without impacting their daily lives or increasing the burden of disease with treatment side effects. While the current treatments in this space are effective in delaying onset of metastases, the side effects can be unpleasant and disruptive to men’s lives; particularly cognitive issues, seizures, impact on balance which may lead to falls and bone fractures, rash and hypertension. Furthermore, new treatment options that have limited interactions with medications typically used in this patient population are also important.  (more…)
Author Interviews, Breast Cancer, Brigham & Women's - Harvard, Chemotherapy, NEJM / 24.02.2019

MedicalResearch.com Interview with: Aditya Bardia, MBBS, MPH Director, Precision Medicine, Center for Breast Cancer, Attending Physician Massachusetts General Hospital Cancer Center Harvard Medical School Boston, MA 02114 MedicalResearch.com: What is the background for this study? Response: Metastatic triple negative breast cancer is associated with aggressive tumor biology, and tends to affect younger patients and African Amerians. The response rate with standard chemotherapy regimens in patients with pre-treated metastatic TNBC ranges from 10-15%, and median progression-free survival ranges from 3-4 months. The median survival of metastatic TNBC is around 12 months and has not changed in the past 20 years. Thus, treatment of metastatic triple negative breast cancer represents an unmet clinical need.   (more…)
Author Interviews, Dermatology, MRI, NEJM / 06.02.2019

MedicalResearch.com Interview with:

Dr. Martina Callaghan PhD Head of Physics & Senior Lecturer Wellcome Centre for Human Neuroimaging Institute of Neurology University College London London

MedicalResearch.com:  What is the background for this study?  What are the main findings?

Response: As mirrors the situation in the general population, we found that an increasing number of volunteers who were seeking to enter cognitive neuroscience studies at our Centre had tattoos. However, the magnetic fields used in magnetic resonance imaging (MRI) pose a potential safety risk for people with tattoos. A number of case reports have described such incidents.  However, as these describe isolated cases retrospectively, there was not enough information to objectively assess the risk of tattoo-related adverse reactions for persons having an MRI scan.  Therefore, in 2011, we decided to embark upon this first prospective study to quantitatively assess this risk.

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Author Interviews, Cancer Research, Esophageal, NEJM, Surgical Research / 11.01.2019

MedicalResearch.com Interview with: Guillaume Piessen, MD, PhD University Hospital Centre Lille, Franc MedicalResearch.com: What is the background for this study? Response: Patients requiring surgery for esophageal cancer fare better after undergoing a hybrid minimally invasive esophagectomy (HMIE) with a combined laparoscopy+thoracotomy procedure compared to an open esophagectomy (OE), according to results of the MIRO trial published in the last issue of the New England Journal Of Medicine (link article). This French prospective multi-center randomized controlled study was funded by the French National Cancer Institute (Grant n° 1907). The study was conducted by Pr Mariette who sadely passed away in 2017 and Pr Piessen (Department of Digestive and Oncological Surgery, CHU Lille), under the hauspice of FRENCH (Fédération de Recherche EN Chirurgie) and FREGAT (French Eso-Gastric Tumors) working group (https://www.fregat-database.org/fr/). Postoperative morbidity, especially pulmonary complications, affects more than half of patients after open esophagectomy for esophageal cancer. Hybrid minimally invasive esophagectomy (HMIE) combines a laparoscopic abdominal phase with an open thoracotomy, which may have specific advantages including lower rate of pulmonary complications, without laparoscopic tumor dissection limiting potential tumor spillage and easier reproducibility of the technique [12]. Postoperative morbidity, especially pulmonary complications, affects more than half of patients after open esophagectomy for esophageal cancer. Hybrid minimally invasive esophagectomy (HMIE) combines a laparoscopic abdominal phase with an open thoracotomy, which may have specific advantages including lower rate of pulmonary complications, without laparoscopic tumor dissection limiting potential tumor spillage and easier reproducibility of the technique [12]. (more…)
Author Interviews, NEJM, Pediatrics, Smoking, Tobacco, Tobacco Research, University of Michigan / 30.12.2018

MedicalResearch.com Interview with: Richard Miech Ph.D Professor Principal Investigator, Monitoring the Future Institute for Social Research University of Michigan MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Every year Monitoring the Future conducts a survey to examine trends in adolescent substance use.  We draw a random sample of schools from a list of all schools in the United States and conduct our survey in ~400 schools.  Our survey is representative of U.S. 8th, 10th, and 12th grade students.  In other words, our results are what you would find if you surveyed every single 8th, 10th, and 12th graders in the United States, within the bounds of a small sampling error of a few percentage points. An increase in vaping is the big news for 2018.  In 10th and 12th grade the increase in nicotine vaping was the largest we've ever seen for any substance in the past 43 years.  As a result of this increase in nicotine vaping, overall use of nicotine increased as well, which suggests that vaping is drawing youth into nicotine use.  We also saw a significant increase in marijuana vaping. (more…)
Author Interviews, Cancer Research, NEJM, Pancreatic / 21.12.2018

MedicalResearch.com Interview with: Prof. Thierry Conroy MD, Director Department of Medical Oncology Institut de Cancérologie de Lorraine Vandoeuvre-lès-Nancy CEDEX MedicalResearch.com: What is the background for this study? Response:  Surgery of pancreatic cancer offers the only chance of cure. Despite the low response rate (5% - 9%) of gemcitabine in metastatic disease, a 6-month regimen of adjuvant therapy with gemcitabine increases 5-year survival from 10% to 20% and is recognized as standard of care. However, recurrence rate remain high despite adjuvant treatment with 69-75% of patients relapsing within 2 years. -       The combination of bolus and continuous infusion Fluorouracil, Folinic Acid, Irinotecan and Oxaliplatin (Folfirinox) was shown to increase response rate (31.6% versus 9.4%) in metastatic disease as compared to Gemcitabine and increase survival (11.1 versus 6.8 months). -       Deletion of bolus Fluorouracil in the Folfirinox regimen (mFOLFIRINOX) decreased toxicity and do not reduce efficacy in advanced disease. -       We performed a randomized trial in patients with good performance status, ECOG 0-1 CA 19.9 ≤ 180 U/L and no cardiac contraindication to fluorouracil. (more…)
Author Interviews, Bone Density, NEJM, Orthopedics / 21.12.2018

MedicalResearch.com Interview with: Prof Ian Reid MD Faculty of Medical and Health Sciences University of Auckland Auckland New Zealand MedicalResearch.com: What is the background for this study?  Response: Bisphosphonates prevent fractures in patients with osteoporosis, but their efficacy in women with osteopenia is unknown. Most fractures in postmenopausal women occur in osteopenic patients, so therapies with efficacy in osteopenia are needed. (more…)
Author Interviews, Gastrointestinal Disease, Microbiome, NEJM, Pediatrics, Probiotics / 22.11.2018

MedicalResearch.com Interview with: Stephen Freedman MDCM, MSc Alberta Children's Hospital Foundation Professor in Child Health and Wellness Sections of Pediatric Emergency Medicine and Gastroenterology Alberta Children's Hospital & Research Institute University of Calgary Calgary, AB  MedicalResearch.com: What is the background for this study? Response: Vomiting and diarrhea remain extremely common diseases in children and are the most common reason children are brought for emergency department care in North America.  While we have options to reduce vomiting there historically has been little physicians can offer to reduce the severity of the diarrhea. Probiotics have recently emerged as an option with some early evidence of benefit in clinical trials but the studies performed to date have been small and few little research has been conducted in North America in outpatient or emergency department children. The one study to date that was performed in a US emergency department did not find probiotic use to be beneficial.  Given the increasing importance of clarifying this issue we undertook this study. (more…)
Author Interviews, NEJM, STD / 07.11.2018

MedicalResearch.com Interview with: Edward W. Hook, III, MD University of Alabama at Birmingham Medicine / Infectious Diseases Birmingham, AL MedicalResearch.com: What is the background for this study? What are the main findings? Response: Zoliflodacin represents a new class of antibiotics (spiropyrimidinetriones) with in vitro activity against Neisseria gonorrhoeae, as well as other STD  pathogens (Chlamydia trachomatis and Mycoplasma genitalium).  Because of this promising data and the fact that the manufacturer (Entasis Pharmaceuticals) was willing to pursue the possibility of using this drug to treat gonorrhea, a Phase II trial was conducted which showed he drug to be 96% effective for genital or rectal infections.  The drug was well tolerated as well making it a promising drug for gonorrhea treatment which might help to combat the increasing problem of antibiotic resistant gonorrhea.  (more…)
Author Interviews, Cognitive Issues, Critical Care - Intensive Care - ICUs, NEJM, Vanderbilt / 31.10.2018

MedicalResearch.com Interview with: Brenda Truman Pun, DNP, RN Program Clinical Manager Vanderbilt University Medical Center MedicalResearch.com: What is the background for this study? Response: Delirium is a serious problem in Intensive Care Units around the world. Approximately 80% of mechanically ventilated patients develop delirium, acute confusion, while in the ICU. Once thought to be a benign side effect of the ICU environment, research now shows that delirium is linked to a myriad of negative outcomes for patients which include longer ICU and Hospital stays, prolonged time on the ventilator, increased cost, long-term cognitive impairment and even mortality. For a half a century clinicians have been using haloperidol, an typical antipsychotic, to treat delirium in the ICU. However, there has never been evidence to support the use of haloperidol or its pharmacologic cousins, the atypical antipsychotics, to treat delirium. These drugs have serious side effects that include heart arrhythmias, muscle spasms, restlessness and are associated with increased mortality when given for prolonged periods in the outpatient settings leading to a black box warning for their use in this setting. The MIND-USA study was a double blind placebo controlled trial which evaluated the efficacy and safety of antipsychotics (i.e., haloperidol and ziprasidone) in the treatment delirium in adult ICU patients.   (more…)
Author Interviews, Genetic Research, NEJM, Pulmonary Disease, Rheumatology / 24.10.2018

MedicalResearch.com Interview with: Joyce S. Lee, MD Associate Professor Director, Interstitial Lung Disease Program Department of Medicine Division of Pulmonary Sciences and Critical Care Medicine University of Colorado School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Rheumatoid arthritis (RA) is a common inflammatory arthritis that can be complicated by interstitial lung disease (ILD). Patients with RA-ILD share clinical characteristics with another ILD called idiopathic pulmonary fibrosis (IPF). Given the similar clinical phenotype, our goal was to see if these lung diseases (IPF and RA-ILD) shared a common genetic risk factor. The MUC5B promoter variant is the most common risk factor (genetic and otherwise) for the development of IPF. Our findings demonstrate the MUC5B promoter variant is also a strong risk factor for the development of RA-ILD among patients with RA. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Mental Health Research, NEJM, Vanderbilt / 24.10.2018

MedicalResearch.com Interview with: Eugene Wesley Ely, M.D. Dr. E. Wesley Ely is a Professor of medicine at Vanderbilt University School of Medicine with subspecialty training in Pulmonary and Critical Care Medicine.  MedicalResearch.com: What is the background for this study? Response: Critically ill patients are not benefitting from antipsychotic medications that have been used to treat delirium in intensive care units (ICUs) for more than four decades, according to a study released today in the New England Journal of Medicine. Each year, more than 7 million hospitalized patients in the United States experience delirium, making them disoriented, withdrawn, drowsy or difficult to wake. The large, multi-site MIND USA (Modifying the INcidence of Delirium) study sought to answer whether typical and atypical antipsychotics — haloperidol or ziprasidone —affected delirium, survival, length of stay or safety. Researchers screened nearly 21,000 patients at 16 U.S. medical centers. Of the 1,183 patients on mechanical ventilation or in shock, 566 became delirious and were randomized into groups receiving either intravenous haloperidol, ziprasidone or placebo (saline). (more…)
Addiction, Author Interviews, Mental Health Research, NEJM / 23.10.2018

MedicalResearch.com Interview with: Marc Lewis, Ph.D. Klingelbeekseweg Arnhem The Netherlands MedicalResearch.com: What is the background for this study? Response: According to the brain disease model, addiction is a chronic disease brought about by changes in brain systems that mediate the experience and anticipation of reward and higher-order systems underlying judgment and cognitive control. Its proponents propose that these changes are driven by exposure to drugs of abuse or alcohol. The brain disease model is the most prevalent model of addiction in the Western world. The disease model's narrow focus on the neurobiological substrates of addiction has diverted attention (and funding) from alternative models. Alternatives to the brain disease model highlight the social-environmental factors that contribute to addiction and the learning processes that translate these factors into negative outcomes. Learning models propose that addiction, though obviously disadvantageous, is a natural, context-sensitive response to challenging environmental contingencies, not a disease. In this review I examine addiction within a learning framework that incorporates the brain changes seen in addiction without reference to pathology or disease.  (more…)
Author Interviews, NEJM, Osteoporosis / 04.10.2018

MedicalResearch.com Interview with: Prof Ian Reid Faculty of Medical and Health Sciences University of Auckland Auckland New Zealand  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Bisphosphonates prevent fractures in patients with osteoporosis, but their efficacy in women with less marked bone loss (referred to as osteopenia) is unknown. Most fractures in postmenopausal women occur in osteopenic patients, so therapies with efficacy in osteopenia are needed. (more…)
Author Interviews, Clots - Coagulation, Critical Care - Intensive Care - ICUs, NEJM / 04.10.2018

MedicalResearch.com Interview with: Alex C Spyropoulos, MD, FACP, FCCP, FRCPC Professor of Medicine – The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Professor - The Center for Health Innovations and Outcomes Research - The Feinstein Institute for Medical Research System Director – Anticoagulation and Clinical Thrombosis Services Northwell Health at Lenox Hill Hospital New York, NY 10075 MedicalResearch.com: What is the background for this study? Response: Hospitalised medically ill patients have a significant risk of developing venous thromboembolism (VTE) within 6 weeks after discharge. The role of extended thromboprophylaxis in this population with either low molecular weight heparin or the direct oral anticoagulants remains uncertain, as it has shown either excess bleeding or beneficial effects mainly from reducing asymptomatic deep vein thrombosis (DVT). The MARINER trial was designed to compare rivaroxaban with placebo for the prevention of the composite outcome of symptomatic VTE and VTE-related death in medically ill patients at increased risk of VTE post-hospital discharge. The principal safety objective was major bleeding. The trial was a randomized, double-blind, placebo-controlled, event-driven study that included a total of 12,024 patients aged ≥40 years who had been hospitalised with an acute medical illness for 3-10 consecutive days and had additional VTE risk factors as defined by the modified IMPROVE VTE risk score of ≥4 or a score of 2 or 3 plus a plasma D-dimer level more than twice the upper limit of normal). The rivaroxaban regimen consisted of 10 mg once daily in patients with a creatinine clearance (CrCl) of >=50ml/min or 7.5 mg for patients with a CrCl of 30 to <50 ml/min. The first dose was given on the day of discharge and the last dose at Day 45. Patients were followed up for an additional 30 days. Baseline characteristics were well matched between groups and typical of a medically ill population. (more…)
Addiction, Author Interviews, Clots - Coagulation, NEJM / 27.09.2018

MedicalResearch.com Interview with: Dr. Amar Kelkar MD Clinical Fellow Division of Hematology & Oncology, Department of Medicine University of Florida College of Medicine, UF Health Shands Hospital MedicalResearch.com: What is the background for this study? What are synthetic cannabinoids? Response: Starting in March 2018, patients began reporting to hospitals and clinics with unexplained and prolonged bleeding symptoms, first in Chicago, Illinois, and then spreading to Peoria, Illinois and elsewhere. This gained a lot of press because the initial identifying factor was that all the patients had reported recent use of synthetic cannabinoids. As the matter was studied further, it was determined that these patients were likely exposed to an anticoagulant poison mixed in with the synthetic cannabinoids. Synthetic cannabinoids are lab-derived illicit drugs that target the cannabinoid receptors that are also targeted by marijuana. They go by many names including synthetic marijuana, K2, and Spice. (more…)
Author Interviews, Cost of Health Care, NEJM, Outcomes & Safety / 07.09.2018

MedicalResearch.com Interview with: Prof. Bruce Guthrie PhD Head of Population Health Sciences Division Professor of Primary Care Medicine and Honorary Consultant NHS Fife  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The UK Quality and Outcomes Framework (QOF)) is a primary care pay for performance programme (P4P) implemented in 2004. QOF was and still is the largest healthcare P4P programme in the world, initially having ~150 indicators and accounting for ~20% of practice income. QOF has been reduced in scale and scope over time, with 40 indicators retired in 2014. It was abolished in Scotland in 2016 and is due to be further reformed in England. There is some evidence that P4P (and QOF itself) is associated with modest improvements in quality when introduced, but little evidence about what happens when financial incentives are withdrawn. Our study examined what happened when incentives were withdrawn in 2014 for 12 indicators where there is good before and after data. There were immediate reductions in documented quality of care, which were similar in size to improvements observed when incentives were introduced. These reductions were small to modest (~10%) for indicators relating to care that is already systematically delivered (eg routine diabetes, hypertension and cardiovascular disease) and large for indicators which has historically been less systematically delivered (eg lifestyle advice). (more…)
Author Interviews, Hematology, NEJM / 07.09.2018

MedicalResearch.com Interview with: Dr. Johnny Mahlangu  MBBCh Faculty of Health Sciences University of the Witwatersrand and National Health Laboratory Service Johannesburg, South Africa MedicalResearch.com: What is the background for this study? What are the main findings? Response: Current unmet needs in patients with haemophilia without inhibitors are the high disease burden imposed by the frequent injections which have to be given intravensously . Emicizumab which is given subcutaneously weekly or fortnightly aims to address these unmet needs. (more…)
Author Interviews, Cleveland Clinic, Multiple Sclerosis, NEJM / 30.08.2018

MedicalResearch.com Interview with: Robert J. Fox, MD, FAAN Principal Investigator | SPRINT-MS Trial Mellen Center for MS  |  Cleveland Clinic Cleveland, OH 44195  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The current treatment options for progressive multiple sclerosis are very limited. The SPRINT-MS trial sought to obtain proof-of-concept evidence that ibudilast has beneficial activity in progressive multiple sclerosis. In a placebo-controlled, 96-week trial of 255 people living with progressive MS, treatment with ibudilast slowed the progression of brain atrophy (brain shrinkage) by 48% compared to placebo. Side-effects of ibudilast included gastrointestinal symptoms, headache, and depression.  (more…)
Author Interviews, Heart Disease, NEJM, Surgical Research / 27.08.2018

MedicalResearch.com Interview with: Jean François Obadia Adult Cardiovascular Surgery and Transplantation Louis Pradel HospitalJean François Obadia MD PhD Adult Cardiovascular Surgery and Transplantation Louis Pradel Hospital MedicalResearch.com: What is the background for this study? -By definition a secondary MR concerns a normal valve or sub normal valve inside a dilated heart with poor LV function in a population of Heart failure patients. It is perfectly established today that secondary MR is a predictor of poor clinical outcomes of thissevere population. -Therefore,it has been proposed to treat those regurgitation either by surgery (mainly the downsizing anuloplasty) or by percutaneous technique like the mitraclipwhich has been used more and more frequently recently. -However, a beneficial effect on hardclinical outcomes has never been provedandwe still don’t know if those regurgitations need to be corrected or not, We still don’t Know if the regurgitation is the cause, the consequence or just a marker of poor prognosis. -In this context according to the guidelines, there is a low level of evidence to support those treatments, and Europe and US Guidelines call for prospective randomized studies in this severe population.​ And this excatly what we have done with MITRA-FR (more…)
Author Interviews, CT Scanning, Heart Disease, NEJM / 25.08.2018

MedicalResearch.com Interview with: Prof David Newby FRSE FMedSci Personal Chair - BHF John Wheatley Chair of Cardiology University of Edinburgh MedicalResearch.com: What is the background for this study? What are the main findings? Response: There are many tests that can try and determine whether a patient has heart disease. All are imperfect and do not directly see if the heart arteries are diseased. This study used a CT heart scan to see if there was any heart disease in patients who presented to the outpatient clinic with chest pains that could be due to coronary heart disease. The doctor use the scan result to decide whether they had heart disease and how to manage the patient. The study has found that if you use a CT heart scan then you are less likely to have a heart attack in the future. In the first year, you may require treatment with an angiogram and heart surgery (stent or heart bypass) but after the first year, you are less likely to need these treatments because the disease has already been treated promptly. (more…)
Author Interviews, HIV, NEJM, Yale / 17.08.2018

MedicalResearch.com Interview with: Brinda Emu, MD Assistant Professor of Medicine (Infectious Diseases) Yale School of Medicine MedicalResearch.com: What is the background for this study? Response: This was a Phase 3 study of a new antiretroviral agent, ibalizumab, for the treatment of HIV-1 infection.  Ibalizumab is a monoclonal antibody that targets the CD4 receptor on host cells.  CD4 is the receptor that HIV uses to infect CD4+ T cells.  By binding to the CD4 receptor, ibalizumab prevents viral entry.  This study recruited patients that harbor multi-drug resistant HIV and were failing their current regimen of antiretroviral agents, and thus had limited options for treatment of their HIV-1 infection using approved medications. (more…)
Author Interviews, JAMA, NEJM, OBGYNE, University Texas / 09.08.2018

MedicalResearch.com Interview with: George R. Saade, MD Professor Jennie Sealy Smith Distinguished Chair Professor, Obstetrics & Gynecology, and Cell Biology Chief of Obstetrics and Maternal Fetal Medicine Director, Perinatal Research Division Department of Obstetrics and Gynecology Division of Maternal Fetal Medicine UTMB at Galveston MedicalResearch.com: What is the background for this study? Response: Several analyses show that the lowest risk to the baby is if delivered at 39 weeks. As pregnancy goes beyond 39 weeks, the risk to the baby increases. On the other hand, the general belief was that induction of labor at 39 increases the risk of cesarean and may not be good for the baby. The guideline were that induction without medical indication, or what we call elective induction of labor, should not be done. However, the studies on which this belief was based were not appropriately designed or analyzed. These studies compared women who were induced at 39 weeks to those who had spontaneous labor at 39 weeks. This comparison is not appropriate. While induction is a choice, having spontaneous labor at 39 weeks is not by choice.  So the correct comparison should be between women who were induced at 39 weeks to those who were not induced and continued their pregnancy beyond 39 weeks. In other words, they continued until they had spontaneous labor or developed an indication to be delivered (expectantly managed). That is how the study was done. First time pregnant women were randomized between these 2 options. The reason the study was done in first time mothers is that they have the highest risk of cesarean compared with women who had delivered vaginally before. (more…)
Author Interviews, Endocrinology, NEJM / 01.08.2018

MedicalResearch.com Interview with: Prof. Dr. Mirjam Christ-Crain Professor of endocrinology, diabetes and metabolism Heads the Department of Clinical Research University and University Hospital of Basel   MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by Diabetes Insipidus? Response: Drinking more than three litres per day with the equivalent increase in urination is regarded as too much. This drinking by the liter – known as “polyuria polydipsia syndrome" – usually develops over time through habit, or can be a side effect of a mental illness. In rare cases, however, it may be caused by diabetes insipidus. This is when the pituitary gland lacks the hormone vasopressin, which regulates the water and salt content in our body. Patients have a decreased ability to concentrate the urine, therefore lose a lot of fluid and have to increase their fluid intake accordingly to prevent dehydration (= Diabetes insipidus). The distinction between what is considered a "harmless" primary polydipsia and a diabetes insipidus is crucial, as their therapy is fundamentally different. Diabetes insipidus must be treated with the hormone vasopressin, while patients with primary polydipsia require behavioural therapy to reduce their habitual drinking. A wrong therapy can have life-threatening consequences as treatment with vasopressin without indication can lead to water intoxication. (more…)
Author Interviews, Biomarkers, Infections, NEJM, University of Pittsburgh / 19.07.2018

MedicalResearch.com Interview with: David T. Huang, MD, MPH Associate Professor, Critical Care Medicine, Emergency Medicine, Clinical and Translational Science Director, MACRO (Multidisciplinary Acute Care Research Organization) Director, CRISMA Administrative Core (Clinical Research, Investigation, and Systems Modeling of Acute illness) University of Pittsburgh MedicalResearch.com: What is the background for this study? Response: The overuse of antibiotics has become a serious threat to global public health, causing antibiotic resistance and increasing health care costs. Physicians have long known that antibiotics are usually unnecessary for acute bronchitis and for some other cases of lower respiratory tract infections, and that antibiotics treat only bacterial infections, not viral. But in daily practice, many physicians often prescribe them. Previous research had reported that using a biomarker blood test and following an antibiotic guideline tied to the test results could reduce antibiotic use in lower respiratory tract infections. In February 2017, the U.S. Food and Drug Administration approved the biomarker test that measures procalcitonin – a peptide that typically increases in bacterial infections, but not viral. We conducted the Procalcitonin Antibiotic Consensus Trial (ProACT) trial to evaluate whether a procalcitonin antibiotic prescribing guideline, implemented for the treatment of suspected lower respiratory tract infection with reproducible strategies, would result in less exposure to antibiotics than usual care, without a significantly higher rate of adverse events. The ProACT trial involved 14 predominately urban academic hospitals. We enrolled 1,656 adult patients who presented to the hospital emergency department and were initially diagnosed with a lower respiratory tract infection. All the patients were tested for their procalcitonin levels, but the results were shared only with the physicians of the patients randomly assigned to procalcitonin-guided antibiotic prescription. (more…)