CTE Brain Pathology Found More Commonly in Former Athletes and Men

MedicalResearch.com Interview with:

Kevin F. Bieniek, Ph.D. Assistant Professor, Department of Pathology & Laboratory Medicine Joe R. & Teresa Lozano Long School of Medicine Director, Biggs Institute Brain Bank Core Glenn Biggs Institute for Alzheimer’s & Neurodegenerative Diseases University of Texas Health Science Center San Antonio San Antonio, Texas 78229

Dr. Bieniek

Kevin F. Bieniek, Ph.D.
Assistant Professor, Department of Pathology & Laboratory Medicine
Joe R. & Teresa Lozano Long School of Medicine
Director, Biggs Institute Brain Bank Core
Glenn Biggs Institute for Alzheimer’s & Neurodegenerative Diseases
University of Texas Health Science Center San Antonio
San Antonio, Texas 78229

MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by CTE?  

Response: CTE, or chronic traumatic encephalopathy, is a progressive neurodegenerative disorder that is linked to prior exposure to repetitive traumatic brain injuries.  CTE pathology, characterized by a distinct deposition pattern of the protein ‘tau’, is most often observed in the brains former contact sport athletes and military veterans.  The public health impacts of this disorder are largely unknown, as this disease is often studied in individuals which advanced levels of exposure, particularly professional American football player.

This study aimed to understand what the presence of this disorder might be in the general population by studying athletes and non-athletes, a number of different sports, different levels of participation, and both males and females.

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Lowered Price of Repatha® (evolocumab) Translates to Cost Effectiveness for Range of Heart Conditions in Some High Risk Patients

MedicalResearch.com Interview with:

Gregg C. Fonarow, MD, FACC, FAHA Eliot Corday Professor of Cardiovascular Medicine and Science Director, Ahmanson-UCLA Cardiomyopathy Center Co-Chief of Clinical Cardiology, UCLA Division of Cardiology Co-Director, UCLA Preventative Cardiology Program David Geffen School of Medicine at UCLA Los Angeles, CA, 90095-1679

Dr. Gregg Fonarow

Gregg C. Fonarow, MD, FACC, FAHA
Eliot Corday Professor of Cardiovascular Medicine and Science
Director, Ahmanson-UCLA Cardiomyopathy Center
Co-Chief of Clinical Cardiology, UCLA Division of Cardiology
Co-Director, UCLA Preventative Cardiology Program
David Geffen School of Medicine at UCLA
Los Angeles, CA 

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

Response: Last year, Amgen made the PCSK-9 inhibitor evolocumab available at a reduced list price of $5,850 per year This 60% reduction was aimed at improving patient access by lowering patient copays, especially for Medicare beneficiaries.

Additionally, the treatment landscape for PCSK9 inhibitors was further defined in 2018 when the American College of Cardiology/American Heart Association Multisociety Clinical Guideline on the Management of Blood Cholesterol recommended PCSK9 inhibitors for, among other patient populations, patients with very high-risk (VHR) ASCVD whose low-density lipoprotein cholesterol levels remain at 70 mg/dL or more  despite a heart-healthy lifestyle and treatment with standard background therapy.

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Most Older Adults Have Eyes Examined, But Disparities Remain

MedicalResearch.com Interview with:

Joshua R. Ehrlich, MD, MPH Assistant Professor, Ophthalmology and Visual Sciences Kellogg Eye Center Department of Ophthalmology and Visual Sciences University of Michigan

Dr. Ehrlich

Joshua R. Ehrlich, MD, MPH
Assistant Professor, Ophthalmology and Visual Sciences
Kellogg Eye Center
Department of Ophthalmology and Visual Sciences
University of Michigan 

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

Response: This study came out of data collected as part of the National Poll on Healthy Aging (NPHA). The NPHA is funded by AARP and the Institute for Healthcare Policy and Innovation at the University of Michigan to inform the public, healthcare providers, and policymakers on a variety issues related to health. The vision survey, conducted in March 2018, was just one of many NPHA surveys.

Due to aging of the population, the number of older U.S. adults with blindness and vision impairment is expected to double over the next 30 years. Thus, this study was designed to provide crucial data  on contemporary data on patterns of eye care utilization in older adults.

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A Painless Heat Patch May Help Resolve Warts

MedicalResearch.com Interview with:

Richard J. Antaya, MD, FAAD, FAAP Professor, Dermatology and Pediatrics Yale University School of Medicine

Dr. Antaya

Richard J. Antaya, MD, FAAD, FAAP
Professor, Dermatology and Pediatrics
Yale University School of Medicine 

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

Response: Localized hyperthermia has been reported to hasten the resolution of warts and treat both benign and malignant neoplasms. Numerous clinical studies employing various methods to increase the cutaneous surface temperature, including: infrared radiation, radiofrequency, Nd:YAG laser, moxibustion, warm water immersion, ultrasound, and exothermic heat patches, have all yielded positive results.

We published a proof-of-concept, open-label trial, representing the largest experience to date employing chemical reaction induced exothermic heat patches for the treatment of warts. Localized hyperthermia from all sources currently has a low level of evidence and strength of recommendation because of the lack of well-designed, sufficiently powered studies.  Continue reading

Type 2 Diabetes More Aggressive in Youth

MedicalResearch.com Interview with:
Dr. Ellen Leschek MD
Program Director: Division of Diabetes, Endocrinology, and Metabolic Diseases
The National Institute of Diabetes and Digestive and Kidney Diseases
Health Information Center

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

Response: Type 2 diabetes (T2D) is thought to be characterized by a progressive loss of pancreatic beta cell (insulin producing/releasing cell) function. For this reason, T2D medications eventually stop working and individuals with T2D require treatment with insulin.

The Restoring Insulin Secretion (RISE) Consortium was established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to evaluate the effects of treatment and treatment withdrawal on the loss of pancreatic beta cell function. In the RISE Study, progression of disease was assessed by the measurement of pancreatic beta cell function in youth and adults who had either impaired glucose tolerance (IGT; prediabetes) or recently diagnosed Type 2 diabetes before, during and after treatment with study medications. Importantly, the RISE Pediatric Medication Study and the RISE Adult Medication Study were designed in tandem to allow direct comparison of the effects of two pharmacologic treatment regimens (the only two FDA-approved medications for Type 2 diabetes in youth) on disease progression in youth and adults. For more information about the RISE Study, please visit https://rise.bsc.gwu.edu/web/rise.

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Opioids During Hospitalization Linked to Post-Discharge Opioid Prescriptions

MedicalResearch.com Interview with:

Dr. Julie Donohue, Ph.D. Professor, Department of Health Policy and Management Vice Chair for Research Graduate School of Public Health University of Pittsburgh

Dr. Donohue

Dr. Julie Donohue, Ph.D.
Professor, Department of Health Policy and Management
Vice Chair for Research
Graduate School of Public Health
University of Pittsburgh

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

Response: The opioid epidemic is exacting a significant burden on families, communities and health systems across the U.S. Prescription and illicit opioids are responsible for the highest drug overdose mortality rates ever recorded. We know from previous studies that some surgical and medical patients who fill opioid prescriptions immediately after leaving the hospital go on to have chronic opioid use. Until our study, however, little was known about how and if those patients were being introduced to the opioids while in the hospital.

My colleagues and I reviewed the electronic health records of 191,249 hospital admissions of patients who had not been prescribed opioids in the prior year and were admitted to a community or academic hospital in Pennsylvania between 2010 and 2014. Opioids were prescribed in 48% of the admissions, with those patients being given opioids for a little more than two-thirds of their hospital stay, on average.

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Use of AV Grafts Drops in Dialysis Patients, But Still Room For Improvement

MedicalResearch.com Interview with:

Caitlin W. Hicks, M.D., M.S. Assistant Professor of Surgery Recipient of the Department of Surgery Rothman Early Career Development Award for Surgical Research Johns Hopkins Medicine

Dr. Hicks

Caitlin W. Hicks, M.D., M.S.
Assistant Professor of Surgery
Recipient of the Department of Surgery
Rothman Early Career Development Award for Surgical Research
Johns Hopkins Medicine

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

Response: Arteriovenous fistula are associated with better long-term patency, lower rates of infection, and lower long-term costs compared to arteriovenous graft. As a result, the Fistula First Catheter Last Guidelines recommend placement of an arteriovenous fistula over an AVG whenever possible.

We looked at individual physician utilization of AVF vs AVG for first-time AV access in Medicare beneficiaries. We found that the median physician utilization rate for AVG was only 18%, but that 21% of physicians use AVG in more than 34% of cases, which is above currently recommended  practice guidelines. 

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Metagenomic Sequencing Enhanced Diagnosis of Meningitis and Encephalitis Infections

MedicalResearch.com Interview with:

Dr. Charles Chiu, M.D./Ph.D. Professor, Laboratory Medicine and Medicine / Infectious Diseases Director, UCSF-Abbott Viral Diagnostics and Discovery Center Associate Director, UCSF Clinical Microbiology Laboratory UCSF School of Medicine

Dr. Chiu

Dr. Charles Chiu, M.D./Ph.D.
Professor, Laboratory Medicine and Medicine / Infectious Diseases
Director, UCSF-Abbott Viral Diagnostics and Discovery Center
Associate Director, UCSF Clinical Microbiology Laboratory
UCSF School of Medicine

MedicalResearch.com: What is the background for this study? Would you describe what is meant by metagenomic sequencing?

Response: Metagenomic next-generation sequencing (mNGS) is the use of technology to generate millions of sequence reads to diagnose infection sin patients by characterizing the full range of potential pathogens (bacteria, viruses, fungi, and parasites) in a single sample. Although shown to be a promising diagnostic tool for  infectious diseases in case reports and limited case series (Chiu and Miller Nature Reviews Genetics 20, 341-355 (2019)), to date the “real-life” utility of this approach for patient care has hitherto not been demonstrated.  This study is the first prospective, multi-center study of clinical mNGS testing for the diagnosis of neurological infections in acutely ill hospitalized patients presenting with meningitis and/or encephalitis.

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PCSK9 Inhibitor (evolocumab) Added to Statin Lowered Risk of Cardiovascular Events in Kidney Disease Patients

MedicalResearch.com Interview with:

David Charytan, MD MSc Chief, Nephrology Division NYU Langone Medical Center New York, NY 10010

Dr. Charytan

David Charytan, MD MSc
Chief, Nephrology Division
NYU Langone Medical Center
New York, NY 10010 

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

Response: Cardiovascular events are much more frequent in patients with impaired kidney function (chronic kidney disease), and cardiovascular disease is the most common cause of death in advanced chronic kidney disease. This risk remains high despite the use of standard medical therapies including statins, the most commonly used cholesterol lowering agents.

The PCSK9 inhibitor evolocumab is a new class of highly potent cholesterol lowering medications that can further reduce the risk of cardiovascular events in patients already taking statins. We analyzed data from the FOURIER trial, which randomized study patients with clinically evident atherosclerosis and an LDL cholesterol level >=70 mg/dL or HDL cholesterol level >= while on a statin, to assess the safety and efficacy of evolocumab, a PCSK9 inhibitor, compared with placebo in individuals with mild to moderate chronic kidney disease.

There were several major findings

  • a) evolocumab appears to be equally safe in individuals with preserved and mild to moderately impaired kidney function
  • b) evolocumab appears to have preserved efficacy at preventing cardiovascular events as kidney function declines.
  • c) We were unable to detect any significant impact on kidney function.
  • In addition, because the baseline risk of cardiovascular events is much higher in individuals with  chronic kidney disease, the absolute benefits of treatment with evolocumab appear  to be magnified as kidney function declines.  Continue reading

Cardiac Radiation Can Increase Mortality in Lung Cancer Patients

MedicalResearch.com Interview with:

Raymond H Mak, MD Assistant Professor of Radiation Oncology Harvard Medical School

Dr. Mak

 

Raymond H Mak, MD
Assistant Professor of Radiation Oncology
Harvard Medical School
Radiation Oncology
Brigham and Women’s Hospital

 

 

Dr-Katelyn M. Atkins

Dr. Atkins

 

Katelyn M. Atkins MD PhD
Harvard Radiation Oncology Program
Dana-Farber Cancer Institute
Brigham and Women’s Hospital
Boston, Massachusetts

 

 

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

  • Lung cancer remains the leading cause of cancer-related death worldwide and nearly half of patients will require radiation therapy as part of their care.
  • Cardiac toxicity following radiotherapy has been well-studied in breast cancer and lymphomas, however the impact of cardiac toxicity following lung cancer radiotherapy has historically been under-appreciated due to the high risk of lung cancer death.
  • Recent studies highlighting cardiac toxicity following lung cancer radiotherapy have been limited by small numbers of patients and, to our best knowledge, have not included validated cardiac event endpoints defined by the American Heart Association (AHA)/American College of Cardiology (ACC).

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Fat Distribution Linked to Advanced and Fatal Prostate Cancer

MedicalResearch.com Interview with:

Barbra Dickerman, PhD Research Fellow Department of Epidemiology Harvard T.H. Chan School of Public Health Boston, MA

Dr. Dickerman

Barbra Dickerman, PhD
Research Fellow
Department of Epidemiology
Harvard T.H. Chan School of Public Health
Boston, MA

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

Response: Obesity is associated with a higher risk of advanced prostate cancer and poorer prognosis after diagnosis. However, emerging evidence suggests that the specific distribution of body fat may be an important prognostic factor for prostate cancer outcomes. In this original investigation, we analyzed body fat distribution on computed tomography imaging and the risk of being diagnosed with, and dying from, prostate cancer. This study was conducted among 1,832 Icelandic men with over a decade of follow-up in the Age, Gene/Environment Susceptibility-Reykjavik Study.

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Hepatitis C Treatment: Study Finds No Liver, Kidney or Cardiovascular Adverse Effects

MedicalResearch.com Interview with:

Elizabeth A. McGlynn, PhD Vice President for Kaiser Permanente Research Executive Director Kaiser Permanente Center for Effectiveness and Safety 

Dr. McGlynn

Elizabeth A. McGlynn, PhD
Vice President for Kaiser Permanente Research
Executive Director
Kaiser Permanente Center for Effectiveness and Safety 

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

Response: A report from the Institute for Safe Medication Practices based on FDA data and observations from a Kaiser Permanente physician leader raised questions about whether direct acting antiviral medications for the treatment of Hepatitis C posed any significant safety risks for patients. Since the decision to take medications requires making tradeoffs between benefits (which had been clearly established in clinical trials) and risks (which are often harder to ascertain until drugs are in widespread use in the real world) we decided this was an important question to pursue.  We found no evidence of increased risks of significant side effects associated with taking these drugs.  In this cohort study of 33,808 patients in three large health systems we found lower adjusted odds of experiencing the following adverse events:  death, multiple organ failure, hepatic decompensation, acute-on-chronic liver event, and arrhythmia.  Continue reading

Medicaid Expansion Linked to Reduced Deaths from Heart Disease

MedicalResearch.com Interview with:

Sameed Khatana, MD, MPH Fellow, Cardiovascular Medicine, Perleman School of Medicine Associate Fellow, Leonard Davis Institute of Health Economics University of Pennsylvania

Dr. Khatana

Sameed Khatana, MD, MPH
Fellow, Cardiovascular Medicine, Perleman School of Medicine
Associate Fellow,
Leonard Davis Institute of Health Economics
University of Pennsylvania 

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

Response: The Affordable Care Act (ACA) led to the largest increase in Medicaid coverage since the beginning of the program. However, a number of states decided not to expand eligibility. Studies of prior smaller expansions in Medicaid, such as in individual states, have suggested evidence of improved outcomes associated with Medicaid expansion. Additionally, studies of Medicaid expansion under the ACA of certain health measures such as access to preventive care and medication adherence have suggested some improvements as well. However, there have been no large, population-level studies to examine whether Medicaid expansion under the ACA led to changes in mortality rates. Given, a high burden of cardiovascular risk factors in the uninsured, we examined whether states that had expanded Medicaid had a change in cardiovascular mortality rates after expansion, compared to states that have not expanded Medicaid.

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Some Physicians Who Advise FDA Later Form Financial Relationships with Pharmaceutical Companies

MedicalResearch.com Interview with:

Stephanie L. Kuschel, B.A Indiana University School of Medicine Indianapolis, IN, 46202

Dr. Kuschel

Stephanie L. Kuschel, MD
Indiana University School of Medicine
Indianapolis, IN, 46202

Robert Dellavalle, MD, PhD, MSPH
Professor of Dermatology and Public Health
University of Colorado School of Medicine
Colorado School of Public Health
Chief, Dermatology Service
US Department of Veterans Affairs
Eastern Colorado Health Care System
Denver, CO 80220 

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

Response: Physicians can serve as external experts and voting members of FDA advisory committee panels, which help determine if a drug is acceptable for the US market. Considering that financial conflicts of interest (FCOI) have been shown to influence voting member habits, the FDA has regulations in place to minimize these FCOI. However, the FDA can grant waivers for some financially conflicted individuals if they meet certain requirements (like offering key insights that may out-weigh the risk of a possible FCOI). Additionally the FDA does not make stipulations regarding post-advisory role financial relationships. In fact, many former FDA committee advisors later engage in financial relationships with pharmaceutical companies. Some worry these post-hoc financial relationships could pose an ethical dilemma whereby future FDA advisory members are incentivized to alter their voting habits in expectation of future rewards. Others argue the situation may be more complex than expected.

For example, the author of one study, found that while there was evidence for a pro-industry voting bias among committee members with exclusive financial relationships to the sponsoring manufacturer (of the drug under review), this was not the case for members with nonexclusive financial ties to both the sponsor and its competitors 1. Furthermore, the author found that advisors with many corporate ties were (on average) actually more likely than their peers without any financial ties to vote against the sponsor. The author argued that these advisors were more likely to be experienced researchers, and their voting habits may reflect their experience evaluating medical research.

While this author and others have offered valuable insights into financial relationships of advisors during their advisory role, unfortunately little information is available regarding post-advisory role financial relationships and whether these relationship have any influence on the integrity of the voting process. The purpose of our study was to review Open Payment data on industry payments to former physician FDA dermatologic drug committee members.  Continue reading

Traumatic Injuries Cost Medicare More Than Heart Failure, Pneumonia, Stroke or Heart Attacks

MedicalResearch.com Interview with:

Dr. Mark R. Hemmila MD Associate Professor of Surgery Division of Acute Care Surgery University of Michigan

Dr. Hemmila

Dr. Mark R. Hemmila MD
Associate Professor of Surgery
Division of Acute Care Surgery
University of Michigan 

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

Response: Traumatic injury has a tendency to be thought of as a disease that preferentially impacts younger people.  We wanted to explore the prevalence and impact of traumatic injury within the population of patients for whom Medicare is the third party payer.  Continue reading

Circulating DNA Can Indicate Melanoma Treatment Failure

MedicalResearch.com Interview with:

David Polsky, MD, PhDDermatologist and Director of the Digmented Lesion Service

Dr. Polsky

David Polsky, MD, PhD
Dermatologist and Director of the Digmented Lesion Service

Mahrukh M. Syeda, MS
Research Associate

Ronald O. Perelman Department of Dermatology
NYU Langone Health

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

Response: Several studies of metastatic melanoma patients have demonstrated that measuring circulating tumor DNA (ctDNA) associates with their disease burden and survival.  Generally, patients with detectable pre-treatment ctDNA levels and/or detectable ctDNA at various time intervals after starting treatment have shorter survivals than patients with lower pre-treatment or on-treatment ctDNA levels.  Studies have varied in their methods to detect ctDNA, the thresholds chosen to call a sample positive or negative, and the follow up time point for measurement, if any.

In this study, we examined pre-treatment and week 4 on-treatment plasma samples from patients enrolled in Combi-D, the Phase III, randomized, double-blind trial of the BRAF and MEK inhibitors Dabrafenib and Trametinib, which led to FDA approval of the combination therapy for patients with unresectable stage III/IV melanoma.

Only patients with BRAF V600E or V600K mutations identified from tumor genotyping were enrolled in the clinical trial.

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Mortality: Number of Steps Matter, Up To a Point

MedicalResearch.com Interview with:

I-Min Lee, MD, ScDProfessor of Medicine, Harvard Medical SchoolProfessor of EpidemiologyHarvard T.H. Chan School of Public Health

Prof. I-Min Lee

I-Min Lee, MD, ScD
Professor of Medicine, Harvard Medical School
Professor of Epidemiology
Harvard T.H. Chan School of Public Health 

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

Response: While we have many studies showing that physical activity is beneficial for health, there are few data on steps and health, particularly long-term health outcomes.  An expert committee – the 2018 Physical Activity Guidelines Advisory Committee, which reviewed the scientific evidence to support the recently released Physical Activity Guidelines for Americans, 2nd edition – noted this (i.e., the relation between steps and health outcomes) to be a critical gap in knowledge, since many individuals are using wearables and monitoring their step counts.

We often hear the number 10,000 steps cited as a daily goal, but the basis for this number is unclear. It likely originated as a marketing tool: in 1965, the Yamasa Clock and Instrument Company, Japan sold a pedometer called “Manpo-kei” – “ten thousand steps meter” in Japanese.

For many older people, 10,000 steps/day can be a very daunting goal; thus, we wanted to investigate whether this was necessary for lower mortality rates in older women.  Additionally, steps taken can be fast or slow, and there are no published studies on step intensity and long-term health outcomes.  Note that walking pace and step intensity are not the same concept: walking pace gauges intensity when walking purposefully (e.g., for exercise or transportation), while step intensity assesses an overall best natural effort in our daily life. Continue reading

Does Genetic Information Encourage Doctors to Switch Anticoagulation Medications?

MedicalResearch.com Interview with:

Thomas J. Povsic, MD, PhDInterventional CardiologistDuke Clinical Research InstituteDuke University School of MedicineDurham, North Carolina 

Dr. Povsic

Thomas J. Povsic, MD, PhD
Interventional Cardiologist
Duke Clinical Research Institute
Duke University School of Medicine
Durham, North Carolina 

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

Response: The background for this study is that it is unknown how mandatory reporting of CYP2C19 metabolizer status affects how doctors treat patients or to what degree provision of this information would affect choice of a P2Y12 inhibitor within a clinical trial.

As part of the GEMINI-ACS trial, all patients underwent CYP2C19 metabolizer testing.  This trial enrolled patients with a recent acute coronary syndrome and randomized them to aspirin or a low dose of rivaroxaban.  All patients were also to be treated with ticagrelor or clopidogrel, which was at the discretion of the investigator.  Investigators were given information regarding the CYP2C19 metabolizer status about a week after randomization.  Importantly prior to randomization, all investigators were asked how they expected to use this information, and then we followed what they actually did.

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Cesarean Section: Multimodal Program Using Non-Opioid EXPAREL Reduced Pain and Need for Opioids After Surgery

MedicalResearch.com Interview with:
Ashraf Habib, MDChief of the Division of Women’s Anesthesia and Professor of AnesthesiologyDuke University Ashraf Habib, MD
Chief of the Division of Women’s Anesthesia
Professor of Anesthesiology
Duke University 

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

Response: This was a multicenter study conducted in 13 clinical sites in the United States enrolling patients undergoing elective Cesarean-section and receiving spinal anesthesia. 186 patients were enrolled and randomized to receive EXPAREL, a long-acting, non-opioid option to manage postsurgical pain, administered via transversus abdominis plane (TAP) field block, mixed with plain bupivacaine or TAP block with plain bupivacaine alone. A TAP block numbs the nerves that supply the abdominal wall. We presented the data at the 51st Annual Meeting of the Society of Obstetric Anesthesia and Perinatology (SOAP) in Phoenix, AZ.

We aimed to collect clinical evidence that a multimodal postsurgical pain regimen using a TAP block with EXPAREL (bupivacaine liposome injectable suspension) together with regularly scheduled acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) could reduce opioid consumption more so than a standard multimodal pain control approach that combines TAP block with standard bupivacaine, regularly scheduled acetaminophen, and NSAIDs.

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Only 1 in 5 Cancer Drugs Receiving FDA Accelerated Approval Have Proven Benefits in Confirmatory Trials

MedicalResearch.com Interview with:

Bishal Gyawali  MD PhD Med Onc. Asst. Professor 

Dr. Gyawali

Bishal Gyawali  MD PhD

  • Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
  • Department of Oncology, Department of Public Health Sciences, and Division of Cancer Care and Epidemiology, Queen’s University, Kingston, Ontario, Canada

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

Response: Accelerated approval pathway from the FDA allows cancer drugs to come to market sooner by showing improvement in surrogate measures such as change in tumor size. Surrogate measures do not reflect clinical benefit in terms of living longer or feeling better. So, when a drug receives accelerated approval, the drug is required to undergo a confirmatory trial to confirm that true clinical benefit from the drug actually exists.

Last year, a paper from the FDA argued that accelerated approval pathway is working effectively because 55% of such drugs confirmed clinical benefit. However, we saw that most of those drugs were actually improving only a surrogate measure even in confirmatory trials. So the confirmatory trials were not confirming clinical benefit but actually confirming benefit in a surrogate endpoint. We investigate that issue in our study using updated results from the confirmatory trials that were ongoing at the time of FDA review.

Our main finding is that only one-fifth of cancer drugs that received accelerated approval actually improved overall survival later in confirmatory trials. For, 20% of other drugs, the confirmatory trials tested the same surrogate endpoint as did the preapproval trial. For another 21%, the confirmatory trial showed benefit in a surrogate endpoint different from the one used in preapproval trial. Furthermore, when drugs fail to confirm clinical benefits in confirmatory trials, they still continue to remain on market.  Continue reading

Team Sports Benefits Teens With a Troubled Childhood

MedicalResearch.com Interview with:
Molly C. Easterlin, MD

Fellow, UCLA National Clinician Scholars Program
Clinical Instructor, Pediatrics, Cedars-Sinai Medical Center 

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

Response: Adverse childhood experiences or ACEs (including physical or emotional neglect or abuse, sexual abuse, domestic abuse, exposure to household substance misuse or mental illness, parental separation or divorce, and parental incarceration) are common with about half of children experiencing 1 and one-quarter of children experiencing 2 or more.

Children exposed to adverse childhood experiences have worse mental health throughout life, including higher rates of depression and anxiety. However, little is known about what factors improve long-term mental health in those exposed to ACEs. Additionally, as far as we are aware, no studies have looked at team sports participation as a potential factor that may be associated with improved mental health among those with adverse childhood experiences.

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NAYZILAM® (midazolam) Nasal Spray Approved To Treat Seizure Clusters

MedicalResearch.com Interview with:

Dr. Steven S. Chung, MDExecutive Director and Program ChairNeuroscience Institute and Director of the Epilepsy ProgramBanner – University Medical Center

Dr. Chung

Dr. Steven S. Chung, MD
Executive Director and Program Chair
Neuroscience Institute and Director of the Epilepsy Program
Banner – University Medical Center

MedicalResearch.com: What is the background for this study? How is Nayzilam different from other treatments for epilepsy? Who/How is it administered? 

Response: NAYZILAM is the first medication and only FDA-approved nasal option for treating seizure clusters. NAYZILAM allows for administration by a non-healthcare professional to patients when a seizure cluster occurs, which could provide significant value to patients who currently have limited treatment options for SC.

The effectiveness of NAYZILAM was established in a randomized, double-blind, placebo-controlled trial (Study 1; NCT 01390220).

Study 1 was conducted in two phases: an open-label Test Dose Phase followed by a randomized, double-blind, placebo-controlled, Comparative Phase. In the Test Dose Phase, tolerability was assessed in 292 patients. Patients were excluded from participation in the Comparative Phase if they failed to meet pre-defined blood pressure, heart rate, sedation, electrocardiogram, and peripheral oxygen saturation criteria. In the Comparative Phase, 201 patients treated a single seizure cluster episode in an outpatient setting.

Numerical differences in favor of NAYZILAM were observed on each of the components of the treatment success responder definition; termination of seizure(s) within 10 minutes after initial dose of study drug (80.6 versus 70.1%) and the absence of seizure recurrence between 10 minutes and 6 hours after the initial dose of study drug (58.2 versus 37.3%).

Study 1 also evaluated the occurrence and time to next seizure after the initial blinded dose of study drug. A smaller proportion of NAYZILAM-treated patients experienced the next seizure within 24 hours after the initial blinded dose of study drug (37.3% versus 46.3%). NAYZILAM-treated patients experienced a statistically longer time-to-next-seizure than the placebo group.  

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Calcium Channel Inhibitors (Verapamil and Diltiazem) May Be Useful in Allergic Inflammation of Esophagus

MedicalResearch.com Interview with:

Dr. Rhonda Souza, MDBaylor University Medical CenterCenter for Esophageal ResearchDallas, TX 75246

Dr. Souza

Dr. Rhonda Souza, MD
Baylor University Medical Center
Center for Esophageal Research
Dallas, TX 75246 

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

Response: Eosinophilic esophagitis (EoE) is a modern disorder of the esophagus caused by an allergy to certain foods. EoE causes esophageal symptoms like difficulty swallowing and heartburn and is diagnosed when biopsies of the esophagus taken during endoscopy show numerous eosinophils, which are a type of inflammatory blood cell.  There are few established treatments for EoE.

One such treatment is a diet that eliminates the offending food allergens, and another is to use steroids to reduce the number of eosinophils in the esophagus. However, the most common treatment for adults with eosinophilic esophagitis is to use proton pump inhibitors (PPIs), which block the proton pumps in stomach cells that make acid.  In earlier studies, we found that PPIs also can block proton pumps in esophageal cells.  Those proton pumps are activated by chemicals that the body produces in response to allergens including interleukin (IL)-13 or IL-4.  Il-13 and IL-4, which cause the esophagus to produce eotaxin-3, a molecule that attracts eosinophils. What remained unknown, however, was the mechanism whereby these interleukins activate proton pumps in the EoE esophagus. In our present study, we explored whether IL-4 works by increasing calcium levels in esophageal cells from EoE patients.

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Study Finds You Don’t Have To Fast Before Getting Your Lipids Measured

MedicalResearch.com Interview with:

Samia Mora, MD, MHSAssociate Physician, Brigham and Women's HospitalAssociate Professor of Medicine, Harvard Medical SchoolBrigham and Women's HospitalDepartment of MedicinePreventive MedicineBoston, MA 02115 

Dr. Mora

Samia Mora, MD, MHS
Associate Physician, Brigham and Women’s Hospital
Associate Professor of Medicine, Harvard Medical School
Brigham and Women’s Hospital
Department of Medicine
Preventive Medicine
Boston, MA 02115 

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

Response: Lipid testing plays a major role in cardiovascular disease (CVD) risk screening, prediction, and treatment. In the past decade, several pivotal studies (including the Women’s Health Study, the Copenhagen City Heart Study, and the Copenhagen General Population Study) compared populations of individuals who had fasting lipid testing with populations of individuals who had nonfasting lipid testing, and found that non-fasting lipids were at least as good as fasting lipids in cardiovascular risk screening and predicting CVD risk.

To date, however, no study has examined the cardiovascular predictive value of lipids measured on the same individuals who had both fasting and nonfasting lipid testing. This is important because individual-level variability in fasting versus nonfasting lipids may not be captured when looking at population-level risk associations, and evidence from randomized studies is lacking. Furthermore, it is unclear whether substituting nonfasting lipids would misclassify cardiovascular risk for individuals who may be eligible for statin therapy.

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Can Mindfulness-Based Training Reduce Stress and Burnout in Surgeons?

MedicalResearch.com Interview with:

Carter Lebares, MDAssistant Professor of SurgeryDirector, Center for Mindfulness in SurgeryDepartment of Surgery, UCSF

Dr. Lebares

Carter Lebares, MD
Assistant Professor of Surgery
Director, Center for Mindfulness in Surgery
Department of Surgery, UCSF 

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

 Response: This study was inspired by extensive evidence of the effectiveness of mindfulness-based interventions (MBIs) for mitigating stress and enhancing performance in other high-stress populations like police and the military.  We know that overwhelming stress is related to burnout and to cognitive errors – two critical issues within surgery, today. This prompted us to tailor and streamline an MBI specifically for surgeons, and to test it in our trainees.

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Frailty Linked to Unplanned Readmissions After Elective Outpatient Surgery

MedicalResearch.com Interview with:
hospital-frailty-surgeryKara Anne Rothenberg.MD
Postdoctoral Research Fellow, Vascular Surgery
Shipra Arya, MD SM FACS
Associate Professor of Surgery
Stanford University School of Medicine

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

Response: There is a growing body of literature showing that frailty, a syndrome where patients have increased vulnerability to a stressor (such as surgery), is associated with increased postoperative complications, failure to rescue, and hospital readmissions.

The Risk Analysis Index (RAI), is an easy to use frailty measurement tool that better predicts postoperative mortality than age or comorbidities alone. As the rates of outpatient surgeries rise nationwide, we noted that most of the surgical frailty studies focus only on inpatient surgeries. Elective, outpatient surgery is generally considered low risk for complications and unplanned readmissions, however we hypothesized that for frail patients, it might not be.

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Silent Heart Attack Associated with Increased Risk of Embolic Stroke

MedicalResearch.com Interview with:

Lenore J. Launer, PhD.Chief Neuroepidemiology Section Intramural Research ProgramNational Institute on Aging

Dr. Launer

Lenore J. Launer, PhD.
Chief Neuroepidemiology Section Intramural Research Program
National Institute on Aging

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

Response: The prevalence of cerebral infarction on MRI can be as high as 30% in community-based studies. These lesions detected on brain MRI, are often clinically silent, but are associated with impairments in cognitive and physical function and can increase the risk for clinical events. For a large number, the origin of these brain lesions is unknown. There is also a lack of population-based data on unrecognized myocardial infarction, which is associated with an increased for clinical coronary disease and mortality.

Unrecognized MI was detected in 17% of participants using state-of-the-art cardia MRI, a more sensitive measure of the lesions, than the standard ECG. We investigated the contribution to these lesions of recognized and unrecognized myocardial infarction [MI] identified on cardiac MRI.

We found both recognized and unrecognized myocardial infarction increased the risk for cerebral infarction, and that in particular unrecognized MI was associated with cerebral infarction of embolic origins of an unknown source. Given their prevalence, unrecognized MI may be an underestimated contributor to the risk for cerebral infarction in older persons.  Continue reading

Prenatal Exposure to Nicotine May Increase Risk of Nicotine Susceptibility Later in Life

MedicalResearch.com Interview with:

Davide Dulcis, PhDAssociate ProfessorDepartment of Psychiatry, UCSD School of MedicineUniversity of California, San DiegoLa Jolla, CA 92093-0603

Dr. Dulcis

Davide Dulcis, PhD
Associate Professor
Department of Psychiatry, UCSD School of Medicine
University of California, San Diego
La Jolla, CA 92093-0603

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

Response: Previous studies in humans have shown that pre-natal and early life exposure to nicotine can lead to altered children behavior and propensity for drug abuse, but the precise mechanisms involved are still unclear.

In this pre-clinical study we showed how nicotine “primes” neurons of the mouse brain’s reward center for a fate they normally would not have taken, making them more susceptible to the effects of nicotine when the animals are again exposed to nicotine later in life, said Dr. Benedetto Romoli, first author of the research article.   Continue reading

NIH Spends Relatively Little on Hearing Loss

MedicalResearch.com Interview with:

Jan Blustein, MD PhDProfessor of Health Policy and MedicineWagner Graduate School and School of MedicineNew York University, New York

Dr. Blustein

Jan Blustein, MD PhD
Professor of Health Policy and Medicine
Wagner Graduate School and School of Medicine
New York University, New York

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

Response: The National Institutes of Health (NIH), the nation’s largest public funder of health research, provides annual reports about levels of funding for many diseases and conditions.  These reports, issued as part of the NIH’s Research, Condition and Disease Categorization (RCDC) process, allow members of the public to track funding across key conditions and across time.

Hearing loss is not included among the reported conditions. This runs counter to two of the NIH’s stated goals, according to researcher Jan Blustein (M.D., Ph.D.), professor of health policy and medicine at New York University’s Robert F. Wagner Graduate School of Public Service, in a Research Letter in the May 15th issue of the Journal of the American Medical Association Otolaryngology and Head & Neck Surgery.

“First, the NIH is committed to transparency about how it divides funds across diseases and conditions,” said Dr. Blustein.  “Second, it has said that it will prioritize its funding to those conditions that cause the greatest disease burden.”  Hearing loss causes great disease burden, ranking 10th in the U.S. among all conditions as a contributor to Disability Adjusted Life Years (a widely-used measure of disease burden), according to the World Health Organization.

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Do Hospitals Designated as Centers of Excellence Have Better Outcomes?

MedicalResearch.com Interview with:

Sameed Khatana, MDFellow, Cardiovascular Medicine, Perleman School of MedicineAssociate Fellow, Leonard Davis Institute of Health EconomicsUniversity of Pennsylvania

Dr. Khatana

Sameed Khatana, MD
Fellow, Cardiovascular Medicine, Perleman School of Medicine
Associate Fellow, Leonard Davis Institute of Health Economics
University of Pennsylvania

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

Response: There has been a growing use of quality metrics and indices in the US healthcare system. Much attention has been paid to quality measurement programs used by public payors, however, the use of such programs by commercial payors is much less studied. “Centers of excellence” are one type of quality designation program that is growing in use by commercial payors where certain hospitals are determined to be “high quality” for a certain disease state or procedure based on meeting certain criteria. For some people, this is even impacting the choice of providers and hospitals they can use by payors.

We evaluated centers of excellence programs from three large commercial payors, Aetna, Cigna and Blue Cross Blue Shield, targeted at cardiovascular diseases and interventions and examined publicly reported outcomes for all hospitals performing percutaneous coronary interventions (cardiac stenting) in New York State. 

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