Addiction, Author Interviews, JAMA, Opiods / 06.04.2016

MedicalResearch.com Interview with: Dr. Eugenia Oviedo-Joekes PhD Assistant Professor, School of Population and Public Health University British Columbia Centre for Health Evaluation and Outcome Sciences Providence Health Care, St Paul’s Hospital, Vancouver British Columbia, Canada  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Oviedo-Joekes: Diacetylmorphine is the active ingredient in heroin. Medically prescribed diacetylmorphine has shown greater effectiveness than methadone alone for the treatment of patients with long term opioid dependence who are not benefitting from available treatments (i.e., they continue injecting in the street daily for many years).  Medically prescribed diacetylmorphine is being used in a small number of countries in Europe but is unlikely to be accepted in many countries around the world, including Canada and the US.  SALOME is the world’s first study to examine the effectiveness of hydromorphone, a licensed, legal pain medication, as an alternative treatment to diacetylmorphine for chronic heroin addiction. Participants were randomly assigned to receive injectable diacetylmorphine or hydromorphone, double-blinded (up to three times daily) for six months under supervision. Injectable hydromorphone was as effective as injectable diacetylmorphine for long-term street opioid users not currently benefitting from available treatments (about 10 per cent of the heroin-dependent population).Study participants on both medications reported far fewer days of street-heroin and other opioid use at six months compared to almost daily illicit opioid use before taking part in the study. They also reported a reduction in days of illegal activities, from an average of 14.1 days per month to fewer than four. (more…)
Author Interviews, Cost of Health Care, Heart Disease, NYU / 06.04.2016

MedicalResearch.com Interview with: Joseph A. Ladapo, MD, PhD Assistant Professor of Medicine and Population Health Section on Value and Effectiveness Department of Population Health NYU Langone School of Medicine New York NY 10016 MedicalResearch.com: What are the main findings? Dr. Ladapo: While cardiac implantable electronic devices (CIEDs) are increasingly used to treat patients with arrhythmias, heart failure, and other risk factors for sudden cardiac death, these implantable devices require life-long follow-up to assess their performance and functionality. This need for continuous monitoring has galvanized the development of remote monitoring technologies for patients with CIEDs. Although randomized studies have shown that remote monitoring may reduce healthcare utilization and expenditures when compared to in-office monitoring, little is known about whether these findings generalize to day-to-day clinical practice. We aimed to address this uncertainty by evaluating healthcare utilization and expenditures in a cohort of patients with newly-implanted CIEDs who were followed remotely or with in-office monitoring. MedicalResearch.com: What is the background for this study? Dr. Ladapo: Remote monitoring is associated with a reduction in patients’ utilization of ambulatory and acute care and a reduction in expenditures associated with this utilization—at least over 24 months. This reduction was most pronounced among remotely monitored patients with implantable cardioverter defibrillators (ICDs).  Although many of our comparisons between remote and office monitoring were not statistically significant, they trended toward favoring remote monitoring. (more…)
Author Interviews, BMJ, Cannabis, OBGYNE, Pediatrics / 06.04.2016

MedicalResearch.com Interview with: Cara Christ, M.D., M.S. Director of the Arizona Department of Health Services MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Christ: This study was a systematic review. The purpose of a systematic review is to critically assess and summarize the best available research evidence on a specific issue. This usually involves a critical synthesis of the results of several high quality studies on the issue under review. Overall, this review found that infants exposed to cannabis during pregnancy had a 77% higher likelihood of being underweight (<2500grams) at birth, compared to infants whose mothers did not use cannabis. Also, if the mother used cannabis during pregnancy, the likelihood of her infant needing to be placed in a neonatal intensive care unit was two times higher compared to those infants whose mothers did not use cannabis during pregnancy. (more…)
Author Interviews, Diabetes, Diabetologia / 06.04.2016

MedicalResearch.com Interview with: Dr. Dennis James Petrie Melbourne School of Population and Global Health MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Petrie: Life expectancy estimates for those with type 1 diabetes allow gaps with the general population to be identified and improvements to be quantified. This research examined mortality for those with type 1 diabetes in Sweden from 2002 till 2011. The aim was to explore whether life expectancy of those with type 1 diabetes has improved in Sweden over the last decade and how any improvement compared with improvements seen in the general population. It found that for men with type 1 diabetes, the remaining life expectancy at age 20 increased significantly by about 2 years (from 47.7 in 2002–06 to 49.7 years in 2007–11) but for women with type 1 diabetes there was no significant change, with a life expectancy at age 20 of 51.7 years in 2002–06 and 51.9 years in 2007–11. There have been recent gains for both men and women from reductions in cardiovascular mortality however these gains were also seen in the general population which meant that the life expectancy gaps have stayed at about 11 years for men and 12 years for women over the last decade in Sweden. (more…)
Author Interviews, Mental Health Research, NYU, PLoS, PTSD / 06.04.2016

MedicalResearch.com Interview with: Glenn Saxe, MD Arnold Simon Professor of Child and Adolescent Psychiatry and Chair, Department of Child and Adolescent Psychiatry NYU Langone’s Child Study Center Dr. Saxe’s bio page   MedicalResearch.com: What is the background for this approach? What are the main advantages and drawbacks to the CS-CN method in psychiatry research? Dr. Saxe: Psychiatric disorders are complex and, in all likelihood, emerge and are sustained over time because they form what is called a complex system, involving the interaction between a great many variables of different types (e.g. molecules, neurons, brain circuits, developmental, social variables). There is a strong literature on complex systems in other fields that show remarkably similar properties between vastly different types of systems. Unfortunately, data methods used in research in psychiatry are not designed to ‘see’ the possible complex systems nature of a psychiatric disorder. Our method is designed to identify networks of variables related to psychiatric disorders that, together, have properties of complex systems. If such a system is identified, it may reveal new ways to treat these disorders. (more…)
Author Interviews, Brain Cancer - Brain Tumors, Brigham & Women's - Harvard, PNAS / 06.04.2016

MedicalResearch.com Interview with: Rakesh K. Jain, Ph.D. A.W.Cook Professor of Radiation Oncology (Tumor Biology) Director, E.L. Steele Laboratory Department of Radiation Oncology Harvard Medical School and Massachusetts General Hospital Boston, MA    02114

MedicalResearch.com: What is glioblastoma and why is it difficult to treat?

Dr. Jain: Glioblastoma (GBM) is the most common malignant tumor of the brain, and remains highly lethal. The standard treatment consists of surgical removal followed by chemo-radiation and anti-angiogenic therapy with anti-vascular endothelial growth factor (VEGF) antibody. Unfortunately, glioblastoma cells invade the brain far from the original tumor mass. Hence, even with the best surgical techniques it is not possible to remove all tumor cells, as they are embedded in vital parts of the brain at the time of the surgery. As a result, even after multimodal therapies, most  glioblastoma patients succumb to their disease within 2 years. New approaches are desperately needed.

MedicalResearch.com: What is anti-angiogenic therapy and why is it used for glioblastoma?

Dr. Jain: One key feature ofglioblastomas is their highly abnormal, leaky and ineffective vasculature. This leads to brain swelling around the tumor and poor tumor blood perfusion, which in turn can render the tumors more aggressive. These vascular abnormalities are due to the uncontrolled overproduction in GBMs of angiogenic factors such as VEGF. Anti-angiogenic therapies using anti-VEGF agents can transiently “normalize” the GBM vasculature structure and function and reduce brain swelling, increase blood perfusion, and impact morbidity and survival. Unfortunately, even when this therapy is added to the standard therapy with surgery and chemo-radiation, GBM patients typically do not survive on average more than 1.5 years. (more…)
Author Interviews, Blood Pressure - Hypertension, Heart Disease, JACC, Stroke / 06.04.2016

MedicalResearch.com Interview with: Kazuomi Kario, MD, PhD, FACP, FACC, FAHA, FESC Professor, Chairman Division of Cardiovascular Medicine, Department of Medicine Jichi Medical University School of Medicine (JMU) JMU Center of Excellence, Cardiovascular Research and Development (JCARD) Hypertension Cardiovascular Outcome Prevention and Evidence in Asia (HOPE Asia) Network Staff Visiting Professor of Medicine, UCL Institute of Cardiovascular Science University College London, London UK MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Kario: The relationship between out-of-office blood pressure (BP), such as ambulatory BP and home BP, and cardiovascular events has been investigated in several studies. However, there is insufficient evidence as yet regarding which BP measurement predicts coronary artery disease (CAD) events most strongly. The HONEST Study is the largest prospective observational study in the world, which enrolled >20,000 hypertensive patients. The study observed cardiovascular events, monitoring both clinic BP and home BP on treatment of antihypertensive agent. The present analysis shows that home BP measured in morning (morning home BP) is a strong predictor of both CAD and stroke events in future, and may be superior to clinic BP in this regard. Furthermore, there does not appear to be a J-curve in the relationship between morning home BP and CAD or stroke events. (more…)
Author Interviews, JAMA, Pain Research, Surgical Research, University of Pittsburgh, Weight Research / 06.04.2016

MedicalResearch.com Interview with: Wendy King, PhD Associate Professor of Epidemiology Epidemiology Data Center, Room 105 University of Pittsburgh Pittsburgh, PA 15213 MedicalResearch.com: What is the background for this study? What are the main findings? Dr. King: Severe obesity is associated with significant joint pain and impaired physical function, such as difficulty bending, lifting carrying and walking. Excess weight can lead to joint damage and accompanying pain, resulting in activity restriction and walking limitations. Obesity can also contribute to pain and physical limitations through factors such as impaired cardiorespiratory function, systematic inflammation, reduced flexibility, low strength per body mass, and depression.  Previous studies have reported significant improvements in mean values of bodily and joint specific pain, physical function, and walking capacity in the first 3-12 months following RYGB or LAGB. However, very few studies have examined the variability in response to surgery or reported on longer-term follow-up of these procedures. My colleagues and I followed 2,221 patients participating in the Longitudinal Assessment of Bariatric Surgery-2, a large NIH-funded prospective study of adults with severe obesity undergoing weight-loss surgery at one of 10 hospitals across the U.S. Through three years of follow-up, approximately 50 to 70 % of patients who underwent bariatric surgery reported clinically important improvements in bodily pain, physical function and usual walking speed. About three-quarters of the participants with symptoms indicative of osteoarthritis before surgery experienced improvements in knee and hip pain and function. In addition, over half of participants who had a mobility deficit prior to surgery did not post-surgery. Several baseline characteristics such as younger age, male sex, higher household income, lower body mass index, fewer depressive symptoms and no history of diabetes or venous edema with ulcerations, were associated with a higher chance of improvement in pain and physical function following surgery. In addition, pre- to post-surgery reductions in weight and depressive symptoms, and remission of diabetes and venous edema with ulcerations were associated with pre- to post-surgery improvements. Thus, our findings reinforce results from shorter-term studies by addressing the durability or response and expand our understanding of the variability in response, and what factors are related to chance of improvement. (more…)
Author Interviews, Dermatology, PLoS, Stem Cells / 06.04.2016

MedicalResearch.com Interview with: Takashi Tsuji, PhD Team Leader of  Laboratory for Organ Regeneration RIKEN Center fo r Developmental Biology Chuo-ku, Kobe, Hyogo Japan MedicalResearch.com: What was the impetus for this research? What made you think about creating a skin model? Answer. Previously, we successfully demonstrated the functional organ regeneration including tooth (PNAS 2009), hair follicles (Nature Communications 2012), salivary gland (Nature Communications 2013a) and lachrymal gland (Nature Communications 2013b). We focused onto a complex organogenesis through the epithelial and mesenchymal cell interaction. In the current study as a continuous work, we would like to regenerate organ system by using multipotent stem cells such as ES and iPS cells. In this study, we first demonstrated the generation of a functional bioengineered 3D integumentary organ system from murine iPS cells. MedicalResearch.com: Can you describe what you created in layperson terms? How big is it, what does it look like and what is it capable of doing? Answer. We succeeded to demonstrate the proof-of-concept to generate 3D integumentary organ system, complete skin, which has skin appendages such as hair follicle and sebaceous gland, by mimicking the organogenesis during embryogenesis. In this work, we performed in murine system, so, the transplantable skin size is small as 1 mm2 /1 site. We think that further studies for humanization and the development of in vitro culture system would lead to realize of clinical applications for severe burned patients and severe hair loss. Furthermore, this method will contribute to understand the onset of dermoid tumor, which has ectodermal organs such as tooth and hair follicle, in human. (more…)
Author Interviews, Heart Disease, Nutrition / 06.04.2016

MedicalResearch.com Interview with: Man-tian Mi Research Center for Nutrition and Food Safety, Chongqing Key Laboratory of Nutrition and Food Safety, Institute of Military Preventive Medicine, Third Military Medical University Chongqing  China  MedicalResearch.com: What is the background for this study? What are the main findings? Reply: Cardiovascular diseases remain the leading cause of death in industrialized societies including the United States, and the incidence is growing in developing countries (1). In recent years, researchers have learned that the gut microbiome plays a role in the build up of plaque inside arteries, otherwise known as atherosclerosis (2, 3). Resveratrol, a polyphenol found in red wine, is thought to have antioxidant properties that protect against conditions such as heart disease (4). Just how resveratrol, a plant compound, does this, however, is unclear. Therefore, we sought to determine whether the anti-atherosclerosis effects of resveratrol were related to changes in the gut microbiota. We found that resveratrol attenuated trimethylamine-N-oxide (TMAO)-induced  atherosclerosis by decreasing TMAO levels and increasing hepatic bile acid (BA) neosynthesis via gut microbiota remodeling, and the BA neosynthesis was partially mediated through the enterohepatic farnesoid X receptor-fibroblast growth factor 15 axis. These results offer new insights into the mechanisms responsible for resveratrol’s anti-atherosclerosis effects and indicate that gut microbiota may become an interesting target for pharmacological or dietary interventions to decrease the risk of developing cardiovascular diseases. (more…)
Author Interviews, CDC, Fertility, OBGYNE, Pediatrics / 06.04.2016

MedicalResearch.com Interview with: Sheree L. Boulet, DrPH, MPH Division of Reproductive Health Centers for Disease Control and Prevention Atlanta, Georgia MedicalResearch.com: What is the background for this study? Dr. Boulet: Findings from some studies have suggested that children conceived with assisted reproductive technology (ART) have increased risks of birth defects compared with spontaneously conceived children. Many of these studies were limited by a small sample size and were unable to assess risks associated with specific ART procedures. MedicalResearch.com: What are the main findings? Dr. Boulet: We found that singleton infants conceived using assisted reproductive technology were 1.4 times more likely to have a non-chromosomal birth defect compared with other infants, and the risks were highest for gastrointestinal and musculoskeletal defects. However, when our study was restricted to only ART-conceived infants, no single procedure substantially increased the risk for birth defects. This suggests that the higher risk of birth defects may be due to underlying issues related to infertility, rather than to ART itself. (more…)
Author Interviews, Gender Differences, Heart Disease, NYU, Women's Heart Health / 06.04.2016

MedicalResearch.com Interview with: Nathaniel Smilowitz, MD Fellow, Cardiovascular Disease NYU Langone Medical Center MeicalResearch: What is the background for this study? What are the main findings? Dr. Smilowitz: Myocardial infarction (MI), commonly known as a heart attack, is a leading cause of death worldwide.  In the majority of patients with MI, examination of the coronary blood vessels by angiography reveals an obstruction that limits blood flow to the heart muscle.  However, some patients develop MI with non-obstructive coronary arteries (MINOCA) at angiography.  This condition is identified more commonly in younger patients and women, and in prior studies, in-hospital death after MINOCA was lower than for MI with obstructive coronary artery disease (MI-CAD).  Despite favorable outcomes associated with MINOCA, young women paradoxically have overall higher in-hospital death after MI in comparison to younger men.  Although sex differences in post-MI mortality are known to vary with age, the interaction between age, sex, and the presence of obstructive coronary artery disease at angiography on death post-MI had not been previously established. In this study, we confirmed that in-hospital mortality is lower after MINOCA than MI-CAD and that women are more likely to have MINOCA than men.  No sex difference in mortality was observed among patients with MINOCA, but women of all ages had significantly higher mortality after MI-CAD than men.  With advancing age, mortality increased to a greater degree in patients with MI-CAD than MINOCA and in men vs. women. (more…)
Author Interviews, Cognitive Issues, Dental Research / 06.04.2016

MedicalResearch.com Interview with: Elham Emami, DDS, MSc, PhD Director , Oral Health and Rehabilitation Research Unit & Associate Professor Faculty of Dental Medicine & School of Public Health Université de Montréal Adjunct Professor McGill University MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Emami: Over the past 20 years, scientific evidence has shown that oral and general health are closely linked. Recently, studies have shown that there is also a link between the number of teeth an older person has and his/her cognitive status. We carried out a meta-analysis using the data from these latter studies. Our results indicate that, taking into account socioeconomic differences and other potential confounding variables, a person with less than 20 teeth has a 20% greater risk of having cognitive decline (HR= 1.26, 95% CI = 1.14 to 1.40) and dementia (HR = 1.22, 95% CI = 1.04 to 1.43) than someone who has 20 or more teeth. (more…)
Author Interviews, Heart Disease, JACC, Vitamin D / 05.04.2016

MedicalResearch.com Interview with: Dr Klaus Witte MD, FRCP, FESC, FACC Associate Professor and Consultant Cardiologist Lead Clinician for Cardiology University of Leeds and Leeds Teaching Hospitals NHS Trust  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Witte: Chronic heart failure (CHF) is a condition of heart muscle weakness that despite optimal treatment often leaves patients with ongoing symptoms of breathlessness and fatigue. Vitamin D has a large number of effects in the body beyond its known effects on the skeleton. Patients with  Chronic heart failure are frequently deficient in vitamin D, but until now there were no data demonstrating a benefit from supplements. We conducted a randomised, placebo-controlled study of a non-calcium-based vitamin D supplement providing 4000IU or 100mcg per day of vitamin D3 (VINDICATE). Endpoints included 6-minute walk distance and cardiac function. We saw no improvement in 6 minute walk distance but a large and significant improvement in heart function (left ventricular ejection fraction) and heart size (left ventricular dimensions and volumes) after on year. We saw no significant adverse effects and the tablets were well tolerated. (more…)
Author Interviews, Cost of Health Care, Heart Disease, JACC / 05.04.2016

MedicalResearch.com Interview with: Dr. Jordan B. King Post Doctoral Fellow Pharmacotherapy Outcome Resctr, University of Utah MedicalResearch.com: What is the background for this study? What are the main findings? Response: The cornerstone of treatment in heart failure with reduced ejection fraction (HFrEF) revolves around low-cost generic medications such as angiotensin converting enzyme inhibitors (ACEIs) and beta-blockers (BBs). However, recently the dual-acting angiotensin receptor neprilysin inhibitor (ARNI) sacubitril-valsartan, demonstrated improved survival and reduction in heart failure hospitalizations relative to enalapril, an ACEI, and optimal background therapy. This creates a situation in which we have a new medication which improves outcomes, but carries a high price tag ($4,560 per year) compared with ACEIs, the standard of care over the last 20 years, and are available as generic medications for <$50 per year. We set out to determine the incremental cost-effectiveness ratio (ICER) per quality adjusted life year gained (QALY) from the perspective of a health care payer in the U.S. The ICER is a measure of how much we have to pay for sacubitril-valsartan to gain 1 unit of health relative to enalapril. In this case the unit of health is a year of life adjusted for quality. We used a Markov model to estimate the costs and effectiveness of the two treatment options over a lifetime. In the base case, the ICER for sacubitril-valsartan was $50,959 per QALY gained. Health care interventions which cost <$50,000 per QALY are generally considered cost-effective, but some argue that <$100,000 per QALY is a more appropriate threshold in the U.S. In a probabilistic sensitivity analysis, 57% and 80% of all simulations fell below the $50,000 and $100,000 per QALY thresholds, respectively. Sacubitril-valsartan was the less costly treatment arm in 5% of simulations, and enalapril dominated (less costly and more effective) in 17% of simulations. (more…)
Allergies, Asthma, Author Interviews, OBGYNE, Pulmonary Disease / 05.04.2016

MedicalResearch.com Interview with: Anick Bérard PhD FISPE Research chair FRQ-S on Medications and Pregnancy and Director Réseau Québécois de recherche sur le médicament (RQRM) and Professor, Research Chair on Medications, Pregnancy and Lactation Faculty of Pharmacy,University of Montreal and Director, Research Unit on Medications and Pregnancy Research Center CHU Ste-Justine MedicalResearch.com: What is the background for this study? What are the main findings? Response: Intranasal corticosteroid (Nasacort) use during pregnancy for the treatment of seasonal allergies has increased over the past decade. Nasacort is now available over the counter since October 2013 in the US and January 2015 in Canada. Given that seasonal allergies are prevalent during pregnancy and that a medication available over-the-counter is likely to be used frequently, we aimed to study the risk of using Nasacort during gestation. Furthermore, given the potential public health impact, the objectives of our study were to assess the safety of intranasal triamcinolone exposure during pregnancy on the occurrence of major congenital malformations, small-for-gestational-age (SGA) newborn, and spontaneous abortions. Use of intranasal triamcinolone during the first trimester of pregnancy was not significantly associated with the risk of overall congenital malformations (OR 0.88, 95%CI 0.60-1.28; 31 exposed cases) compared to non-exposure; it was however associated with the risk of respiratory defects (OR 2.71, 95%CI 1.11-6.64; 5 exposed cases). This is important given that a medication given for the treatment of respiratory diseases is associated with respiratory defects in newborns. Pregnancy exposure to intranasal triamcinolone was not significantly associated with the risk of spontaneous abortions (OR 1.04, 95%CI 0.76-1.43; 50 exposed cases). No association was found between 2nd or 3rd trimester exposure to intranasal triamcinolone and the risk of SGA (OR 1.06, 95%CI 0.79-1.43; 50 exposed cases). (more…)
Author Interviews, Cancer Research / 05.04.2016

MedicalResearch.com Interview with: Katriina Heikkila, PhD Lecturer, London School of Hygiene and Tropical Medicine Honorary Researcher, the Finnish Institute of Occupational Health MedicalResearch.com: What is the background for this study? Dr. Heikkila:  Governments across the world have set regulations on working time, many recommending a maximum of 48- or 55-hour working week but many men and women today regularly work longer than recommended maximum hours. Working exceedingly hours is associated with many adverse health outcomes, such as an increased risk of cardiovascular disease, but the relationship of excess working hours with incident cancer has so far been unclear. To address this gap in the knowledge, we investigated the association between weekly working hours and incident cancer using individual-level data from over 116 000 initially cancer-free men and women from 12 research studies from Finland, Denmark, Sweden, Germany, the Netherlands and the UK. (more…)
Author Interviews, Breast Cancer, JAMA, Nutrition, UCSD / 05.04.2016

MedicalResearch.com Interview with: Ruth E. Patterson, PhD Professor, Department of Family Medicine and Public Health Associate Director, Population Sciences Program Leader, Cancer Prevention Moores Cancer Center UC San Diego La Jolla, CA MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Patterson: Our research team was intrigued with studies in mice showing that even when eating a high-fat diet, mice who were subjected to a 16-hour fasting regimen during the sleep phase were protected against abnormal glucose metabolism, inflammation and weight gain; all of which are associated with poor cancer outcomes. We had access to a study conducted in breast cancer survivors called the Women’s Healthy Eating and Living Study (WHEL).  Participants in this study completed food records, which give the time of eating meals and snacks.  We used the food records to estimate the average nightly fasting interval in 2413 breast cancer survivors.  Overall, we found that women who had a nightly fasting interval of less than 13 hours had a 36% increased risk of breast cancer recurrence and a nonsignificant increase in mortality.  We also found that women with a short nightly fast had poorer glucoregulation and worse sleep, both of which might explain the link to breast cancer. (more…)
Author Interviews, Heart Disease, JACC / 05.04.2016

MedicalResearch.com Interview with: Ross T. Tsuyuki, BSc(Pharm), PharmD, MSc, FCSHP, FACC Professor of Medicine (Cardiology) and Director, EPICORE Centre Faculty of Medicine and Dentistry University of Alberta EPICORE CENTRE Research Transition Facility University of Alberta Edmonton, AB MedicalResearch.com: What is the background for this study? What are the main findings? Response: As you know, most cardiovascular disease is caused by modifiable risk factors. However, the identification and control of these risk factors continues to elude us. Pharmacists in the community are the most accessible primary healthcare providers. That is being increasingly recognized and the scope of practice for pharmacists has been changing to meet these needs. In Alberta, Canada, pharmacists have one of the broadest scopes of practice - many can independently prescribe and order laboratory tests. We sought to test the effect of a pharmacist-based prescribing and care program in patients at high risk for cardiovascular events. We enrolled 723 patients at high risk for cardiovascular events (defined as those with diabetes, vascular disease (coronary, cerebrovascular, or peripheral arterial disease), chronic kidney disease, or high Framingham risk (>20%) primary prevention. All patients were recruited by their pharmacist and had to have at least one modifiable risk factor not well controlled. Patients were randomized to receive pharmacist intervention or usual care. Intervention patients received a Medication Therapy Management review, consisting of assessment of cardiovascular risk, patient education, and management of the patients' risk factors, according to the latest Canadian guidelines. Pharmacists conducted follow-up visits monthly. Usual care patients were the control (comparison) group and received usual pharmacist and physician care. Both groups were followed for 3 months. The primary outcome measure was the difference in estimated cardiovascular risk at 3 months, as calculated using validated risk engines such as Framingham, the International Risk Score, and the UKPDS risk. We found a 21% reduction in the risk for cardiovascular events in the pharmacist care group compared to control. There was also significant reductions in blood pressure, LDL cholesterol, glycated hemoglobin in those with diabetes, and 21% fewer smokers in the pharmacist care group compared to control. (more…)
Author Interviews, Global Health, Infections / 05.04.2016

MedicalResearch.com Interview with: Prof. Ciccozzi Massimo Clinical Pathology and Microbiology Laboratory University Hospital Campus Bio-Medico of Rome, Italy; Department of Infectious, Parasitic, and Immune-Mediated Diseases, Epidemiology Unit, Reference Centre on Phylogeny, Molecular Epidemiology, and Microbial Evolution (FEMEM), National Institute of Health, Rome, Italy. Prof. Ciccozzi Massimo Clinical Pathology and Microbiology Laboratory University Hospital Campus Bio-Medico of Rome, Italy; Department of Infectious, Parasitic, and Immune-Mediated Diseases, Epidemiology Unit, Reference Centre on Phylogeny, Molecular Epidemiology, and Microbial Evolution (FEMEM), National Institute of Health, Rome, Italy.   MedicalResearch.com: What is the background for this study? What are the main findings?  Prof. Massimo: In the spring 2011 civil war becoming in Syria providing condition for diseases outbreaks In the Syrian Arab Republic before the crisis, the access to health services increased since the 1980s, with better equity between the rural populations and the middle class. the capacity of the health system, so as the quality of care, were not sufficient to improve the decrease the inequity. As normally happens the onset of civil war can led to the complete deterioration of the health infrastructure through the destruction of facilities. We describe a group of 48 Syrian migrants arrived in the second week of October 2015 in the asylum seekers centre (ASC) in Rome (Italy) where they receive social, legal and health assistance. An internal healthcare facility (IHF) is operative where specialized personnel (e.g. infectivologist, nurses and psychologist) was prompt to receive the Syrian people making them all the tests for microbial agents presence (bacterial and virus agents). This group is of importance not only because refugee from the tremendous civil war but also because stopped in this Centre for only twenty days. Our aim was the knowledge of their health status, this is important for people that have to travel in north Europe facing many kilometers again. Rectal, nasal and pharyngeal swabs were collected from all refugees, whereas serum samples were available from 30/48 subjects. Eighteen refugees refused phlebotomy for blood collection for religious reasons. All refugees resulted negative for HBV, HBC and HIV infections. Bacterial microorganism and fungi isolated from surveillance swabs were found with Gram-negative bacteria representing by a larger number of species than Gram-positive and fungi microorganisms. These reports enforce the hypothesis that circulation of new emerging pathogens found, can be source of infection in susceptible patients or nosocomial settings. Interestingly, in some subjects, polymicrobial colonization was found and in some cases until to six different microorganisms, potentially pathogens, were isolated in the same individual. The microbiological surveillance performed in this group of Syrian migrants upon their arrival in Italy evidenced the carriage of unusual microorganism, potentially pathogens and carriers of antimicrobial resistance in some cases, that could be introduced in the country giving asylum. These migrants moving from a country to another could promote the diffusion of these microorganisms within different settings during their traveling around the world. (more…)
Author Interviews, Microbiome, Multiple Sclerosis / 05.04.2016

MedicalResearch.com Interview with: Professor JF Cryan PhD Department of Anatomy and Neuroscience APC Microbiome Institute University College Cork Cork, Ireland MedicalResearch.com: What is the background for this study? What are the main findings?  Prof. Cryan: Over the past decade there has been an ever growing body of preclinical studies that highlight an essential role of the gut microbiota in many aspects of physiology including and perhps most surprtisingly the brain . Germ-free animals are one useful approach used to establish causality in gut microbiota-brain relationships. This model has been extremely useful in establishing that the microbiota is essential for appropriate stress responsibility, anxiety-like behaviours, neurogenesis, blood-brain barrier function and microglia activity. From these findings we can see that there is a clear cut role for the microbiota in CNS developmental processes. Here we wanted to investigate using next generation sequencing, as we had done previously in the amygdala what impact life without microbes has on transcriptional regulation in the prefrontal cortex, a brain region essential in many aspects of emotional behaviour. What we uncovered from this was that there was a large number of dysregulated genes in germ-free animals that have a direct role in myelination. We found increased expression levels of genes that encode for structural proteins that are key in forming the myelin sheath. We followed up this finding with transmission electron microscopy to identify whether this marked increase in myelin related gene expression was functional at a structural level. What we found was germ-free myelinated axons in the prefrontal cortex were hypermyelinated (lower g-ratio), they had thicker myelin sheaths compared to conventionally raised mice. Additionally we also had germ-free colonized animals, animals that were born germ-free but have been colonized with a conventional microbiome early in life. These animals displayed no change in myelin related gene expression and appeared to be indistinguishable from the conventional animals. However, at the protein levels they appeared to have increased myelin protein like germ-free mice. This could be due to the fact that these mice were germ-free for at least 3 weeks of life and the hypermyelinated axons had already been established before colonization. Really this shows that we can still target the microbiota in later life that can have an impact of myelin gene regulation. (more…)
Author Interviews, JAMA, Pediatrics, Social Issues / 05.04.2016

MedicalResearch.com Interview with: Paula Braitstein, PhD Division of Epidemiology, Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada Department of Medicine, College of Health Sciences, School of Medicine, Moi University, Eldoret, Kenya Department of Epidemiology, Fairbanks School of Public Health, Indiana University, Indianapolis Regenstrief Institute Inc, Indianapolis, Indiana MedicalResearch.com: What is the background for this study? Dr. Braitstein: There are vast numbers of children and youth in the world who find themselves in street circumstances. Yet, there is an absence of consensus among academics, policymakers, stakeholders, and international organizations regarding the causes of child and youth street-involvement around the world. Without data concerning these reasons, policies are developed or implemented to mitigate street-involvement without taking these causes into account. Often, the prevailing paradigm assumes that children and youth on the street are juvenile delinquents and the government response is often characterized by social exclusion, criminalization, and oppression by police and civic authorities. Therefore we wanted to find out what reasons do children and youth self-report for their street-involvement globally. MedicalResearch.com: What are the main findings?  Dr. Braitstein: We systematically reviewed the literature and compiled data from 49 studies representing 24 countries globally. Street-connected children and youth most frequently reported poverty, family conflict, and abuse as their reasons for street-involvement. They infrequently identified delinquent behaviours for their circumstances. There were no significant differences between males and females reported reasons, with the exception of females in developed regions who were more likely to report abuse. (more…)
Author Interviews, Heart Disease, Lancet / 05.04.2016

MedicalResearch.com Interview with: Dr Henning Kelbæk MD Department of Cardiology Roskilde Hospital,Denmark MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Kelbæk : In some patients with large acute myocardial infarcts, stent implantation has been connected with an increased risk of downstream embolization of thrombus material and disturbances in flow impairing the prognosis of the patients. In accordance, previous smaller studies have shown a benefit in angiographic and other parameters in patients having their stent implanted several hours after the artery was opened, allowing the infarct-related lesion to ’cool down’ and residual thrombus to dissolve under antithrombotic treatment, whereas larger randomised trials focusing on clinical data have been missing. Our trial demonstrates, a bit surprisingly, that delaying or deferring stent implantation does not improve the clinical outcome of these patients.  (more…)
Author Interviews, Brigham & Women's - Harvard, Heart Disease / 04.04.2016

MedicalResearch.com Interview with: Jacob Joseph, MD, FACC, FAHA Associate Professor of Medicine, Harvard Medical School Cardiology Consortium Lead, VA Clinical Trial Network, Associate Physician, Brigham & Women's Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Joseph: The background for this study is the fact that heart failure with preserved ejection fraction (HFPEF) continues to be a challenge for cardiology. Clinical trials have thus far failed to give us a treatment. One of the major issues in clinical care and research is the marked heterogeneity of this condition.  Is an 80 year old woman with HFPEF, chronic kidney disease, and atrial fibrillation the same as a 50 year old hypertensive with left ventricular hypertrophy and HFPEF? In fact the recently reported TOPCAT study showed that the outcomes in patients enrolled in North and South America were significantly different from patients enrolled from Russia and Georgia, an effect that may have partly affected the results of the entire trial. In this study we examined whether a simple clinical tool like QRS duration measured on ECG could help to identify a subgroup of HFPEF patients who are at risk of adverse outcomes. When we analyzed the patients enrolled in the TOPCAT trial, we did in fact find that prolonged QRS duration is associated with worse outcomes in HFPEF. This association was independent of the region of enrollment and traditional cardiac risk factors. We also found that the association was seen in different types of conduction blocks. Furthermore the risk of adverse events started at QRS duration of approximately 100ms. (more…)
Annals Internal Medicine, Author Interviews, Cost of Health Care / 04.04.2016

MedicalResearch.com Interview with: Quinn Grundy, PhD, RN Postdoctoral Research Associate Charles Perkins Centre Faculty of Pharmacy The University of Sydney MedicalResearch.com: What is the background for this study? Dr. Grundy: In 2010, United States (US) lawmakers passed the Physician Payments Sunshine Act as part of the Affordable Care Act. The goal of this legislation was to make publicly transparent the financial relationships between physicians and pharmaceutical and medical device companies. These relationships are associated with increased prescribing of high cost, brand name medications with limited track records for safety. Policymakers hoped that increased transparency would help to deter relationships between physicians and industry that could bias treatment decision-making in this way. What caught our attention was that nurses, though they represent the largest proportion of health professionals, are omitted from the US Sunshine legislation. We questioned whether policymakers believed that nurses did not have the same kinds of relationships with industry as their physician counterparts, or, whether they did not believe that the consequences of nurse-industry interactions would warrant regulation. Rather than assuming that nurses interacted with industry in the same way that physicians do, we conducted an exploratory, in-depth qualitative study of nurses’ interactions with industry representatives in day-to-day clinical practice. At 4 hospitals in the western US, we interviewed 72 nurses, hospital administrators, supply chain professionals and industry representatives. Over a period of 2 years, we also directly observed nurses’ interactions with what we call “medically-related” industry, including pharmaceutical, medical equipment and device, infant formula, and health technology companies. (more…)
Author Interviews, CMAJ, Opiods, Pain Research / 04.04.2016

MedicalResearch.com Interview with: Shawn Bugden B.Sc. (Pharm), M.Sc., Pharm.D. Associate Professor College of Pharmacy, Faculty of Health Sciences University of Manitoba Winnipeg, Manitoba, Canada MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Bugden: Fentanyl is 100 times more potent than morphine.  While there has been a great deal of attention to fentanyl deaths associated with substance abuse, our study focused on the safety of fentanyl use in standard medical practice.   Fentanyl is most commonly prescribed as a transdermal (skin) patch that delivers the medication over 3 days. The product monograph and numerous safety warnings (FDA, Health Canada…) make it clear that fentanyl patches should not be used unless the patient has had considerable previous opioid exposure (more than 60mg morphine per day for more than 1 week).  Failure to heed these warnings may result in opioid overdose, respiratory depression and death. This study examined over 11 000 first prescriptions for fentanyl patches over a 12-year period to determine if patients had received adequate exposure to opioids.  Overall 74.1% of first prescriptions were filled by patients who had not received adequate prior opioid exposure. An improvement was seen over the study period but even at the end of the study, 50% of prescriptions would be classed as unsafe.  More than a quarter (26.3%) of fentanyl prescriptions were given to patients who were completely opioid naïve and had no exposure to opioids of any kind in the previous 60 days.  Older adults, who may be more sensitive to the effects of fentanyl overdose, were more likely to receive unsafe prescriptions than younger adults. (more…)
Author Interviews, Cost of Health Care, Hospital Readmissions, Outcomes & Safety, UT Southwestern / 04.04.2016

MedicalResearch.com Interview with: Oanh Kieu Nguyen, MD, MAS | Assistant Professor UT Southwestern Medical Center Divisions of General Internal Medicine and Outcomes and Health Services Research Dallas, TXOanh Kieu Nguyen, MD, MAS | Assistant Professor UT Southwestern Medical Center Divisions of General Internal Medicine and Outcomes and Health Services Research Dallas, TX MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Nguyen: The impetus for this study was Steven Brill’s 2013 Time magazine award-winning article, “Bitter Pill: Why Medical Bills Are Killing Us.” This report investigated inflated charges for hospital bills, and and suggested that a major driver of irrationally high charges was the disproportionate negotiating power of hospitals, as evidenced through their high profit margins. As hospital physicians, our reaction was “But what if hospitals that make more money are delivering more value and better outcomes to patients? If that’s the case, wouldn’t most people say that their profits justifiably earned?” Surprisingly, we found that no one had really looked at this issue in a systematic way. We set out to answer this question using hospital financial data from California’s Office of Statewide Health Planning and Development (OSHPD) and outcomes data on 30-day readmissions and mortality for congestive heart failure, acute myocardial infarction (‘heart attacks’), and pneumonia from the Centers for Medicare and Medicaid Services (CMS) Hospital Compare website. California has more hospitals than any other state other than Texas, and also has a wide diversity of hospital types. The OSHPD financial data are also audited, so we thought these would be more reliable than using data from other sources. Because the outcomes reported on Hospital Compare are viewable by the general public, we thought hospitals would be most motivated to target improvements in these outcomes. We found that there was almost no association between how much money a hospital made and its subsequent performance on outcomes. The exception to this was we found that hospitals that had better finances reported higher rates of 30-day mortality for congestive heart failure, which was counterintuitive. We’re not sure why this was the case but speculate that it is possible that hospitals with better finances take care of sicker heart failure patients because they have more advanced (and more expensive) treatments available. Additionally, we looked to see if hospitals with lower readmissions rates subsequently made less money. This is a specific area of policy concern given federal penalties in the U.S. for excessive hospital readmissions. Many critics of these penalties have argued that reducing readmissions makes no financial sense for hospitals, since readmissions still generate hospital revenue despite the penalties. Thus, reducing readmissions would reduce a key source of hospital revenue and lead to poorer hospital finances. However, our analysis showed that lower readmissions rates were not associated with poorer hospital finances, as has been feared.  (more…)
Author Interviews, Sexual Health / 04.04.2016

MedicalResearch.com Interview with: Nick G. Sitchon, CEO S1 Biopharma Mr. Sitchon discusses the S1 Biopharma  drug under development for hypoactive sexual desire disorder, Lorexys: MedicalResearch.com: What is the background for hypoactive sexual desire disorder? How common is this condition? Mr. Sitchon: Hypoactive sexual desire disorder affects more than 12 million women and 8 million men in the US alone, yet it is widely misunderstood and often misdiagnosed and undertreated. It is characterized by low sexual desire that causes significant personal distress or interpersonal difficulty. It is important to note that HSDD is not a physical disorder, such as erectile dysfunction (ED) or pain during intercourse. MedicalResearch.com: What is Lorexys and how might it work in HSDD therapy? Mr. Sitchon: Lorexys is our lead product in development for the treatment of HSDD in women. It is an oral, non-hormonal, fixed-dose combination of two antidepressants: bupropion and trazodone. It is formulated with a ratio that is precisely balanced to neutralize the side effects of its individual components and maximize efficacy. When taken together, bupropion and trazodone modulate the neurotransmitters NE, DA, and 5HT2 in selective brain areas, ultimately increasing sexual desire. The combination also balances out the effects of each drug to reduce the risk of adverse events. Lorexys recently completed a Phase 2a clinical trial that evaluated its safety, tolerability, and pro-sexual efficacy compared to bupropion, one of its constituent drugs. Clinical trial results found Lorexys to be highly tolerable with minimal side effects, and showed a 38% stronger efficacy than the use of bupropion alone. Trazodone by itself is not expected to have success in treating hypoactive sexual desire disorder. (more…)