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…)
Author Interviews, Brain Injury / 01.04.2016

MedicalResearch.com Interview with: Dr. David W. Lawrence, MD Department of Family & Community Medicine St Michael's Hospital, University of Toronto Toronto, Ontario, Canada MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Lawrence: The risk of all-cause injury and concussion for NFL athletes is significant. There has been a lot of discussion recently about this risk of injury in the NFL and general player safety, particularly regarding concussions. The first step in improving player safety and lowering that risk is to identify the factors affecting injury rates. Once we can answer those questions, we can begin to modify player exposure. (more…)
Author Interviews, Blood Pressure - Hypertension, Kidney Disease, Salt-Sodium / 31.03.2016

MedicalResearch.com Interview with: Matthew Bailey PhD Faculty Principal Investigator British Heart Foundation Centre for Cardiovascular Science The University of Edinburgh, Edinburgh, United Kingdom. MedicalResearch.com: What is the background for this study? Dr. Bailey: This study started with our interest in salt homeostasis and long term blood pressure, so it’s firmly rooted in the cardiovascular/renal disease risk factor arena. We were interested in salt-sensitivity- why does blood pressure go up in some people when they eat salt but not in others. I’m a renal physiologist, so we had a number of papers looking at renal salt excretion and blood pressure. We initially used a gene targeting approach to remove a gene (Hsd11b2) which acts as a suppressor of the mineralocorticoid pathway. It’s mainly expressed in the kidney and when we deleted the gene  throughout the body we saw a number of renal abnormalities all associated with high mineralocorticoid activity. This was consistent with the “hypertension follows the kidney” theory of blood pressure control. There is a human disease called “Apparent Mineralocorticoid Excess”- there are people do not have the gene and are thought to have renal hypertension. Our study threw up some anomalies which we couldn’t easily interpret but suggested that the brain was involved. We moved to a more refined technology that allowed us to knockout a gene in one organ system but not another. We knew the gene was in the brain and localized to a very restricted subset of neurons linked to salt-appetite and blood pressure control. Previous studies had shown that these neurons were activated in salt-depleted rats (ie rats that needed to eat salt). We started there but didn’t anticipate that the effect on salt hunger and on blood pressure would be so large because renal function is -as far as we can tell- normal. (more…)
Author Interviews, Endocrinology, Toxin Research, UCLA / 31.03.2016

MedicalResearch.com Interview with: Nancy L. Wayne, PhD Professor, Department of Physiology UCLA School of Medicine Los Angeles, CA 90095 MedicalResearch.com editor’s note: Campbell Soup Co. will stop using the chemical Bisphenol A in its canned products by the middle of 2017 due to consumers concerns that BPA raises the risk of cancer, brain damage and hormonal problems. Professor Nancy Wayne, is a reproductive endocrinologist and professor of physiology at UCLA. She has conducted extensive research on the health effects of the endocrine disruptors bisphenol A (BPA), a chemical widely used by manufacturers to strengthen plastic, and its replacement, bisphenol S (BPS). Professor Wayne was kind of enough to discuss the implications of the Campbell Soup Co. announcement for the readers of MedicalResearch.com.  MedicalResearch.com: What is the background for this announcement?  What are the real and potential harmful effects of BPAs? Prof. Wayne: There has been increasing research publications on the impact of BPA on body functions in animal models, human cells in culture, and associations between high levels of BPA in human urine samples and dysfunctions and diseases. a pubmed (biomedical article search engine) keyword search of bisphenol + BPA showed 39 articles published in the 1990s, 1127 articles published in the 2000s, and over 2300 articles published since January 2010. The public is much more aware of this research now — even though the message from the U.S. FDA has been consistently that low levels of BPA are not harmful (this is not the case according to independent research). Public pressure is causing companies to re-think their use of BPA in their products that could lead to environmental exposure of humans to this chemical. BPA has been shown in animal models to alter genes in fetal heart that are known to play a role in heart diseases, leads to increased genetic abnormalities in fertilized eggs and miscarriages, increased premature birth, increases susceptibility to breast cancer, stimulates early development of the reproductive system, and increases the risk of obesity. We cannot do controlled studies in humans with toxins like we can with laboratory animals. However, there has been shown to be an association between high levels of BPA in human urine and many of the same problems seen in animals: increased body weight and fat in children, increased risk of miscarriages and premature birth, and increased incidence of prostate cancer. Although association doesn’t mean cause-and-effect, taken together with the animal studies — it is meaningful. (more…)
Author Interviews, Heart Disease, Technology / 31.03.2016

MedicalResearch.com Interview with: Dr. Nicola Gaibazzi Department of Cardiology Parma University Hospital Parma Italy MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Gaibazzi: As clinical and research cardiologists we have never accepted that cardiac arrests are so frequently deadly throughout the world (sudden cardiac arrest is the world’s leading cause of death) because many of such events could be easily reversed by early defibrillation if only witnessed by a bystander who could quickly call emergency in place of the incapacitated subject. This would be lifesaving for most of them, gaining quick  access to defibrillation within the golden 8-10 minutes (in the Oregon state study 6.5 minutes is the average time from call to defibrillation). While this issue of early defibrillation access is not easy to be solved for cardiac arrest in the general population, it was surprising to us that there was no available tool to date to automatically alert emergency contacts for people who regularly practice outdoor sports alone, such as running or cycling, and may undergo sudden and unexpected sports-associated cardiac arrest. It is a rare event, but it may happen during exercise, when cardiac arrest is actually several times more frequent than during resting condition, both in sedentary and active subjects. It was surprising to us seeing all people practicing with their earbuds, listening to music from their last-generation smartphone, often used only as if it were an old music cassette “walkman”, while it is a powerful and wireless-connected portable computer with an incredible potential for emergency rescue. Consequently, in 2015 we founded a startup company (www.parachute-app.com or temporary new site http://nicolagaibazzi.wix.com/mysite) and started building an app that could take advantage of the capabilities of modern smartphones to automatically detect sports-associated cardiac arrest, specifically aiming at recognizing ventricular tachycardia or ventricular fibrillation. This was not an easy task, since we wanted to use simple, cheap and commercially-available hardware, possibly already at hand for sportspeople; otherwise too few subjects would use it and you would not impact such infrequent disease with only few sportsmen using it, since sports-associated cardiac arrest is rare (2/100000 athletes/year) but not negligible, with 2450 deaths in US only each year. We finally chose to use as the only additional required hardware a BT+ heart rate monitor chest strap (a chest strap can be bought if not already owned at 40$), which is cheap, reliable, able to transmit heart rate with trivial battery drainage detected through cardiac electrical signal with trivial battery drainage, and much more reliable than pulse-plethysmographic methods which fully depend on the device contact with the arm or wrist skin to collect a correct signal. We could not afford in our lifesaving app that a wrong wrist or arm device contact would cause absence of pulse signal detection erroneouslytriggering a cardiac arrest alert or not doing so when a cardiac arrest is truly present. Chest straps on the contrary send heart rate sensed from electrical heart activity and are almost impossible to displace even in case of an unconscious subject falling down. We built and tested our Parachute app for the iPhone during 2015, through long testing in the outdoor field and with arrhythmia simulators and at the ACC congress we present just part of the data collected from such tests in athletes running and cycling and with advanced arrhythmia simulators. Parachute was incredibly accurate both to avoid false positives and false negatives, thanks to continuously combined chest strap heart rate data and motion or, better, detection of “no motion”, corresponding to a possible incapacitated subject. These two mechanisms act together and complete each other, they are synergic, since while our patent-pending algorithm using heart rate data is very sensitive for serious arrhythmias, motion detection can easily exclude false positives during outdoor sports, where motion is by definition almost continuous. (more…)
Addiction, Author Interviews, NEJM, NYU / 31.03.2016

MedicalResearch.com Interview with: Joshua D. Lee MD, MSc Associate Professor in Medicine and Psychiatry NYU Langone Medical Center MedicalResearch.com: What is the background for this study? Dr. Lee: Opioid use disorders, both from prescription pain medication and heroin use, and related death rates are increasing annually in the US.  Many states, counties, and cities that have previously not had great experience with heroin addiction are now overwhelmed.  This presents unprecedented challenges to affected families and communities, and also health providers and criminal justice systems that have historically not provided high rates of evidence-based treatment for opioid addictions.  Left untreated or inadequately treated, opioid use disorders are chronic, destructive, and often fatal. Extended-release naltrexone, an opioid receptor blocker, is a promising relapse prevention medication intervention, but had not been evaluated in a US criminal justice system (CJS) setting or under real-world conditions. This effectiveness study recruited 308 adults with US criminal justice system involvement (i.e., recent jail or prison incarceration, on parole or probation) and a history of opioid dependence (addiction), who were not currently accessing methadone or buprenorphine maintenance treatment, and were interested in treatment with extended-release naltrexone (XR-naltrexone).  All participants were off opioids (detoxed or recently abstinent) at the time of study start (randomization).  Participants randomized to an open-label, non-blinded evaluation of XR-naltrexone versus treatment-as-usual for six months of treatment.  Long-term follow-up occurred at 12 months and 18 months (6 and 12 months post-treatment).  We estimated rates of opioid relapse and opioid use between the two arms over the course of treatment.  We also tracked other drug and alcohol use, re-incarceration rates, and overdose rates throughout the study. (more…)