MedicalResearch.com Interview with:
Ana Blasco, MD, PhD
Cardiology Department,
Hospital Universitario Puerta de Hierro–Majadahonda
Madrid, Spain
MedicalResearch.com: What is the background for this study?
Response: Our group has been investigating issues related to coronary thrombosis in patients with acute myocardial infarction for years. Recently, we developed a standardized technique for the detection and quantification of extracellular neutrophil networks (NETs) in coronary thrombi. During the first wave of the COVID-19 pandemic in Madrid, Spain, we had some cases of myocardial infarctions with ST elevation and a large thrombotic component among patients with severe SARS-CoV-2 infection.
Given the important participation of NETs in severe COVID-19 disease, causing occlusion of microvessels as shown in pulmonary samples, we decided to analyze their role in coronary thrombi. Thanks to similar previous analyzes in patients without COVID-19, we have been able to compare our results with a historical series. (more…)
MedicalResearch.com Interview with:
Dongmei Li, Ph.D., Associate Professor
Clinical and Translational Science Institute
University of Rochester Medical Center
MedicalResearch.com: What is the background for this study? Response: Previous animal and human studies have found that nicotine exposure could harm adolescents’ brain development and impact their cognitive functions. Electronic cigarettes, which have become very popular among youth in the US in recent years, usually contain nicotine at equivalent or possibly higher levels than traditional tobacco cigarettes. Thus, it is reasonable to assume that vaping might be associated with self-reported cognitive complaints.
MedicalResearch.com: What are the main findings?Response: Main findings from our study are:
Our cross-sectional youth and adult studies are the first to associate vaping with self-reported complaints of serious difficulty concentrating, remembering, or making decisions.
Our youth study also found that students who reported starting to vape early – between eight and 13 years of age – had higher odds of reporting difficulty concentrating, remembering, or making decisions than those who started vaping at 14 or older.
These studies add to a growing list of conditions and diseases (wheezing, COPD, cardiovascular disease, cancer) that have been associated with vaping/electronic cigarette use.
MedicalResearch.com Interview with:
Li Li, MS, PhD Candidate
Division of Epidemiology, College of Public Health, Ohio State University
Graduate Research Associate, Center for Injury Research and Policy
The Abigail Wexner Research Institute at Nationwide Children’s Hospital
MedicalResearch.com: What is the background for this study? Response: Marijuana use impairs cognitive abilities necessary for safe driving, including reaction time, road lane-tracking ability, and attention maintenance. Given increasing legalization of marijuana use in the US, our study aimed to estimate marijuana-impaired driving among teens at a national level and help to identify the current prevalence to guide future intervention programs. (more…)
MedicalResearch.com Interview with:
Dr. Roopa Rajan MD, DM
Post Doctoral Fellowship (Movement Disorders)
Assistant Professor
Department of Neurology
AIl India Institute of Medical Sciences
New DelhiMedicalResearch.com: What is the background for this study? Response: This study was inspired by the need for more effective treatments for patients with disabling hand tremor, particularly dystonic tremor. Dystonic tremor is a movement disorder in which both dystonia (abnormal posturing) and tremor co-exist in the same body part. In general, this common and often disabling disease responds only modestly to oral medications. Surgical treatments such as deep brain stimulation may be offered to persons with severe tremor, however the outcomes are not as robust as seen in other tremor conditions, for instance, essential tremor. Therefore, there is a critical need for more effective treatments for people living with this disease. Botulinum toxin injections are known to be effective for dystonic tremor affecting the head and voice, although these remain off-label indications. Previous studies using botulinum toxin injections for other hand tremors like essential tremor led to limited clinical application, in part due to transient hand weakness that may be a side effect of botulinum toxin injections. Recently, advances in injection delivery such as electromyographically guided botulinum toxin injections with individualized muscle and dose selections were reported to be beneficial in essential tremor. We built upon this existing data to explore the effects of such a treatment in patients with dystonic hand tremor. (more…)
MedicalResearch.com Interview with:Kenneth Freedberg, MD
Director, Medical Practice Evaluation Center
Massachusetts General Hospital
Professor of Medicine at Harvard Medical School
Study senior author
Jessie Gaeta, MD
Chief Medical Officer
Boston Health Care for the Homeless Program
Assistant Professor of Medicine
Boston University School of Medicine
Travis P. Baggett, MD, MPH
Faculty clinician-investigator
MGH Division of General Internal Medicine
Assistant Professor of Medicine
Harvard Medical School
MedicalResearch.com: What are the main findings?Dr. Baggett: We found that two strategies are crucial for addressing COVID-19 among people staying in homeless shelters:
1) Proactively identifying and testing people with symptoms, and
2) Providing a dedicated, medically supervised, non-hospital space for isolation and management of people with mild to moderate COVID.
Together these two strategies would reduce infections, hospitalizations, and health care costs compared to not doing them. During a pandemic surge, like we are seeing now, it makes sense to add periodic universal testing of all shelter residents, even those without symptoms. (more…)
MedicalResearch.com Interview with:
Elena Losina, PhD
Robert W. Lovett Professor of Orthopedic Surgery
Harvard Medical School
Director, Policy and Innovation eValuations in Orthopedic Treatments (PIVOT) Center
Co-Director, Orthopedic and Arthritis Center for Outcomes Research
Department of Orthopedic Surgery
Brigham and Women’s HospitalBoston, MA, 02115
MedicalResearch.com: What is the background for this study? Response: Since the pandemic began, there have been over 320,000 COVID-19 cases and 80 deaths at over 1,700 colleges, highlighting the consequences of different mitigation strategies, and as colleges are closing the fall semester and preparing for the spring semester, figuring out what worked what did not, in term of COVID-19 mitigation, is critical to minimize the impact of COVID-19 on college campuses during the spring semeste.(more…)
MedicalResearch.com Interview with:
Ariana M. Stickel, Ph.D.
Postdoctoral Scholar
Department of Neurosciences
University of California, San Diego
MedicalResearch.com: What is the background for this study? Response: Latinos are projected to have the largest increase in Alzheimer’s disease and related dementia in the coming years, yet we know so little about important risk factors for dementia amongst Latinos.
As there has been too little widespread research on diverse Latinos and dementia until recently, we examined the individual and combined relationships of two important risk factors for dementia --hearing impairment and cardiovascular disease risk--in over 9,000 Latinos 45 – 74 years old.
Diverse Latinos participated in the study, including Central Americans, Cubans, Dominicans, Mexicans, Puerto Ricans and South Americans residing in the Bronx, NY; Chicago, IL; Miami, FL and San Diego, CA. It is important to study a wide range of Latinos in order to appropriately reflect the diversity of this population.
Each participant underwent extensive cardiovascular and diabetes testing, hearing examinations, and cognitive assessments.
(more…)
MedicalResearch.com Interview with:
Mia StråvikPhD-student | Doktorand
Department of Biology and Biological Engineering
Division of Food and Nutrition Science
Chalmers University of Technology
MedicalResearch.com: What is the background for this study? Response: There is a need of research investigating the role of maternal diet during pregnancy and lactation on the baby’s allergy risk. Allergy is one of the most common chronic diseases of childhood, causing great suffering for the allergic child but also the entire family. Yet, the possibilities to cure and prevent this, in many cases life long, suffering are very limited. Previous research have indicated that maternal diet during pregnancy and lactation may affect the propensity of the child to develop an allergy, and diet is a factor you as a parent really can influence.
(more…)
MedicalResearch.com Interview with:
Michalis Katsoulis PhDImmediate PostDoctoral BHF fellow
Institute of Health Informatics
Senior Research Fellow, UCL
MedicalResearch.com: What is the background for this study?Response: In the early stage of the pandemic, we observed a decline in patient visits to Emergency Departments (ED), including those for cardiac diseases. This decline may have been due to fear of coronavirus infection when attending hospital, public reluctance to overload National Health Service facilities, or difficulty accessing care.
In our study, we tried to estimate the impact of reduced ED visits on cardiac mortality in England. We used data from ED visits from the Public Health England Emergency Department Syndromic Surveillance System (EDSSS). For cardiovascular disease outcomes, we obtained mortality counts for cardiac disease from the Office of National Statistics (ONS) for England.
(more…)
MedicalResearch.com Interview with:Aaron B. Caughey, M.D.,M.P.P., M.P.H.
Professor and Chair of the Department of Obstetrics and Gynecology
Associate Dean for Women’s Health Research and Policy
Oregon Health & Science University
Portland, OR
Founder and Chair
Centers for Disease Control and Prevention–funded Oregon Perinatal Collaborative
USPSTF Task Force MemberMedicalResearch.com: What is the background for this study? What are the main findings?Response: Hepatitis B virus infection is a serious condition that affects about 860,000 people in the United States. Screening for hepatitis B can detect the infection early, so that you can receive treatment that will reduce the potential for serious complications, including cancer, liver failure, and even death. Hepatitis B often has no signs or symptoms, so clinicians should screen teens and adults who are at increased risk for hepatitis B to help protect their health.
(more…)
MedicalResearch.com Interview with:
Harriët Schellekens MSc PhD
Lecturer
Department of Anatomy & Neuroscience,
and APC Microbiome Ireland SFI Research Centre
University College Cork, Cork, IRELAND.MedicalResearch.com: What is the background for this study? Response: There has been an increased emphasis on gut microbiota-targeted therapeutics for the amelioration of obesity. Recent studies have identified several probiotic strains with different anti-obesity effects, including members of the genus Bifidobacterium, but the exact mechanisms of action are still lacking.
Moreover, positive effects in animal studies often do not translate in human studies.
The APC Microbiome Ireland has set up a “culture-to-product” platform, a well catalogued and quality controlled collection of bacteria with potential biofunctional activities. In my laboratory, I have developed a state-of the art “bug-to-drug” screening approach, using high-throughput biochemical and cellular assays, to fully characterize bacteria and identify the most promising bacterial strains with specific desirable probiotic and functional properties. This careful in vitro screening of APC’s strains (or customer strains) is designed to identify the most potent candidates that can impact on host physiology and overall gut-brain axis function, e.g. by producing microbial metabolites or neuroactives, altering gut-barrier function, reducing inflammation, or modifying G-protein coupled receptors. This comprehensive screening approach facilitates the precise selection and prediction of the best strains that are likely to yield a specific positive health effects in subsequent animal and human studies, based on their in vitro probiotic and functional properties.(more…)
MedicalResearch.com Interview with:
Andrey Vyshedskiy PhD
Boston University, Boston
MedicalResearch.com: What is the background of ImagiRation?
Response: ImagiRation is a Boston-based startup with links to MIT, Harvard, and Boston University. ImagiRation has developed a highly innovative adaptive language therapy application for children with autism, Mental Imagery Therapy for Autism (MITA).
MedicalResearch.com: How is the Mental Imagery Therapy for Autism program delivered?Response: MITA language therapy is administered by parents at home. MITA application works on all smartphones and tablet devices and is designed for children ages 2 to 12 years.(more…)
MedicalResearch.com Interview with:
Chris Clark, PhD
Clinical Senior Lecturer in General Practice
Primary Care Research Group
St Luke's Campus, Exeter
MedicalResearch.com: What is the background for this study? What are the main findings?Response: Various individual studies have suggested that a blood pressure difference between arms is associated with increased mortality and cardiovascular events since we first reported this association in 2002. Such studies have been limited, due to smaller numbers of participants, in the conclusions that could be drawn. Therefore we sought to pool data from as many cohorts as possible to study this association in more detail.MedicalResearch.com: What are the main findings?Should it be standard practice to measure blood pressure in both arms?Response: Systolic inter-arm difference was associated with increased all-cause and cardiovascular mortality. We found that all-cause mortality increased with inter-arm difference magnitude from a ≥5 mmHg threshold. Systolic inter-arm difference was also associated with cardiovascular events in people without pre-existing disease. This remained significant after adjustment for various internationally used cardiovascular risk scores, namely ASCVD, Framingham or QRISK2. Essentially we found that each increase of 1mmHg in inter-arm difference equated to a 1% increase for a given cardiovascular risk score.
When undertaking a cardiovascular assessment, or determining which arm should be used for blood pressure measurement, it is recommended to measure both arms.
(more…)
MedicalResearch.com Interview with:
Brian J. Piper, PhD, MS
Department of Medical Education
Geisinger Commonwealth School of Medicine
Scranton, PA 18510
MedicalResearch.com: What is the background for this study? Response: The US continues to be adversely impacted by an iatrogenic opioid epidemic. There have been increasing reports of “vet shopping” or diverting opioids from pets to their owners [2]. In humans, methadone is the number one prescription opioid when expressed in terms of morphine mg equivalents (MME) [3]. The goal of this study was to examine the changing pattern of opioid and other controlled substance use by veterinary teaching institutions.(more…)
MedicalResearch.com Interview with:
John T. Poirier, PhDAssistant Professor of Medicine, NYU Grossman School of Medicine
Director, Preclinical Therapeutics Program
Perlmutter Cancer Center
An NCI-designated Comprehensive Cancer Center
NYU Langone Health
Smilow Research Center
New York, NY 10016MedicalResearch.com: What is the background for this study? Response: The goal of this study was to identify in as much detail as possible the genes that SARS-CoV-2, the virus that causes COVID-19, needs to successfully infect a human host cell. CRISPR technology played a key role in this research; it was used to disrupt every gene in the human genome in parallel and study which ones were required for infection. (more…)
MedicalResearch.com Interview with:
Rebecca McAdams, MA, MPH
Senior research associate
Center for Injury Research and Policy
Nationwide Children’s Hospital
Columbus, OH
MedicalResearch.com: What is the background for this study?Response: Sledding is a popular winter activity in communities across the country, but it may not be as risk-free as many people think.
MedicalResearch.com: What are the main findings?Response: We found that 220,488 patients were treated in U.S. emergency departments for injuries related to sledding from 2008 through 2017. Nearly 70% of these patients were children age 19 years and younger. Compared to adults, children were almost seven times as likely to be treated in an emergency department for a sledding-related injury.
The majority of patients were injured as the result of a collision (63%). Collision injuries occurred when the patient made contact with an object in the environment (47%), when they hit the ground (16%), or when they ran into another person (10%) or sled (7%).
Head injuries are a serious concern during sledding. The head was the most frequently injured body part for children. In fact, nearly 82% of those who sustained an injury to the head were children. The type of sled can also impact the risk of head injury. Children injured while riding snow tubes and disks had a greater risk of sustaining a concussion or CHI than children who were riding sleds or toboggans. Researchers recommend wearing a helmet while sledding to reduce the risk and severity of head injuries.
While less frequent (3% of all cases), injuries occurring as a result of the sled being pulled by a motorized vehicle such as a car, ATV or snowmobile resulted in more serious injuries that required hospitalization (14%). This practice should be avoided.(more…)
MedicalResearch.com Interview with:
Emily Largent, PhD, JD, RN
Senior Fellow
Leonard Davis Institute of Health EconomicsAssistant Professor, Medical Ethics and Health Policy
Perelman School of MedicineMedicalResearch.com: What is the background for this study? Response: Ending the COVID-19 pandemic through vaccination will require sufficient vaccine uptake. Various means are being considered to promote uptake, including mandatory vaccination. For instance, COVID-19 vaccination might be mandated by states (e.g., as a condition for children to attend public school) or by employers. Given the opposition we’ve seen to masks, to choose just one example, our team wanted to gauge the acceptability of COVID-19 vaccine mandates.
(more…)
MedicalResearch.com Interview with:
Dr. Louis Aronne, MD, FACP
Chief Medical Officer, Intellihealth
Medical Director, Comprehensive Weight Control Center
Weill Cornell Medicine
MedicalResearch.com: What is the background for the study “Effect of an Online Weight Management Program Integrated With Population Health Management on Weight Change: A Randomized Clinical Trial”?Response: More than 70% of U.S. adults have overweight or obesity. Online programs promoting lifestyle change have had some success in helping people achieve and maintain weight loss, but study results have been variable, and these programs have not been widely implemented in primary care. We studied the effectiveness of an online program we have developed (Intellihealth, formerly known as BMIQ) in routine primary care practices, both alone and integrated with population health management (with participants receiving additional support and outreach from nonclinical staff). The study’s objective was to determine whether a combined intervention integrating online weight management with population health management would increase weight loss at 12 months among primary care patients compared with the online program only and usual care.
(more…)
MedicalResearch.com Interview with:
Karin Magnusson PT, PhD
Associate ResearcherLund University and
Norwegian Institute of Public Health
MedicalResearch.com: What is the background for this study? Response: Anterior cruciate ligament (ACL) injury is one of the most common knee injuries, for which very limited data has been presented on the genetic contribution. Based on our knowledge of the role of genetics in the development of ACL-rupture related traits, such as joint hypermobility and knee osteoarthritis, we hypothesized that heritability might play a role also in ACL injury.
Using the Swedish Twin Registry, which is the world's largest twin registry and in this study including more than 88.000 twins, we had unique data to for the first time reliably estimate the heritability for this common knee injury.(more…)
MedicalResearch.com Interview with:
Robert Van Haren, MD, MSPH
College of Medicine
University of CincinnatiMedicalResearch.com: What is the background for this study? Response: The COVID-19 pandemic has impacted all areas of society including the field of oncology. This study evaluated the impact of COVID-19 on lung cancer screening. Screening with low-dose computed tomography (LDCT) scans are important because they reduce lung cancer mortality by at least 20%. Our lung cancer screening program was closed in March 2020 due to COVID 19 and reopened again in June 2020. We cancelled over 800 LDCTs during that time period. (more…)
MedicalResearch.com Interview with:
Joshua Brody MD
Director, Lymphoma Immunotherapy Program
Icahn School of Medicine at Mount Sinai
Hess Center for Science and Medicine
New York, New York 10029
MedicalResearch.com: What is the background for this study? Response: Cancer Immunotherapies target "antigens" on the surface of cells.
-CAR-T cells targets antigens e.g. CD19
-Bispecific antibodies target antigens e.g. CD20
-Anti-PD1 antibodies awaken T cells that target antigens on e.g. MHC-I
Cancer Immunotherapies frequently fail because a small percent of tumor cells simply lack the antigen and cause cancer relapse ('Antigen Escape')
(more…)
MedicalResearch.com Interview with:
Xiaolei Yang
The State Key Laboratory of Nonlinear Mechanics, Institute of Mechanics
School of Engineering Sciences
University of Chinese Academy of Sciences
Beijing, China
MedicalResearch.com: What is the background for this study? What are the main findings?Response: The most important finding of this study is that the transmission of COVID-19 is highly influenced by the airflow and that a slight difference in the airflow can significantly alter the virus spreading pattern in the air. In this study, the change of airflow is caused by a minor difference in the corridor width and the walking speed. However, such a change can also come from other factors, such as the indoor architectural structure, the temperature, the humidity, etc. In many of these cases, the common guideline of 6-feet may not be enough when the influence of airflow is taken into account. Due to this complexity, there is still a gap of knowledge to fill before a safety guideline for different indoor environments can be provided to the public, many research efforts are needed from the fluid mechanics’ aspect.
(more…)
MedicalResearch.com Interview with:
Kevin Moore, MD
UCL Institute of Liver and Digestive Health
Royal Free Hospital, University College London
MedicalResearch.com: What is hepatorenal syndrome – acute kidney injury (HRS-AKI) and how does terlipressin fit into the treatment landscape?Response: HRS-AKI, also known as hepatorenal syndrome type 1 (HRS-1), is an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis.[i] HRS-1 can progress to life-threatening renal failure within daysi and has a median survival time of approximately two weeks and greater than 80 percent mortality within three months if left untreated.[ii],[iii]
Terlipressin, a potent vasopressin analogue selective for V1 receptors, is an investigational agent, and its safety and effectiveness have not yet been established by the U.S. Food and Drug Administration. In the U.S., there are currently no approved pharmacologic treatments for HRS-1; however, terlipressin is approved in most other countries, where it has been a standard of care for the last 20 years in the treatment of patients with HRS-1.[iv],[v]
The current standard of care for HRS-1 in the U.S. includes other vasoconstrictors such as midodrine (a drug which can increase blood pressure and potentially improve blood flow into the kidneys) along with concomitant albumin and frequent monitoring, but current data do not support good efficacy.2 Dialysis (a type of renal replacement therapy) is sometimes used in hepatorenal syndrome, but dialysis is not curative and it can be costly.(more…)
MedicalResearch.com Interview with:
Isaac Chua, MD, MPH
Division of General Internal Medicine and Primary Care
Brigham and Women's Hospital
MedicalResearch.com: What is the background for this study? Response: Patient surveys have shown that most people prefer to die at home at the end-of-life. However, during the initial wave of the COVID-19 pandemic, anecdotal evidence from our colleagues and findings from a prior study published in the Journal of the American Geriatrics Society suggested that majority of COVID-19 decedents died in a medical facility. However, less is known about care intensity at the end-of-life according to place of death among patients who died of COVID-19. Therefore, we characterized end-of-life care by place of death among COVID-19 decedents at Mass General Brigham (MGB), the largest health system in Massachusetts.(more…)
MedicalResearch.com Interview with:
Sheela Maru, MD, MPH
Department of Health System Design and Global Health and
Arnhold Institute for Global Health and
Department of Obstetrics, Gynecology and Reproductive Science
Icahn School of Medicine at Mount Sinai
MedicalResearch.com: What is the background for this study?
Response: Universal screening for SARS-CoV-2 infection on Labor and Delivery (L&D) units is a critical strategy to manage patient and health worker safety, especially in a vulnerable high-prevalence community. We describe the results of a SARS-CoV-2 universal screening program at the L&D Unit at Elmhurst Hospital in Queens, NY, a 545-bed public hospital serving a diverse, largely immigrant and low-income patient population and an epicenter of the global pandemic.
(more…)
MedicalResearch.com Interview with:
Nilanjan Chatterjee, PhD
Bloomberg Distinguished Professor
Departments of Biostatistics and Epidemiology
Johns Hopkins Bloomberg School of Public HealthMedicalResearch.com: What is the background for this study?
Response: Calculation of risks or severe COVID-19 disease and mortality for individuals in the general population can help to prioritize prevention efforts, such as early vaccination. We developed a model to estimate risks for COVID-19 mortality for currently uninflected individuals based on sociodemographic factors, pre-existing conditions and local pandemic intensity. The model captures factors associated with both risk of infection and complications after infection.
The model was developed using information from a large UK based cohort study called OpenSAFELY, and was adapted to the US population based on information on mortality rate associated with age and race/ethnicity available through CDC. The model also utilizes information on state level projected death rates from pandemic forecasting models.(more…)
MedicalResearch.com Interview with:
Auriel Willette, PhD
Assistant Professor
Food Science and Human Nutrition
Iowa State University
MedicalResearch.com: What is the background for this study? Response: To date, pharmacology therapies done to slow down or halt Alzheimer's disease have been inconclusive. Lifestyle interventions like changes in diet and activity are also mixed but do show some promise. Dietary clinical trials or self-reported diet have tended to focus on groups of foods such as the Mediterranean or MIND diet. To build from this excellent work, we were curious if we could pinpoint specific foods that were correlated with changes in fluid intelligence over time. Fluid intelligence represents our ability to creatively use existing knowledge, working memory, and other components of "thinking flexibly."
Further, we tested if these patterns of association differed based on genetic risk. In this case, genetic risk was defined as having a family history of Alzheimer's disease or having 1-2 "bad" copies of the Apolipoprotein E (APOE) gene, which is the strongest genetic risk factor for Alzheimer's disease.
(more…)
MedicalResearch.com Interview with:
Andrew W. McHill, PhD
Research Assistant Professor
Oregon Institute of Occupational Health Sciences
Oregon Health & Science University, Portland OR
Portland, OR 97239
MedicalResearch.com: What is the background for this study? Response: It has long been known that there is a home court advantage in sports, whether it be due to the home fans cheering, playing within familiar settings, or travel of the opposing team. However, the contribution of travel to home-court advantage could never be fully teased apart due to all the confounds of the other aspects of playing at home.
In March, the National Basketball Association had to pause their season due to COVID-19 concerns, only to start again several months later with the top 22 teams playing in a “bubble” environment where no teams were required to travel. This created a ‘natural experiment’ wherein we could test the impact of travel on winning and performance before the COVID-19 shutdown with games played in the bubble environment with no travel.
(more…)
MedicalResearch.com Interview with:
Asimanshu Das, Ph.D. student
Brown University School of Engineering
MedicalResearch.com: What is the background for this study? What are the main findings?Response: Driving in a car with ride-share or car-pool is a widely prevalent social interaction. The study aimed to address the airflows inside cars in various window open/closed configurations using computer simulations, and also looking into the possibility of movement of aerosol-type of particles from one occupant to other.
The main findings are that opening windows provides a likely benefit to reduce the potentially pathogenic aerosols inside the cabin. Generally, more windows the better, but at the least it would be advisable to have one rear side window and one frontside window open.
(more…)
MedicalResearch.com Interview with:
William K. Schmidt, Ph.D.
Senior VP Clinical Development
Helixmith Co. Ltd.
MedicalResearch.com:What is the background for this study? How common is diabetic peripheral neuropathy and how does it affect patients?Response: According to the Centers for Disease Control and Prevention (CDC), over 34 million people in the United States have diabetes (about 10% of the U.S. population) and about one in four patients do not know that they have it (https://www.cdc.gov/chronicdisease/resources/publications/factsheets/diabetes-prediabetes.htm). Diabetes can cause significant damage to nerves in the feet, hands, eyes, and other parts of the body.
Diabetic peripheral neuropathy (DPN) is the most common form of nerve damage worldwide; it affects approximately half of the patients with diabetes (Iqbal et al., 2018). In many individuals, severe burning, tingling, “pins and needles,” or cramping pain can occur simultaneously in both feet without external evidence of foot damage. Despite the pain, symptoms may be accompanied by numbness or loss of sensation in the feet. This is called painful diabetic peripheral neuropathy (painful DPN or P-DPN) and may affect up to one-third of the general diabetic population (Yoo et al., 2013). P-DPN may cause increased anxiety and depression, sleep impairment, and difficulties with walking. Up to one-third of P-DPN patients may require the use of a cane, walker, or even a wheelchair due to extreme foot pain. Once P-DPN occurs, it may result in a lifetime of pain and disability.
FDA-approved daily oral medications often used to treat P-DPN include Neurontin (gabapentin), Lyrica (pregabalin), Cymbalta (duloxetine), and Nucynta ER (tapentadol). While these “neuropathic pain” medications may dull the pain for some subjects, they produce significant side effects that may be troubling for many patients. Indeed, many patients stop using these pain killers due to lack of effectiveness at doses that they can tolerate (van Nooten et al., 2017) There is also a topical 8% capsaicin patch, but again with limited efficacy. It is well known that the most severely affected patients may require opioid analgesics to control P-DPN (Pesa et al., 2013).
None of the currently used medications have disease-modifying effects. However, our new injectable medication is now in advanced clinical development that has the potential disease-modifying effects lasting months after each treatment, with limited or no side effects for most patients aside from brief injection site discomfort.
(more…)
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