Author Interviews, Heart Disease, Lipids, NEJM, Pharmacology / 14.11.2016

MedicalResearch.com Interview with: Kevin Fitzgerald, Ph.D. Alnylam Pharmaceuticals Cambridge, MA 02142 MedicalResearch.com: What is the background for this study? Response: Inclisiran (ALN-PCSsc) is a subcutaneously administered RNAi therapeutic targeting PCSK9 in development for the treatment of hypercholesterolemia. The Phase 1 trial of inclisiran was conducted in the U.K. as a randomized, single-blind, placebo controlled, single ascending-and multi-dose, subcutaneous dose-escalation study in 69 volunteer subjects with elevated baseline LDL-C (≥ 100 mg/dL). The primary objective of the study was to evaluate the safety, side effect profile, and pharmacodynamics effects of inclisiran. (more…)
Author Interviews, Pharmacology, Weight Research / 03.11.2016

MedicalResearch.com Interview with: Dr Todd Hobbs MD Chief medical officer (CMO) Novo Nordisk in North America MedicalResearch.com: What is the background for this study? Response: There is little data that describes weight loss and other outcomes separately in early weight loss responders and early weight loss non-responders. Early weight loss, whether through lifestyle or pharmacotherapy, can be a good predictor of long-term weight loss. Consequently, all recently-approved weight loss medication labels include ‘stopping rules’ for discontinuing medication if a threshold weight loss is not achieved by a specified milestone. Bottom line, it’s important patients don’t continue on a therapy that isn’t working for them. This makes this form of research important from a clinical standpoint but also in the larger obesity treatment paradigm - including payers and how pharmaceutical treatments are labeled. (more…)
Author Interviews, Endocrinology, OBGYNE, Pharmacology / 19.10.2016

MedicalResearch.com Interview with: Hugh S. Taylor, MD Anita O'Keeffe Young Professor of Obstetrics, Gynecology, and Reproductive Sciences and Professor of Molecular, Cellular, and Developmental Biology; Chair of Obstetrics Gynecology, and Reproductive Sciences, Yale School of Medicine Chief of Obstetrics and Gynecology Yale-New Haven Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: The abstract presented at ASRM featured results from two replicate pivotal Phase 3 clinical trials evaluating the efficacy and safety of Elagolix in premenopausal women who suffer from endometriosis. Elagolix is an investigational, orally administered, gonadotropin-releasing hormone (GnRH) receptor antagonist that blocks endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration results in rapid, reversible, dose-dependent inhibition of luteinizing hormone and follicle-stimulating hormone secretion, leading to reduced ovarian production of the sex hormones, estradiol and progesterone, while on therapy. The data demonstrated dose-dependent superiority in reducing daily menstrual and non-menstrual pelvic pain associated with endometriosis compared to placebo. At month three and month six, patients treated with Elagolix reported statistically significant reductions in scores for menstrual pain (dysmenorrhea) and non-menstrual pelvic pain associated with endometriosis as measured by the Daily Assessment of Endometriosis Pain scale. The safety profile of Elagolix was consistent across both Phase 3 trials and also consistent with prior Elagolix studies. (more…)
Author Interviews, FASEB, Heart Disease, Imperial College, Pain Research, Pharmacology / 17.10.2016

MedicalResearch.com Interview with: Dr Nicholas Kirkby BHF Intermediate Fellow | Vascular Biology National Heart & Lung Institute | Imperial College London London MedicalResearch.com: What is the background for this study? What are the main findings? Response: We know drugs like ibuprofen, called ‘non-steroidal anti-inflammatory drugs’ cause an increase in the risk of heart attacks. These side effects cause very real concerns for the many millions of people who rely on them. They are also the reason why there are no new drugs in this class and why they have been withdrawn (2011) for use as a preventative treatment for colon cancer. Previous research from our group suggests that L-arginine supplements may prevent the cardiovascular side effects caused by these drugs. Our findings here suggest that a particular formulations of ibuprofen, called ibuprofen arginate, which is already available in many parts of the world, can act like an L-arginine supplement and that this could potentially protect the cardiovascular system. (more…)
Author Interviews, Cancer Research, Pharmacology / 17.10.2016

MedicalResearch.com Interview with: Dr Pan Pantziarka, PhD Scientist: Anticancer Fund (www.anticancerfund.org) Coordinator: Repurposing Drugs in Oncology (www.redo-project.org) MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study is part of the Repurposing Drugs in Oncology (ReDO) project to look at a series of non-cancer drugs which have strong evidence of anti-cancer effects. Other drugs have included the antacid cimetidine, the antibiotic clarithromycin and the NSAID diclofenac. The data for propranolol comes from multiple sources: epidemiological data and retrospective data from cancer patients who have also been treated concurrently with propranolol, pre-clinical work in vitro and in animal models and from case series reports in which cancer patients have had propranolol added to their existing treatments. The main findings are that propranolol has multiple mechanisms of action, including anti-proliferative and immunomodulation. There is particularly strong evidence that shows that propranolol has potent effects in the treatment of the rare soft-tissue sarcoma angiosarcoma. It is also suggested that when used at the time of surgery, propranolol in combination with a COX-2 inhibitor, can reduce the risk of metastatic spread. (more…)
Author Interviews, Compliance, Outcomes & Safety, Pharmacology / 12.10.2016

MedicalResearch.com Interview with: Neil Smiley Founder and CEO of Loopback Analytics Editor's note: Loopback Analytics mission is to "integrate data across a myriad of healthcare information systems to bridge the expanding gaps within the care continuum". CEO Neil Smiley discusses the problem of medication adherence and possible means to address the issue. MedicalResearch.com: What is meant by medication "adherence"? How big a problem does this represent in term of health care outcomes and costs? Response: Medication adherence is the degree to which a patient is taking medications as prescribed. Poor medication adherence takes the lives of 125,000 Americans annually, and costs the health care system nearly $300 billion a year in additional doctor visits, emergency department visits and hospitalizations. MedicalResearch.com: What can be done by health care providers, systems and pharmacists to improve medication adherence? Response: There are many potential failure points after a prescription is written, that range from affordability, transportation, literacy, confusion over brand vs. generics, duplication of therapy. Many patients simply stop taking medications when they start feeling better or fail to refill chronic maintenance medications. Healthcare providers can improve adherence by anticipating and eliminating potential points of failure before they become problems. For example, high risk patients leaving the hospital are less likely to be readmitted if they get their prescriptions before they are discharged. Follow-up consultations by pharmacists can assist patients with side effects that may otherwise cause patients to abandon their treatment plan and provide patients with education on how to take medications correctly. (more…)
Alcohol, Author Interviews, NIH, Pharmacology / 12.10.2016

MedicalResearch.com Interview with: Megan Ryan M.B.A. Clinical Program Director, DMD Technology Development Coordinator National Institute on Alcohol Abuse and Alcoholism National Institutes of Health Bethesda, MD MedicalResearch.com: What is the background for this study? Response: Alcohol use disorder (AUD) has been linked to the dysregulation of the brain stress systems (e.g. corticotropin-releasing factor, glucocorticoids, and vasopressin) creating a negative emotional state leading to chronic relapsing behavior. Several pre-clinical studies have shown that by blocking the V1b receptor with a V1b receptor antagonist, dependence induced compulsive-like alcohol intake is also blocked. This is the first multi-site trial to assess the efficacy of the V1b receptor antagonist novel compound (ABT-436) for the treatment of alcohol dependence. (more…)
Author Interviews, Cancer Research, Cost of Health Care, JAMA, Pharmacology / 12.10.2016

MedicalResearch.com Interview with: Dr. Sham Mailankody, MBBS Memorial Sloan Kettering Cancer Center MedicalResearch.com: What is the background for this study? Response: The high price of older drugs has been increasingly criticized in part because of recent dramatic price hikes. There are some well known examples like pyrimethamine and more recently EpiPen. Whether and to what degree examples like pyrimethamine represent a common problem or exceptional cases remains unknown. Using Medicare data available for Part B, we sought to analyze the change in average sales price of cancer drugs between January 2010 and January 2015, and whether older drugs were more likely to undergo price increases than newer drugs. (more…)
Author Interviews, Pharmacology, Schizophrenia / 10.10.2016

Antony Loebel, M.D. Executive Vice President and Chief Medical Officer, Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma GroupAntony Loebel, M.D. Executive Vice President and Chief Medical Officer Sunovion Head of Global Clinical Development Sumitomo Dainippon Pharma Group MedicalResearch.com: What is the background for this study? Response: Lurasidone hydrochloride (HCl) is an atypical antipsychotic approved by the FDA for the treatment of schizophrenia in 2010. There are a number of publications on lurasidone studies, pooled data that were included in a network meta-analysis of RCTs in schizophrenia. The meta-analysis compares lurasidone with other antipsychotics using RCTs where both medications were studied at the same time. Such approach (meta-analysis of similarly designed trials) allows for a state of the art review of efficacy, safety and tolerability of medications where direct head-to-head trials are not available. (more…)
Author Interviews, ESMO, Pharmacology / 09.10.2016

MedicalResearch.com Interview with: Paolo Bossi MD Medical Oncologist Head and Neck Cancer Department IRCCS Istituto Nazionale dei Tumori Foundation Milan, Italy MedicalResearch.com: What is the background for this study? What are the main findings? Response: Precise, clear and unbiased reporting of adverse events (AE) is essential to ensure safety of the new drugs. It is crucial also in engaging patients and physicians in a shared decision making: before starting a new treatment I need to discuss with my pt what are the expected benefits and what the toxicities of a new drugs. However, in parallel to the discovery and development of new drugs, little attention has been paid to modernization of the way of collecting toxicities. This line of reasoning is particularly true for new or "relatively new" drugs, such as immunotherapy (IT) and targeted agents (TT). So, we analysed all the trials that lead to the approval of TT or IT from 2000 – 2015 retrieved by FDA database. (more…)
Author Interviews, Depression, Mental Health Research, Pharmacology / 09.10.2016

MedicalResearch.com Interview with: Antony Loebel, M.D. Executive Vice President and Chief Medical Officer, Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma GroupAntony Loebel, M.D. Executive Vice President and Chief Medical Officer Sunovion Head of Global Clinical Development Sumitomo Dainippon Pharma Group MedicalResearch.com: What is the background for this study? Response: Early predictors of subsequent clinical response are important in the treatment of depression, since 6-10 weeks of treatment are often required before full antidepressant response may occur. Early identification of patients who are unlikely to eventually achieve a response permits clinicians to intervene early to adjust the dose of medication, or switch to an alternative therapy. Multiple studies in major depressive disorder (MDD, unipolar) have reported that early improvement at 2 weeks is significantly predictive of treatment response at 6-8 weeks.The most common early improvement criterion is a 20-25% reduction in the Hamilton Depression Rating Scale (HAM-D) or the Montgomery-Asberg Depression Rating Scale (MADRS) scores1-6. Major depressive disorder with mixed features (MDD-MF) has recently been recognized as a diagnostic subtype in DSM-5. No research we are aware of has examined the predictive value of early improvement in patients diagnosed with MDD-MF. The aim of the current post-hoc analysis was to evaluate the value of early improvement in the MADRS or the Clinical Global Impressions, Severity (CGI-S) scale as predictors of response to lurasidone in patients with MDD-MF. (more…)
AHA Journals, Author Interviews, Heart Disease, Pharmacology / 06.10.2016

MedicalResearch.com Interview with: Xiaoxi Yao, PhD, MPH, MS Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery Mayo Clinic Rochester, MN MedicalResearch.com: What is the background for this study? What are the main findings? Response: Atrial fibrillation (AF) is the most common arrhythmia requiring treatment, affecting 3-6 million Americans. AF is associated with a 5 fold risk of stroke, which can be substantially reduced by oral anticoagulants. For over a half century, warfarin was the only option for long-term oral anticoagulation in the U.S., but the use of warfarin can be cumbersome. Warfarin has numerous interactions with food and other drugs, and requires regular lab testing and dose adjustment. Since 2010, four non–vitamin K antagonist oral anticoagulants (NOACs) have been approved by the FDA. In comparison to warfarin, the fixed-dosage NOACs provide more convenient therapeutic options and demonstrated at least equivalent efficacy and safety in large phase III clinical trials. However, the outcomes achieved in idealized clinical trial settings may not necessarily translate to routine clinical practice. In this large cohort of patients with nonvalvular AF, we assessed the real-world effectiveness and safety of three NOACs (dabigatran, rivaroxaban, and apixaban), comparing each agent with warfarin. We found apixaban was associated with lower risks of both stroke and major bleeding, dabigatran was associated with similar risk of stroke but lower risk of major bleeding, and rivaroxaban was associated with similar risks of both stroke and major bleeding in comparison to warfarin. (more…)
Author Interviews, Cost of Health Care, Ophthalmology, Pharmacology / 06.10.2016

MedicalResearch.com Interview with: Aleksandra Rachitskaya, MD Assistant Professor of Ophthalmology Retina Service, Department of Ophthalmology Cole Eye Institute Cleveland, OH 44195 MedicalResearch.com: What is the background for this study? Response: The Centers for Medicare and Medicaid Services (CMS) Open Payments database lists payment records from drug and device manufacturers to physicians. Anti-vascular endothelial growth factor (anti-VEGF) agents such as ranibizumab (Lucentis®, Genentech, Inc., San Francisco, CA), aflibercept (Eylea™, Regeneron, Tarrytown, NY) and off-label bevacizumab (Avastin®, Genentech, Inc., San Francisco, CA) are used for a variety of indications in ophthalmology. The current study examined the payments made to ophthalmologists related to ranibizumab and aflibercept and correlated those payments to provider usage of these medications. The former was achieved by utilizing Centers for Medicare and Medicaid Services (CMS) Provider Utilization and Payment database. (more…)
Author Interviews, Cost of Health Care, Pharmacology / 04.10.2016

MedicalResearch.com Interview with: Kevin Bowen MD MBA Senior Health Outcomes Researcher Prime Therapeutics LLC 1305 Corporate Center Drive Eagan, MN 55121 MedicalResearch.com: What is the background for this study? What are the main findings? • Autoimmune specialty drugs now account for about one of every 10 dollars of combined drug expense through the medical and pharmacy benefits in a commercially insured population. • The autoimmune drug class is one of the fastest growing, with this study finding a doubling in autoimmune drug expenditures and a 38 percent increase in utilization, in the most recent four years. • Integrated analysis of medical and pharmacy claims is essential for this category of drugs because more than 25 percent of autoimmune specialty drug use is paid through the medical benefit and medical claims diagnosis coding provides a means of determining what conditions were treated with drugs covered by pharmacy claims. (more…)
Author Interviews, Parkinson's, Pharmacology / 28.09.2016

MedicalResearch.com Interview with: Rosa & Co. LLC,Dr. Christina Friedrich Chief Engineer, PhysioPD Rosa & Co. LLC MedicalResearch.com: What is the background for this study? Response: Elan was developing compounds for the treatment of Parkinson’s Disease. The compounds were designed to modify negative effects of alpha-synuclein on neurotransmitter vesicle trafficking, but these effects are poorly understood. Elan and Rosa collaborated in the development of a Synuclein PhysioMap®, a graphical model architecture to support hypothesis generation and testing. The objectives of the project were to provide insight into alpha-synuclein function in vesicle trafficking, memorialize and communicate the current state of knowledge within Elan, and to recommend experiments to test hypotheses, resolve uncertainties and identify and prioritize potential targets. (more…)
Author Interviews, Multiple Sclerosis, Pharmacology / 27.09.2016

MedicalResearch.com Interview with: Marcia Kayath, MD Vice President and Head US Clinical Development and Medical Affairs US General Medicines Novartis Pharmaceuticals Corporation MedicalResearch.com: What is the background for this study? What are the main findings? Response: Injectable disease-modifying therapies (DMTs) are typically used first-line in patients with multiple sclerosis (MS), but discontinuation of injectable DMTs is common, especially within the first 12 months of treatment1,2. PREFERMS is the largest, prospective, randomized, active-controlled, open-label study to evaluate patient retention in patients with relapsing-remitting multiple sclerosis (RRMS). In the 12-month, Phase IV study, a total of 875 patients were randomized (1:1) to Gilenya® (fingolimod) 0.5 mg or to a pre-selected injectable DMT (IFNβ-1a, IFNβ-1b or glatiramer acetate), and followed up quarterly for 12 months3. After a minimum of 3 months of treatment, a single on-study treatment switch was allowed, however, switches due to efficacy or safety were allowed (based on patient-doctor consultation) at any month following randomization3. The primary endpoint was to compare the patient retention on randomized treatment over 12 months3. This study was powered for the primary endpoint (retention rate)3. The study was not powered to detect the treatment difference in the secondary efficacy endpoints or treatment effects related to switching study medication3. (more…)
Author Interviews, JAMA, Pharmacology, Rheumatology / 23.09.2016

MedicalResearch.com Interview with: Jacques-Eric Gottenberg, MD, PhD Department of Rheumatology National Reference Center for Systemic Autoimmune Diseases Strasbourg University Hospital, Université de Strasbourg Strasbourg, FranceJacques-Eric Gottenberg, MD, PhD Department of Rheumatology National Reference Center for Systemic Autoimmune Diseases Strasbourg University Hospital, Université de Strasbourg Strasbourg, France MedicalResearch.com: What is the background for this study? What are the main findings? Response: There is no recommendation for the choice of the second biologic in patients with rheumatoid arthritis and insufficient response to a first anti-TNF, which is a common situation in our daily practice (approximately one third of patients treated with anti-TNF). We therefore conducted the first randomized trial to date to investigate the best strategy in such a setting. (more…)
Author Interviews, Columbia, Depression, Nature, Orthopedics, Pharmacology / 09.09.2016

MedicalResearch.com Interview with: Patricia Ducy, PhD Associate Professor Department of Pathology & Cell Biology Columbia University New York, NY 10032 MedicalResearch.com: What is the background for this study? Response: In the past few years, several large clinical studies have reported an association between the use of selective serotonin reuptake inhibitors (SSRIs) and an increased risk of bone fractures. Yet, a few studies conducted on small cohorts using these drugs for a short time showed a decrease in bone resorption parameters and thus minor bone gain. To understand this paradox and to define how the deleterious effect of SSRIs could be prevented we conducted a series of studies in mice treated with fluoxetine, the active molecule of the widely prescribed SSRI Prozac. (more…)
Author Interviews, Ophthalmology, Pharmacology, Technology / 08.09.2016

MedicalResearch.com Interview with: Heather Sheardown PhD PEng FCAE Scientific Director 20/20 NSERC Ophthalmic Materials Network Professor, Department of Chemical Engineering Canada Research Chair in Ophthalmic Biomaterials McMaster University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Putting drops in the eye is well accepted from the standpoint of practitioners but is problematic for many patients. Therefore, particularly in cases where multiple drops are required in a day such as is the case with certain infections for example or a lifetime of drops is required such as is the case with diseases like glaucoma, patient compliance is a real issue. In addition, as much as 95% of any drop instilled in the eye is lost within the first 5 minutes, meaning that drug concentrations within the drop need to be higher to ensure that the required dose gets into the patient’s eye. Therefore there is a real need for a better alternative to traditional eyedrops is needed. We have developed a new method of formulating drugs for delivery as drops that adhere to the mucous layer of the tear film, allowing for smaller amounts of drug to be delivered over a prolonged period of time. This means that fewer drops with lower drug concentrations can be delivered. This is a micelle based system that allows for the formulation of more hydrophobic drugs. A mucoadhesive component associated with the micelle binds to the mucin layer of the tears, meaning that the residence time on the eye is similar to that of this layer - between 4 and 7 days. Drug is slowly released from the micelle, allowing for prolonged treatment. (more…)
Asthma, Author Interviews, NEJM, Pediatrics, Pharmacology / 01.09.2016

MedicalResearch.com Interview with: David A Stempel, MD Medical Affairs Lead US Medical Affairs GlaxoSmithKline MedicalResearch.com: What is the background for this study? What are the main findings? Response: Long-acting beta-agonists (LABAs) have been shown to increase the risk of asthma-related death among adults and the risk of asthma-related hospitalization among children. It is unknown whether the concomitant use of inhaled glucocorticoids with LABAs mitigates those risks. This trial prospectively evaluated the safety of the LABA salmeterol, added to fluticasone propionate, in a fixed-dose combination in children. (more…)
Author Interviews, Brigham & Women's - Harvard, Heart Disease, JACC, Pharmacology / 31.08.2016

MedicalResearch.com Interview with: Aaron S. Kesselheim, M.D., J.D., M.P.H. Associate Professor of Medicine at Harvard Medical School Director, Program On Regulation, Therapeutics, And Law (PORTAL) Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women's Hospital Boston MA 02120 MedicalResearch.com: What is the background for this study? What are the main findings? Response: It has been previously reported that the number of new cardiovascular drugs approved by the U.S. Food and Drug Administration (FDA) has declined in recent years. So we sought to empirically assess trends in the development of new cardiovascular therapeutics. (more…)
Author Interviews, Lipids, Pharmacology / 23.08.2016

MedicalResearch.com Interview with: Prof. Dr. Ioana Gouni-Berthold MD Center for Endocrinology, Diabetes and Preventive Medicine (ZEDP) University of Cologne Cologne, Germany MedicalResearch.com: What is the background for this study? Response: In Europe, up to half of the population aged between 35 and 64 has hypercholesterolemia (high levels of low-density lipoprotein cholesterol [LDL-C]), putting them at risk of heart disease. Despite increased treatment rates in recent years, many patients still do not receive adequate therapy, and heart disease remains the biggest cause of death in the USA and most European countries. Two drugs, alirocumab and evolocumab, have recently been approved for lowering LDL-C in patients with hypercholesterolaemia as an ‘add-on’ therapy to other lipid-lowering medication, or for use alone in patients unable to tolerate statins. These drugs have a unique mode of action– they inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that binds to LDL receptors and targets them for degradation. In the absence of PCSK9, the LDL receptor recycling is restored and the receptors are able to remove LDL from the blood. Both alirocumab and evolocumab have been tested in numerous patient populations in phase 3 trials; albeit evolocumab has an additional indication of homozygous familial hypercholesterolemia. We therefore felt that there was a need to collate the available data to assess the efficacy and safety of each agent. We chose reduction in LDL-C as our outcome of interest, because this was the primary endpoint of the pivotal clinical trials. (more…)
Addiction, Author Interviews, Compliance, Opiods, Pharmacology / 23.08.2016

MedicalResearch.com Interview with: F. Leland McClure III, MSci, PhD, F-ABFT Medical science liaison director Quest Diagnostics MedicalResearch.com: What is the background for this study? What are the main findings? Response: Many physicians associate Quest Diagnostics with their lab service needs because of our leadership in laboratory testing. But Quest is more than a lab, which is why we refer to ourselves as a diagnostic information services provider. This means that we help providers, health plans and even patients use the insights we derive from our lab testing data to deliver better care, quality and outcomes, both for the patient and the managed population. Our 2016 Quest Diagnostics Health Trends(TM) Prescription Drug Monitoring Report is an example of how we provide important health insights from Quest's laboratory data. Prescription drug misuse is a major epidemic in the United States. Laboratory testing can help identify if a patient is using or misusing prescribed medications. For instance, lab tests can show evidence of additional medications and other drugs in a patient’s urine specimen, suggesting potentially dangerous drug combinations. Earlier this year, the CDC issued guidelines that call for laboratory testing for patients prescribed certain medications, such as opioids, that carry a risk of abuse. Quest's prescription drug monitoring services help the physician identify if a patient is taking or not taking up to about four dozen drugs, such as oxycodone, Adderall XR® and Percocet®. For the Quest analysis, we analyzed more than 3 million de-identified lab test results. In this report, we found that 54 percent of patients’ results tested in 2015 showed evidence of drug misuse, slightly above the 53 percent misuse rate in 2014. That is certainly unacceptably high, but it’s a significant decline from the high of 63 percent we observed in 2011. We also found that an increasing proportion of patients who misuse medications combine their prescription medication with non-prescribed drugs. Among patients with inconsistent test results, forty-five percent of these patients showed evidence of one or more other drug(s) in addition to their prescribed drug regimen. That’s much higher than our findings of 35 percent in 2014 and 2013, 33 percent in 2012, and 32 percent in 2011. Finally, we were alarmed by the data showing the connection between heroin and benzodiazepines misuse. Our data showed one in three heroin users combine their drug use with benzodiazepines, the vast majority of which were unprescribed. This is an extremely dangerous practice given that benzodiazepines can have strong respiratory depressant effects when combined with other substances. Drug combinations, but particularly of heroin with benzodiazepines, can be potentially very dangerous, leading to coma and even death in some cases. (more…)
Author Interviews, Frailty, Hip Fractures, JAMA, Pharmacology / 22.08.2016

MedicalResearch.com Interview with: Jeffrey Munson, MD, MSCE Assistant Professor The Dartmouth Institute for Health Policy & Clinical Practice Assistant Professor, Department of Medicine Geisel School of Medicine at Dartmouth MedicalResearch.com: What is the background for this study?  Response: Fragility fractures due to osteoporosis are a common and costly event among older Americans. Patients who experience one fragility fracture are at increased risk to have a second fracture. Our group is interested in exploring ways in which the risk of a second fracture could be reduced. In this paper, we studied prescription drug use both before and after fracture. We know many prescription drugs have been shown to increase the risk of fracture, but we don’t know whether doctors try to reduce the use of these drugs after a fracture has occurred. Our study was designed to answer this question. (more…)
Author Interviews, JAMA, Pediatrics, Pharmacology / 16.08.2016

MedicalResearch.com Interview with: Dr Evie Stergiakouli Lecturer in Genetic Epidemiology and Statistical Genetics MRC Integrative Epidemiology Unit University of Bristol Bristol UK MedicalResearch.com: What is the background for this study? What are the main findings? Response: Acetaminophen is considered safe to use during pregnancy. However, research suggests that acetaminophen use in pregnancy is associated with abnormal neurodevelopment. It is possible that this association might be confounded by unmeasured behavioural factors linked to acetaminophen use. We compared acetaminophen use during pregnancy to postnatal acetaminophen use and partner's acetaminophen use. Only acetaminophen use during pregnancy has the potential to cause behavioural problems in the offspring. Any associations with postnatal acetaminophen use and partner's acetaminophen use would be due to confounding. Behavioural problems in the offspring were only associated with acetaminophen use during pregnancy. (more…)
Author Interviews, Dermatology, Pharmacology / 15.08.2016

MedicalResearch.com Interview with: Kin F. Chan, PhD Executive Vice President of Research and Technology BioPharmX Corporation MedicalResearch.com: What is the background for this study? What are the main findings? Response: There were two studies in this series.  The purpose is to get a better understanding of the blood plasma and skin levels of minocycline in a relevant animal model (minipig) for both the oral form of minocycline (Solodyn) and topical BPX-01, and to elucidate the same for oral minocycline only in a clinical study. The results provided valuable guidance and assurance to our upcoming Clinical Phase 2b dose-ranging study design. (more…)
Author Interviews, Immunotherapy, Lymphoma, Pharmacology / 14.08.2016

MedicalResearch.com Interview with: Dirk Huebner, MD Senior Medical Director Oncology Therapeutic Area Unit Takeda Pharmaceutical Company MedicalResearch.com: What is the background for this study? What are the main findings? Response: Cutaneous lymphomas are a category of non-Hodgkin lymphoma that primarily involve the skin. Cutaneous T-cell lymphoma, also known as CTCL, is the most common type of cutaneous lymphoma and typically presents with red, scaly patches or thickened plaques of skin that often mimic eczema or chronic dermatitis. ADCETRIS® (brentuximab vedotin) is an antibody-drug conjugate directed to CD30, which is expressed on skin lesions in approximately 50 percent of patients with CTCL. The Phase 3 ALCANZA trial compared the use of single-agent ADCETRIS to a control arm of investigator’s choice of standard therapies, methotrexate or bexarotene, in 131 patients with CD30-expressing CTCL who received prior systemic or radiation therapy. The study met its primary endpoint, demonstrating a highly statistically significant improvement in the rate of objective response lasting at least four months (ORR4). The ORR4 was 56.3 percent in the ADCETRIS arm compared to 12.5 percent in the control arm. (more…)
Author Interviews, Pharmacology / 11.08.2016

MedicalResearch.com Interview with: Willemien J. Kruik-Kollöffel, PharmD Medisch Spectrum Twente in Enschede Netherlands, MedicalResearch.com: What is the background for this study? Response: Safety concerns of the concomitant use of clopidogrel and proton pump inhibitors (PPIs) were published in 2009 and 2010 by the medicines regulatory agencies, including a direct healthcare professional communication. Those publications caused a lot of turmoil. We examined the association between various safety statements and prescription behavior for gastroprotective drugs in naïve patients in the Netherlands during the years 2008–2011. (more…)
Author Interviews, Heart Disease, Kidney Disease, Pharmacology, UCLA / 09.08.2016

MedicalResearch.com Interview with: Jenny Shen, MD, MS Assistant Professor of Medicine David Geffen School of Medicine at UCLA Los Angeles Biomedical Institute at Harbor-UCLA Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: With cardiovascular disease being the No. 1 cause of death in end-stage kidney disease patients on peritoneal dialysis, we examined two classes of medications commonly prescribed to prevent cardiovascular events in these patients and found no significant difference in outcomes. The two classes of medications, angiotensin-converting enzyme inhibitors (ACEI) and angiotensin-II receptor blockers (ARB), have slightly different mechanisms and could theoretically have differing outcomes. Previous studies had suggested that ACEI may lead to a kinin-mediated increase in insulin sensitivity not seen with ARB. This could potentially lower the cardiovascular risk in patients on peritoneal dialysis because they are exposed to high glucose loads in their dialysate that may lead to insulin resistance and its associated cardiovascular risk. Using a national database, the U.S. Renal Data System, we surveyed records for all patients enrolled in Medicare Part D who initiated maintenance peritoneal dialysis from 2007 to 2011. Of those, we found 1,892 patients using either drug class. Surveying their medical records, we found no difference in cardiovascular events or deaths between the users for each class of medication. (more…)
Author Interviews, Pharmacology / 01.08.2016

MedicalResearch.com Interview with: PD Dr. Andreas Koeberle Lehrstuhl für Pharmazeutische/Medizinische Chemie Institut für Pharmazie Biologisch-Pharmazeutische Fakultät Friedrich-Schiller-Universität Jena Philosophenweg Jena MedicalResearch.com: What is the background for this study? What are the main findings? Response: Natural products from plants used in traditional medicine are valuable sources for identifying novel strategies as well as lead structures for drug development. The diterpenoids carnosol and carnosic acids from Salvia spp. (sage) represent such candidate compounds. They exert prominent anti-inflammatory activities though their molecular mechanisms are incompletely understood, which hampers their pharmacological use. Our study investigated the potential of carnosol and carnosic acid in inflammatory pain and addressed the cellular consequences and the molecular interactions with key targets. We demonstrate that the two diterpenoids have anti-inflammatory and anti-nociceptive effects in established mouse models of inflammation, and describe 5-lipoxygenase and microsomal prostaglandin E2 synthase-1, two key enzymes of inflammation, as primary targets. Moreover, we characterized the functional consequences of enzyme inhibition in a cellular context and investigated structural aspects of ligand/target interactions. (more…)