Blog – Medical Research News and Interviews
04 Apr Omega-3 Fatty Acid Supplementation Improves Luteal Function in Obese Women
MedicalResearch.com Interview with: [caption id="attachment_33632" align="alignleft" width="133"]
Dr. Polotsky[/caption]
Alex J. Polotsky, MD
Associate Professor of Obstetrics and Gynecology
University of Colorado Denver
Practice homepage
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: It has been well established that profound dietary changes occurred over the past 100 years. The type and amount of fat consumed has changed quite a bit over the course of 20th century. Intake of omega-3 polyunsaturated fatty acids (PUFAs), previously consumed in large quantities by humans from vegetable and fish sources, has dropped significantly. The typical Western diet (sometimes also called the typical American diet) provides an omega-6 to omega-3 fatty acid ratio of as high as 25:1, which is quite different from what it used to up until about the 19th century (believed to be about 1:1 ratio).
In animal studies, diets enriched with omega-3 PUFA enhance early embryonic development and boost progesterone secretion. Obesity is well known to be associated with decreased progesterone production in women (even if a obese woman ovulates). The reasons for this are not clear. Obesity is also a state of low-grade chronic inflammation. Omega-3 fatty acids are well known to have anti-inflammatory properties.
We sought to test whether dietary supplementation with omega-3 PUFA favorably affects reproductive hormones in women and whether this effect includes normalization of progesterone production in obesity.
All women in the study tolerated supplementation well, and had significantly decreased their omega-6 to omega-3 ratios (they were normalized much closer to a 1:1 ratio). Omega-3 supplementation resulted in a trend for increased progesterone in obese women, thus enhancing ovulatory function. A 16 to 22 percent increase was observed. Additionally, the supplementation resulted in reduced systemic inflammation.
04 Apr Study Finds Statin Use Not Associated With Breast Cancer Prognosis
MedicalResearch.com Interview with: [caption id="attachment_33622" align="alignleft" width="134"]
Dr. Leiter[/caption]
Amanda Leiter, MD MSCR
Medical Resident, Internal Medicine
Icahn School of Medicine at Mount Sinai
MedicalResearch.com: What is the background for this study?
Response: Black women are more likely than White women to have breast cancer with poor prognostic features, which cannot be completely explained by differences in screening, treatment and established risk factors for breast cancer mortality. Black women have higher rates of obesity, insulin resistance and dyslipidemia when compared to White women. Prior studies have shown a decreased risk of breast cancer recurrence and improved survival with statin use.
As statins have an association with decreased breast cancer recurrence and potentially improved survival, disparities in statin use between Black and White women with breast cancer are important to investigate. We aimed to elucidate whether or not statin use differs between Black and White women with breast cancer and if racial disparities in breast cancer can be partially explained by differences in statin use.
03 Apr Suicide Risk Increased in Cancer Patients
MedicalResearch.com Interview with: [caption id="attachment_33625" align="alignleft" width="152"]
Dr. Calati[/caption]
Raffaella Calati, Psy.D., Ph.D.
University of Montpellier
INSERM U 1061: Neuropsychiatry: Epidemiological and Clinical Research
Department of Emergency Psychiatry and Post Acute Care
Lapeyronie Hospital, Centre Hospitalier Universitaire
Montpellier, France
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: A number of previous original studies investigated suicidal thoughts and behaviours in cancer patients, finding them to be higher than those in the general population. However, to our knowledge, we performed the first meta-analysis on this link, pooling all the published data to calculate the size of this increased risk.
Our main finding is an increased suicide risk in patients with cancer compared to individuals without it.
It should be underlined that the analyses presented are the first stage in our work, since at the moment we are analyzing a higher number of studies and we are planning to control for confounders, not considered in our first analyses. This means that the exact strength of this association will be more precisely known.
02 Apr Economic Evaluation of a Home-Based Age-Related Macular Degeneration Monitoring System
Posted at 13:17h
in Author Interviews, Cost of Health Care, JAMA, Macular Degeneration, Ophthalmology, Telemedicine
MedicalResearch.com Interview with:
John Wittenborn
Senior research scientist
NORC's Public Health Analytics
University of Chicago
MedicalResearch.com: What is the background for this study? What are the main findings?
Response:The emergence of anti-VEGF treatment for wet-form AMD (choroidal neovascularization) has had a dramatic impact on preserving vision for many Americans. However, community-based studies show that most patients are not diagnosed with wet-form AMD until they have already lost a significant, and largely unrecoverable amount of their vision. Early detection of wet-form AMD is key to effective treatment and the preservation of vision. The ForeseeHome telemonitoring technology provides patients with a means to check their own eyes on a daily basis to detect the earliest signs of vision loss from wet-form AMD.
This is a novel technology that has the potential to improve visual health outcomes for AMD patients. A prior clinical trial (the AREDS-2 HOME study) demonstrated that this technology can detect wet-form AMD earlier, and with less vision loss than standard care alone. However, that is exactly where that study ended as it reported no cost information nor follow-up. Since the end of this study, the device has been cleared by the FDA and approved for reimbursement by Medicare for certain higher risk patients, but no study has yet considered the long-term implications of adoption of this technology.
In our analysis, we use a computer simulation model to essentially estimate what will come next, after patients realize earlier detection of wet-form AMD by utilizing home monitoring. Basically, we follow simulated patients from the time they begin monitoring for the rest of their lives, recording the likely impacts of home monitoring on patients’ long term outcomes including visual status, costs and quality of life.
We find that home telemonitoring among the population indicated for reimbursement by Medicare would cost $35,663 per quality adjusted life year (QALY) gained. Medicare would expect to incur $1,312 in net budgetary costs over 10 years for each patient who initiates monitoring. However, Medicare patients may expect to achieve lifetime net savings when accounting for the chance of avoided vision loss and its associated costs later in life.
02 Apr Promising New Drug Can Stop Malaria After Mosquito Bite
MedicalResearch.com Interview with: [caption id="attachment_33617" align="alignleft" width="150"]
Dr Mihály Sulyok[/caption]
Dr Mihály Sulyok MD
Eberhard Karls University
Institute of Tropical Medicine,
Tübingen, Germany
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: New antimalarials are desperately needed, not just for treatment, but also for prophylaxis. DSM265, a novel antimalarial compound that selectively inhibits the plasmodial dihydroorotate dehydrogenase has a promising pharmacokinetic profile characterized by a long elimination half-life.
We performed a study at the Institute of Tropical Medicine, Eberhard Karls University (Tübingen, Germany) to investigate safety, tolerability and efficacy of DSM265 using controlled human malaria infection. In the first cohort, 400mg of DSM265 was administered orally to five healthy, malaria naive individuals one day before direct venous inoculation of an established infective dose of P. falciparum sporozoites (PfSPZ Challenge). Placebo was administered to two volunteers. The study was randomized and double blinded. In this cohort all placebo participants developed malaria, whereas all DSM265 participants were protected.
In a second cohort, 400mg DSM265 was administered 7 days before the sporozoite inoculation for six participants, two participants recieved placebo. In this cohort, the two placebo and three of six DSM265 volunteers developed thick blood smear positive malaria. The remaining three DSM265 volunteers developed transient submicroscopic parasitemia without symptoms or thick blood smear positivity. The only possible DSM265-related adverse event was a slight transient elevation in serum bilirubin in one volunteer.
The study was funded by the Global Health Innovative Technology Fund, Wellcome Trust, Bill & Melinda Gates Foundation through Medicines for Malaria Venture, and the German Center for Infection Research.
02 Apr Flame Retardant Chemicals In Homes May Be Raising Risk of Thyroid Cancer
MedicalResearch.com Interview with: [caption id="attachment_33607" align="alignleft" width="156"]
Dr. Sosa[/caption]
Julie Sosa, MD MA FACS
Professor of Surgery and Medicine
Chief, Section of Endocrine Surgery
Director, Surgical Center for Outcomes Research
Leader, Endocrine Neoplasia Diseases Group
Duke Cancer Institute and Duke Clinical Research Institute
Durham, NC 2771
MedicalResearch.com: What is the background for this study?
Response: The incidence of thyroid cancer has dramatically increased world-wide over the last several decades. In the United States, thyroid cancer is the fastest increasing cancer among women and men. This observation has been almost exclusively the result of an epidemic of papillary thyroid cancer, or PTC, which now comprises approximately 90% of new cases.
The use of flame retardant chemicals, or Flame Retardant Chemicals, also increased over the last several decades due to the implementation of mandatory and voluntary flammability standards for furniture, electronics, and construction materials. Over time, FRs come out of these products and accumulate in indoor environments where humans are exposed. Animal studies suggest that FRs can disrupt thyroid function, and many contribute to cancer risk. But many human health endpoints have not been investigated.
Our work was aimed at investigating whether exposure to Flame Retardant Chemicals could be associated with PTC. To address our research question, we recruited 140 adults, 70 with PTC and 70 who were healthy volunteers without evidence for thyroid cancer or thyroid disease. Then we visited participants’ homes and collected dust samples, a metric that we have previously shown is an indicator of long-term exposure to Flame Retardant Chemicals in the home.
02 Apr Rate of Contralateral Prophylactic Mastectomy Varies Among States
MedicalResearch.com Interview with: Ahmedin Jemal, DVM, PHD Vice President, Surveillance and Health Services Research American Cancer Society, Inc. Atlanta, GA 30303 MedicalResearch.com: What is the background for this study? Response: Previous studies reported that Contralateral Prophylactic Mastectomy (CPM) increased in the United States among women diagnosed with unilateral early-stage breast cancer with surgery without evidence for survival benefit. Previous studies also reported that receipt of this procedure is more common in younger than older patients, in white than in black patients, and in privately insured than uninsured patients. However, the extent of variation in receipt of CPM by state of residence was unknown.02 Apr Consequences of Interpersonal Violence Against Child Athletes Persist into Adulthood
Posted at 12:14h
in Abuse and Neglect, Author Interviews, BMJ, Exercise - Fitness, Mental Health Research
MedicalResearch.com Interview with:
[caption id="attachment_33615" align="alignleft" width="134"]
Tine Vertommen[/caption]
Tine Vertommen, Criminologist
Faculty of Medicine and Health Sciences
Universiteitsplein 1
Antwerp, Belgium
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: A recent prevalence study into interpersonal violence against child athletes in the Netherlands and Belgium showed that 6% experienced severe sexual violence, 8% experienced severe physical violence, and 9% of respondents experienced severe psychological violence in sport (Vertommen et al., 2016). While general literature has repeatedly shown that exposure to interpersonal violence during childhood is associated with mental health problems in adulthood, this relationship has not yet been demonstrated in (former) athletes. Thus, the objective of the current study is to assess the long-term consequences of these experiences on adult mental health and quality of life.
31 Mar First Diagnostic Blood Test for Coronary Artery Plaque Detection
MedicalResearch.com Interview with: [caption id="attachment_33595" align="alignleft" width="141"]
Dr. Voros[/caption]
Szilard Voros, MD, FACC, FSCCT, FAHA
CEO of Global Genomics Group
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Atherosclerotic coronary artery disease (ASCAD) is the leading cause of death and morbidity in the United States and worldwide, despite relatively successful medical therapies such as statins, like Zocor or Lipitor. A significant majority of patients with ASCAD present with sudden cardiac arrest, and the clinical evaluation of those patients who present with chest pain to their physicians is very inefficient. Based on current clinical guidelines, patients who present to their physician with complaints of new onset chest pain or its equivalent, such as exertional dyspnea should be assessed for the probability of the presence of significant ASCAD based on simple clinical predictors. Approximately 60% of such patients have an intermediate probability, and they are typically referred for initial non-invasive evaluation, such as a stress test with cardiac imaging, or for some other type of non-invasive test. Strikingly, no more that 5% of such stress tests performed in the United States are actually positive, and even when patients with positive stress test are taken for invasive coronary angiography, no more than 40% have significant ASCAD.
A blood test that could serve as first step, as a “gatekeeper”, to non-invasive evaluation, would be highly desirable. Global Genomics Group, or G3, has performed one of the largest, unbiased, mass-spectrometry-based discovery studies in over 1,000 patients who underwent detailed cardiac CT to assess the presence or absence of ASCAD, by measuring over 1,000 metabolites from the blood. Using sophisticated bioinformatics tools, the researchers identified 8 important metabolites that were significantly abnormal in patients with ASCAD, and generated a biomarker signature for the detection of ASCAD based on those analytes, called “knowPLAQUETM”. The biomarker signature was generated in approximately 800 subjects, and was validated in an independent set of approximately 400 subjects, showing an area under the curve (“AUC”) of 0.82 for the diagnosis of Atherosclerotic coronary artery disease. This biomarker signature can be adapted relatively easily on commercial mass spectrometry platforms, and the researchers anticipate that this signature may be available for physicians to use by 2018. In addition to its diagnostic power, this biomarker signature also has uncovered important biological insights for the development of ASCAD, which can be leveraged for therapeutic purposes.
31 Mar Colorectal Cancer Risk Model Using Environmental and Genetic Factors
MedicalResearch.com Interview with: [caption id="attachment_33583" align="alignleft" width="125"] Dr. Moreno[/caption] Victor Moreno, PhD. Director of Cancer Prevention and Control Program, Catalan Institute of Oncology-IDIBELL, L’Hospitalet de Llobregat, Spain Department of Clinical Sciences, Faculty of Medicine University of Barcelona Barcelona, Spain [caption id="attachment_33584" align="alignleft" width="125"] Dr. Ibáñez-Sanz[/caption] Gemma Ibáñez-Sanz, MD Gastroenterologist. *Cancer Prevention and Control Unit, Catalan Institute of Oncology. L’Hospitalet deLlobregat,...
31 Mar Large Regional Variations in Rates of Contralateral Prophylactic Mastectomy
MedicalResearch.com Interview with: Rebecca Nash, MPH Rollins School of Public Health Emory University MedicalResearch.com: What is the background for this study? Response: Contralateral prophylactic mastectomy (CPM) in women with invasive early-stage unilateral breast cancer has significantly increased in the U.S. over the past decade, despite the lack of evidence for a survival benefit. This procedure is particularly common among patients younger than 45 years old. It is also more common in whites compared to blacks, and in privately insured patients compared to uninsured or Medicaid insured patients. However, the extent of regional variation across the United States was unknown.31 Mar Insomnia Linked to Increased Risk of Stroke and Heart Attack
MedicalResearch.com Interview with: Qiao He Master’s degree student China Medical University Shenyang, China MedicalResearch.com: What is the background for this study? Response: Sleep is an important factor for biological recovery functions, but in modern society, more and more people have complained having sleep problems like insomnia, one of the main sleep disorders. It is reported that approximately one-third of the German general population has been suffering from insomnia symptoms. In decades, many researchers have found associations between insomnia and bad health outcomes. Insomnia seems to be a big health issue. However, the results from previous studies regarding the association of insomnia and cardiovascular or cerebrovascular events were inconsistent. Therefore, we conducted this study.31 Mar Which Patients With Advanced Respiratory Disease Die in the Hospital?
MedicalResearch.com Interview with: [caption id="attachment_33567" align="alignleft" width="180"]
Dr Sabrina Bajwah[/caption]
Dr Sabrina Bajwah
MBChB MRCGP MSc MA PhD
Consultant Palliative Medicine, King’s College NHS Foundation Trust
Honorary Senior Lecturer
King's College London
Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation
London, UK
MedicalResearch.com: What is the background for this study?
Response: Where people die is often important to them and their families, as well as being important for planning health care services. Most people want to die at home, but instead most die in hospital. While the trends have been studied in cancer, other diseases, such as respiratory, are rarely looked at even though they are common and increasing causes of death.
Chronic Obstructive Pulmonary Disease (COPD) and Interstitial Pulmonary Diseases (IPD) are common respiratory conditions. Both conditions result in a high use of hospital services, especially among people in advanced stages. This leads to high healthcare costs.1 In the UK in 2010, it is estimated that IPD costs £16.2 million per year in hospitalisations.2 The NHS spends more than £810 million annually managing COPD, with inpatient stays accounting for around £250 million annually.
Understanding which factors affect place of death is vital for planning services and improving care, especially given our ageing population, rising chronic diseases and the high costs of hospital admissions. Strategies in many countries have sought to improve palliative care and reduce hospital deaths for non-cancer patients, but their effects are not evaluated.
We aimed to determine the trends and factors associated with dying in hospital in COPD and IPD, and the impact of a national end of life care (EoLC) strategy3 to reduce deaths in hospital. This study analysed a national data set of all deaths for COPD and IPD, covering 380,232 people over 14 years.
31 Mar Higher Dose IPI for Some Advanced Melanoma Patients?
MedicalResearch.com Interview with: [caption id="attachment_33563" align="alignleft" width="181"]
Dr. Ascierto[/caption]
Dr Paolo A Ascierto MD
Melanoma Cancer Immunotherapy and Innovative Therapy Unit
Istituto Nazionale Tumori Fondazione
Naples Italy
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Although IPI was approved for the treatment of melanoma at dosage of 3 mg/kg, a dose-ranging phase 2 trial suggested longer overall survival (OS) but more treatment-related adverse events with ipilimumab 10 mg/kg vs 3 mg/kg. However, the study MDX010-020 (randomized phase III study which compared ipilimumab 3 mg/kg + gp100 vaccination and ipilimumab 3mg/kg + placebo vs gp100 vaccination + placebo) performed as second line treatment of advanced melanoma patients, showed an OS curve similar to that of the study CA184-169 (randomized phase III study which compared dacarbazine + ipilimumab 10 mg/kg to dacarbazine + placebo) as first line treatment of metastatic melanoma.
For this reason FDA approved ipilimumab at dosage of 3 mg/kg as first and second line treatment for advanced melanoma, but asked for a randomized phase III study of comparison of ipilimumab at the different dosage in order to explore if there was a difference in the outcome of patients with different dosages.
31 Mar Comparison Zika Outbreaks in French Polynesia, Colombia and the State of Bahia in Brazil
MedicalResearch.com Interview with: [caption id="attachment_33551" align="alignleft" width="90"]
Dr. Daihai He[/caption]
Daihai He PhD
Department of Applied Mathematics
The Hong Kong Polytechnic University
Hung Hom, Kowloon
Hong Kong (SAR), China
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Zika virus disease has large outbreaks in many Pacific and American countries in 2016, and the outbreaks are still on-going. Our work is conducted against this background. We compared data from three localities: French Polynesia in 2013-2014, Colombia and Brazil in 2016. We found that in French Polynesia the infection attack rate (i.e. the proportion of the population who got infected) is about 3/4, which matched previous serological studies. We then make estimation for the other two place. We found that the infection attack rate in Colombia in 2016 was most likely less than 50%. For Bahia province of Brazil, we did not arrive at a very accurate estimation, as the confidence interval is wide, and our best estimate is 30%. The relatively low infection attack rate in Colombia and Brazil implies that future outbreaks of Zika virus diseases are still possible. Thus control and surveillance efforts should be continued.
30 Mar Biomarker VCAM-1 Associated With New Onset Atrial Fibrillation
MedicalResearch.com Interview with: Stefan Kiechl, MD and Karin Willeit, MD Department of Neurology Medical University Innsbruck Innsbruck, Austria MedicalResearch.com: What is the background for this study? Response: Atrial fibrillation (AF) is the most common cardiac arrhythmia and a major contributor to thromboembolic stroke and population morbidity and mortality. Aside from well-established risk factors such as age, heart failure, and hypertension, inflammation has been suggested to play a significant role in the pathogenesis of AF. This is evidenced by histologic studies that found marked inflammatory infiltrates in atrial biopsies of AF patients and by epidemiological studies demonstrating an association of circulatory inflammation markers with incident AF. Of note, an increased endocardial expression of vascular intercellular adhesion molecule 1 (VCAM-1), a mediator of leukocyte trafficking, during rapid atrial pacing was demonstrated which was shown to contribute to an inflammatory and prothrombotic environment within atrial tissue. Because it is still unclear whether inflammation related to AF is primarily a systemic or localized phenomenon, we sought to examine the association of 13 baseline inflammation markers with incident atrial fibrillation in the prospective population-based Bruneck Study and to replicate key findings in a second cohort, the SAPHIR Study.30 Mar Quadrivalent HPV Vaccination and the Risk of Adverse Pregnancy Outcomes
MedicalResearch.com Interview with: Anders Hviid Senior Investigator, M.Sc.,Dr.Med.Sci. Department of Epidemiology Research Division of National Health Surveillance & Research MedicalResearch.com: What is the background for this study? Response: HPV vaccination targeting girls and young women has been introduced in many countries throughout the world. HPV vaccines are not recommended for use in pregnancy, but given the target group, inadvertent exposure will occur in early unrecognized pregnancies. However, data on the safety of HPV vaccination in pregnancy is lacking.30 Mar Nurse-Driven Clinical Pathway for Asthma Improves Efficiency, Reduces Length of Stay
MedicalResearch.com Interview with: [caption id="attachment_33542" align="alignleft" width="180"]
Dr. Catherine Pound[/caption]
MedicalResearch.com: What is the background for this study?
Response: Asthma is the most common chronic disease of childhood and contributes to a large portion of Canadian hospital pediatric admissions. Once patients are admitted to hospitals, they receive salbutamol, a medication used for acute asthma exacerbations, at a pre-determined frequency. In most hospitals, physicians are the ones to decide of the frequency of administration of the salbutamol, and they decide when to wean patients off it. However, children whose salbutamol treatment administration can be decreased are usually considered stable, and often do not require immediate medical attention, which may results in delays in reassessments as well as administration of unneeded salbutamol treatments, particularly if physicians are busy looking after other sicker patients. Additionally, physicians’ assessments of children with asthma and their decisions to wean salbutamol frequency are not standardized, and vary among physicians. Therefore, in order to improve efficiency and standardize patient assessments, we developed a clinical pathway allowing nurses to wean salbutamol for children hospitalized with asthma based on a validated asthma scoring system.
30 Mar Ischemic Stroke: Collateral Blood Vessels Detected by Arterial Spin Labeling MRI Correlates With Good Neurological Outcome
MedicalResearch.com Interview with: Jalal B. Andre M.D., D.A.B.R.® Drector of neurological MRI and MRI safety officer at Harborview Medical Center University of Washington MedicalResearch.com: What is the background for this study? Response: Acute ischemic stroke (AIS) patients with good collaterals have better clinical outcomes. AIS is characterized by an ischemic penumbra, a region of salvageable brain tissue, that surrounds a core of irreversible ischemic infarct. The penumbra is tenuously perfused by collateral blood vessels which, if extensive enough, can maintain penumbral perfusion, improving the odds that a larger volume of brain tissue will survive. Standard, first-line methods for evaluating collaterals in the acute setting include CT angiography, MR angiography, and (less commonly) digital subtraction angiography. Arterial spin labeling (ASL) is an emerging MRI technique that assesses cerebral perfusion. Its advantages include relatively short scan time (4-6 minutes), lack of ionizing radiation, and independence from an exogenous contrast agent (contraindicated in patients with impaired renal function or documented sensitivity). Collaterals can be identified within ASL images as foci of curvilinear hyperintensity bordering regions of hypoperfusion. We sought to explore a novel relationship between the presence of ASL collaterals (ASLc) and neurological outcome in acute ischemic stroke patients.30 Mar Secukinumab Provides Sustained Improvements in Dermatology-Specific Quality of Life in Moderate to Severe Psoriasis Patients Through 3 Years of Treatment
Posted at 22:59h
in Author Interviews, Boehringer Ingelheim, Dermatology, Eli Lilly, Immunotherapy, J&J-Janssen, Merck
MedicalResearch.com
Eric Hughes
Global Development Franchise Head Immunology & Dermatology
Novartis
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Psoriasis is a chronic immune-mediated inflammatory disease that negatively impacts patients’ quality of life (QOL); therefore QOL outcomes are increasingly recognized as an important measure of efficacy in psoriasis, complementing traditional measures of severity such as the Psoriasis Area and Severity Index (PASI).
Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin-17A (IL-17A), exhibits significant efficacy in the treatment of moderate-to-severe psoriasis, ankylosing spondylitis and psoriatic arthritis, demonstrating a rapid onset of action and a favorable safety profile.
Biologic therapies for psoriasis have previously been associated with a fall-off in efficacy over time; accordingly, extended follow-up is required to adequately evaluate novel therapeutic strategies like IL-17A inhibition. Recently, results from the extension of the SCULPTURE secukinumab trial showed that high responses initially achieved with secukinumab at year 1 in the SCULPTURE study were sustained over time up to 3 years with no new or unexpected safety concerns. In this analysis, we examined whether the sustained efficacy observed in SCULPTURE up to 3 years was translated into sustained effect of secukinumab on patient’s QOL measured by the Dermatology Life Quality Index (DLQI) questionnaire.
SCULPTURE, a multi-center extension study, was conducted with subjects who completed 52 weeks of treatment. Subjects were randomized into two maintenance dosing regimens; a fixed-interval schedule of secukinumab 300 mg every 4 weeks (Fixed interval dosing regimen (FI) cohort), and secukinumab retreatment-as-needed (Retreatment as needed (RAN) cohort), in which subjects received placebo until start of relapse, at which time secukinumab 300 mg every 4 weeks was re-initiated.
The analysis using as-observed data showed that at Year 3, improvements in the total score on DLQI was well sustained in both FI and RAN cohorts. Approximately two-thirds of the subjects in the FI cohort reported no impact of skin disease on QOL (corresponding to a score of 0 or 1 on DLQI). The proportion of patients in the RAN cohort reporting no impact of the disease on their QOL was well sustained through 3 years but remained consistently lower than those observed in the FI cohort. The results for each subscale of the DLQI questionnaire were consistent with those with DLQI total score i.e. showing high and sustained proportions of patients reporting no impact of the disease on different domains of health-related QOL in the two secukinumab cohorts with greater effect in the FI cohort compared to the RAN cohort.
30 Mar Review of Systemic Immunomodulating Therapies for Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis
MedicalResearch.com Interview with: Prof. Dr. Maja Mockenhaupt Dept. of Dermatology Medical Center - University of Freiburg Deutschland / Germany MedicalResearch.com: What is the background for this study? Response: Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN) are severe cutaneous adverse reactions that are associated with high morbidity and mortality. Primarily due to their rareness, therapeutic effects are often studied in observational settings. An evidence-based standardized treatment protocol for SJS/TEN is still missing.29 Mar Gene Expression-based Breast Cancer Index Can Improve Decision Making For ER+ Patients
MedicalResearch.com Interview with: [caption id="attachment_33526" align="alignleft" width="133"]
Dr. Tara Sanft[/caption]
Tara Sanft, MD
Assistant Professor of Medicine (Medical Oncology)
Medical Director of Adult Survivorship
Yale Cancer Center Survivorship Clinic
MedicalResearch.com: What is the background for this study?
Response: Previous studies have demonstrated the benefit of extended endocrine therapy (EET) for hormone receptor-positive (HR+) breast cancer in preventing late relapse, however that benefit is limited to 3-5% of women where late recurrence was prevented or staved off. However, EET has become common practice and as a result we are exposing many patients to risks of side effects and toxicities associated with anti-estrogen therapies when they may not be benefitting, and, conversely may not be treating the patients that might actually benefit. There is a real need to better identify the patients who are both at most risk of late distant recurrence, and most likely to benefit from EET.
This prospective study included 141 patients with a mean age of 62. In the study, 83% of patients were postmenopausal, 73% were stage I.
Breast Cancer Index (BCI) is a gene expression-based test and is the only currently available validated biomarker that is both prognostic for late distant recurrence and predictive for likelihood of benefit from EET. The purpose of this prospective study was to assess the impact of BCI on: physician EET recommendations; physician confidence; patient satisfaction, anxiety, and decision-conflict; and the cost impact of BCI.
29 Mar Knee Replacement Would Be More Cost Effective If Limited To Those With Severe Symptoms
MedicalResearch.com Interview with: [caption id="attachment_33519" align="alignleft" width="130"]
Dr. Bart Ferket[/caption]
Bart S Ferket, MD, PhD
Assistant Professor, Population Health Science and Policy
Icahn School of Medicine at Mount Sinai
MedicalResearch.com: What is the background for this study?
Response: The annual rate of total knee replacement in the US has doubled since 2000, and especially in those aged 45-65 utilization of this procedure has increased. The increase in practice cannot fully be explained by an increase in the prevalence of osteoarthritis and population growth, and has been partly attributed to expansion to people with less severe symptoms. The total number of procedures performed each year now exceeds 640,000. The evidence for the benefit of total knee replacement has been based on studies without a comparison group of no total knee replacement, and so far only one randomized clinical trial has been published. Although the published literature shows large improvements of pain, physical functioning and overall quality of life following the procedure, patients included in these studies generally had severe preoperative symptoms. A number of studies have suggested, however, that up to a third of recipients of total knee replacement show no benefit, and that those with poor physical functioning before surgery may show larger improvements. Therefore, the current US patient population undergoing total knee replacement might show less significant improvement in symptoms on average as compared with a hypothetical scenario in which eligibility is limited to those with more severe symptoms.
29 Mar Women With Health Insurance for IVF More Likely To Have Successful Live Birth
MedicalResearch.com Interview with: [caption id="attachment_33423" align="alignleft" width="133"]
Dr. Jungheim[/caption]
Emily S. Jungheim, MD, MSCI
Assistant Professor, Obstetrics and Gynecology
Division of Reproductive Endocrinology and Infertility
Washington University
St. Louis, Missouri
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Many women with health insurance lack coverage for fertility treatment so they end up being self-pay for fertility treatments which can be expensive and limit access to care.
15 states have responded with mandates for employers to include fertility coverage in their employee insurance benefits, and 5 of these have comprehensive mandates that include IVF. Illinois is one of these states. Washington University is located on the border between Illinois and Missouri so our fertility center treats a number of women with coverage for fertility treatment and a large number of women who are self-pay for fertility treatment. We suspected that women requiring IVF to conceive were more likely to follow through with treatments if they had coverage so we decided to look at our data.
Ultimately we confirmed our suspicions. Women with coverage were more likely to come back for additional cycles of IVF if they didn't conceive. Ultimately this ability to come back for additional treatment cycles led to a higher chance of live birth.
29 Mar Phase 3 Study Finds XARELTO® Superior to Aspirin for Long-Term Prevention of Recurrent Blood Clots in VTE
MedicalResearch.com Interview with: [caption id="attachment_33502" align="alignleft" width="200"]
Dr. Paul Burton[/caption]
Paul Burton, MD, PhD, FACC
Vice President, Medical Affairs
Janssen
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), affects more than 900,000 Americans each year; one-third of these occurrences are fatal. Once a person experiences a VTE, they are at risk of having another occurrence. Guidelines currently recommend anticoagulant therapy with a non-vitamin K antagonist oral anticoagulant (NOAC), like XARELTO® (rivaroxaban), for three months or longer. Once anticoagulant therapy is stopped, up to 10 percent of people will experience a recurrence during the first year and up to 20 percent within three years. In people who decide to stop anticoagulant therapy, guidelines currently suggest using aspirin for long-term prevention of recurrent VTE rather than no aspirin at all.
The Phase 3 EINSTEIN CHOICE study was designed to compare the efficacy and safety of XARELTO® to aspirin for continued VTE management in people who experienced an initial VTE. The study met its primary endpoint, finding both XARELTO® doses (10 mg or 20 mg once daily) to be superior to aspirin 100 mg once daily in preventing recurrent VTE, with no significant impact on safety. Specifically, XARELTO® 10 mg reduced the risk of recurrent VTE by 74 percent and XARELTO® 20 mg by 66 percent. Rates of major bleeding were comparable and low across all treatment groups.
These results were presented at the American College of Cardiology's 64th Annual Scientific Session (ACC.17) during a Joint ACC/Journal of American Medical Association Late-Breaking Clinical Trials session and published simultaneously in The New England Journal of Medicine.
29 Mar Could Babies From Wealthier Families Reduce Egg Allergies By Eating Them Earlier?
MedicalResearch.com Interview with: [caption id="attachment_33418" align="alignleft" width="200"]
Dr. Debra Palmer[/caption]
Dr. Debra Palmer (BSc, BND, PhD)
on behalf of my fellow co-authors on this publication
Childhood Allergy and Immunology Research
University of Western Australia
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: We conducted a multicentre trial, Starting Time of Egg Protein (STEP) involving 820 infants, and found a 25% risk reduction in egg allergy with early regular egg intake from 4-6.5 months compared with egg avoidance to 10 months of age, although this did not achieve statistical significance.
So we also investigated in exploratory analyses whether the effect of regular egg introduction in solid foods was modified by any maternal, family or infant characteristics. Our results found that infants from families of higher socioeconomic status and those families who consume few eggs per week could benefit by less egg allergy at 12 months of age from regular egg intake once they start eating solid foods.
29 Mar Patients With Clostridium difficile Infections Should Have Need For Gastric Acid Suppression Reassessed
MedicalResearch.com Interview with: [caption id="attachment_33270" align="alignleft" width="166"]
Dr. Sahil Khanna[/caption]
Sahil Khanna, M.B.B.S. MS
Division of Gastroenterology and Hepatology
Mayo Clinic, Rochester, Minnesota
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Clostridium difficile infection (CDI) is the most common cause of hospital-acquired diarrhea and has recently shown increasing incidence especially in the community. Novel risk factors for CDI development include the use of gastric acid suppression medication, presence of systemic comorbid conditions, C difficile carriage in water and food sources, amongst others.
Gastric acid suppression medications such as proton-pump inhibitors (PPIs) and histamine-2 receptor blockers (H2Bs) are commonly prescribed and consumed over the counter for gastroesophageal reflux disease, peptic ulcer disease, or functional dyspepsia, but they are also sometimes prescribed for unnecessary indications, which leads to overuse of these medications. Recurrent CDI after a primary infection is a major problem, with the risk being as high as 50% to 60% after 3 or more Clostridium difficile infections. Data on the association between acid suppression and recurrent CDI are conflicting and therefore we performed a systematic review and meta-analysis to study the association between the use of gastric acid suppression medications and the risk of recurrent CDI.
29 Mar Safer Immunotherapy Dupilumab (Dupixent) FDA Approved For Atopic Dermatitis
MedicalResearch.com Interview with: [caption id="attachment_33490" align="alignleft" width="130"]
Dr. Guttman[/caption]
Emma Guttman, MD, PhD
Professor, Dermatology, Medicine and Clinical Immunology
Vice Chair of Research in the Dermatology Department
Director of the center for Excellence
Eczema in the Occupational/Contact Dermatitis clinic
Director of the Laboratory of Inflammatory Skin Diseases
Icahn School of Medicine at Mount Sinai Medical Center
New York
MedicalResearch.com: Would you briefly explain what is meant by atopic dermatitis? How many people are affected by this disorder?
Response: Atopic dermatitis or eczema as most people know it is an itchy red scaly skin disorder characterized by a very severe itch, that disrupts daily activities, and sleep and severely impairs the quality of life of patients. In the US 30 million people are affected by it, and 1/3 of these we expect to be moderate to severe.
MedicalResearch.com: What is the background for Dupilumab therapy? How does it differ from emollients, steroids or topical immunomodulator treatments for eczema ie Protopic?
Response: The background is that we currently do not have good treatments for long term use for our moderate to severe patients. The only approved drug by the FDA for atopic dermatitis in the US is oral prednisone, that has many long term side effects and causes disease rebound upon discontinuation. Other treatments with many side effects
are broad immune suppressants--Cyclopsorin A, Mycophenolate mofetyl and phototherapy that is not feasible for most patients.
Thus there is a large unmet need for safer and better treatments for moderate to severe atopic dermatitis patients.
Dupilumab is different since it only targets one immune axis--Th2 axis, providing a safer alternative, with high efficacy, that is equal or even better than cyclosporin A, that is the current gold standard immune suppressant, and harbors many side effects including permanent effects on the kidneys after long term use. Topical treatments, while useful for mild patients, are often not adequate or sufficient to control moderate to severe patients that usually have more than 10% body surface area involved and need a systemic treatment.