ADA Standards of Medical Care in Diabetes 2018

Total Page:16

File Type:pdf, Size:1020Kb

ADA Standards of Medical Care in Diabetes 2018 THE JOURNAL OF CLINICAL AND APPLIED RESEARCH AND EDUCATION VOLUME 41 | SUPPLEMENT 1 WWW.DIABETES.ORG/DIABETESCARE JANUARY 2018 PLE M E P N U T S 1 AMERICAN DIABETES ASSOCIATION STANDARDS OF MEDICAL CARE IN DIABETES—2018 ISSN 0149-5992 January 2018 Volume 41, Supplement 1 [T]he simple word Care may suffice to express [the journal’s] philosophical mission. The new journal is designed to promote better patient care by serving the expanded needs of all health professionals committed to the care of patients with diabetes. As such, the American Diabetes Association views Diabetes Care as a reaffirmation of Francis Weld Peabody’s contention that “the secret of the care of the patient is in caring for the patient.” —Norbert Freinkel, Diabetes Care, January-February 1978 EDITOR IN CHIEF Matthew C. Riddle, MD ASSOCIATE EDITORS EDITORIAL BOARD George Bakris, MD Nicola Abate, MD Maureen Monaghan, PhD, CDE Lawrence Blonde, MD, FACP Vanita R. Aroda, MD Kristen J. Nadeau, MD, MS Andrew J.M. Boulton, MD Geremia Bolli, MD Kwame Osei, MD David D’Alessio, MD John B. Buse, MD, PhD Kevin A. Peterson, MD, MPH, FRCS(Ed), Mary de Groot, PhD Robert J. Chilton, DO, FACC, FAHA FAAFP Eddie L. Greene, MD Kenneth Cusi, MD, FACP, FACE Jonathan Q. Purnell, MD Frank B. Hu, MD, MPH, PhD Paresh Dandona, MD, PhD Peter Reaven, MD Steven E. Kahn, MB, ChB J. Hans DeVries, MD, PhD Ravi Retnakaran, MD, MSc, FRCPC Sanjay Kaul, MD, FACC, FAHA Ele Ferrannini, MD Helena Wachslicht Rodbard, MD Derek LeRoith, MD, PhD Franco Folli, MD, PhD Elizabeth Seaquist, MD Robert G. Moses, MD Meredith A. Hawkins, MD, MS Guntram Schernthaner, MD Stephen Rich, PhD Richard Hellman, MD David J. Schneider, MD Julio Rosenstock, MD Norbert Hermanns, PhD, MSc Norbert Stefan, MD William V. Tamborlane, MD Irl B. Hirsch, MD, MACP Jan S. Ulbrecht, MB, BS Judith Wylie-Rosett, EdD, RD George S. Jeha, MD Joseph Wolfsdorf, MD, BCh Lee M. Kaplan, MD, PhD Tien Yin Wong, MBBS, FRCSE, FRANZCO, M. Sue Kirkman, MD MPH, PhD Ildiko Lingvay, MD, MPH, MSCS Bernard Zinman, CM, MD, FRCPC, FACP Harold David McIntyre, MD, FRACP AMERICAN DIABETES ASSOCIATION OFFICERS CHAIR OF THE BOARD PRESIDENT-ELECT, MEDICINE & SCIENCE Karen Talmadge, PhD Louis Philipson, MD PRESIDENT, MEDICINE & SCIENCE PRESIDENT-ELECT, HEALTH CARE & Jane Reusch, MD EDUCATION Gretchen Youssef, MS, RD, CDE PRESIDENT, HEALTH CARE & EDUCATION SECRETARY/TREASURER-ELECT Felicia Hill-Briggs, PhD, ABPP Brian Bertha, JD, MBA SECRETARY/TREASURER INTERIM CHIEF EXECUTIVE OFFICER Michael Ching, CPA Martha Parry Clark CHAIR OF THE BOARD-ELECT CHIEF SCIENTIFIC, MEDICAL & MISSION OFFICER David J. Herrick, MBA William T. Cefalu, MD The mission of the American Diabetes Association is to prevent and cure diabetes and to improve the lives of all people affected by diabetes. Diabetes Care is a journal for the health care practitioner that is intended to increase knowledge, stimulate research, and promote better management of people with diabetes. To achieve these goals, the journal publishes original research on human studies in the following categories: Clinical Care/Education/Nutrition/ Psychosocial Research, Epidemiology/Health Services Research, Emerging Technologies and Therapeutics, Pathophysiology/Complications, and Cardiovascular and Metabolic Risk. The journal also publishes ADA statements, consensus reports, clinically relevant review articles, letters to the editor, and health/medical news or points of view. Topics covered are of interest to clinically oriented physicians, researchers, epidemiologists, psychologists, diabetes educators, and other health professionals. More information about the journal can be found online at care.diabetesjournals.org. Copyright © 2017 by the American Diabetes Association, Inc. All rights reserved. Printed in the USA. Requests for permission to reuse content should be sent to Copyright Clearance Center at www.copyright.com or 222 Rosewood Dr., Danvers, MA 01923; phone: (978) 750-8400; fax: (978) 646-8600. Requests for permission to translate should be sent to Permissions Editor, American Diabetes Association, at [email protected]. The American Diabetes Association reserves the right to reject any advertisement for any reason, which need not be disclosed to the party submitting the advertisement. Commercial reprint orders should be directed to Sheridan Content Services, (800) 635-7181, ext. 8065. Single issues of Diabetes Care can be ordered by calling toll-free (800) 232-3472, 8:30 A.M. to 5:00 P.M. EST, Monday through Friday. Outside the United States, call (703) 549-1500. Rates: $75 in the United States, $95 in Canada and Mexico, and $125 for all other countries. Diabetes Care is available online at care.diabetesjournals.org. Please call the numbers listed above, e-mail [email protected], or visit the online journal for more information about submitting manuscripts, publication charges, ordering reprints, PRINT ISSN 0149-5992 subscribing to the journal, becoming an ADA member, advertising, permission to reuse ’ ONLINE ISSN 1935-5548 content, and the journal s publication policies. PRINTED IN THE USA Periodicals postage paid at Arlington, VA, and additional mailing offices. AMERICAN DIABETES ASSOCIATION PERSONNEL AND CONTACTS SENIOR VICE PRESIDENT, PUBLISHER CONTENT PRODUCTION MANAGER ADVERTISING REPRESENTATIVES Michael Eisenstein Kelly Newton American Diabetes Association Paul Nalbandian ASSOCIATE PUBLISHER, EDITORIAL CONTENT MANAGER Associate Publisher, Advertising & SCHOLARLY JOURNALS Nancy C. Baldino Sponsorships Christian S. Kohler [email protected] (703) 549-1500, ext. 4806 EDITORIAL OFFICE DIRECTOR TECHNICAL EDITOR Lyn Reynolds Theresa Cooper Tina Auletta Senior Account Executive PEER REVIEW MANAGER DIRECTOR, MEMBERSHIP/SUBSCRIPTION [email protected] Shannon Potts SERVICES (703) 549-1500, ext. 4809 Donald Crowl PHARMACEUTICAL/DEVICE DIGITAL ADVERTISING ASSOCIATE MANAGER, PEER REVIEW The Walchli Tauber Group Larissa M. Pouch SENIOR ADVERTISING MANAGER Maura Paoletti Julie DeVoss Graff National Sales Manager DIRECTOR, SCHOLARLY JOURNALS [email protected] [email protected] Heather Norton Blackburn (703) 299-5511 (443) 512-8899, ext. 110 January 2018 Volume 41, Supplement 1 Standards of Medical Care in Diabetes—2018 S1 Introduction S86 9. Cardiovascular Disease and Risk S3 Professional Practice Committee Management S4 Summary of Revisions: Standards of Medical Care in Hypertension/Blood Pressure Control Diabetes—2018 Lipid Management S7 1. Improving Care and Promoting Health in Antiplatelet Agents Populations Coronary Heart Disease Diabetes and Population Health S105 10. Microvascular Complications and Foot Care Tailoring Treatment for Social Context Diabetic Kidney Disease S13 2. Classification and Diagnosis of Diabetes Diabetic Retinopathy Neuropathy Classification Foot Care Diagnostic Tests for Diabetes Categories of Increased Risk for Diabetes (Prediabetes) S119 11. Older Adults Type 1 Diabetes Type 2 Diabetes Neurocognitive Function Gestational Diabetes Mellitus Hypoglycemia Monogenic Diabetes Syndromes Treatment Goals Cystic Fibrosis–Related Diabetes Pharmacologic Therapy Posttransplantation Diabetes Mellitus Treatment in Skilled Nursing Facilities and Nursing Homes S28 3. Comprehensive Medical Evaluation and End-of-Life Care Assessment of Comorbidities S126 12. Children and Adolescents Patient-Centered Collaborative Care Comprehensive Medical Evaluation Type 1 Diabetes Assessment of Comorbidities Type 2 Diabetes Transition From Pediatric to Adult Care S38 4. Lifestyle Management S137 13. Management of Diabetes in Pregnancy Diabetes Self-Management Education and Support Nutrition Therapy Diabetes in Pregnancy Physical Activity Preconception Counseling Smoking Cessation: Tobacco and e-Cigarettes Glycemic Targets in Pregnancy Psychosocial Issues Management of Gestational Diabetes Mellitus S51 5. Prevention or Delay of Type 2 Diabetes Management of Preexisting Type 1 Diabetes and Type 2 Diabetes in Pregnancy Lifestyle Interventions Pregnancy and Drug Considerations Pharmacologic Interventions Postpartum Care Prevention of Cardiovascular Disease Diabetes Self-management Education and Support S144 14. Diabetes Care in the Hospital S55 6. Glycemic Targets Hospital Care Delivery Standards Glycemic Targets in Hospitalized Patients Assessment of Glycemic Control Bedside Blood Glucose Monitoring A1C Testing Antihyperglycemic Agents in Hospitalized Patients A1C Goals Hypoglycemia Hypoglycemia Medical Nutrition Therapy in the Hospital Intercurrent Illness Self-management in the Hospital S65 7. Obesity Management for the Treatment of Type 2 Standards for Special Situations Diabetes Transition From the Acute Care Setting Preventing Admissions and Readmissions Assessment Diet, Physical Activity, and Behavioral Therapy S152 15. Diabetes Advocacy Pharmacotherapy Metabolic Surgery Advocacy Position Statements S73 8. Pharmacologic Approaches to Glycemic Treatment S154 Professional Practice Committee, American College of Cardiology—Designated Representatives, and Pharmacologic Therapy for Type 1 Diabetes American Diabetes Association Staff Disclosures Surgical Treatment for Type 1 Diabetes Pharmacologic Therapy for Type 2 Diabetes S156 Index This issue is freely accessible online at care.diabetesjournals.org. Keep up with the latest information for Diabetes Care and other ADA titles via Facebook (/ADAJournals) and Twitter (@ADA_Journals). PROFESSIONAL PRACTICE COMMITTEE Diabetes Care Volume 41, Supplement 1, January 2018 S3 Professional Practice Committee: Standards of Medical Care in Diabetesd2018
Recommended publications
  • Boada SEA Eagenda 2020
    TheBestof South East Asia 2020 Bangladesh, Brunei, Cambodia, Indonesia, Laos, Malaysia, Maldives, Myanmar, Philippines, Singapore, Sri Lanka, Vietnam FACULTY The American Diabetes Association (ADA) and Novo Nordisk are pleased to invite you to a series of official webinars highlighting the most important education from the American Diabetes Association Scientific Sessions. Mark your calendars now. Athena Philis-Tsimikas, MD Simon Heller, MD Jay H. Shubrook DO FACOFP, FAAFP Derek LeRoith, MD, PhD, FACP Corporate Vice President of the Scripps Whittier Professor of Clinical Diabetes Professor. Primary Care Department Director of Research Diabetes Institute at Scripps Health. Director of University of Sheffield Director of Clinical Research and Diabetes Services Division of Endocrinology, Diabetes Monday, June 22 Community Engagement at Scripps Translational Sheffield, England Touro University California College of Osteopathic and Bone Diseases Icahn School Science Institute. San Diego, California, USA Medicine, Vallejo, California, USA of Medicine, Mount Sinai, New York, USA Webinar 1: 6:00PM-7:30PM Malaysia Time Monday, June 29 Webinar 2: 6:00PM-7:30PM Malaysia Time Monday, July 6 Webinar 3: 6:00PM-7:30PM Malaysia Time Monday, July 13 Webinar 4: 6:00PM-7:30PM Malaysia Time Kenneth Cusi, M.D., Andrew JM Boulton, MD, DSc (Hon), Michelle Magee, MD, MBBCh, Richard E. Pratley, MD F.A.C.P., F.A.C.E. FACP, FICP, FRCP BAO, LRCPSI AdventHealth. Samuel E. Crockett Chair in Diabetes Research. Professor of Medicine President, International Diabetes
    [Show full text]
  • Mount Sinai Health System Appoints New Chief for Division of Endocrinology, Diabetes and Bone Disease
    Mount Sinai Health System Appoints New Chief for Division of Endocrinology, Diabetes and Bone Disease mountsinai.org /about-us/newsroom/press-releases/mount-sinai-health-system-appoints-new-chief-for-division- of-endocrinology-diabetes-and-bone-disease New York, NY – May 31, 2017 /Press Release/ –– Andrea Dunaif, MD, an internationally renowned diabetes and women’s health expert, has been appointed the new Chief for the Hilda and J. Lester Gabrilove Division of Endocrinology, Diabetes, and Bone Disease for the Mount Sinai Health System. Dr. Dunaif replaced Derek Leroith, MD, PhD, who has served as interim chief for the last year. In her new role, Dr. Dunaif will build on Mount Sinai’s considerable strengths in research on diabetes, metabolism, and endocrine disorders. Dr. Dunaif also plans to expand Mount Sinai’s comprehensive clinical services for patients with diabetes and other endocrine disorders, including its artificial pancreas program. Dr. Dunaif is an exceptional physician and researcher in the field of diabetes and women’s health,” said Dennis S. Charney, MD, Anne and Joel Ehrenkranz Dean, Icahn School of Medicine at Mount Sinai, and President for Academic Affairs, Mount Sinai Health System. “We look forward to her help in building on our long and distinguished tradition of excellence in research and education in the field of endocrinology, diabetes and bone disease.” Dr. Dunaif comes to Mount Sinai from Northwestern University’s Feinberg School of Medicine, in Chicago, where she is the Charles F. Kettering Professor of Endocrinology and Metabolism and was the Chief of the Division of Endocrinology, Metabolism, and Molecular Medicine for 10 years.
    [Show full text]
  • Joint Statement on Public Disclosure of Results from Clinical Trials
    Joint statement on public disclosure of results from clinical trials Signatories on 18 May 2017 Indian Council of Medical Research Research Council of Norway UK Medical Research Council Médecins Sans Frontières Epicentre CEPI PATH Institut Pasteur Bill and Melinda Gates Foundation Wellcome Trust Introduction The current 2013 Declaration of Helsinki states that “Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.” and that “Researchers have a duty to make publicly available the results of their research .... Negative and inconclusive as well as positive results must be published or otherwise made publicly available”. In addition to the ethical imperative, poor allocation of resources for product development and financing of available interventions, and suboptimal regulatory and public health recommendations may occur where decisions are based on only a subset of all completed clinical trials. The signatories of this joint statement affirm that the prospective registration and timely public disclosure of results from all clinical trials is of critical scientific and ethical importance. Furthermore timely results disclosure reduces waste in research, increases value and efficiency in use of funds and reduces reporting bias, which should lead to better decision-making in health. Within 12 months of becoming a signatory of this statement, we each pledge to develop and implement a policy with mandated timeframes for prospective registration and public disclosure of the results of clinical trials that we fund, co-fund, sponsor or support. We each agree to monitor registration and endorse the development of systems to monitor results reporting on an ongoing basis.
    [Show full text]
  • Adverse Drug Reaction News Published by the Health Products Regulation Group, HSA and the HSA Pharmacovigilance Advisory Committee
    ISSN: 0219 - 2152 April 2011 Vol.13 No.1 Adverse Drug Reaction News Published by the Health Products Regulation Group, HSA and the HSA Pharmacovigilance Advisory Committee Consumer health product recalls Voluntary recalls of mouth rinses and cleansing wipes Over the recent months, the following four products were voluntarily recalled by their Reports of B. cepacia-contaminated distributors following detection of Burkholderia cepacia (B. cepacia) in certain batches of products overseas1-3 the products: B. cepacia is known to contaminate health ■ “Oral Guard Antiseptic-Antiplaque Mouthwash” by Medimex Singapore products. There have been reported cases ■ “Trihexid Chlorhexidine 0.2% Mouth Rinse” by Trident Pharm Pte Ltd of B. cepacia detected in a variety of ■ “Pearlie White Fluorinze Fluoride Mouth Rinse” by Corlison Pte Ltd products in other countries such as the United States (US), Australia and Canada. ■ “Care Wipes” by Tai Sun Paper Products Pte Ltd (Singapore) The types of products affected include mouthwashes, mouth gels, nasal sprays and hand sanitisers. A recent case in November 2009 involved the recall of three lots of Vicks Sinex Nasal Spray by Procter & Gamble2 in the US, Germany and the United Kingdom. The company detected B. cepacia in the product during routine quality control at its plant located in Germany. The company’s analysis showed that the problem was limited to a single batch of raw material mixture involving three lots of product sold in the US, Germany and the UK. No reports of illness were received by The consumer level recall was initiated as a precautionary measure to safeguard public the company.
    [Show full text]
  • Transparency in the Time of Constant Change
    PhUSE 2014 Paper RG02 Transparency in the Time of Constant Change Todd Case, Biogen Idec, Cambridge MA, USA ABSTRACT The time has come, after years of hard work, to submit your application to the regulatory agency for review and possible approval! What a relief to be able to finally hand off all of your hard work and, wait a minute, ensure that all data can be reproducible?!? While CDISC has been widely adopted and its SDTM and AdAM models widely implemented, there is still the need to understand the process of ensuring that all the data is a reflection of how it was originally collected, which in some cases can be very challenging. This paper will discuss some more trending ways of both creating and presenting data in ways that ensure it is consumable and can be understood not only for analysis/submission purposes but also that post-approval it is transparent and that everyone who has a vested stake can review the data in an appropriate way. INTRODUCTION With the publication of Bad Pharma: How Medicine is Broken , and How We Can Fix it, by Dr. Ben Goldacre in 2013 a bright spotlight was shone on the data behind/supporting clinical trials. A large part of his thesis is that pharmaceutical companies exaggerate the efficacy of successful trials and that, in addition to drug companies, regulators , physicians (who are educated by the drug companies) and even patient groups have failed to protect us. Another rather striking revelation was that a clinical trial with positive results is twice more likely to be published than one with negative results (although it should be noted that this specifically is related to results – the protocol is always provided).
    [Show full text]
  • Patents, Partnerships, and the Pre-Competitive Collaboration Myth in Pharmaceutical Innovation
    Patents, Partnerships, and the Pre-Competitive Collaboration Myth in Pharmaceutical Innovation Liza S. Vertinsky* Public-private partnerships offer a promising alternative paradigm for pharmaceutical innovation in complex disease areas where there are both strong commercial interests and significant public need. They have the potential to reduce the tremendous waste associated with duplicative unsuccessful drug development efforts and to encourage the sharing of knowledge essential to accelerate pharmaceutical innovation. Patents threaten the potential of partnership strategies, however, by making it harder to sustain robust systems of knowledge sharing. Policymakers have tried to avoid this problem by focusing partnership strategies on areas deemed to be pre-competitive — areas of collaboration without competition and typically also without patents. This Article suggests that the current pre-competitive approach to partnership strategies in pharmaceutical innovation is fundamentally flawed for two reasons. First, it ignores the competitive market pressures that both shape what is deemed to be pre-competitive and fuel tensions * Copyright © 2015 Liza S. Vertinsky. Associate Professor of Law, Emory University School of Law. Many thanks to Timothy Holbrook, Timothy Terrell, Yaniv Heled, Cynthia Ho, Kevin Outterson, and Michael Carroll, as well as Sean O’Connor, Roger Ford, Dan Burk, Mark McKenna, and other participants of the Yale Innovation Beyond IP conference 2014; Arti Rai, Jerome Reichman, Katherine Strandburg, Brett Frischmann, Michael Madison, Peter Lee, Margaret Chon, Sonali Shah, and the other participants in the Medical Commons Workshop at NYU in May 2014 and the 2nd Thematic Conference on the Knowledge Commons at NYU in September 2014; participants in the summer workshop at Georgia State College of Law in July 2014; participants of the Emory Faculty Colloquium; Simon Stern, Abraham Drassinower, Margaret J.
    [Show full text]
  • Report on Transparency and Registration in Clinical Research In
    Transparency and Registration in Clinical Research in the Nordic Countries By the Nordic Trial Alliance Working Group on Transparency and Registration Transparency and Registration in Clinical Research in the Nordic Countries Nordic Trial Alliance NordForsk Stensberggata 25 NO-0170 Oslo www.nta.nordforsk.org Design: jnd.no Printed by: 07 Group ISSN 1504-8640 ER JØM KE IL T M 2 4 9 1 7 3 Trykksak Transparency and Registration in Clinical Research in the Nordic Countries By the Nordic Trial Alliance Working Group on Transparency and Registration 1 Table of Contents Preface 4 The Nordic Trial Alliance Working Group on Transparency and Registration 6 Conflicts of Interest 7 Abbreviations 8 1. Executive summary 16 2. Background 20 3. Introduction to transparency 30 4. International policies and regulations impacting the future of transparency 36 4.1 The Declaration of Helsinki 36 4.2 The Food and Drug Administration Amendments Act of 2007 36 4.3 The European Clinical Research Infrastructures Network (ECRIN) 37 4.4 European Medicines Agency 37 4.5 Horizon 2020 38 4.6 Regulation on clinical trials on medicinal product for human use 39 4.7 EU Regulation for data protection 40 5. Arguments in favour of and against transparency 44 5.1 Arguments in favour 44 5.2 Arguments against 49 6. Does publication of trial protocols or trial results in registers impede journal publications? 54 7. Registries and repositories 58 2 8. Status of the Nordic countries 62 8.1 Current national procedures for public, prospective registration and reporting of clinical
    [Show full text]
  • Histories of Medical Lobbying’
    ‘Histories of medical lobbying’ The lobbying of government ministers by medical professionals is a live issue. In Britain and around the world medical practitioners have become active in the pursuit of legislative change. In the UK, the AllTrials campaign co-founded by the physician-researcher Ben Goldacre continues to exert pressure on parliamentarians in a bid to force greater transparency in the publication of clinical trial results. Meanwhile, the California Medical Association advocates the legalisation of the recreational use of marijuana, and doctors in Australia refuse to release child refugees from hospital into detention centres damaging to their mental health. It was precisely the lobbying of medical humanitarians such as Médecins sans Frontières in France that effected a change in the law there in 1998, permitting undocumented immigrants with life-threatening conditions to remain in the country for medical treatment. Each of these examples represents an organised attempt on the part of medical professionals to change government policy on matters related to public health – in other words, lobbying. Yet a recent announcement by the UK cabinet office suggests that henceforth recipients of public funding will be banned from directly lobbying government ministers in the hope of changing public policy. When questioned in parliament David Cameron stated that charities should be devoting themselves to ‘good causes’ rather than ‘lobbying ministers’. Unless some qualification is forthcoming, medical researchers too will be proscribed from carrying out such activity. This insinuates that lobbying is in some way outside the proper remit of researchers, medical or otherwise. Yet even a cursory glance at the history of the medical profession’s engagement with public health reveals a longstanding and significant engagement with the political process.
    [Show full text]
  • High-Density Lipoproteins in Kidney Disease
    International Journal of Molecular Sciences Review High-Density Lipoproteins in Kidney Disease Valentina Kon 1, Hai-Chun Yang 1,2, Loren E. Smith 3, Kasey C. Vickers 4 and MacRae F. Linton 4,5,* 1 Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN 37232, USA; [email protected] (V.K.); [email protected] (H.-C.Y.) 2 Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, TN 37232, USA 3 Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN 37232, USA; [email protected] 4 Atherosclerosis Research Unit, Department of Medicine, Division of Cardiovascular Medicine, Vanderbilt University Medical Center, Nashville, TN 37232, USA; [email protected] 5 Department of Pharmacology, Vanderbilt University, Nashville, TN 37232, USA * Correspondence: [email protected] Abstract: Decades of epidemiological studies have established the strong inverse relationship be- tween high-density lipoprotein (HDL)-cholesterol concentration and cardiovascular disease. Recent evidence suggests that HDL particle functions, including anti-inflammatory and antioxidant func- tions, and cholesterol efflux capacity may be more strongly associated with cardiovascular disease protection than HDL cholesterol concentration. These HDL functions are also relevant in non- cardiovascular diseases, including acute and chronic kidney disease. This review examines our current understanding of the kidneys’ role in HDL metabolism and homeostasis, and the effect of kidney disease on HDL composition and functionality. Additionally, the roles of HDL particles, proteins, and small RNA cargo on kidney cell function and on the development and progression of both acute and chronic kidney disease are examined. The effect of HDL protein modification Citation: Kon, V.; Yang, H.-C.; Smith, by reactive dicarbonyls, including malondialdehyde and isolevuglandin, which form adducts with L.E.; Vickers, K.C.; Linton, M.F.
    [Show full text]
  • SENSE ABOUT SCIENCE 14A Clerkenwell Green London EC1R 0DP T 020 7490 9590
    SENSE ABOUT SCIENCE 14A Clerkenwell Green London EC1R 0DP T 020 7490 9590 Registered Charity No. 1146170 Company No. 6771027 Registered in England and Wales Response to House of Commons Science and Technology Select Committee inquiry on research integrity 10th March 2017 Sense about Science is an independent charity that challenges the misrepresentation of science and scientific evidence in public life. We advocate for openness and honesty about research findings, and work to ensure the public interest in sound science and evidence is represented and recognised in public discussion and policy making. Sense about Science runs the AllTrials campaign which calls for all past and present clinical trials to be registered and their full methods and summary results reported. The AllTrials campaign is providing a separate submission for this inquiry. However there are two other areas under the terms of this inquiry that we would like to bring the committee’s attention. A single, publicly searchable database of all government-commissioned research In June 2015 Sense about Science began an inquiry into whether the government is reporting the policy research it commissions, following a spate of accusations of suppression of inconvenient results. Led by the former Appeal Court judge, Rt Hon Sir Stephen Sedley, its report Missing Evidence was published in June 2016.1 The inquiry revealed widespread confusion in the way research commissioned by government is handled, both internally and with the public: • There are significant differences in the way departments report and record research; • 11 government departments were unable to provide a list of research they have commissioned; • Of these, seven said that they did not hold that information centrally and it would be too costly to gather.
    [Show full text]
  • Tredaptive, INN-Nicotinic Acid/Laropiprant
    European Medicines Agency Evaluation of Medicines for Human Use Doc.Ref.: EMEA/348364/2008 CHMP ASSESSMENT REPORT FOR Tredaptive International Nonproprietary Name: nicotinic acid / laropiprant Procedure No. EMEA/H/C/889 Assessment Report as adopted by the CHMPauthorised with all information of a commercially confidential nature deleted. longer no product Medicinal 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 85 45 E-mail: [email protected] http://www.emea.europa.eu © European Medicines Agency, 2008. Reproduction is authorised provided the source is acknowledged. 1. BACKGROUND INFORMATION ON THE PROCEDURE........................................... 3 1.1 Submission of the dossier ........................................................................................................ 3 1.2 Steps taken for the assessment of the product.......................................................................... 3 2 SCIENTIFIC DISCUSSION................................................................................................. 4 2.1 Introduction.............................................................................................................................. 4 2.2 Quality aspects......................................................................................................................... 5 2.3 Non-clinical aspects................................................................................................................. 9 2.4 Clinical aspects .....................................................................................................................
    [Show full text]
  • Highly Specific Role of the Insulin Receptor in Breast Cancer Progression
    R Rostoker et al. Insulin receptor in breast cancer 22:2 145–157 Research progression Highly specific role of the insulin receptor in breast cancer progression Ran Rostoker1, Sagi Abelson2, Keren Bitton-Worms1, Inna Genkin1, Sarit Ben-Shmuel1, Maria Dakwar1, Zila Shen Orr1, Avishay Caspi1, Maty Tzukerman2 and Derek LeRoith1,3 1Clinical Research Institute at Rambam (CRIR) and the Faculty of Medicine, Technion, Diabetes and Metabolism Clinical Research Center of Excellence, Haifa, Israel Correspondence 2The Laboratory of Molecular Medicine, Rambam Health Care Campus and Rappaport Faculty of Medicine and should be addressed Research Institute, Technion, Haifa 31096, Israel to D LeRoith 3Division of Endocrinology, Diabetes and Bone Diseases, Icahn School of Medicine at Mount Sinai, New York City, Email New York, USA [email protected] Abstract Accumulating evidence from clinical trials indicates that specific targeting of the IGF1 receptor Key Words (IGF1R) is not efficient as an anti-breast cancer treatment. One possible reason is that the " hyperinsulinemia mitogenic signals from the insulin receptor (IR) can be processed independently or as " insulin receptor compensation to inhibition of the IGF1R. In this study, we highlight the role of the IR in " insulin-like growth factor 1 mediating breast tumor progression in both WT mice and a hyperinsulinemic MKR mouse receptor model by induction of Ir (Insr)orIgf1r knockdown (KD) in the mammary carcinoma Mvt-1 cell " breast cancer and CD24 line. By using the specific IR antagonist-S961, we demonstrated that Igf1r-KD induces elevated responses by the IR to IGF1. On the other hand, Ir-KD cells generated significantly smaller tumors in the mammary fat pads of both WT and MKR mice, as opposed to control cells, whereas Endocrine-Related Cancer the Igf1r-KD cells did not.
    [Show full text]