Patient Retention With DMTs vs Gilenya in Adults With Relapsing-Remitting Multiple Sclerosis

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MedicalResearch.com Interview with:
Marcia Kayath, MD
Vice President and Head
US Clinical Development and Medical Affairs US General Medicines
Novartis Pharmaceuticals Corporation

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

Response: Injectable disease-modifying therapies (DMTs) are typically used first-line in patients with multiple sclerosis (MS), but discontinuation of injectable DMTs is common, especially within the first 12 months of treatment1,2. PREFERMS is the largest, prospective, randomized, active-controlled, open-label study to evaluate patient retention in patients with relapsing-remitting multiple sclerosis (RRMS).

In the 12-month, Phase IV study, a total of 875 patients were randomized (1:1) to Gilenya® (fingolimod) 0.5 mg or to a pre-selected injectable DMT (IFNβ-1a, IFNβ-1b or glatiramer acetate), and followed up quarterly for 12 months3. After a minimum of 3 months of treatment, a single on-study treatment switch was allowed, however, switches due to efficacy or safety were allowed (based on patient-doctor consultation) at any month following randomization3. The primary endpoint was to compare the patient retention on randomized treatment over 12 months3. This study was powered for the primary endpoint (retention rate)3. The study was not powered to detect the treatment difference in the secondary efficacy endpoints or treatment effects related to switching study medication3. Continue reading

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Can Low Dose Oral Nicotine Have Beneficial Health Effects?

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MedicalResearch.com Interview with:

U. H. Winzer-Serhan Ph.D. Associate Professor Department of Neuroscience and Experimental Therapeutics Texas A&M Health Science Center

Dr. Ursula H. Winzer-Serhan

Ursala. H. Winzer-Serhan Ph.D.
Associate Professor
Department of Neuroscience and Experimental Therapeutics
Texas A&M Health Science Center

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

Response: Nicotine is a plant alkaloid that is naturally occurring in the tobacco plant. Smoking delivers nicotine to the brain where it acts as a stimulant. Tobacco and electronic cigarette smoking delivers many other chemicals to the body, which are harmful and can cause cancer.

However, the drug nicotine by itself is relatively benign and poses few health risks for most people. Nicotine acts in the brain on nicotinic receptors, which are ion channels that are widely expressed in the brain. They play an important role in cognitive functions. Research with rodents and in humans has shown that nicotine can enhance learning and memory, and furthermore, can protect neurons during injuries and in the aging brain. With the increasingly older population, it becomes more and more important to delay cognitive decline in the elderly. Right now, there is no drug available that could delay aging of the brain.

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A Novel Algorithm Utilizing Expanded Donor Criteria for the Allocation of Dual Kidneys in Adults

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MedicalResearch.com Interview with:
Adam Johnson, MD, PhD, MBA, FACS

Thomas Jefferson University

Dr. Cataldo Doria, senior author and designer of the study, emphasized that the work was a team effort

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

Response: The goal was to develop an algorithm to identify which donors would be most suitably transplanted as dual kidneys instead of as single kidneys.

Dual kidney transplantation is a resource intensive procedure, but may make the most out of two kidneys whose function may be too marginal to transplant independently.

Currently allocation decisions are based on individual surgeon and institutional experience and without much available outcome data. This score provide decision support for which donor grafts would have the greatest benefit if transplanted as dual kidneys.

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Depressive disorders are the most frequent neuropsychiatric complication of TBI

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MedicalResearch.com Interview with:

Ricardo E. Jorge MD Professor of Psychiatry and Behavioral Sciences Director Houston Translational Research Center for TBI and Stress Disorders Senior Scientist Beth K. and Stuart C. Yudofsky Division of Neuropsychiatry Michael E DeBakey VA Medical Center Baylor College of Medicine

Dr. Ricardo Jorge

Ricardo E. Jorge  MD
Professor of Psychiatry and Behavioral Sciences
Director Houston Translational Research Center for TBI and Stress Disorders
Senior Scientist  Beth K. and Stuart C. Yudofsky Division of Neuropsychiatry
Michael E DeBakey VA Medical Center
Baylor College of Medicine

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

Response: Depressive disorders affect between one-third and one-half of patients with traumatic brain injury. Once established, these disorders are difficult to treat and frequently follow a chronic and refractory course.

Depression has a deleterious effect on TBI outcomes, particularly affecting the community reintegration of TBI patients.

In this randomized clinical trial that included 94 adult patients with TBI, the hazards for developing depression for participants receiving placebo were about 4 times the hazards of participants receiving sertraline treatment.

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Is Muscle Memory a Myth?

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MedicalResearch.com Interview with:

Maléne Lindholm, PhD Karolinska Institutet Dept. of Physiology & Pharmacology Stockholm Sweden

Dr. Maléne Lindholm

Maléne Lindholm, PhD
Karolinska Institutet
Dept. of Physiology & Pharmacology
Stockholm Sweden

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

Response: It is well known that exercise training provides marked health benefits and can prevent and treat a broad set of diseases. Therefore, a deeper understanding and characterization of the molecular processes behind training adaptation is essential for human health.

This study aimed at exploring the effects of endurance training on the human skeletal muscle transcriptome (activity of all genes) and investigate the possible presence of a muscle memory of training. To do this, the healthy volunteers in this study first trained only one leg, 4 times per week for 3 months. After 9 months of detraining, the subjects then came back and trained both legs in the same way as during the first training period, thus one leg was then previously well-trained and one previously untrained. This meant that each individual was their own control, as both legs have the same genome, experience the same stress, diet etc. Only the training status differed.

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Opioid Overdose Associated With Even Higher Health Care Costs Than Dependence or Abuse

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MedicalResearch.com Interview with:

Jaren Howard, PharmD, BCPS Associate Director, Medical Affairs Strategic Research Purdue Pharma L.P.

Dr. Jared Howard

Jaren Howard, PharmD, BCPS
Associate Director
Medical Affairs Strategic Research
Purdue Pharma L.P.

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

Response: The existing scientific literature estimating the healthcare burden of opioid misuse disorders often combines all patients within the broad category of “opioid abuse,” defined as opioid abuse, dependence, or overdose/poisoning.
Collectively, these three conditions can significantly increase healthcare costs among commercially insured patients.

• Real world medical coding practices present challenges to researchers aiming to separately analyze excess costs by diagnosis, though combining these diagnoses may mask some variation in excess costs.

• Furthermore, little is known about the specific drivers of excess costs in terms of medical conditions driving excess costs or places of service at the diagnosis-level.

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Immunity to the Acellular Whooping Cough Vaccine Wanes With Time

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MedicalResearch.com Interview with:
Dr. Kevin Schwartz, MD MSc
Infection Prevention and Control Physician
Infection Prevention and Control
Public Health Ontario | Santé publique Ontario

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

Response: There has been a resurgence of pertussis, or ‘whooping cough’, in several countries and regions since the introduction of the new “acellular” pertussis vaccine in the 1990s to replace the older “whole cell” vaccine. In Ontario, we have not seen large increases but observed a small outbreak in 2012 that affected both unvaccinated people, as well as in those who have been vaccinated against pertussis. Our objective was to evaluate the effectiveness of the current acellular vaccine used in Ontario. We wanted to find out whether immunity wanes with time in the same way as had been previously observed during a large outbreak in California. We also wanted to study the impact of receiving the older ‘whole cell’ vaccine, which we used in Ontario until 1997.

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Nausea and Vomiting During Pregnancy May Signal Less Risk of Pregnancy Loss

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MedicalResearch.com Interview with:
Stefanie N. Hinkle, Ph.D.

Staff Scientist | Epidemiology Branch
Division of Intramural Population Health Research
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institutes of Health

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

Response: Thank you for the interest in our research. Nausea and vomiting are very common early in pregnancy and these symptoms can be difficult for women. Before we began this study there was very limited high-quality data on the implications of these difficult symptoms in pregnancy. Our study is unique because we asked women to report their symptoms continuously throughout their pregnancy before they may or may not have gone on to have a loss. We found that among women with 1 or 2 prior pregnancy losses, women who have nausea, and particularly nausea with vomiting, were less likely to have a pregnancy loss.

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Parkinson’s Disease Linked To Increase in Number of Inflammatory Markers

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MedicalResearch.com Interview with:

Yong Cheng, PhD, post-doc fellow Section on Cellular Neurobiology Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health Bethesda, Maryland

Dr. Yong Cheng

Yong Cheng, PhD, post-doc fellow
Section on Cellular Neurobiology
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institutes of Health
Bethesda, Maryland

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

Response: Parkinson’s disease is the second most neurodegenerative disease after Alzheimer’s disease. The symptoms of the disease are typically movement related. However, the nonmotor features in PD are increasingly recognized. Evidence suggests that inflammation may play a role in the development of AD, and a substantial number of studies have demonstrated altered levels of peripheral blood inflammatory cytokines in patients with  Parkinson’s disease, but findings have been inconsistent for individual cytokines and between studies. Therefore, we undertook a systematic review of the scientific literature, using a meta-analysis to quantitatively summarize clinical data on blood cytokine levels in patients with PD, compared with healthy controls.

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Doctors: “I would never want to have a mental health diagnosis on my record”

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MedicalResearch.com Interview with:

Katherine J. Gold, MD MSW MS Department of Family Medicine Institute for Healthcare Policy and Innovation; Depression Center University of Michigan

Dr. Katherine Jo Gold

Katherine J. Gold, MD MSW MS
Department of Family Medicine
Institute for Healthcare Policy and Innovation; Depression Center
University of Michigan

With co-authors Louise B. Andrew MD JD; Edward B. Goldman JD; Thomas L. Schwenk MD

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

Response: It is common knowledge that physicians are often hesitant to seek care for mental health concerns. Knowing that female physicians have increased rates of both depression and suicide, we surveyed female physicians who were mothers and who participated in a closed FaceBook group about their mental health, treatment, and opinions about licensing. More than 2100 U.S. physicians responded, representing all specialties and states.

Almost half of participants reported that at some point since medical school they had met criteria for a mental illness but didn’t seek treatment. Reasons included feeling like they could get through without help (68%), did not have the time (52%), felt a diagnosis would be embarrassing or shameful (45%), did not want to ever have to report to a medical board or hospital (44%), and were afraid colleagues would find out (39%). Overall, 2/3 identified a stigma-related reason for not seeking help.

Almost half reported prior diagnosis or treatment, but just 6% of these women stated they had disclosed this to a state medical board on a licensing application, though states vary on what information they require be disclosed.

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Early Immune Intervention May Prevent Atopic March of Eczema and Allergies

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MedicalResearch.com Interview with:
Emma Guttman-Yassky, MD, PhD

Professor of Dermatology and Immunology
Vice Chair of the Department of Dermatology at the Icahn School of Medicine and
Amy S. Paller, MD
Walter J. Hamlin Professor
Chair of the Department of Dermatology at Northwestern

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

Response: Researchers for the first time have identified the skin phenotype of pediatric eczema or atopic dermatitis (AD) in infants, opening the door for personalized treatment approaches for young children with eczema. The study, led by researchers at the Icahn School of Medicine at Mount Sinai and Northwestern University’s Feinberg School of Medicine, was published online today in the Journal of Allergy and Clinical Immunology.

Emma Guttman-Yassky, MD, PhD, Professor of Dermatology and Immunology, and Vice Chair of the Department of Dermatology at the Icahn School of Medicine, and Amy S. Paller, MD, Walter J. Hamlin Professor and Chair of the Department of Dermatology at Northwestern, investigated lesional and non-lesional skin biopsies from 19 AD infants under the age of five, and compared them to age-matched pediatric controls, in addition to adult AD biopsies. The researchers found that the non-lesional, or normal-appearing, skin of young children with early eczema is already highly abnormal with significant immune activation, simulating that of lesional skin of adults with many years of active disease.

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Impact of Renal Dysfunction on Results of TAVR Outcomes

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MedicalResearch.com Interview with:
Pablo Codner, MD; Amos Levi, MD (firsts authors)
and Prof. Ran Kornowski, MD, FACC, FESC (senior author)
Rabin Medical Center Derech Ze`ev
Israel.

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

Response: Transcatheter aortic valve replacement (TAVR) is a well-established treatment for patients with severe aortic stenosis (AS) who are deemed inoperable by the “heart team”, for those at high risk for surgery and also for patients at intermediate surgical risk. Currently this therapeutic alternative is being compared with surgical aortic valve replacement in patients at low risk for surgery. Patients with chronic kidney disease were excluded from most randomized trials.

We evaluated outcomes within a large multicenter cohort of patients undergoing TAVR distinguished by renal function, from 11 high volume centers in 8 different countries across Europe and Asia. In our experience patients with renal dysfunction were associated with poor clinical outcomes. All-cause and cardiovascular mortality rates during the follow-up period increased with declining renal function. A glomerular filtration rate ≤30 mL/min was identified on multivariate analysis as an independent predictor for all-cause and cardiovascular mortality.

We also found higher rates of severe bleeding and vascular complications among patient with advanced or end stage renal failure.

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