Atrial Fibrillation: Study Finds Quality of Life Better After Ablation vs Medication

Posted on March 19, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Blomström-Lundqvist

Dr. Carina Blomström-Lundqvist, MD
Professor of Cardiology
Department of Cardioloy
Institution of Medical Science
Uppsala, Sweden

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

Response: While all previous trials comparing atrial fibrillation (AF) ablation and antiarrhythmic drugs to our best knowledge have evaluated the efficacy of these treatments in terms of atrial fibrillation (AF) recurrences (with an AF episode of 30 seconds duration as standard primary endpoint) we wanted to use quality of Life (QoL) – general health – as primary endpoint, since the indication for treatment is improving QoL.

This was important since, despite the fact that the indication for treatment is to improve (QoL) and reduce symptom, all prior trials have used 30 seconds AF episodes as standard primary endpoint, which if occurred it would be defined as a failed treatment.

We also wanted to assess effects on various clinical outcome events.

We know from registries such as ORBIT AF registry that around 60 % of AF patients have symptoms resulting in repeated hospitalisation visits in at least 30-40% of patients annually, and that only around 5 % of the AF population are being referred for AF ablation.

Previous trials have used intermittent 24 hours Holter recordings whioch does not give the true AF burden (% of time in AF). We therefore also wanted to assess and compare treatments effects on true AF burden by implanting an implantable cardiac monitor (ICM) which continuosly records the heart rhythm. We would then be able to prove that improvement in QoL was directly related to a reduction in AF burden and that treatment differences in QoL was related to a difference in reduction in AF burden.

We also wanted to study an AF population in their early AF disease state so that we could offer atrial fibrillation ablation to a broader AF population before their atria have become remodelled and too damaged for a pulmonary vein isolation to be effective.

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New HeartMate 3 LAVD Reduces Risk of Strokes and Clots

Posted on March 19, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Mehra

Mandeep R. Mehra, MD, MSc, FRCP (London)
The William Harvey Distinguished Chair in Advanced Cardiovascular Medicine
Medical Director, Heart and Vascular Center
Brigham and Women’s Hospital
Executive Director
Center for Advanced Heart Disease
Brigham and Women’s Hospital
Professor of Medicine, Harvard Medical School

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

Response: The MOMENTUM 3 trial is the largest study of LVAD therapy in Advanced Heart Failure with over 1000 randomized patients followed to at least 2 years. This trial tested a novel fully magnetically levitated LVAD, the HeartMate 3 pump against a mechanical bearing containing LVAD, the HeartMate II pump in patients suffering from advanced heart failure (85% of whom were on continuous intravenous Inotropic therapy or IABP device at the time of randomization). While LVADs have improved survival for such patients, the morbidity has remained excessive due to serious complication as a result of problems with hemocompatibility.

The principal concerns revolve around complications of pump thrombosis requiring surgical replacement, strokes and bleeding events, especially gastrointestinal bleeding. The trial has previously reported two interim analyses which suggested signals for superiority on pump replacement and even a decrease in ischemic stroke.

This final full report concludes convincingly that all three domains of hemocompatibility related adverse events are reduced with the novel LVAD with near elimination of pump thrombosis, halving of strokes of any kind and any severity and a marked decrease in bleeding complications.

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Opioid Crisis Linked To Rapid Increase in Chronically Infected Heart Valves

Posted on March 18, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Serena Day

Serena Day, MD
Ohio State University

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

Response: The idea for this research came from my own observations of patients that I was caring for in the hospital first as an Internal Medicine Resident and now as a senior Cardiology Fellow. I did my residency here at Ohio State and noticed a marked increase in the number of patients with endocarditis that we were caring for just in my short time here as a trainee.

Over 5 years, we saw an increase of 436% in intravenous drug use related endocarditis. How this disease is treated as changed as well. It used to be that if a patient was a good surgical candidate, we would offer a replacement valve. Now, we see that these patient’s have such a high rate of recurrent intravenous drug use and reinfection of their heart valves that we now treat with antibiotics only rather than surgery. In many cases, the infection never goes away because we can’t offer definitive therapy with surgery due to their high relapse and reinfection rates of nearly 50%.
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Home Treatment of Patients with Low-Risk Pulmonary Embolism

Posted on March 18, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:
Stavros V. Konstantinides, MD, PhD, FESC, FRCP(Glasg)
Professor, Clinical Trials, and Medical Director
Center for Thrombosis and Hemostasis (CTH)
Johannes Gutenberg University Mainz
Mainz, Germany

Stavros V. Konstantinides, MD, PhD, FESC, FRCP(Glasg)Professor, Clinical Trials, and Medical DirectorCenter for Thrombosis and Hemostasis (CTH)Johannes Gutenberg University MainzMainz, Germany

Dr. Konstantinides

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

Response: Acute pulmonary embolism (PE) is the third most frequent acute cardiovascular syndrome. It encompasses a wide spectrum of clinical symptoms and severity, ranging from massive, immediately life-threatening PE with hemodynamic collapse to the low-risk, stable patient with very few symptoms. These latter patients with acute low-risk PE may qualify for early discharge from hospital (e.g., within 48 hours) and continuation of treatment at home. This is a very promising strategy, because it may not only increase patient satisfaction and quality of life, but also help to reduce hospital-related complications and costs. However, it needed to be clearly determined, and tested in a prospective management trial, who are the appropriate candidates for an effective and safe home treatment approach. To this date, trials suggesting favorable clinical outcomes with home treatment of PE are small and date back to the era of vitamin K antagonists. Direct oral anticoagulants permitting a single drug treatment of PE are more promising in this regard, as they may make an early transition from hospital to ambulatory care both safer and more convenient.

The international Home Treatment of Pulmonary Embolism (HoT-PE) phase 4 management trial tested the efficacy and safety of early discharge and ambulatory anticoagulation treatment with the direct factor Xa inhibitor rivaroxaban in patients with acute low-risk PE. Patients were identified on the basis of

clinical criteria or PE severity, comorbidity, and contraindications; and
the absence of right heart failure or intracardiac thrombi on cardiac imaging. Early termination of the study was possible following the prespecified interim analysis, which was performed after recruitment and 3-month evaluation of 525 patients (50% of the planned trial population). At the interim analysis, the primary efficacy outcome of symptomatic recurrent venous thromboembolism or PE-related death occurred in only 3 (0.6%) patients (compared to an estimated 1.7% rate based on historical data). This rate was sufficiently low to reject the primary hypothesis as predefined in the statistical analysis plan. None of the recurrent events was nonfatal.Major bleeding occurred in 6 (1.2%) patients of the safety population. The study could therefore be terminated early for efficacy.

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Even with Controlled LDL-Cholesterol, PCI Stent Patients Have Residual Inflammatory Risk

Posted on March 18, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Dangas

Dr. George Dangas MD PhD
Professor of Medicine, Cardiology
Mount Sinai Health System

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

Response: Widespread use of statins targeted to decrease levels of low density lipoprotein cholesterol (LDL-C) below 70mg/dL are recommended by guidelines. However, residual cholesterol risk may only be one part of the residual risk equation. Indeed, Biological inflammation has long been known as a pathophysiological mechanism of atherosclerosis and the recent CANTOS trial opened new therapeutic perspective by demonstrating that inflammation modulation via selective interleukin-1β inhibition could result in improved diagnosis in patients with coronary artery disease.

However, the prevalence and impact of a residual inflammatory biological syndrome in patients with controlled cholesterol risk is unclear. Continue reading →

Upper Arm Fractures: Comordid Conditions Linked to More Opioids and Longer Hospital Stays

Posted on March 18, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Cagle

Paul Cagle, Jr. MD
Assistant Professor of Orthopedic Surgery
Icahn School of Medicine at Mount Sinai

MedicalResearch.com: What is the background for this study? What are the main findings ie What are some of the significant comorbidities?

Response: In this study our goal was to better understand what medical issues (medical comorbidities) can cause trouble or issue for patients with a proximal humerus fracture (shoulder fracture). To tackle this issue we used a large national sample of patients and sorted our the different medical issues the patients had.

We found that patients with increased medical issues had longer hospital stays and higher use of opioid medications (pain medications).

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Do Elevated Troponins Always Indicate a Heart Attack?

Posted on March 18, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Prof. Curzen

Prof. Nick Curzen BM(Hons) PhD FRCP
Professor of Interventional Cardiology/Consultant Cardiologist
University Hospital Southampton
Southampton

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

Response: The commonest blood test now used to assess whether a patient has had a heart attack or not is called high sensitivity troponin (hs trop). The test is supplied with an Upper Limit of Normal, which is based upon results from relatively healthy people. When doctors take the hs trop, they then use this ULN to decide if the patient had has a heart attack.

This study set out to see what the hs trop level is in a large number of patients attending the hospital for any reason, either inpatient or outpatient, in most of whom there was no clinical suspicion of heart attack at all. We therefore took hs trop measurements on 20,000 consecutive patients attending our hospital and having a blood sample for any reason. Continue reading →

Knee Replacement: Benefits and Risks of Antibiotic-Loaded Bone Cement

Posted on March 18, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Chen

Darwin Chen, MD
Assistant Professor of Orthopedic Surgery
Icahn School of Medicine at Mount Sinai

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

Response: Periprosthetic joint infection unfortunately remains a leading cause of total knee arthroplasty failure. One method of mitigating the risk of PJI is to use antibiotic loaded bone cement in a prophylactic fashion.

While the use of antibiotic cement makes inherent sense, the decision is not as simple as it seems. There are potential side effects such as renal damage, antibiotic hypersensitivity, and antibiotic resistance. Antibiotics decrease the mechanical strength of cement fixation, which may impact component loosening. Additionally, antibiotic cement is significantly more expensive than standard cement, driving up cost. Currently there is no consensus on if antibiotic cement truly reduces infection risk and there are many conflicting studies.

The purpose of our study is the use a large national database to evaluate real world utilization patterns of antibiotic cement, and assess outcomes, complications, and cost associated with antibiotic cement usage. Our hypothesis was that antibiotic cement is associated with a decreased risk of infection and no increased risk of systemic complications.

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Lack of Patient Education as a Cause of Increased Postoperative Opioid Use

Posted on March 18, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Colvin

Dr. Alexis Colvin, MD
Associate Professor of Orthopedic Surgery
Icahn School of Medicine at Mount Sinai

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

Response: 40% of all opioid overdose deaths involve a prescription opioid and orthopaedic surgeons are the 3rd highest prescribers of opioids. Set guidelines for post surgery opioid prescriptions have not been established. Arthroscopic knee meniscectomy is one of the most common orthopaedic procedures. The purpose of this study was to determine how many opioids were being prescribed among a group of six sports fellowship trained orthopaedic surgeons versus how many patients were actually using.

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Formal Education Not Enough To Teach Effective Patient Handoffs Among Medical Residents

Posted on March 14, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Rattray

Nicholas A. Rattray, Ph.D.
Research Scientist/Investigator
VA HSR&D Center for Health Information and Communication
Implementation Core, Precision Monitoring to Transform Care (PRISM) QUERI
Richard L. Roudebush Veterans Affairs Medical Center
Indiana University Center for Health Services & Outcomes Research
Regenstrief Institute, Inc.
Indianapolis, Indiana

on behalf of study co-authors re:
Rattray NA, Flanagan ME, Militello LG, Barach P, Franks Z, Ebright P, Rehman SU,
Gordon HS, Frankel RM

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

Response: End-of-shift handoffs pose a substantial patient safety risk. The transition of care from one doctor to another has been associated with delays in diagnosis and treatment, duplication of tests or treatment and patient discomfort, inappropriate care, medication errors and longer hospital stays with more laboratory testing. Handoff education varies widely in medical schools and residency training programs. Although there have been efforts to improve transfers of care, they have not shown meaningful improvement.

Led for the last decade by Richard Frankel, Ph.D., a senior health scientist at Regenstrief Institute and Indiana University and professor at Indiana University School of Medicine, our team has studied how health practitioners communicate during end-of-shift handoffs. In this current study, funded by VA Health Services and Research Development, we conducted interviews with 35 internal medicine and surgery residents at three VA medical centers about a recent handoff and analyzed the responses. Our team also video-recorded and analyzed more than 150 handoffs.

Published in the Journal of General Internal Medicine, this study explains how the person receiving the handoff can affect the interaction. Medical residents said they changed their delivery based on the doctor or resident who was taking over (i.e., training level, preference for fewer details, day or night shift). We found that handoff communication involves a complex combination of socio-technical information where residents balance relational factors against content and risk. It is not a mechanistic process of merely transferring clinical data but rather is based on learned habits of communication that are context-sensitive and variable, what we refer to as “recipient design”.

In another paper led by Laura Militello, we focus on how residents cognitively prepare for handoffs. In the paper published in The Joint Commission Journal of Quality and Patient Safety®, researchers detailed the tasks involved in cognitively preparing for handoffs. A third paper, published in BMC Medical Education, reports on the limited training that physicians receive during their residency. Residents said they were only partially prepared for enacting handoffs as interns, and clinical experience and enacting handoffs actually taught them the most.

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Lung Cancer: AI Can Reduce False Positives on Low-Dose CT Screening

Posted on March 14, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Benos

Panayiotis (Takis) Benos, Ph.D.
Professor and Vice Chair for Academic Affairs
Department of Computational and Systems Biology
Associate Director, Integrative Systems Biology Program
Department of Computational and Systems Biology, SOM and
Departments of Biomedical Informatics and Computer Science
University of Pittsburgh

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

Response: Low-dose computed tomography (LDCT) scans is the main method used for early lung cancer diagnosis. Early lung cancer diagnosis significantly reduces mortality. LDCT scans identify nodules in the lungs of 24% of the people in the high-risk population, but 96% of these nodules are benign. Currently there is no accurate way to discriminate benign from malignant nodules and hence all people with identified nodules are subjected to follow up screens or biopsies. This increases healthcare costs and creates more anxiety for these individuals. By analyzing a compendium of low-dose computed tomography scan data together with demographics and other clinical variables we were able to develop a predictor that offers a promising solution to this problem.

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

Posted on March 14, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

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.
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Genetic Evidence Suggests New LDL-C Lowering Drug May Decrease Cardiovascular Events and Have Additive Effect with Statins

Posted on March 13, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Ference

Brian A Ference, MD, MPhil, MSc, FACC, FESC
Professor and Director of Research in Translational Therapeutics
Executive Director, Centre for Naturally Randomized Trials
Strangeways Research Laboratory
University of Cambridge
Cambridge, UK

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

Response: Bempedoic acid is a novel therapy currently in development that lowers LDL-C by inhibiting ATP-citrate lyase, an enzyme in the same cholesterol biosynthesis pathway as HMG-CoA reductase (the target of stains). However, whether lowering LDL-C by inhibiting ATP-citrate lyase will reduce the risk of cardiovascular events to the same extent as lowering LDL-C by inhibiting HMG-CoA reductase with a statin is unknown.

We conducted a “naturally randomized trial” using Mendelian randomization in more than 650,000 participants who experienced more than 100,000 cardiovascular events to evaluate the potential clinical benefit of lowering LDL-C by inhibiting ATP-citrate lyase as compared to lowering LDL-C by inhibiting HMG-CoA reductase.

Continue reading →

Number of Opioid Prescriptions for New Users Has Dropped More Than 50%

Posted on March 13, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Zhu

Wenjia Zhu, PhD.
Marshall J. Seidman Fellow
Department of Health Care Policy
Harvard Medical School

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

Response: The current opioid epidemic continues to cause deaths and tremendous suffering in the United States, driven in large part by overuse of prescription opioids. Of special concern are new opioid prescriptions, i.e. opioids given to patients who have not used opioids before, which research tells us are an important gateway to long-term opioid use, misuse, overdoes and death. Recently, in their efforts to curb over prescribing of opioids, the CDC issued guidelines (December 2015 in draft form; March 2016 in final version) to encourage opioid prescribers to limit the use, duration and dose of opioids, particularly opioids to first-time users. Despite these, little is known about the prescribing of opioids to first-time users on a national scale, particularly among commercially insured patients.

In this study, we examined national monthly trends in the rate at which opioid therapy was started among commercially insured patients. Using administrative claims from Blue Cross Blue Shield Association commercial insurers from 2012 to 2017, we analyzed more than 86 million commercially insured patients across the United States.

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Ultrashort TB Therapy Found Just As Effective as 6 Month Course

Posted on March 13, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Swindells

Susan Swindells MBBS
Professor and Medical Director, HIV Clinic
Department of Internal Medicine
University of Nebraska Medical Center
Omaha, NE

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

Response: More than one quarter of the world’s population is infected with tuberculosis (TB), and there is effective treatment for this but only a small fraction of those eligible actually receive it. TB is the leading cause of death for people with HIV infection, globally. One of the major problems with currently available treatments for TB infection is that they take too long, and people just stop taking them after a while. We identified an ultra-short course of treatment (only one month) and tested it against the conventional 6-month course of treatment.

Our main findings were that the new short course was just as effective as the standard 6 month course, more patients taking the short course completed their treatment, and had less adverse effects. Continue reading →

Bempedoic Acid Lowers LDL When Statins Alone Aren’t Enough

Posted on March 13, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Ray

Prof. Kosh Ray, MB ChB, MD, MPhil
Faculty of Medicine, School of Public Health
Chair in Public Health (Clinical)
Imperial College London

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

Response: Bempedoic acid is the first in class of a new therapy for lowering LDL cholesterol. This is the largest and longest study to date with this therapy and involved about 2200 pts with patients with either established cardiovascular disease or familial hypercholestrolaemia and in whom LDL was > 70mg/dl or 1.8 mmol/L despite maximally tolerated statins. %0% were on high intensity statins and the majority of the rest on moderate intensity.

The aim was to show long term safety 1 year and efficacy at 24 weeks and at 1 year. Continue reading →

Actinic Keratosis: What is the Best Treatment for Pre-Skin Cancers?

Posted on March 13, 2019 by Marie Benz MD FAAD

One example of actinic keratoses on hands DermNZ

MedicalResearch.com Interview with:
Maud Jansen, MD | Resident Dermatology | PhD candidate
Dermatologie, Maastricht

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

Response: Actinic keratosis is the most frequent premalignant skin disease in the white population and is caused by exposure to ultraviolet radiation. With a prevalence of 37.5% among whites 50 years of age or older, actinic keratosis is one of the most frequent reasons for patients to visit a dermatologist. If left untreated, actinic keratosis may develop into squamous cell carcinoma.

Current guidelines provide no clear recommendations about which treatment approach is preferred. Currently, the choice of treatment often depends on the preferences of patients and their treating physicians. Evidence from randomized trials with direct comparison between treatments and with long-term follow-up is scarce.

Frequently prescribed and studied field-directed treatment approaches are 5-fluorouracil cream, imiquimod cream, photodynamic therapy (PDT), and ingenol mebutate gel.

We investigated the effectiveness of these four frequently used field-directed treatments (for multiple lesions in a continuous area). Over 600 patients in four different hospitals (Maastricht UMC+, Zuyderland (Heerlen), VieCuri (Venlo and Venray) en Catharina (Eindhoven)participated in the study. Patients were randomly assigned to one of the four treatments.

The main result of our study was that we found that after 12 months of follow-up, 5% fluorouracil cream was the most effective treatment in the treatment of patients with multiple actinic keratosis lesions. Moreover, patient satisfaction and increase in health-related quality of life were highest in the 5-fluorouracil group. Continue reading →

Lowering Blood Pressure Target Would Greatly Increase Number of People Diagnosed with Hypertension

Posted on March 12, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Leung

Alexander A. Leung, MD, MPH
Department of Community Health Sciences
Department of Medicine
University of Calgary
Calgary, Alberta, Canada

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

Response: The 2017 American College of Cardiology and American Heart Association (ACC/AHA) blood pressure guidelines redefined hypertension according to a blood pressure cutoff of ≥130/80 mm Hg, compared to the traditional cutoff of ≥140/90 mm Hg.

Continue reading →

Smartphone App Will Be Able to Predict Diabetes

Posted on March 12, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Robert Avram

Robert Avram MD MSc
Division of Cardiology
University of California, San Francisco

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

While analyzing the heart rate data as collected using smartphones apps in the Health-eHeart study, we noticed that diabetic patients had, on average, a higher ‘free-living’ heart rate than non-diabetic patients when adjusted from multiple factors. This pushed us to analyze the signal to see if there were other features that would help differentiate diabetes patients from non-diabetes patients. By identifying these features, we saw a huge opportunity to develop a screening tool for diabetes using deep learning and a smartphone camera and flash, in order to classify patients as having prevalent diabetes/no-diabetes.

Photoplethysmography is the technique of measuring the difference in light absorption by the skin in order to detect blood volume changes in the microvasculature. Most modern mobile devices, including smartphones and many fitness trackers (Apple Wathc, FitBit), have the ability to acquire PPG waveforms, providing a unique opportunity to detect diabetes-related vascular changes at population-scale. Continue reading →

High-Dose Vitamin D During Pregnancy Did Not Reduce Risk of Childhood Asthma

Posted on March 12, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Chawes

Bo Chawes, MD, PhD, DMSc
Associate Professor
C‌openhagen Prospective Studies on Asthma in Childhood
H‌erlev and G‌entofte H‌ospital
U‌niversity of C‌openhagen

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

Response: There has been a global surge in vitamin D deficiency happening in parallel with an increase in prevalence of childhood asthma, which suggests that low maternal vitamin D levels during pregnancy may increase asthma risk in the child.

Due to that we conducted a randomized double-blinded controlled trial within the Danish COPSAC2010 cohort (www.copsac.com) of 7-fold (2,800 IU/d) vs. standard dose (400 IU/d) of vitamin D supplementation from pregnancy week 24 aiming to reduce offspring asthma risk. At age 3, we observed a non-significant 24% reduced risk of recurrent asthma-like symptoms, ie. recurrent wheeze, in the high-dose vitamin D group. In the current study, we followed 545 of the 581 children in the study till age 6, where an asthma diagnosis can be established and observed no effect of the high-dose vitamin D supplement on the child’s risk of asthma.

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Opioid-Induced Constipation: Can Your Hospital Afford the Financial Burden?

Posted on March 12, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Franklin

Howard Franklin, MD, MBA
Vice President of Medical Affairs and Strategy
Salix Pharmaceuticals

MedicalResearch.com: What is opioid-induced constipation?

Response: Opioid-induced constipation (OIC) is a side effect in as many as 80 percent of chronic pain patients on opioids. OIC is unlikely to improve over time without treatment and can lead to suffering and discomfort. More importantly, the insufficient treatment of OIC can have negative implications for patients, both those on opioid therapy for chronic non-cancer pain as well as advanced illness, and for hospitals.

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Combination of Alcohol and High BMI Linked to Liver Injury Biomarkers

Posted on March 12, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:
Alice R Carter MSc
Doctor of Philosophy Student
MRC Integrative Epidemiology Unit
Population Health Science, Bristol Medical School
University of Bristol

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

Response: Higher body mass index and alcohol intake have been shown to increase the risk of liver disease. Some studies have looked at their combined effect by comparing the risk of liver disease between individuals with both high BMI and high alcohol intake and individuals with low BMI and low alcohol intake. However, these studies have produced mixed results. Some possible reasons for that are errors in self-reported BMI and alcohol intake, other factors confounding the association of BMI & alcohol intake with liver disease risk and changes in lifestyle that individuals with ill health may have been advised to adopt.

One way to overcome these limitations is to use a technique called Mendelian randomisation. This method uses genetic differences between individuals that influence their characteristics (e.g. their body mass and how much alcohol they drink) to help understand whether these characteristics are causally related to diseases.

Our study used this method to explore the joint effects of BMI and alcohol consumption on liver disease and biomarkers of liver injury. Continue reading →

Steroids for Risk of Late Preterm Delivery Help Babies and Reduce Costs

Posted on March 12, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Gyamfi-Bannerman

Cynthia Gyamfi-Bannerman, MD, MSc
Ellen Jacobson Levine and Eugene Jacobson
Professor of Women’s Health in Obstetrics and Gynecology
Director, Maternal-Fetal Medicine Fellowship Program
Co-Director, CUMC Preterm Birth Prevention Center
Columbia University

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

Response: In 2016 our group published the findings of the Antenatal Late Preterm Steroids (ALPS) trial in the NEJM. We found that administration of antenatal corticosteroids to women at high risk for delivery from 34-36 weeks decreased breathing problems in their neonates. This treatment had been traditionally only given at less than 34 weeks.

The current paper is a cost analysis of that trial. We found that the treatment was also cost effective. From a cost perspective treatment was both low cost and highly effective (the options are low cost, low effect/low cost/high effect, high cost/low effect, high cost/high effect). Continue reading →

BELVIQ®: FDA accepts sNDA To Include Long Term Safety/Efficacy Data

Posted on March 12, 2019 by Marie Benz MD FAAD

WeightControl.com Interview with:

Dr. Kramer

Dr. Lynn Kramer, MD FAAN
VP and Chief Clinical Officer & Chief Medical Office
Eisai Co., Ltd

WeightControl.com: What is the background for this announcement?

Response: On February 25^th, Eisai announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application to potentially update the label for BELVIQ® (lorcaserin HCI) CIV 10 mg twice-daily/BELVIQ XR (lorcaserin HCI) CIV once daily to include long-term efficacy and safety data from CAMELLIA-TIMI 61, a clinical trial of BELVIQ in 12,000 overweight and obese patients with cardiovascular (CV) disease and/or multiple CV risk factors such as type 2 diabetes mellitus (T2DM).

Continue reading →

Most Deaths From Sepsis Occur in Frail Older Adults and Are Not Preventable

Posted on March 12, 2019 by Marie Benz MD FAAD

MedicalResearch.com Interview with:

Dr. Rhee

Chanu Rhee, MD,MPH
Assistant Professor of Population Medicine
Harvard Medical School / Harvard Pilgrim Health Care Institute
Assistant Hospital Epidemiologist
Brigham and Women’s Hospital

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

Response: Sepsis is the body’s reaction to a serious infection that results a cascade of inflammation in the body and organ dysfunction, such as low blood pressure, confusion, or failure of the lungs, kidneys, or liver. Sepsis is a major cause of death, disability, and cost in the U.S. and around the world. Growing recognition of this problem has led to numerous sepsis performance improvement initiatives in hospitals around the country. Some of these efforts have also been catalyzed by high-profile tragic cases of missed sepsis leading to death, which may have contributed to a perception that most sepsis deaths are preventable if doctors and hospitals were only better at recognizing it.

However, the extent to which sepsis-related deaths might be preventable with better hospital-based care is unknown. In my own experience as a critical care physician, a lot of sepsis patients we treat are extremely sick and even when they receive timely and optimal medical care, many do not survive. This led myself and my colleagues to conduct this study to better understand what types of patients are dying from sepsis and how preventable these deaths might be. Continue reading →