PCSK 9 Inhibitors May Be Cost Effective For Subset of High Risk Patients, If Price is Right

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? What are the main findings?

Response: The study identifies the clinical and economic consequences of treating a population of patients with established atherosclerotic cardiovascular disease (ASCVD ) at high-risk of cardiovascular (CV) events and defines the cost-effectiveness of the PCSK-9 inhibitor evolocumab under various clinical scenarios. The analysis is based on the clinical outcomes from the Repatha Outcomes Study (FOURIER) in patients with established atherosclerotic cardiovascular disease (ASCVD), such as those who have already had a heart attack or stroke who require additional therapy.

This is the first cost-effectiveness assessment of evolocumab using a model based on a high-quality outcomes trial, combined with U.S. clinical practice data. The analysis identifies the types of high-risk patients for whom this therapy is both clinically beneficial and cost-effective. This study utilized cost-effectiveness and value thresholds employed by the World Health Organization and the American College of Cardiology/American Heart Association.

Evolocumab was found to exceed generally accepted cost-effectiveness thresholds at current list price. However, this medication could be a cost-effective treatment for patients with established ASCVD in the U.S. when the net price is at or below $9,669 per year.

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Familial Hypercholesterolemia: “Junk” RNA May Facilitate Gene Therapy

MedicalResearch.com Interview with:

Tamer Sallam, MD PhD Assistant Professor of Medicine Co-Director UCLA Center for Lipid Management Lauren B. Leichtman and Arthur E. Levine CDF Investigator Assistant Director, STAR Program Division of Cardiology, Department of Medicine David Geffen School of Medicine at UCLA Los Angeles, California 90095-1679 

Dr. Sallam

Tamer Sallam, MD PhD
Assistant Professor of Medicine
Co-Director UCLA Center for Lipid Management
Lauren B. Leichtman and Arthur E. Levine CDF Investigator
Assistant Director, STAR Program
Division of Cardiology, Department of Medicine
David Geffen School of Medicine at UCLA
Los Angeles, California 90095-1679

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

Response: This study is extension of our previous work published in Nature showing that a gene we named LeXis (Liver expressed LXR induced sequence) plays an important role in controlling cholesterol levels. What is unique about  LeXis is that it belongs to a group of newly recognized mediators known as long noncoding RNAs. These fascinating factors were largely thought to be unimportant and in fact referred to as “junk DNA” prior the human genome project but multiple lines of evidence suggest that they can be critical players in health and in disease.

In this study we tested whether we can use  LeXis “gene therapy”  to lower cholesterol and  heart disease risk. This type of approach is currently approved or in testing for about 80 human diseases.

Our finding was that a single injection of LeXis compared with control significantly  reduced heart disease burden in mouse subjects. Although the effect size was moderate we specifically used a model that mimics a very challenging to treat human condition known as familial hypercholesterolemia..Familial hypercholesterolemia is one of the most common genetic disorders affecting up to 2 million Americans and characterized by 20 fold  fold increase risk of early heart attacks and often suboptimal response to currently available treatments.

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Remediation Programs Linked To Reduced Attrition Among Surgical Residents

MedicalResearch.com Interview with:

Christian de Virgilio, MD LA BioMed lead researcher and corresponding author for the study He also is the former director of the general surgery residency program Harbor-UCLA Medical Center and the recipient of several teaching awards.

Dr. de Virgilio

Christian de Virgilio, MD
LA BioMed lead researcher and corresponding author for the study
He also is the former director of the general surgery residency program
Harbor-UCLA Medical Center and the recipient of several teaching awards.

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

Response: Recent forecasts have predicted the United States will have a deficit of as many as 29,000 surgeons by 2030 because of the expected growth in the nation’s population and the aging of the Baby Boomers. This expected shortfall in surgeons has made the successful training of the next generation of surgeons even more important than it was before. Yet recent studies have shown that as many as one in five general surgery residents leave their training programs before completion to pursue other specialties.

Our team of researchers studied 21 training programs for general surgeons and published our findings in the Journal of the American Medical Association Surgery (JAMA Surgery) on August 16, 2017. What we found was the attrition rate among residents training in general surgery was lower than previously determined – just 8.8% instead of 20% – in the 21 programs we surveyed. Our study also found that program directors’ attitudes and support for struggling residents and resident education were significantly different when the authors compared high- and low-attrition programs.

General surgeons specialize in the most common surgical procedures, including abdominal, trauma, gastrointestinal, breast, cancer, endocrine and skin and soft tissue surgeries. General surgery residency training follows medical school and generally requires five to seven years. The programs are offered through universities, university affiliated hospitals and independent programs.

In this study, the research team surveyed 12 university-based programs, three program affiliated with a university and six independent programs. In those programs, 85 of the 966 general surgery residents failed to complete their training during the five-year period the research team studied, July 1, 2010 to June 30, 2015. Of those who failed to complete their general surgery training, 15 left during the first year of training; 34 during the second year, and 36 during the third year or later.

Notably, we found a nearly seven-fold difference between the training program with the lowest attrition rate, 2.2%, and the one with the highest rate, 14.3%, over the five-year period surveyed. In the programs with lower attrition rates, we found about one in five residents received some support or remediation to help ensure they would complete their https://medicalresearch.com/author-interviews/reduction_in_surgical_residents_work_hours/4475/ In the programs with higher attrition rates, the research team reported that only about one in 15 residents received such remediation. Continue reading

USPSTF: Behavioral Counseling to Promote a Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults Without Cardiovascular Risk Factors

MedicalResearch.com Interview with:

Carol M. Mangione, MD, MSPH, FACP Barbara A. Levey, MD, and Gerald S. Levey, MD Endowed chair in medicine David Geffen School of Medicine University of California, Los Angeles Professor of public health at the UCLA Fielding School of Public Health

Dr. Mangione

Carol M. Mangione, MD, MSPH, FACP
Barbara A. Levey, MD, and Gerald S. Levey, MD
Endowed chair in medicine
David Geffen School of Medicine
University of California, Los Angeles
Professor of public health at the UCLA Fielding School of Public Health

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

Response: Americans can experience several health benefits from consuming healthy foods and engaging in physical activity. The Task Force recommends that primary care professionals work together with their patients when making the decision to offer or refer adults who are not obese and do not have hypertension, high cholesterol, high blood sugar, or diabetes to behavior counseling to promote healthful diet and physical activity. Our focus was on the impact of a healthful diet and physical activity on cardiovascular risk because this condition is the leading cause of premature morbidity and mortality. The Task Force evaluates what the science tells us surrounding the potential benefits and harms of a particular preventive service. In this case, the Task Force found high quality evidence focusing on the impact a healthful diet and physical activity can have on a patient’s risk of cardiovascular disease. Relying on this evidence, the Task Force was able to conclude that there is a positive but small benefit of behavioral counseling to prevent cardiovascular disease.

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Study Finds Single Antibiotic Cephalexin Alone Is Appropriate Outpatient Treatment For Cellulitis

MedicalResearch.com Interview with:
Gregory John Moran, MD, FACEP
Emergency Medicine Dept. & Infectious Diseases Service
UCLA Medical Center

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

Response: The bacterial etiology of cellulitis is difficult to determine because there is usually no material for culture, but streptococci are believed to be the most common etiology. Since the emergence of MRSA as a common cause of skin infections in the community, many clinicians add a second antibiotic with MRSA activity to an oral cephalosporin, such as a combination of cephalexin plus trimethoprim-sulfamethoxazole. It is unknown if there is an additional benefit to adding MRSA activity for treatment of cellulitis. This randomized, blinded trial compared cephalexin plus placebo to cephalexin plus trimethoprim-sulfamethoxazole for outpatient treatment of cellulitis without an abscess or wound.

Bottom line: We did not find a benefit from addition of trimethoprim-sulfamethoxazole.

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Gene Dosage at 22q11.2 Helps Determine Schizophrenia vs Autism Brain Differences

MedicalResearch.com Interview with:

Carrie Bearden, Ph.D. Professor, Departments of Psychiatry and Biobehavioral Sciences and Psychology Semel Institute for Neuroscience and Human Behavior University of California, Los Angeles

Dr. Bearden

Carrie Bearden, Ph.D.
Professor, Departments of Psychiatry and Biobehavioral Sciences and Psychology
Semel Institute for Neuroscience and Human Behavior
University of California, Los Angeles

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

Response: A 22q11.2 deletion confers the highest known genetic risk for schizophrenia, but a duplication in the same region is strongly associated with autism and is less common in schizophrenia cases than in the general population.

Thus, we became interested in trying to understand whether there were differences in brain development that might predispose to one condition vs. the other.

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Antibiotic Failure in Community Acquired Pneumonia Surprisingly Common

MedicalResearch.com Interview with:

Dr. James A. McKinnell, MD LA BioMed Assistant Professor of Medicine David Geffen School of Medicine at UCLA

Dr. McKinnell

Dr. James A. McKinnell, MD
LA BioMed
Assistant Professor of Medicine
David Geffen School of Medicine at UCLA

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

Response: Pneumonia is the leading cause of death from infectious disease in the United States. We conducted this study because current community-acquired pneumonia guidelines from the American Thoracic Society and the Infectious Disease Society America, published in 2007, provide some direction about prescribing antibiotics for community-acquired pneumonia. But large-scale, real-world data are needed to better understand and optimize antibiotic choices and to better define clinical risk factors that may be associated with treatment failure. Antibiotic failure for community-acquired pneumonia is associated with substantial morbidity and mortality and results in significant medical expenditures.

We examined databases containing records for 251,947 adult patients who were treated between 2011 and 2015 with a single class of antibiotics (beta-lactam, macrolide, tetracycline, or fluoroquinolone) following a visit to their physician for treatment for community-acquired pneumonia. We defined treatment failure as either the need to refill antibiotic prescriptions, antibiotic switch, ER visit or hospitalization within 30 days of receipt of the initial antibiotic prescription.

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Brain Triggers For Eating Differ in Obese Men vs Women

MedicalResearch.com Interview with:

Arpana Gupta, Ph.D. Assistant Professor G. Oppenheimer Center for Neurobiology of Stress and Resilience Ingestive Behavior and Obesity Program Vatche and Tamar Manoukin Division of Digestive Diseases David Geffen School of Medicine, UCLA

Dr. Gupta

Arpana Gupta, Ph.D.
Assistant Professor
G. Oppenheimer Center for Neurobiology of Stress and Resilience
Ingestive Behavior and Obesity Program
Vatche and Tamar Manoukin Division of Digestive Diseases
David Geffen School of Medicine, UCLA

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

Response: Past studies have demonstrated how an imbalance in the processing of rewarding and salient stimuli results in maladaptive or excessive eating behaviors. However, stress and drug use are known to affect how sex and sex hormones modulate responses of the dopamine system involved in reward, and are thought to underlie sex differences in the pathophysiology of drug addiction and treatment response. These results suggest similar sex effects on the mesolimbic reward system may also be at play in obesity.

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Restrictions on Pharmaceutical Detailing Linked To Increase in Generic Drug Prescription

MedicalResearch.com Interview with:

Ian Larkin, PhD</strong> Assistant Professor of Strategy UCLA Anderson School of Management

Dr. Ian Larkin

Ian Larkin, PhD
Assistant Professor of Strategy
UCLA Anderson School of Management

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

Response: The study examined whether restrictions put in by medical centers on salesperson visits to physicians, known as “detailing,” affected subsequent physician prescribing behavior. Detailing represents the most prominent form of pharmaceutical marketing. Detailing visits allow the sharing of scientific information, but they also often involve small gifts for physicians and their staff, such as meals.

Pharmaceutical companies incur far greater expenditures on detailing visits than they do on direct-to-consumer marketing, or even on research and development of new drugs. Specifically, the study examined detailing restrictions put into place by 19 academic medical centers (AMCs) in five states in the U.S. It compared changes in prescribing by thousands of AMC physicians whose practices limited typical elements of detailing visits, such as provisions of meals and educational gifts, to a carefully matched control group of similar physicians practicing in the same geographic regions but not subject to such detailing restrictions.

The study, which included more than 25,000 physicians and all 262 drugs in eight major drug classes — from statins to sleep aids to antidepressants, representing more than $60 billion in aggregate sales in the United States — was, to date, by far the most comprehensive to examine the impact of detailing restrictions. The comprehensive and quasi-experimental methodology, which compared prescribing behavior before and after implementation of policies, and which included a large matched control group of physicians not subject to policy changes, was an important innovation relative to prior research. The study used prescription data from CVS Caremark, one of the largest pharmacy benefit managers in the United States.

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Hospital Based Primary Care Practices Provide More Low Value Services

MedicalResearch.com Interview with:

John N. Mafi, MD, MPH Assistant Professor of Medicine Division of General Internal Medicine and Health Services Research UCLA David Geffen School of Medicine Los Angeles, CA 90024 Affiliated Natural Scientist in Health Policy RAND Corporation 1776 Main St, Santa Monica, CA 90401

Dr. John Mafi

John N. Mafi, MD, MPH
Assistant Professor of Medicine
Division of General Internal Medicine and Health Services Research
UCLA David Geffen School of Medicine
Los Angeles, CA 90024
Affiliated Natural Scientist in Health Policy
RAND Corporation
1776 Main St, Santa Monica, CA 90401

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

Response: Between 10-30% of healthcare costs are due to low value care, or patient care that provides little to no benefit to patients, and can sometimes cause harm (e.g., radiation exposure from diagnostic imaging tests). In this study, we found that hospital-based primary care practice provide more low value care than community-based primary care practices across the United States. Understanding where and why low value care occurs is going to be essential if we want to get serious about eliminating it.

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