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. (more…)
Annals Thoracic Surgery, Author Interviews, Diabetes, Duke, Heart Disease, Hepatitis - Liver Disease, Pharmacology / 04.01.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Cost of Health Care, Immunotherapy, Melanoma, Pharmacology / 22.12.2016

MedicalResearch.com Interview with: 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. (more…)
AHA Journals, Author Interviews, Lipids, Pharmacology / 16.12.2016

MedicalResearch.com Interview with: 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. (more…)
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. (more…)
Author Interviews, Pharmacology / 02.12.2016

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Electronic Records, Geriatrics, Pharmacology / 29.11.2016

MedicalResearch.com Interview with: 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. (more…)
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. (more…)
Author Interviews, Blood Pressure - Hypertension, Bone Density, JAMA, Kaiser Permanente, Osteoporosis, Pharmacology / 22.11.2016

MedicalResearch.com Interview with: 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. (more…)
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 (CKD) 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. (more…)
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. (more…)
Author Interviews, Brigham & Women's - Harvard, Compliance, Gastrointestinal Disease, Pharmacology, Technology / 18.11.2016

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Cost of Health Care, Heart Disease, JAMA, Pharmacology / 16.11.2016

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Pharmacology, Scripps, Weight Research / 15.11.2016

MedicalResearch.com Interview with: 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. (more…)
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…)