Alzheimer's - Dementia, Author Interviews, Eli Lilly, NEJM / 16.03.2021

MedicalResearch.com Interview with: Stephen Salloway, M.D., M.S. Director of Neurology and the Memory and Aging Program, Butler Hospital Martin M. Zucker Professor of Psychiatry and Human Behavior Professor of Neurology, Alpert Medical School of Brown University Providence, RI 02906  MedicalResearch.com: What is the background for this study? Response: This 78 week phase 2 study tested donanemab in patients with early Alzheimer’s disease. Donanemab is a an anti-amyloid monoclonal antibody that targets the N3 pyroglutamate epitope.  MedicalResearch.com: What are the main findings? Response: The drug produced a substantial lowering of amyloid plaques and showed a slowing in cognitive decline. Key innovations included using PET scans to ensure all patients were amyloid positive and had a moderate level of tau build-up and switching from drug to placebo once the amyloid level was below the expected cut-off for Alzheimer’s disease. There were no new safety signals. The main side-effect was amyloid-related imaging abnormalities (ARIA) that have been seen with other anti-amyloid treatments. ARIA is managed with regular safety MRI scans.  Donanemab is now being tested in a larger phase 3 trial that could lead to regulatory approval. (more…)
Author Interviews, Cancer Research, Dermatology, NEJM / 11.02.2021

MedicalResearch.com Interview with: Jane Fang, MD Clinical Athenex, Inc.  MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by actinic keratoses? How common are they and who is primarily affected? Response: Actinic keratosis is a very common precancerous skin condition that affects about 58 millions people in the US. Most commonly affected people are older (over 40 years old) men with fair skin type. Actinic keratosis lesions are red scaly bumps on sun-damaged skin mostly on the face, scalp, back of hands, forearms and legs. As there is a risk of 0.025-16% per year for each actinic keratosis to progress to skin cancer and it is not possible to predict which actinic keratosis will become cancerous, early treatment of actinic keratosis is generally recommended. Currently approved topical treatments require weeks or months of application and may lead to intolerable side effects that undermine compliance and reduce efficacy of treatment. Tirbanibulin ointment is a novel anti-proliferative agent that inhibits tubulin polymerization and disrupts Src kinase signaling, and has the potential to inhibit growth of abnormal skin cells in actinic keratosis. The current report described two Phase 3 randomized vehicle or placebo-controlled clinical studies that demonstrated that a 5-day course of tirbanibulin ointment applied once daily by patients was safe, well-tolerated, and effective in clearing actinic keratosis on the face or scalp compared to vehicle control. (more…)
Author Interviews, Blood Pressure - Hypertension, NEJM, OBGYNE / 28.01.2021

MedicalResearch.com Interview with: DAVID K. TUROK, MD, MPH, FACOG ASSOCIATE PROFESSOR OF OBSTETRICS AND GYNECOLOGY CHIEF OF THE DIVISION OF FAMILY PLANNING UNIVERSITY OF UTAH MedicalResearch.com: What is the background for this study? Response: Researchers and clinicians have long known that copper intrauterine devices (IUDs) work extremely well for emergency contraception, using contraception after sex to prevent pregnancy. However, the hormonal IUD (levonorgestrel 52 mg IUD) has distinct characteristics that many people prefer. Namely, it reliably reduces or eliminates menstrual bleeding and cramping. Until now we did not know if the levonorgestrel IUD worked for emergency contraception. Now we know. In a first-of-its-kind study, our team at the University of Utah Health and Planned Parenthood Association of Utah found that hormonal IUDs were comparable to copper IUDs for use as emergency contraceptives. (more…)
AstraZeneca, Author Interviews, Cancer Research, ESMO, Lung Cancer, NEJM, Yale / 08.10.2020

MedicalResearch.com Interview with: Roy S. Herbst, M.D., Ph.D. Ensign Professor of Medicine (Medical Oncology) and Professor of Pharmacology Chief of Medical Oncology Yale Cancer Center and Smilow Cancer Hospital Associate Cancer Center Director for Translational Research Yale Cancer Center  MedicalResearch.com: What is the background for this study? How does osimertinib differ from prior versions of EGFR-TKI Inhibitors? o   ADAURA is a randomized, double-blinded, global and placebo-controlled Phase III trial in the adjuvant treatment of 682 patients with Stage IB, II, and IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated. Patients were treated with osimertinib 80 mg once-daily oral tablets or placebo for three years or until disease recurrence. The primary endpoint is disease free survival (DFS) in Stage II and IIIA patients, and a key secondary endpoint is DFS in Stage IB, II and IIIA patients. Osimertinib is not currently approved in the adjuvant setting in any country. o   Osimertinib is a third-generation, irreversible EGFR-TKI with clinical activity against central nervous system metastases. The results of the Phase III ADAURA trial of osimertinib demonstrate for the first time in a global trial that an EGFR inhibitor can change the course of early-stage EGFR-mutated lung cancer for patients. o   ADAURA results were first presented in May during the American Society of Clinical Oncology ASCO20 Virtual Scientific Program. (more…)
Author Interviews, COVID -19 Coronavirus, Emory, NEJM, NIH, Vaccine Studies / 04.10.2020

MedicalResearch.com Interview with: Evan J. Anderson, MD Associate Professor of Medicine and Pediatrics Emory University School of Medicine MedicalResearch.com: What is the background for this study? Response: Older adults have suffered a disproportionate number of the hospitalizations and deaths due to COVID-19. A vaccine is clearly needed for older adults.  For a number of vaccines, the immune response and efficacy of vaccines decreases with increasing age. A prime example would be influenza and the need for high dose influenza vaccine in the elderly. We had previously conducted a Phase I study in 18 – 55 year old adults of mRNA-1273 vaccine – published in NEJM 2020 with Lisa Jackson as the lead author. This phase I study was expanded to include older adults in 2 separate cohorts (56 – 70, >70 years of age) and 2 different doses. (more…)
Author Interviews, Cancer Research, HPV, Karolinski Institute, NEJM, Vaccine Studies / 30.09.2020

MedicalResearch.com Interview with: Dr. Jiayao Lei PhD Prof. Pär Sparén PhD Karolinski Institute MedicalResearch.com: What is the background for this study? Response: The efficacy and effectiveness of quadrivalent HPV (qHPV) vaccine protecting against HPV infection, genital warts and high-grade precancerous cervical lesions have been shown. However, there is lack of population-based studies in examining the association between HPV vaccine and invasive cervical cancer on individual level.  (more…)
Author Interviews, Diabetes, NEJM / 24.09.2020

Remarks from: Julio Rosenstock, M.D Director, Dallas Diabetes and Endocrine Center Clinical Professor of Medicine University of Texas Southwestern Medical Center Dallas, TX MedicalResearch.com: Why was the study initiated / What is the background of the study? Response: Most people with type 2 diabetes, would prefer simplicity, with fewer injections than currently provided by once-daily basal insulin treatment regimens. Therefore, there is a need to continue to offer innovative treatment options to support people living with type 2 diabetes and hopefully improve their glycemic outcomes. As a once-weekly basal insulin, insulin icodec has the potential to offer a simpler, efficacious and well-tolerated treatment option thereby reducing the potential burden on people living with type 2 diabetes. (more…)
Author Interviews, ESMO, Immunotherapy, Melanoma, NEJM / 03.09.2020

MedicalResearch.com Interview with: Reinhard Dummer, Prof. Dr. med. Stv. Klinikdirektor Universitätsspital Zürich, Dermatologische Klinik Zürich MedicalResearch.com: What is the background for this study? Response: Based on molecular biology analysis, a substantial proportion of melanomas are driven by mutations of BRAF resulting in an ongoing growth activating signal. Based on the key role of BRAF several multiple kinase molecules have been developed in order to target this crucial pathway. These medications have shown to improve progression free survival and overall survival in advanced metastatic melanoma. Because there is a tendency for improved outcome in patients with low tumor burden, combined targeted therapy using Dabrafenib and Trametinib have been investigated in the adjuvant (after complete surgical resection) setting in stage III melanoma. And the 5 year data are now available in the New England Journal of Medicine. (more…)
Author Interviews, Clots - Coagulation, NEJM / 12.08.2020

MedicalResearch.com Interview with: Elizabeth Webb, M.P.H Physiotherapy Department Calvary Public Hospital Bruce Bruce, Australia MedicalResearch.com: What is the background for this study? Response: Our study showed that in patients with a history of leg swelling (chronic edema), compression therapy by a skilled lymphedema therapist reduced the risk of infection in the leg (cellulitis) by a huge 77%. With up to 47% of patients experiencing recurrence of cellulitis in their legs within 3 years, this result is a game-changer in terms of our approach to managing patients with leg swelling and recurrent cellulitis. Until now, the use of prophylactic antibiotics to prevent cellulitis has been the only evidence-based practice. We know however, there are many reasons why avoidance of antibiotics is important within our community. (more…)
Author Interviews, NEJM, OBGYNE, Surgical Research / 29.07.2020

MedicalResearch.com Interview with: Jane Daniels PhD Professor of Clinical Trials, Faculty of Medicine & Health Sciences School of Medicine University of Nottingham MedicalResearch.com: What is the background for this study? MedicalResearch.com: What are the main findings? Response: Uterine fibroids are the most common non-cancerous tumour in women of childbearing age. They are associated with heavy bleeding, lower chances of having children and reduced quality of life. Traditional surgical options were either to remove the fibroids (myomectomy) or completely remove the womb. A newer approach, known as uterine artery embolization, involves blocking the blood supply to the fibroids in the womb. Fibroids may be associated with infertility and problems during pregnancy, including miscarriage and preterm birth. As more women are having children at a later age, fibroids are becoming more of an issue for them and safe and effective fertility sparing treatments are needed. Both treatments improve quality of life, but myomectomy will provide greater benefit to women on average. MedicalResearch.com: What should readers take away from your report? Response: This study is the largest to date comparing women treated with either myomectomy or uterine-artery embolization for their fibroids. It was completed in hospitals across the UK, and included a substantial number of women of African-Caribbean ethnicity, who are more likely have bothersome fibroids, so we can be confident that the findings are important and relevant. Women, including those desiring a future pregnancy, should be provided with the evidence generated by the FEMME trial to enable to make a fully informed decision regarding their fibroid treatment. (more…)
Author Interviews, Flu - Influenza, Infections, NEJM, Vaccine Studies / 15.07.2020

MedicalResearch.com Interview with: Frederick Hayden MD Stuart S Richardson Professor Emeritus of Clinical Virology Professor Emeritus of Medicine Division of Infectious Diseases and International Health University of Virginia  MedicalResearch.com: What is the background for this study? Response: Although primary prevention approach for influenza infections is vaccination, vaccine efficacy is incomplete and uptake rates are variable in the population. Preventing people who have been exposed to someone with influenza from developing the disease is an important way to prevent its rapid spread, reduce the disruption to peoples' lives and, in some cases, reducing the risk of serious illness or even death.  Prior studies have shown that antivirals like oseltamivir and inhaled zanamivir can reduce the risk influenza illness in those exposed. The BLOCKSTONE study was designed to assess the efficacy of postexposure prophylaxis with a single oral dose of baloxavir for the preventing influenza in household contacts. This antiviral drug was approved first in 2018 for treatment of adults with uncomplicated influenza.  (more…)
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, 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…)
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…)