Author Interviews, Heart Disease, Pharmacology / 20.03.2017

MedicalResearch.com Interview with: [caption id="attachment_33131" align="alignleft" width="133"]Kathrine Bach Søndergaard MD, Research Fellow Gentofte University Hospital Department of Cardiology Hellerup Dr. Søndergaard[/caption] Kathrine Bach Søndergaard MD, Research Fellow Gentofte University Hospital Department of Cardiology Hellerup  MedicalResearch.com: What is the background for this study? Response: Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used and have in previous studies been associated with an increased risk of cardiovascular adverse events, such as myocardial infarction and heart failure. Cardiac arrest is the ultimate adverse event; however, no research exists of the association between cardiac arrest and use of NSAIDs, which we aimed to assess in this study.
Author Interviews, Boehringer Ingelheim, Dermatology, Pharmacology / 08.03.2017

MedicalResearch.com Interview with: [caption id="attachment_32763" align="alignleft" width="180"]Andrew Blauvelt, M.D., M.B.A. President and Investigator Oregon Medical Research Center Dr. Blauvelt[/caption] Andrew Blauvelt, M.D., M.B.A. President and Investigator Oregon Medical Research Center  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Findings from the Phase 3 VOYAGE 1 study showed that patients with moderate to severe plaque psoriasis receiving guselkumab, an human anti-interleukin (IL)-23 monoclonal antibody, achieved significant improvement in skin clearance and in comparison with Humira® (adalimumab), a TNF blocker.  The Phase 3 study and head-to-head analysis of guselkumab vs. adalimumab showed the significant and durable efficacy of guselkumab as maintained through one year when compared with adalimumab, and the robust efficacy of this novel IL-23 targeted therapy in meeting all primary and major secondary endpoints.
ASCO, Author Interviews, Outcomes & Safety, Pharmacology, Prostate Cancer, University of Michigan / 03.03.2017

MedicalResearch.com Interview with: [caption id="attachment_32608" align="alignleft" width="128"]Megan Elizabeth Veresh Caram MD Clinical Lecturer Internal Medicine, Hematology & Oncology University of Michigan Dr. Caram[/caption] Megan Elizabeth Veresh Caram MD Clinical Lecturer Internal Medicine, Hematology & Oncology University of Michigan   MedicalResearch.com: What is the background for this study? Response: Abiraterone and enzalutamide are oral medications that were approved by the Food & Drug Administration in 2011 and 2012 to treat men with metastatic castration-resistant prostate cancer. Most men with advanced prostate cancer are over age 65 and thus eligible for Medicare Part D. We conducted a study to better understand the early dissemination of these drugs across the United States using national Medicare Part D and Dartmouth Atlas data.
Author Interviews, BMJ, Flu - Influenza, Karolinski Institute, OBGYNE, Pediatrics, Pharmacology / 01.03.2017

MedicalResearch.com Interview with: [caption id="attachment_32424" align="alignleft" width="146"]Dr. Sophie Graner Department of Women's and Childrens Health Karolinska Institute, Stockholm, Sweden Dr. Graner[/caption] Dr. Sophie Graner Department of Women's and Childrens Health Karolinska Institute, Stockholm, Sweden MedicalResearch.com: What is the background for this study? What are the main findings? Response: Pregnant women are at increased risks of severe disease and death due to influensa infection, as well as hospitalization. Also influenza and fever increase the risk of adverse pregnancy outcomes for their infants such as intrauterine death and preterm birth. Due to this, the regulatory agencies in Europe and the US recommended post exposure prophylaxis and treatment for pregnant women with neuraminidase inhibitors during the last influenza pandemic 2009-10. Despite the recommendations, the knowledge on the effect of neuraminidase inhibitors on the infant has been limited. Previously published studies have not shown any increased risk, but they have had limited power to assess specific neonatal outcomes such as stillbirth, neonatal mortality, preterm birth, low Agar score, neonatal morbidity and congenital malformations.
Author Interviews, Epilepsy, Pharmacology / 28.02.2017

MedicalResearch.com Interview with: [caption id="attachment_32486" align="alignleft" width="200"]Robert Lutjens, PhD Head of Discovery at Addex Therapeutics Geneva, Switzerland Dr. Lutjens[/caption] Robert Lutjens, PhD Head of Discovery at Addex Therapeutics Geneva, Switzerland MedicalResearch.com: What is the background for this study? What are the main findings? Response: Metabotropic glutamate receptors represent an attractive therapeutic target for various neurologic conditions. In particular, the metabotropic glutamate receptor subtype 2 (mGlu2) can affect excitatory synaptic transmission by decreasing glutamate release. As excess gluatamate is observed in epilepsy, targeting mGlu2 could lead to new avenues of therapy. Positive allosteric modulators (PAMs) of mGlu2 could be valuable candidate drugs as they do not directly activate receptors. Therefore, they may avoid tachyphylaxis and side effects emerging from direct receptor agonism.  The publication summarizes the effects obtained when the mGlu2 receptor is activated using an agonist or PAM, such as ADX71149, in the 6Hz psychomotor seizure test, considered to be the most relevant model of pharmacoresistant limbic seizures. The data show that while seizures are reduced when mGlu2-acting compounds are administered alone, their combination with the antiseizure drug levetiracetam (LEV) result in a potent reduction of doses required to produce full efficacy, which is important because higher doses of LEV are associated with dose-limiting side effects, such as aggression, nervousness/anxiety, somnolence and fatigue. In this study, a fixed dose of ADX71149 was seen to increase the potency of LEV, leading to an approximate 35-fold increase in its potency. Conversely, using a fixed dose of LEV with varying doses of ADX71149 resulted in an approximate 14-fold increase in ADX71149 potency.
Author Interviews, Dermatology, Pharmacology / 24.02.2017

MedicalResearch.com Interview with: [caption id="attachment_32369" align="alignleft" width="133"]Prof. Dr. med. Kristian Reich Dermatologie, Allergologie Psoriasis- und Neurodermitis-Trainer Hamburg Prof.  Kristian Reich[/caption] Prof. Dr. med. Kristian Reich Dermatologie, Allergologie Psoriasis- und Neurodermitis-Trainer Hamburg MedicalResearch.com: What is the background for this study? What are the main findings? Response: Ustekinumab is an antibody against the p40 molecule shared by IL-12 and IL-23. The antibody shows a favorable benfit-risk profile in the treatment of psoriasis. IL-23 is regarded a key driver in psoriasis pathology. It is speculated that antibodies against the IL-23-specific subunit p19 may produce even higher levels of clinical response than ustekinumab or the anti-TNF antagonist adalimumab. Guselkumab is the first IL-23p19 antibody to publish phase III data in psoriasis.   
Author Interviews, Depression, JAMA, Pharmacology, Yale / 23.02.2017

MedicalResearch.com Interview with: [caption id="attachment_32285" align="alignleft" width="160"]Adam Chekroud PhD Candidate Human Neuroscience Lab Adam Chekroud[/caption] Adam Chekroud PhD Candidate Human Neuroscience Lab Department of Psychology Yale University MedicalResearch.com: What is the background for this study? Response: We know that depression includes a wide range of symptoms, from low mood and feeling worthless, to problems sleeping, slowed thinking, and suicidal ideation. We wanted to know whether antidepressants work well in treating all of these symptoms, or whether they are primarily effective on certain kinds of symptoms.
Author Interviews, HIV, Pharmacology / 20.02.2017

MedicalResearch.com Interview with: [caption id="attachment_32236" align="alignleft" width="200"]Kati Vandermeulen Senior Director, Global Regulatory Leader and Compound Development Team Lead IDV Janssen Kati Vandermeulen[/caption] Kati Vandermeulen Senior Director, Global Regulatory Leader and Compound Development Team Lead IDV Janssen MedicalResearch.com: What is the background for this study? What are the main findings? Response:  SWORD is the first large trial program specifically conducted to look at the combination of dolutegravir and rilpivirine as a complete, two-drug antiretroviral regimen. Results of the two identical Phase III SWORD studies have been positive and demonstrate that the two-drug regimen of dolutegravir and rilpivirine is as effective, with comparable tolerability, to traditional three- or four-drug (integrase inhibitor-, non-nucleoside reverse transcriptase inhibitor-, or boosted protease inhibitor-based) antiretroviral regimens for the maintenance treatment of HIV.
Author Interviews, Biomarkers, Pharmacology, Prostate Cancer / 19.02.2017

MedicalResearch.com Interview with: Teemu J Murtola, MD, PhD, adjunct professor University of Tampere, Faculty of Medicine and Life Sciences Tampere University Hospital, Department of Urology Tampere, Finland MedicalResearch.com: What is the background for this study? Response: A previous study called Prostate Cancer Prevention Trial (PCPT) showed that finasteride, which belongs to a drug group called 5alpha-reductase inhibitors lowers serum PSA and increases sensitivity of PSA to detect high-grade prostate cancer in men who had little or no symptoms of the lower urinary tract. We postulated that this effect would increase the accuracy and benefits of PSA-based prostate cancer screening. Finnish Randomized Study of Screening for Prostate Cancer was a large trial of over 80,000 men randomized either to be screened for prostate cancer with a PSA test at 4-year intervals or to be followed for prostate cancer incidence and mortality via national registries. Three consecutive screening rounds were commenced between 1996-2008. In the current study we compared the effects of PSA-based screening on prostate cancer risk and mortality separately among men who were using 5alpha-reductase inhibitors finasteride or dutasteride and among men who were not.
Author Interviews, Heart Disease, JACC, Pharmacology / 15.02.2017

MedicalResearch.com Interview with: [caption id="attachment_31864" align="alignleft" width="180"]Gavin Y Oudit, MD, PhD, FRCPC Associate Professor, Department of Medicine, University of Alberta Clinician-Scientist, Mazankowski Alberta Heart Institute Canada Research Chair in Heart Failure Division of Cardiology, 2C2 Walter Mackenzie Health Sciences Centre Edmonton, Alberta Dr. Gavin Oudit[/caption] Gavin Y Oudit, MD, PhD, FRCPC Associate Professor, Department of Medicine, University of Alberta Clinician-Scientist Mazankowski Alberta Heart Institute Canada Research Chair in Heart Failure Division of Cardiology Edmonton, Alberta Heart specialist Gavin Oudit and his research team discovered a molecule — angiotensin converting enzyme 2 (ACE2)—that works to restore balance to the pathways responsible for chronic and acute heart failure, including in hearts from patients with advanced heart failure who underwent heart transplants. In developing the new drug, Oudit and his team discovered to an extent not seen before how the renin-angiotensin system (RAS), which regulates the body’s sodium balance, fluid volume, and blood pressure, is at play in both acute and chronic heart failure. In collaboration with Dr. Oudit, recombinant human ACE2 was made by Apeiron Biologics, purchased by GlaxoSmithKline, and has recently completed phase II clinical trial.
Author Interviews, Lancet, Multiple Sclerosis, Neurological Disorders, Pharmacology / 12.02.2017

MedicalResearch.com Interview with: [caption id="attachment_31938" align="alignleft" width="147"]Tomas Kalincik, MD, PhD, PGCertBiostat Neurologist and Senior Research Fellow Melbourne Brain Centre | Department of Medicine | University of Melbourne Department of Neurology | Royal Melbourne Hospital Melbourne | Victoria | Australia Dr. Tomas Kalincik[/caption] Tomas Kalincik, MD, PhD, PGCertBiostat Neurologist and Senior Research Fellow Melbourne Brain Centre | Department of Medicine | University of Melbourne Department of Neurology | Royal Melbourne Hospital Melbourne | Victoria | Australia MedicalResearch.com: What is the background for this study? What are the main findings? Response: Multiple sclerosis is a disease predominantly of young adults, with the peak of incidence in the 3rd and 4th decades. It is the most common cause of neurological disability in young adults. Only in Australia, 23,000 people are living with MS, with MS representing an annual cost of almost 1 billion $AU to the Australian society. It is a disease that presents with broad range of neurological symptoms and signs, which are typically temporary (these are called relapses) that with time can lead to permanent neurological disability. While there is currently no cure for MS, with appropriate therapy, its symptoms can be controlled and the disability progression slowed down.
Author Interviews, Infections, Pharmacology / 09.02.2017

MedicalResearch.com Interview with: Dr. Fernanda Buzzola IMPaM, UBA-CONICET MedicalResearch.com: What is the background for this study? Response: Staphylococcus aureus represents a serious problem to public health due to methicillin-resistance and the bacterial persistence over a long period of time in the host. Approximately the 20% of the human population is at risk to acquire an endogenous infection by S. aureus as a consequence of its asymptomatic nasal colonization. Aspirin, the main source of salicylic acid in the human host, is currently taken by millions of human beings worldwide without medical prescription and widely indicated for defined purposes, including prevention of coronary thrombosis. Salicylic acid is a plant hormone known too for its use as a key ingredient in anti-acne preparations and medications for skin conditions. We also consume mild doses of salicylic acid when we eat fruits and vegetables. Iron is an important trace element for the human body and plays an essential role in blood formation. The metabolism of many bacteria, including S. aureus, also depends on the availability of iron molecules. Salicylic acid forms complexes with iron ions in the blood and so deprives not only us but also the staphylococcal bacteria of this element. S. aureus modifies its metabolism if the iron content is insufficient. The microorganism reacts to the changed – from its perspective, negative – conditions through the intensified formation of a biofilm, a sort of layer of slime formed by the aggregation of individual bacteria. The enhanced biofilm production allows the bacteria to survive for an even longer period under unfavourable living conditions.
Author Interviews, BMJ, Pain Research, Pharmacology / 07.02.2017

MedicalResearch.com Interview with: [caption id="attachment_31800" align="alignleft" width="180"]Dr. Gustavo Machado BPhty (Hons) Cert.MDT The George Institute for Global Health Sydney Medical School, University of Sydney Sydney, New South Wales, Australia Dr. Gustavo Machado[/caption] Dr. Gustavo Machado BPhty (Hons) Cert.MDT The George Institute for Global Health Sydney Medical School, University of Sydney Sydney, New South Wales, Australia MedicalResearch.com: What is the background for this study? What are the main findings? Response: People with back pain are usually told by their health care practitioners to take analgesic medications to relieve their pain. But our previous research published in the BMJ showed that paracetamol does not have a measurable impact on patient’s symptoms. This resulted in recent changes in guidelines' recommendations. The 2017 National Institute for Health and Care Excellence (NICE) guidelines/UK no longer recommend paracetamol as a stand-alone intervention for back pain. So now non-steroidal anti-inflammatory drugs (NSAIDs) are recommended as the analgesic of first choice. However, our results show that compared to placebo, commonly used NSAIDs, such as Ibuprofen (e.g. Nurofen) and Diclofenac (e.g. Voltaren), provide only small benefits for people with back pain while increasing the risk of gastrointestinal adverse effects by 2.5 times.
Author Interviews, Diabetes, Endocrinology, Heart Disease, Lipids, Pharmacology, Weight Research / 30.01.2017

MedicalResearch.com Interview with: [caption id="attachment_31502" align="alignleft" width="130"]Gianluca Iacobellis MD PhD Professor of Clinical Medicine Division of Endocrinology, Diabetes and Metabolism Department of Medicine University of Miami, FL Dr. Gianluca Iacobellis[/caption] Gianluca Iacobellis MD PhD Professor of Clinical Medicine Division of Endocrinology, Diabetes and Metabolism Department of Medicine University of Miami, FL MedicalResearch.com: What is the background for this study? What are the main findings? Response: We know that epicardial fat, the visceral fat of the heart, is associated with coronary artery disease, diabetes and obesity. My studies have shown that epicardial fat can be easily measured with non invasive imaging procedures. Remarkably, epicardial fat has recently emerged as therapeutic target responding to medications targeting the fat. Liraglutide, a GLP-1 analog has shown to provide modest weight loss and beneficial cardiovascular effects beyond its glucose lowering action. So , we sought to evaluate the effects of liraglutide on epicardial fat.
Anemia, Author Interviews, Kidney Disease, Pharmacology, Stanford / 16.01.2017

MedicalResearch.com Interview with: [caption id="attachment_31275" align="alignleft" width="200"]Dr. Glenn M. Chertow, MD Professor Medicine, Nephrology Stanford University School of Medicine Dr. Glenn M. Chertow[/caption] Dr. Glenn M. Chertow, MD Professor Medicine, Nephrology Stanford University School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: Iron deficiency is common in persons with moderate to advanced (non-dialysis-dependent) chronic kidney disease (CKD), for a variety of reasons. Conventional iron supplements tend to be poorly tolerated and of limited effectiveness. In earlier studies of patients treated with ferric citrate for its effect as a phosphate binder, we saw increases in transferrin saturation and ferritin (markers of iron stores) and hemoglobin and hematocrit (the “blood count”). Therefore, we thought we should test the safety and efficacy of ferric citrate specifically for the treatment of iron deficiency anemia (IDA). With respect to the key findings, more than half (52%) of patients treated with ferric citrate experienced a sizeable (>=1 g/dL) increase in hemoglobin over the 16-week study period compared to fewer than one in five (19%) patients treated with placebo. Rates of adverse events (“side effects”) were similar to placebo; diarrhea in some patients and constipation in others were the most common. There were also favorable effects of ferric citrate on laboratory metrics of bone and mineral metabolism.
Author Interviews, Cancer Research, Diabetes, Pharmacology, Science / 05.01.2017

MedicalResearch.com Interview with: Dr. Don Gary Benjamin Biozentrum, University of Basel Basel, Switzerland. MedicalResearch.com: What is the background for this study? What are the main findings? Response: We initiated the study to find a co-drug that would increase the anti-cancer effect of the commonly prescribed anti-diabetic drug metformin. Metformin is a very well tolerated medication, however the dosage required to show anti-cancer activity is higher than that usually prescribed, hence the aim of the study. We found that metformin in combination with a second drug, syrosingopine (an anti-hypertensive), potently kills cancer cells in a variety of pre-clinical models. Quite nicely, both these drugs combine to kill the cells at a concentration where they have no impact on cell growth when applied singly.
Annals Thoracic Surgery, Author Interviews, Diabetes, Duke, Heart Disease, Hepatitis - Liver Disease, Pharmacology / 04.01.2017

MedicalResearch.com Interview with: [caption id="attachment_30926" align="alignleft" width="156"]Matthew J. Crowley, MD, MHS Assistant Professor of Medicine Member in the Duke Clinical Research Institute Duke University Medical Center Dr. Matthew Crowley[/caption] Matthew J. Crowley, MD, MHS Assistant Professor of Medicine Member in the Duke Clinical Research Institute Duke University Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Although metformin is widely considered to be the first-line drug for type 2 diabetes, concerns about lactic acidosis have traditionally limited its use in some populations. However, FDA now indicates that metformin may be used safely for patients with mild-moderate chronic kidney disease and other historical contraindications like congestive heart failure. With the lactic acidosis question addressed for these groups, this review asked “what do we know about how metformin affects mortality and other outcomes for patients with historical contraindications and precautions?” The main take-home message is that metformin appears associated with lower mortality in patients with mild-moderate chronic kidney disease, congestive heart failure, and chronic liver disease.
Author Interviews, Cost of Health Care, Immunotherapy, Melanoma, Pharmacology / 22.12.2016

MedicalResearch.com Interview with: [caption id="attachment_30744" align="alignleft" width="141"]Herbert H F Loong MBBS(HK), PDipMDPath(HK), MRCP(UK), FHKCP, FHKAM(Medicine) Specialist in Medical Oncology Clinical Assistant Professor, Department of Clinical Oncology Deputy Medical Director, Phase 1 Clinical Trials Centre The Chinese University of Hong Kong Prince of Wales Hospital Hong Kong SAR Dr. Herbert Loong[/caption] Herbert H F Loong MBBS(HK), PDipMDPath(HK), MRCP(UK), FHKCP, FHKAM(Medicine) Specialist in Medical Oncology Clinical Assistant Professor, Department of Clinical Oncology Deputy Medical Director, Phase 1 Clinical Trials Centre The Chinese University of Hong Kong Prince of Wales Hospital Hong Kong SAR MedicalResearch.com: What is the background for this study?  Response: Advanced melanoma have previously been known to be a disease with a dismal prognosis. Over the last few years, clinical trials data and real-world clinical experience of checkpoint inhibitors have significantly changed the treatment landscape for advanced melanoma patients. This was first demonstrated with the Anti-CTLA4 Ab Ipilimumab, and more recently with the Anti-PD1 Ab pembrolizumab. Whilst we have seen dramatic improvements in disease control with the use of these agents, the high costs of these drugs may be prohibitive to the average patient who has to pay out-of-pocket and potentially may place significant burdens on healthcare systems. There is a need to rationally assess the cost-effectiveness of these new agents, specifically addressing the potential benefits to the individual patient and to society, whilst balancing the costs that such a treatment may entail. The assessment of cost-effectiveness of a particular treatment is extremely important in Hong Kong, as this has direct implications on drug reimbursement and accessibility of the particular drug in question at public hospitals in Hong Kong. The aim of the study is to assess the cost-effectiveness of pembrolizumab in patients with advanced melanoma used in the first-line setting in Hong Kong, and comparing it to (1) ipilimumab and (2) cytotoxic chemotherapy. Cytotoxic chemotherapy chosen for comparison were drugs commonly used in the first line setting in Hong Kong, which included dacarbazine, temozolomide and carboplatin+paclitaxel combination. It is important to note that whilst ipilimumab is registered for this indication in Hong Kong, there is no reimbursement of this drug by the Hospital Authority in Hong Kong and patients have to pay out-of-pocket. The cost of ipilimumab and the associated side effects has been prohibitive to most advanced melanoma patients in the public setting.
AHA Journals, Author Interviews, Lipids, Pharmacology / 16.12.2016

MedicalResearch.com Interview with: [caption id="attachment_30566" align="alignleft" width="100"]Dr. Eli M. Roth MD, FACC President, Medical Director Sterling Research Group Cincinnati, OH Dr. Eli Roth[/caption] Dr. Eli M. Roth MD, FACC President, Medical Director Sterling Research Group Cincinnati, OH MedicalResearch.com: What is the background for this study? What are the main findings? Response: At this year’s AHA 2016, we presented a pharmacodynamics analysis of ODYSSEY CHOICE I, which evaluated the effects of Praluent 300 mg administered every four weeks (Q4W) for 24 weeks in hypercholesterolemia patients at moderate to very high cardiovascular risk who were on maximally tolerated statin or no statin and/or other lipid-lowering therapies. The pharmacodynamic analysis of CHOICE I in patients on statins supports the use of Praluent 300 mg Q4W as an alternative starting dose for patients who prefer a Q4W dosing regimen and demonstrates the value of LDL-C based dosing interval adjustment. The findings from this analysis were consistent with prior ODYSSEY Phase 3 studies, showing that Praluent substantially reduced circulating free PCSK9 concentration, resulting in significant LDL-C reductions. Additionally, Praluent was generally well tolerated.
Author Interviews, Depression, JAMA, McGill, Pharmacology, Stroke / 09.12.2016

MedicalResearch.com Interview with: Christel Renoux, MD, PhD Assistant Professor, Dept. of Neurology & Neurosurgery McGill University Centre For Clinical Epidemiology Jewish General Hospital - Lady Davis Research Institute Montreal  Canada MedicalResearch.com: What is the background for this study? Response: Selective serotonin reuptake inhibitors (SSRIs) increase the risk for abnormal bleeding, in particular, gastrointestinal tract bleeding. Previous studies also suggested an increased risk for intracranial hemorrhage (ICH) in patients treated with SSRIs compared to non users. However, even if this risk exists, the comparison with a non-treated group may exaggerate the strength of a potential association and the comparison with a group of patients treated with other antidepressants may help better delineate the risk. The potential bleeding effect of antidepressants is linked to the strength of serotonin inhibition reuptake, and antidepressants that are strong inhibitors of serotonin reuptake have been associated with the risk for gastrointestinal or abnormal bleeding compared with weak inhibitors but the risk of ICH is unclear.
Author Interviews, Pharmacology / 02.12.2016

MedicalResearch.com Interview with: [caption id="attachment_30138" align="alignleft" width="200"]Dr. Charles Pollack MD Professor of Emergency Medicine Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia. Dr. Charles Pollack[/caption] Dr. Charles Pollack MD Professor of Emergency Medicine Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia. MedicalResearch.com: What is the background for this study? What are the main findings? Response: RE-VERSE AD™ is a multinational, open-label cohort Phase III trial studying the safety and efficacy of idarucizumab (PRAXBIND) to reverse the anticoagulant effects of dabigatran (PRADAXA) in patients with life-threatening or uncontrolled bleeding, or those who require emergency procedures. It is the largest patient study investigating a reversal agent for a novel oral anticoagulant (NOAC) in real world emergency settings. At the American Heart Association’s Scientific Sessions 2016, we presented updated results from 494 patients participating in the ongoing study, showing that administration of 5g of idarucizumab immediately reversed the anticoagulant effect of dabigatran.
Author Interviews, Electronic Records, Geriatrics, Pharmacology / 29.11.2016

MedicalResearch.com Interview with: [caption id="attachment_30022" align="alignleft" width="130"]Jashvant Poeran MD PhD Assistant Professor Dept. of Population Health Science & Policy Icahn School of Medicine at Mount Sinai New York, NY Dr. Jashvant Poeran[/caption] Jashvant Poeran MD PhD Assistant Professor Dept. of Population Health Science & Policy Icahn School of Medicine at Mount Sinai New York, NY MedicalResearch.com: What is the background for this study? Response: Falls are an important patient safety issue among elderly patients and may lead to extended hospitalization and patient harm. Particularly important in elderly patients are high risk drugs such as sleep medications which are known to increase fall risk and should be dosed lower in elderly patients. In this study we looked at patients aged 65 years or older who fell during hospitalization. We found that in 62%, patients had been given at least one high risk medication that was linked to fall risk, within 24 hours before their fall. Interestingly, we found that also a substantial proportion of these medications were given at doses higher than generally recommended for elderly patients.
Author Interviews, HIV, Pharmacology / 28.11.2016

MedicalResearch.com Interview with: Arkaitz Imaz Vacas HIV and STD Unit, Department of Infectious Diseases Hospital Universitari de Bellvitge MedicalResearch.com: What is the background for this study? Response: Sexual transmission is the most common route of human immunodeficiency virus (HIV) acquisition in most regions of the world. The male genital tract is a separate reservoir for HIV and may contribute to HIV shedding in seminal fluid even in individuals receiving antiretroviral (ARV) therapy (ART). Treatment of HIV-infected patients with currently available combined ART suppresses HIV in blood and also in genital fluids and reduces the risk of HIV acquisition by their sexual partners. However, sexual HIV transmission is possible even in patients on ART, especially if treatment was initiated recently. Thus, the ability of ARV drugs to penetrate into the male genital tract is a key factor for achieving HIV suppression in seminal fluid and preventing sexual transmission of the virus. Dolutegravir (DTG) is a new integrase inhibitor (INI) with high antiviral potency and a high genetic barrier to resistance. In large phase III-a randomized clinical trials, DTG in combination with 2 nucleos(t)ide reverse-transcriptase inhibitors (NRTIs) has shown noninferiority compared with raltegravir and superiority to efavirenz or ritonavir-boosted darunavir as first-line therapy in treatment-naive HIV-1 infected patients. A study in healthy volunteers showed that DTG penetration in seminal fluid was <7% of DTG exposure in blood plasma (BP), and the median seminal concentration at the end of the dosing interval (C24h) was lower than the in vitro protein-adjusted (PA) 90% inhibitory concentration (IC90) for wild-type HIV-1. However, information about protein unbound DTG fraction in seminal fluid is lacking and there is no information regarding DTG concentrations in the semen of HIV-1–infected patients or the antiviral activity of a DTG-based ARV combination in this compartment. The aim of this study was to compare viral decay kinetics and DTG concentrations (total drug and unbound fraction) in the seminal plasma (SP) and BP in a group of treatment-naive HIV-1 infected patients starting DTG plus abacavir (ABC) and lamivudine (3TC) once daily.
Author Interviews, Blood Pressure - Hypertension, Bone Density, JAMA, Kaiser Permanente, Osteoporosis, Pharmacology / 22.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29895" align="alignleft" width="200"]Joshua I. Barzilay, MD Kaiser Permanente of Georgia Duluth, GA 30096 Dr. Joshua I. Barzilay[/caption] Joshua I. Barzilay, MD Kaiser Permanente of Georgia Duluth, GA 30096 MedicalResearch.com: What is the background for this study? Response: Hypertension (HTN) and osteoporosis (OP) are age-related disorders. Both increase rapidly in prevalence after age 65 years. Prior retrospective, post hoc studies have suggested that thiazide diuretics may decrease the risk of osteoporosis. These studies, by their nature, are open to bias. Moreover, these studies have not examined the effects of other anti HTN medications on osteoporosis. Here we used a prospective blood pressure study of ~5 years duration to examine the effects of a thiazide diuretic, a calcium channel blocker and an ACE inhibitor on hip and pelvic fractures. We chose these fractures since they are almost always associated with hospitalization and thus their occurrence can be verified. After the conclusion of the study we added another several years of follow up by querying medicare data sets for hip and pelvic fractures in those participants with medicare coverage after the study conclusion.
Author Interviews, Gout, Kidney Disease, Pharmacology / 19.11.2016

MedicalResearch.com Interview with: Dr. Ana Beatriz Vargas dos Santos Médica do Serviço de Reumatologia Universidade do Estado do Rio de Janeiro MedicalResearch.com: What is the background for this study? Response: Gout is the most common inflammatory arthritis worldwide and, despite available treatment, the management of gout remains suboptimal. One of the reasons for this suboptimal management of gout is the hesitant use of urate-lowering therapy, including a common reduction in dose or discontinuation of allopurinol in patients with gout who have kidney dysfunction based on the assumption that allopurinol may be worsening kidney function. However, there is no evidence that allopurinol is toxic for the kidneys, and this dose reduction or discontinuation results in more difficult-to-treat gout. Chronic kidney disease stage 3 or above occurs in approximately 20% of people with gout, and there is emerging evidence that urate-lowering therapy may improve kidney function in patients with both gout and CKD. Although CKD is common, most people with gout start out with normal kidney function. Yet, there are limited data regarding the effects of allopurinol on kidney function in such individuals. We, therefore, undertook this study to assess whether people with newly diagnosed gout who are starting allopurinol are at increased risk for developing CKD stage 3 or worse.
Author Interviews, CMAJ, Pharmacology, Urology / 19.11.2016

MedicalResearch.com Interview with: Emma Maund, MSc PhD Nordic Cochrane Centre MedicalResearch.com: What is the background for this study? Response: Duloxetine has been approved in Europe for the treatment of stress urinary incontinence in women. It is not approved for this indication in the US and Canada. Currently, reasons why marketing authorization applications are withdrawn or denied are not published by either the Canadian or the US drug agency. However, the FDA has said that a higher-than-expected rate of suicide attempts - 2.6 timer higher - was observed in the open-label extensions of controlled trials of duloxetine for stress urinary incontinence. Given the FDA’s statement about the rate of suicide attempts, we wanted to determine whether duloxetine increased the risk of suicidality, violence or their possible precursors (drug induced akathisia, an extreme type of restlessness; activation, which consists of stimulating effects such as insomnia, anxiety and agitation; emotional disturbance, such as depersonalization and derealization; or psychotic events, such as delusions and hallucinations) in the randomized phases of the trials. We therefore assessed the benefits and harms of duloxetine in stress urinary incontinence using clinical study reports, including individual patient data, of the 4 main trials submitted by Eli Lilly to the European Medicines Agency.
Author Interviews, Brigham & Women's - Harvard, Compliance, Gastrointestinal Disease, Pharmacology, Technology / 18.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29758" align="alignleft" width="143"]C. Giovanni Traverso, MB, BChir, PhD Gastroenterologist and biomedical engineer Division of Gastroenterology at BWH Instructor of medicine at Harvard Medical School. Dr. Traverso[/caption] C. Giovanni Traverso, MB, BChir, PhD Gastroenterologist and biomedical engineer Division of Gastroenterology at BWH Instructor of medicine at Harvard Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response: We developed a drug delivery system capable of safely residing in the stomach for 2 weeks. Furthermore we demonstrated the capacity of the novel dosage form, in the shape of a star, to protect the drug from the acidic stomach environment and also slowly release drug over the course of 14 days. We applied this new technology towards efforts targeting the elimination of malaria. Specifically, we focused on a drug called ivermectin that has been used to treat parasites but also has the benefit of being toxic to malaria-carrying mosquitos when they bite someone who has ivermectin in their system.
Author Interviews, Cost of Health Care, Heart Disease, JAMA, Pharmacology / 16.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29573" align="alignleft" width="149"]Paul J. Hauptman, MD</strong> Professor Internal Medicine, Division of Cardiology Health Management & Policy, School of Public Health Dr. Paul Hauptman[/caption] Paul J. Hauptman, MD Professor Internal Medicine, Division of Cardiology Health Management & Policy, School of Public Health MedicalResearch.com: What is the background for this study? What are the main findings? Response: We decided to evaluate the cost of generic heart failure medications after an uninsured patient of ours reported that he could not fill a prescription for digoxin because of the cost for a one month's supply: $100. We called the pharmacy in question and confirmed the pricing. At that point we decided to explore this issue more closely. We called 200 retail pharmacies in the bi-state, St. Louis metropolitan area, 175 of which provided us with drug prices for three generic heart failure medications: digoxin, carvedilol and lisinopril. We found significant variability in the cash price for these medications. Combined prices for the three drugs ranged from $12-$400 for 30 day supply and $30-$1,100 for 90 day supply. The variability was completely random, not a function of pharmacy type, zip code, median annual income, region or state. In fact, pricing even varied among different retail stores of the same pharmacy chain.
Author Interviews, Pharmacology, Scripps, Weight Research / 15.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29284" align="alignleft" width="133"]Ken Fujioka M.D. Director of the Center for Weight Management Scripps Clinical Department of Endocrinology La Jolla CA Dr. Ken Fujioka[/caption] Ken Fujioka M.D. Director of the Center for Weight Management Scripps Clinical Department of Endocrinology La Jolla CA MedicalResearch.com: What is the background for this study? Response: Obesity is an odd disease that has many causes (overeating, underactivity, the patient being placed on a medication that drives up weight and a whole lot of other causes that result in a higher weight) so trying to find the right treatment, in this case a weight loss medication, for a particular patient is not an easy task. If there is a way to find out if you’ve picked the right medication (a weight loss of at least 5%) then this can help you decide whether you should keep the patient on the medication or stop the medication. There are two huge benefits to this: 1. Is that you find your responders (patients) that will go on to lose weight and do well and 2. When you stop the medication in the non-responders you eliminate any potential adverse events from the weight loss medication. Thus this study was designed to find out if early weight loss can predict who will go on to lose a significant amount of weight on Liraglutide. And yes those who lose weight go on to lose weight.
Author Interviews, Heart Disease, Lipids, NEJM, Pharmacology / 14.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29622" align="alignleft" width="133"]Kevin Fitzgerald, Ph.D. Alnylam Pharmaceuticals Cambridge, MA 02142 Dr. Kevin Fitzgerald[/caption] 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.