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…)
Author Interviews, Diabetes, Diabetologia / 04.04.2016

MedicalResearch.com Interview with: Associate Professor Dianna Magliano BAppSci(Hon) MPH PhD Head, Diabetes and Population Health Baker IDI Heart and Diabetes Institute Melbourne. VIC MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Magliano: This work shows  that Australians with type 1 diabetes had an estimated life loss of 11.6 years for men and 12.5 years for women compared with the general population. We saw no evidence of improvement in this over recent years. For those who are older with type 1, cardiovascular disease contributed substantially to the years of life lost in type 1 diabetes. Death before 60 years and mortality from endocrine and metabolic disease were also important contributors to the years of life lost in type 1 diabetes. (more…)
Author Interviews, Diabetes, Endocrinology, Surgical Research, Weight Research / 04.04.2016

MedicalResearch.com Interview with: Ana Priscila Soggia Sirio Libanes Hospital, São Paulo, Brazil MedicalResearch.com: What is the background for this study? What are the main findings? Response: For many years, bariatric surgery is performed to treat class II and III obesity with diabetes remission in 80-90% of cases, related to weight loss and change in the secretion of intestinal factors that control blood glucose, like GLP-1 and GIP. In 2010, the International Diabetes Federation (IDF), proposed that diabetic patients with BMI between 30-35kg/m2 could be eligible, for bariatric surgery, in the case of no glycemic control with drug treatment. In this context, once glycemic control after bariatric surgery, was not related only to weight loss and also due to intestinal factors with physiological actions, the protocol was proposed. The objectives were to compare the clinical and surgical treatment in diabetics patients with class I obesity; and to compare the efficacy and security between two different surgical techniques. This study was developed and conducted by a research team from Sirio-Libanês Hospital in partnership with Ministry of Health through its philanthropic program PROADI. It is a clinical trial, with 42 class I obese diabetic type 2 patients with inadequate glycemic control that were randomized to tree arms: clinical treatment, gastric bypass surgery or sleeve with ileal transposition (sleeve-IT) surgery. The results showed that the sleeve-IT procedure is more effective for the treatment of diabetes in these patients compared with treatment with medication and with bypass surgery, currently considered the first choice of treatment. Among patients who underwent sleeve-IT, 100% achieved glycemic control after 1 year (HbA1c<6,5%) compared to 46% for bypass and 8% in the case of medication therapy. In addition, diabetes remission, that was defined as adequate glycemic control without any anti-diabetic medication, occured in 75% of sleeve-IT patients had versus 30% in bypass group. (more…)
Author Interviews, Erectile Dysfunction, Stem Cells, Urology / 03.04.2016

MedicalResearch.com Interview with: Dr. Michael Zahalsky MD Medical Director of Urological Oncology North Broward Medical Center, Florida MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Zahalsky: Erectile dysfunction or the inability to maintain an erection satisfactory for sexual intercourse is a disease that affects hundreds of millions of men worldwide. Currently, the most utilized methods to help treat these men include oral medications, injectable medications and penile prostheses. We sought out new alternatives to treat and potentially even cure erectile dysfunction by using stem cells and biologic-based therapies - treatments that are now being used in various fields of medicine from orthopedics to plastic surgery. We decided to see how their effect will influence Erectile Dysfunction by evaluating blood flow to the penis. In the past we studied Peyronie’s Disease using a similar treatment modality and showed that with a single injection blood flow improved, plaque size decreased, and penile curvature lessened.  There have been many animal studies, as well, showing the benefit of biologic-based therapies in the treatment of Erectile Dysfunction and Peyronie’s Disease. We chose to use placental matrix derived mesenchymal stem cells in this study on Erectile Dysfunction. We had a small sample of 8 patients who underwent treatment. We had statistically significant increase in blood flow into the penis.  This was demonstrated by an increase in peak systolic velocity using color doppler on ultrasound. (more…)
Author Interviews, Endocrinology, Vitamin D / 03.04.2016

MedicalResearch.com-Interview with: Francisco Bandeira,M.D.,PhD.,F.A.C.E. Professor of Medicine and Chairman, Division of Endocrinology, Agamenon Magalhães Hospital, University of Pernambuco Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Bandeira: We had the opportunity to evaluate a population with very high rates of sun exposure in daily life at a tropical region with abundant sunlight (UV index of 5 at 7 am and more than 10 at midday). We found that more exposure to the sun, less vitamin D deficiency, so nature “works”. But more sun exposure led to more tanned skins and despite these very high rates of sun exposure, most people were not able to achieve optimal blood levels of 25OHD (> 30 ng/ml). (more…)
Alcohol, Author Interviews, Diabetes, Endocrinology / 03.04.2016

MedicalResearch.com Interview with: Ken C. Chiu, MD, FACE, FACP Professor Endocrinology Fellowship Training Program Department of Clinical Diabetes, Endocrinology, and Metabolism Diabetes and Metabolism Research Institute City of Hope National Medical Center Duarte, CA 91010-3000  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Chiu: The benefit of moderate alcohol consumption is well established in cardiovascular disease. However, the role of alcohol consumption in type 2 diabetes is less clear. We examined the role of alcohol consumption in type 2 diabetes using the data from the National Health and Nutrition Examination Survey 2005-1012, which is a representative US population. In the rare alcohol consumption group (< 12 drinks per year), 24.04% were diabetic while only 14.67% were diabetic in the moderate alcohol consumption (1-4 drinks per day) group (P><0.000001). In contrast, 21.05% were diabetic in the heavy alcohol consumption (≥ 5 drinks/day) group (P=0.003) when compared to the rare alcohol consumption group. Thus, in compared to the rare alcohol consumption, moderate alcohol consumption was associated with a lower risk of diabetes (OR: 0.72; 95%CI: 0.65-0.79) after adjustment for co-variates, while there was no benefit from heavy alcohol consumption (OR: 0.97; 95%CI: 0.90-1.05). Our study demonstrates that moderate alcohol consumption reduces the risk of diabetes by 28%. (more…)
Author Interviews, Diabetes, Endocrinology, Weight Research / 03.04.2016

MedicalResearch.com Interview with: Olivia Farr, Ph.D. Instructor in Medicine Division of Endocrinology, Beth Israel Deaconess Medical Center 330 Brookline Ave, Stoneman 820B Boston, MA 02215 MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Farr: There are two main studies. In the first, we used immunohistochemistry to analyze 22 human brain tissue samples for the presence of GLP-1 receptors, which are protein molecules that respond to the GLP hormone’s signal. We found—for the first time—that GLP-1 receptors are expressed in the human brain, including the cortex, the part of the brain responsible for higher thought. Our second study was performed in 18 adults with type 2 diabetes. Participants received 17 days of either liraglutide, up to 1.8 milligrams, or a placebo (dummy drug) in a random order. Then after a three-week “washout” of no medication, the same participants received 17 days of the opposite treatment. Participants and investigators were unaware which treatment they received. On day 17 of each treatment, participants underwent brain scanning with functional magnetic resonance imaging (fMRI). During fMRI, participants viewed images of different foods. In response to highly desirable foods such as cake, pastries and fried foods, liraglutide decreased reward- and salience-related brain activations in the cortex compared with images of less desirable foods, such as fruits, vegetables and other low-calorie, low-fat foods.​ (more…)
Author Interviews, Calcium, Heart Disease / 02.04.2016

MedicalResearch.com Interview with: Dr. Chan Soo Shin MD PhD Professor of Medicine Seoul National University College of Medicine Seoul, 03080, Korea MedicalResearch.com: What is the background for this study? What are the main findings? Response: Recently, a series of secondary analyses on large clinical trials and meta-analysis have reveled increased rate of cardiovascular events in women allocated to calcium supplements. As most of these studies were conducted in Western countries where the dietary calcium intake is sufficient, we aimed to investigate the association between dietary calcium intake level and cardiovascular events or mortality in Korea where the average dietary calcium intake is as low as 470 mg per day. We have analyzed data from 4,866 adults aged at least 50 years without previous CDV or stroke history participating in the Ansung and Ansan cohort study, an ongoing, prospective, community-based study in Korea (2,690 women). Participants completed periodic food frequency questionnaires; CVD, stroke and fractures were recorded during interviews and examinations every 2 years. Researchers used proportional Cox regression analysis was used to determine HRs for all-cause mortality, CVD, cerebrovascular disease and fractures, adjusting for age, BMI, vegetable and fruit intake, protein and sodium intake, physical activity, smoking and drinking status, diabetes and hypertension history and total energy from diet. Researchers also adjusted for menopausal status and hormone replacement therapy in women. Women were followed for a mean of 9.2 years; men followed for a mean of 8.9 years. Within the cohort, 359 participants died (243 men); 340 developed CVD (153 men); 157 experienced stroke (59 men); 568 experienced incident fractures (212 men). In comparing the four quartiles for energy-adjusted calcium intake, women experienced an increased reduction in CVD risk with increasing dietary calcium intake. Women in the highest quartile saw the greatest reduced risk for CVD vs. the lowest quartile (HR = 0.53; 95% CI, 0.33-0.86), followed by women in the third (HR = 0.56; 95% CI, 0.36-0.85) and second quartiles (HR = 0.80; 95% CI, 0.55-1.17) when compared with women in the lowest quartile. We found no association between dietary calcium intake and stroke or fracture risk in women. Dietary calcium intake did not affect all-cause mortality, CVD risk, stroke risk or fracture risk in men. (more…)
Asthma, Author Interviews, OBGYNE / 02.04.2016

MedicalResearch.com Interview with: Dr Anju Joham (MBBS (Hons), FRACP, PhD) Endocrinologist, Monash Health Post doctoral Research Fellow Monash Centre for Health Research and Implementation – MCHRI School of Public Health and Preventive Medicine Monash University – in partnership with Monash Healtj MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Johan: Polycystic Ovary Syndrome (PCOS) is a common condition affecting reproductive-aged women. Recent research suggests that asthma may be more commonly seen in women with PCOS; however, there are very limited studies that have examined this relationship. It will be helpful to understand if there is a relationship with PCOS and asthma. Women were randomly selected from the national health insurance database (Medicare) in Australia. Data was available for 8612 women. We found that in women aged 28 to 33 years, PCOS prevalence was 5.8% (95% CI: 5.3%-6.4%). The prevalence of asthma was 15.2% in women reporting PCOS and 10.6% in women not reporting PCOS respectively. PCOS was associated with 34% increased odds of asthma after adjusting for weight. In addition, weight in the overweight and obese range were associated with increased odds of asthma. (more…)
Author Interviews, Compliance, Infections / 01.04.2016

MedicalResearch.com Interview with: Loren G. Miller, M.D., M.P.H. Professor of Medicine, David Geffen School of Medicine at UCLA Division of Infectious Diseases Los Angeles BioMedical Research Institute at Harbor-UCLA Torrance CA 90502  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Miller: We know that medication adherence (compliance) by patients to all sort of treatments for a variety of diseases is suboptimal. Adherence to medication varies a lot by disease state (e.g. it is typically high in cancer and low in hypertension), but adherence to antibiotics for skin infection is unstudied. We wanted to find out what adherence is to antibiotics for patients with skin infections is and whether it was associated with important clinical outcomes. We measured patients adherence to antibiotic dosing by using medication containers fitted with electronic caps that reported when the patient opened the antibiotic container. We followed 87 patients who had been hospitalized and suffered S. aureus associated skin and soft tissue infections We found that patients with S. aureus skin and soft tissue infections, on average, took just 57% of their prescribed antibiotic doses after leaving the hospital. Lower antibiotic adherence was associated with a higher chance of skin infection relapse or recurrence. Interestingly, we also found a large discrepancy in patient reports and the electronic measurement. Patients reported taking, on average, 96% of their medication, or nearly twice the 57% reported by the electronic caps. This suggests that asking patients how well they took their medication is highly problematic as non-adherent patients will typically vastly overstate their medication adherence. We also found higher rates of non-adherence to antibiotic regimens among patients who were prescribed more than one antibiotic after leaving the hospital, didn’t see the same healthcare provider for follow-up visits or felt they didn’t have a regular healthcare provider (more…)
Author Interviews, Bone Density, JAMA, Mediterranean Diet, Menopause / 01.04.2016

MedicalResearch.com Interview with: Bernhard Haring, MD MPH Department of Medicine I Comprehensive Heart Failure Center University of Würzburg Germany MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Haring: The primary aim of this study was to examine the association between adherence to a diet quality index constructed on the basis of dietary recommendations or existing healthy dietary patterns and bone outcomes in a large population of postmenopausal women. We found that higher diet quality based on a Mediterranean diet may play a role in maintaining bone health in postmenopausal women. (more…)
Author Interviews, Genetic Research, Heart Disease, JAMA, UCSD / 01.04.2016

MedicalResearch.com Interview with: H Kirk Hammond, MD Professor of Medicine (Cardiology) University of California San Diego Veterans Affairs San Diego Healthcare System San Diego, CA 92161  MedicalResearch.com: What is the background for this study? Dr. Hammond: Heart failure affects >28 million patients worldwide and is the only cardiovascular disease that is increasing in prevalence. Despite steady improvement in drug therapy for heart failure, recent hospitalization rates and mortality have changed little. New therapies are needed. Adenylyl cyclase type 6 (AC6), is a protein that catalyzes the conversion of ATP to cAMP and is an important determinant of heart function. The amount and function of AC6 are reduced in failing hearts, and preclinical studies have shown benefits of increased cardiac AC6 content on the heart. The aim of the trial was to determine safety and heart function gene transfer of AC6, achieved by intracoronary delivery of an inactivated virus carrying the gene for AC6 (Ad5hAC6) in patients with symptomatic heart failure and reduced ejection fraction. Our hypothesis was that AC6 gene transfer would safely increase function of the failing hearts of patients with heart failure. (more…)
Author Interviews, Fertility, Toxin Research / 01.04.2016

MedicalResearch.com Interview with: Anders Rehfeld MD, PhD Student University of Copenhagen Faculty of Health and Medical Sciences Department of Cellular and Molecular Medicine Copenhagen, Denmark MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Rehfeld: Human fertility is declining in many areas of the world and the reason is largely unknown. Our study shows that 44% tested chemical UV filters can induce calcium signals in human sperm cells, thereby mimicking the effect of progesterone and possibly interfering with the fertilizing ability of human sperm cells. Progesterone-induced calcium signaling, and the sperm functions it triggers, is absolutely essential for the human sperm cell to normally fertilize the human egg. (more…)
Author Interviews, Brigham & Women's - Harvard / 01.04.2016

MedicalResearch.com Interview with: Le Min, MD,PhD Brigham and Women's Hospital, Endocrinology Division MedicalResearch.com: What is the background for this study? Dr. Min: As you know, immune checkpoint blockade therapies by anti-CTLA4 and Anti-PD1 have shown promising and durable anti-cancer effects on several advanced malignancies. Interestingly, endocrine disorders are among the most common adverse effects associated with immune checkpoint blockade therapies. More interestingly, it appears that hypophysitis, the inflammation of the pituitary is commonly related to anti-CTLA4 therapy while thyroid disorders are more commonly seen in anti-PD1 monotherapy and the combined therapy with anti-PD1 and anti-CTLA4. Anti-CTLA4-related hypophysitis has been well characterized but there is no study to characterize the thyroid disorders associated with anti-PD1 monotherapy and the combined therapy with anti-PD1 and anti-CTLA4. As an endocrinologist, I have been taking care of a population of such patients who received either monotherapy with anti-PD1 or combined therapy with anti-PD1 and anti-CTLA4 and developed thyroid disorders. (more…)
Author Interviews, Pulmonary Disease / 01.04.2016

MedicalResearch.com Interview with: Prof Michael Kreuter Center for Interstitial and Rare Lung Diseases, Pneumology and Respiratory Critical Care Medicine, Thoraxklinik, University of Heidelberg and Translational Lung Research Center Heidelberg, Germany MedicalResearch.com: What is the background for this study? What are the main findings? Prof. Kreuter: Already in the 70s, early reports hypothesized a relationship between gastroesophageal reflux disease (GERD) and pulmonary fibrosis (IPF). Since then, clinical and preclinical data suggested that micro-aspirations cause lung parenchymal injuries which may stimulate pulmonary fibrosis. The hypothesis of a potential relationship between idiopathic pulmonary fibrosis (IPF_ and GERD also provoked the question of an effect of GERD-treatment by antacid therapy (i.e. proton pump inhibitors or H2-blockers) on the course of IPF.  In this context, two analyses, one retrospective and one post hoc, reported that antacid treatment had positive effects on the course of pulmonary function and on survival in IPF patients. These data lead to a conditional recommendation for the treatment of patients with IPF with antacid therapy in the current international IPF guideline. However, the low confidence in estimates of the effect prompted us to initiate a new post-hoc analysis pooling data from the placebo arms of three multinational trials on pirfenidone in interstitial pulmonary fibrosis. In this new analysis, published in Lancet Respiratory Medicine, antacid therapy was not associated with a slower disease progression in IPF. Moreover, in patients with advanced disease antacid therapy was associated with a significantly higher incidence of pulmonary and non-pulmonary infections. (more…)
Author Interviews, Pulmonary Disease / 01.04.2016

MedicalResearch.com Interview with – Professor Luca Richeldi University Hospital, Southampton Southampton, UK MedicalResearch.com: What is the background for this study? What are the main findings? Prof. Richeldi: The pooled analysis published in Respiratory Medicine is based on Ofev (nintedanib) data from the Phase II TOMORROW trial and the two Phase III INPULSIS studies, and a total of 1,231 patients with idiopathic pulmonary fibrosis (IPF), 723 of whom were treated with Ofev. The results of this analysis confirm that Ofev significantly slows disease progression by approximately 50%, as measured by decline in forced vital capacity (FVC) across a range of patient types in the clinical trial program. In addition, the analysis confirms that Ofev reduces the risk of acute exacerbations by approximately 50% and has a favorable effect across mortality outcomes with a trend in lower all-cause mortality and a significant lower on-treatment-mortality. (more…)