Asthma, Author Interviews, NEJM / 27.10.2021

MedicalResearch.com Interview with: Professor Chris Brightling, NIHR Senior Investigator Department of Respiratory Sciences University of Leicester Leicester, UK MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Risankizumab is an anti-IL23 monoclonal antibody. It is a very effective licensed therapy for plaque psoriasis. IL23 has been implicated in asthma and therefore we chose to study the effect of risankizumab in people with severe asthma. The time to first asthma worsening was earlier and the frequency of asthma worsenings was higher in those treated with risankizumab versus placebo. We found that the gene expression of key molecules involved in the response to infection were decreased in airway samples in those treated with risankizumab. It is possible that the increased asthma worsening following risankizumab was related to this suppression of anti-microbial immunity.  (more…)
Author Interviews, NEJM, Stroke, University Texas / 08.09.2021

MedicalResearch.com Interview with: James Grotta, MD Director of Stroke Research Clinical Institute for Research and Innovation Memorial Hermann - Texas Medical Center Director, Mobile Stroke Unit Consortium University of Texas Health  MedicalResearch.com: What is the background for this study? Response: We have good stroke treatments (thrombolysis and thrombectomy).  Since the initial studies showing benefit of thrombolysis, it has been difficult to improve on the amount of benefit except by speeding its delivery; the earlier the treatment, the better the outcome. Biologically, treatment in the first hour is likely to have greatest benefit since the brain is less irreversibly damaged and the clot is more soluble. But treatment in the first hour is rare if it is carried out in the emergency department.  So MSUs take the emergency department to the patient. We know that Mobile Stroke Units (MSUs) can speed treatment; our study addressed if this be accomplished in the US, and how much difference does it make in outcome.  In particular, outcomes important to patients given the probable costs of implementing MSUs.  (more…)
Author Interviews, Heart Disease, NEJM, Salt-Sodium, Stroke / 03.09.2021

MedicalResearch.com Interview with: Maoyi TIAN PhD Program Head, Digital Health and Head, Injury & Trauma Senior Research Fellow The George Institute MedicalResearch.com: What is the background for this study? Response: There is clear evidence from the literature that sodium reduction or potassium supplementation can reduce blood pressure. Reduced blood pressure can also lead to a risk reduction for cardiovascular diseases. Salt substitute is a reduced sodium added potassium product combined those effects. Previous research of salt substitute focus on the blood pressure outcome. There is no evidence if salt substitute can reduce the risk of cardiovascular diseases or pre-mature death. This study provided a definitive evidence for this unaddressed question. MedicalResearch.com: What are the main findings? The main findings of the research were:
  • The salt substitute reduced the risk of stroke by 14%
  • The salt substitute reduced the risk of major adverse cardiovascular events by 13%
  • The salt substitute reduced the risk of pre-mature death by 12%
(more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Immunotherapy, Kidney Disease, NEJM / 18.08.2021

MedicalResearch.com Interview with: Toni K. Choueiri, MD Director, Lank Center for Genitourinary Oncology Director, Kidney Cancer Center Jerome and Nancy Kohlberg Chai Professor of Medicine, Harvard Medical School  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The standard of care for patients diagnosed with locoregional RCC is partial or total nephrectomy. Nearly half of patients will eventually experience disease recurrence following nephrectomy and no standard, globally approved adjuvant therapy options are currently available for this population. The phase 3 KEYNOTE-564 study met its primary objective of demonstrating a statistically significant and clinically meaningful improvement in disease-free survival with pembrolizumab vs placebo as adjuvant therapy for patients with RCC post nephrectomy, supporting pembrolizumab as a potential new standard of care for patients at high risk of disease recurrence following surgery. (more…)
Author Interviews, NEJM, Neurology, Pain Research / 18.08.2021

MedicalResearch.com Interview with: Jessica Ailani M.D. FAHS FAAN FANA Director Medstar Georgetown Headache Center Vice Co-Chair of Strategic Planning for MedStar Neurology Professor of Clinical Neurology MedStar Georgetown University Hospital MedicalResearch.com: What is the background for this study? Response: Migraine is a common neurological disease that causes disabling attacks that can be frequent. Preventive treatments can help reduce the frequency of attacks and improve patient function, reducing disease burden. (more…)
Author Interviews, Cancer Research, Dermatology, NEJM / 20.07.2021

MedicalResearch.com Interview with: Jane Fang, MD Clinical Athenex, Inc. MedicalResearch.com: What is the background for this study? Response: Tirbanibulin is a first-in-class synthetic molecule that has potent anti-proliferative activity by inhibiting tubulin polymerization and disrupting src kinase signaling. It has been formulated as an ointment for the treatment of actinic keratosis, a very common precancerous condition of UV-damaged skin that affects over 50 million people in the US. The most commonly adopted management approach is to remove AK lesions as it is hard to predict which lesion will become cancerous. Lesion-directed treatment like cryotherapy can effectively remove lesions one at a time but does not treat larger field of cancerization. Also, it is limited by associated pain and long term complication such as scarring. Currently approved topical treatments involve cumbersome application courses of weeks or months, and induce considerable local skin reactions that were not well tolerated by patients. The Phase 3 studies demonstrated that a short 5-day once daily course of tirbanibulin ointment 1% is an efficacious and safe topical treatment of actinic keratosis. (more…)
Author Interviews, Beth Israel Deaconess, Gastrointestinal Disease, NEJM / 01.07.2021

MedicalResearch.com Interview with: Prof. Dr. D. Schuppan, MD, PhD Professor of Medicine Director Institute of Translational Immunology University Medical Center of the Johannes Gutenberg University Consultant Gastroenterologist and Hepatologist Director Celiac and Small Intestinal Disease Center Director Center for Food Intolerances and Autoimmunity Director Liver Fibrosis and Metabolism Research Research Center for Immune Therapy (FZI) Mainz Project for Chemical Allergology (MPCA) Mainz, Germany Professor of Medicine, Division of Gastroenterology Beth Israel Deaconess Medical Center Harvard Medical School Boston, MA 02215 MedicalResearch.com: What is the background for this study? Response: Celiac disease (CeD) is a common intestinal inflammatory disease that affects about 1% of most wheat consuming populations worldwide. CeD is caused by the ingestion of gluten containing foods, such as wheat, spelt, rye and barley, that activate small intestinal inflammatory T cells. The only current therapy is the rigorous avoidance of even traces of gluten in the daily diet, which is difficult and a social and psychological burden. We previously identified the body’s own enzyme tissue transglutaminase (TG2) as the CeD autoantigen. Moreover, TG2 drives celiac disease pathogenesis by enzymatically modifying dietary gluten peptides that makes them more immunogenic. We therefore developed an oral small molecule (ZED1227) that specifically inhibits TG2 activity in the intestine. While this should attenuate CeD in patients exposed to dietary gluten, it was unclear if  it could prevent gluten induced intestinal inflammation and damage. (more…)
Author Interviews, Dermatology, NEJM / 28.04.2021

MedicalResearch.com Interview with: Prof. Kristian Reich, MD, PhD Professor for Translational Research in Inflammatory Skin Diseases Institute for Health Services Research in Dermatology and Nursing University Medical Center Hamburg-Eppendorf MedicalResearch.com: What is the background for this study? What are the main findings? Response: Complete skin clearance is an important treatment goal for patients with psoriasis and is closely associated with treatment satisfaction and improved quality of life. However, it remains an unmet need for many patients. The interleukin (IL)-17 isoforms IL-17A and IL-17F play central roles in psoriasis pathophysiology and are overexpressed in psoriatic tissues. Existing biologic therapies, such as secukinumab, inhibit IL-17A only. However, increasing evidence indicates that IL-17F contributes independently to the pathobiology of plaque psoriasis, and that blocking both IL-17A and IL-17F may lead to more complete suppression of inflammation and superior clinical outcomes, compared with blocking IL‑17A alone. Bimekizumab is a humanized monoclonal IgG1 antibody that has been designed to selectively inhibit IL-17F in addition to IL-17A. (more…)
Author Interviews, Breast Cancer, Brigham & Women's - Harvard, NEJM / 22.04.2021

MedicalResearch.com Interview with: Aditya Bardia MD, MPH Director, Breast Cancer Research Program, Attending Physician, Massachusetts General Hospital Harvard Medical School  MedicalResearch.com: What is the background for this study? Response: Triple negative breast cancer (TNBC) represents an aggressive subtype of breast cancer associated with guarded prognosis. For patients with pre-treated metastatic TNBC, standard chemotherapy is associated with low response rate (5-10%) and poor progression-free survival (2-3 months), highlighting need for better therapies. Sacituzumab govitecan is an antibody drug conjugate (ADC) which  combines SN-38, an active metabolite of irinotecan, with an antibody against Trop-2, an antigen overexpressed in majority of triple negative breast cancer. (more…)
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…)