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

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.

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.

Continue reading

Neurology Residents Learn to Identify Physician Burnout Through Simulation

MedicalResearch.com Interview with:
Dr. Rebecca Stainman
Dr. Arielle Kurzweil MD
Adult Neurology Program Director
New York University School of Medicine
NYU Langone Health

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

Response: Physician burnout is prevalent. Neurologists have among the highest burnout rates, ranked third among specialties in a 2011 study, and over half of US Neurologists report at least 1 symptom of burnout in a 2016 survey.  Efforts to address burnout in training programs have mostly been aimed at implementing wellness curricula and offering mental health resources.

Training neurology residents to effectively identify, address, and help impaired colleagues is equally crucial in these efforts, yet there is a paucity of literature on this topic. We used simulation as a means of addressing this topic, via identifying and addressing an impaired colleague through an objective structured clinical examination (OSCE).  Continue reading

Multiple Sclerosis: Extended Dosing of Natalizumab Reduces Risk of PML

MedicalResearch.com Interview with:

Lana Zhovtis Ryserson, MDAssistant Professor, Department of NeurologyNYU Langone Health

Dr. Zhovtis Ryserson

Lana Zhovtis Ryserson, MD
Assistant Professor, Department of Neurology
NYU Langone Health

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

Response: Natalizumab is an effective therapy of relapsing remitting multiple sclerosis dosed at 300mg every 4 weeks. However it is associated with a potentially deadly infection – progressive multifocal leukoencephalopathy. In order to mitigate this risk, clinicians have adopted an approach of infusing the medication less frequently, a strategy which has become known as Extended Interval Dosing (EID).

The TOUCH database is US mandatated risk evaluation and mitigation program which is the largest database available to assess PML risk for patients on EID schedule. Previous analysis of this database in 2017, showed a significant risk reduction of PML in patients utilizing extended interval dosing schedule. The aim of the current study was to update on this analysis with another year of data.

Continue reading

NYU Researchers Develop Siri-Like Application to Identify PTSD by Speech Analysis

MedicalResearch.com Interview with:

Charles R. Marmar, MDThe Lucius N. Littauer Professor Chair of the Department of PsychiatryNYU Langone School of Medicine

Dr. Marmar

Charles R. Marmar, MD
The Lucius N. Littauer Professor
Chair of the Department of Psychiatry
NYU Langone School of Medicine

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

Response: Several studies in recent years have attempted to identify biological markers that distinguish individuals with PTSD, with candidate markers including changes in brain cell networks, genetics, neurochemistry, immune functioning, and psychophysiology. Despite such advances, the use of biomarkers for diagnosing PTSD remained elusive going into the current study, and no physical marker was applied in the clinic.

Our study is the first to compare speech in an age and gender matched sample of a military population with and without PTSD, in which PTSD was assessed by a clinician, and in which all patients did not have a major depressive disorder. Because measuring voice qualities in non-invasive, inexpensive and might be done over the phone, many labs have sought to design speech-based diagnostic tools 

Continue reading

Cancer Patients Use THC and CBD Differently Than Other Medical Marijuana Patients

MedicalResearch.com Interview with:

Arum Kim, MDAssistant professor of Medicine and Rehabilitation MedicineNYU School of MedicineDirector of the Supportive Oncology ProgramPerlmutter Cancer Center

Dr. Kim

Arum Kim, MD
Assistant Professor
Medicine and Rehabilitation Medicine
NYU School of Medicine
Director of the Supportive Oncology Program
Perlmutter Cancer Center

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

Response: There is increasing interest in medical marijuana and its applications for patients with cancers. Despite increasing access, little is known regarding doses of cannabinoids – specifically tetrahydrocannabinol (THC)  and cannabidiol (CBD), methods of drug delivery, and differences in patterns of use between cancer and non-cancer patients.

Continue reading

Port Wine Stain Birthmarks in Infants Safely Treated Without Need for General Anesthesia

MedicalResearch.com Interview with:

Roy G. Geronemus, M.D.Director, Laser & Skin Surgery Center of New YorkClinical Professor of DermatologyNew York University Medical CenterNew York, NY 10016

Dr. Geronemus

Roy G. Geronemus, M.D.
Director, Laser & Skin Surgery Center of New York
Clinical Professor of Dermatology
New York University Medical Center
New York, NY 10016

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

Response: We made the observation in clinical practice that port wine stain birthmarks can be safely and effectively treated in early infancy without the need for general anesthesia. This observation is particularly important because of the FDA warnings regarding multiple exposures to general anesthesia under the age of 3 and the potential impact on neurocognitive development as these patients require multiple treatments.
Continue reading

Dapsone Found Effective As Second Line Treatment for Hives

MedicalResearch.com Interview with:

Nicholas A. Soter, MD The Ronald O. Perelman Department of Dermatology New York University School of Medicine New York, New York

Dr. Nicholas Soter

Nicholas A. Soter, MD
The Ronald O. Perelman Department of Dermatology
New York University School of Medicine
New York, New York

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

Response: Nearly 50% of patients with chronic spontaneous urticarial (CSU) (hives) incompletely respond to first-line therapy with H-1 antihistamines.

However, in the current literature, there is limited evidence to guide the treatment of CSU after maximal therapy with antihistamines fails.  Two small, randomized, controlled trials suggest that dapsone, which is an antimicrobial therapeutic agent with anti-inflammatory properties, may be a useful second-line therapeutic agent.

Continue reading

More Patients With Bariatric Surgery Admitted for Gallstone-Related Biliary Disease

MedicalResearch.com Interview with:

Violeta Popov, MD PhD FACG Assistant Professor of Medicine Director of Bariatric Endoscopy, NY VA Harbor Healthcare(Manhattan) Division of Gastroenterology NYU Langone Medical Center 

Dr. Popov

Violeta Popov, MD PhD FACG
Assistant Professor of Medicine
Director of Bariatric Endoscopy, NY VA Harbor Healthcare(Manhattan)
Division of Gastroenterology
NYU Langone Medical Center 

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

Response: Bariatric surgery is the most effective method currently available for durable weight loss. In the first few months after surgery, patients typically experience significant weight loss. Rapid weight reduction though can lead to the development of gallstones and biliary disease, described in up to 40% of post-bariatric patients. To avoid these complications, the gallbladder was removed during open bariatric procedures in the past. However, with the advent of laparoscopic surgery, concomitant cholecystectomy with bariatric surgery is no longer performed for many reasons.  The aim of is study is to assess if biliary diseases such as acute pancreatitis, acute cholecystitis, acute cholangitis, and cholecystectomy have increased with this change in practice. This is a retrospective cohort analysis of the National Inpatient Sample (NIS), the largest publicly available inpatient database in the United States of nonfederal institutions, with approximately 1000 hospitals participating and information on over 7 million inpatient admissions.

We found that from 2006 to 2014 there has been an approximately 10-fold increase in hospital admissions for biliary diseases, as well as similar increase in cholecystectomies, in patients who have a history of bariatric surgery. There was no significant change in admissions in patients without bariatric surgery between 2006 and 2014 admitted for the same biliary diseases.  Continue reading

Artificial Intelligence Can Reliably Diagnosis Specific Types of Lung Cancer

MedicalResearch.com Interview with:

Aristotelis Tsirigos, Ph.D. Associate Professor of Pathology Director, Applied Bioinformatics Laboratories New York University School of Medicine

Dr. Tsirigos

Aristotelis Tsirigos, Ph.D.
Associate Professor of Pathology
Director, Applied Bioinformatics Laboratories
New York University School of Medicine

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

Response: Pathologists routinely examine slides made from tumor samples to diagnose cancer types. We studied whether an AI algorithm can achieve the same task with high accuracy. Indeed, we show that such an algorithm can achieve an accuracy of ~97%, slightly better than individual pathologists.

In addition, we demonstrated that AI can be used to predict genes that are mutated in these tumors, a task that pathologists cannot do. Although the accuracy for some genes is as high as 86%, there is still room for improvement. This will come from collecting more training data and also from improvement in the annotations of the slides by expert pathologists.  

Continue reading

Low Risk Prostate Cancer Imaging More Common Outside of VA Hospitals

MedicalResearch.com Interview with:

Danil V. Makarov, MD, MHS Department of Urology and Department of Population Health New York University Langone School of Medicine VA New York Harbor Healthcare System, Robert F. Wagner Graduate School of Public Service Cancer Institute, New York University School of Medicine, New York

Dr. Makarov

Danil V. Makarov, MD, MHS
Department of Urology and
Department of Population Health
New York University Langone School of Medicine
VA New York Harbor Healthcare System,
Robert F. Wagner Graduate School of Public Service
Cancer Institute, New York University School of Medicine, New York

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

Response: Reducing prostate cancer staging imaging for men with low-risk disease is an important national priority to improve widespread guideline-concordant practice, as determined by the National Comprehensive Cancer Network guidelines. It appears that prostate cancer imaging rates vary by several factors, including health care setting. Within Veterans Health Administration (VHA), physicians receive no financial incentive to provide more services. Outside VHA, the fee-for-service model used in Medicare may encourage provision of more healthcare services due to direct physician reimbursement.

In our study, we compared these health systems by investigating the association between prostate cancer imaging rates and a VA vs fee-for-service health care setting. We used novel methods to directly compare Veterans, Medicare Recipients, and Veterans that chose to receive care from both the VA at private facilities using Medicare insurance through the Choice Act with regard to rates of guideline-discordant imaging for prostate cancer.

We found that Medicare beneficiaries were significantly more likely to receive guideline-discordant prostate cancer imaging than men treated only in VA.

Moreover, we found that men with low-risk prostate cancer patients in the VA-only group had the lowest likelihood of guideline-discordant imaging, those in the VA and Medicare group had the next highest likelihood of guideline-discordant imaging (in the middle), and those in the Medicare-only group had the highest likelihood of guideline-discordant imaging.  Continue reading