DOCSLIB.ORG

Efficacy and Safety of Dapagliflozin in Patients With

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Efficacy and Safety of Dapagliflozin in Patients With 1938 Diabetes Care Volume 41, September 2018 fi Chantal Mathieu,1 Paresh Dandona,2 Ef cacy and Safety of Pieter Gillard,1 Peter Senior,3 fl Christoph Hasslacher,4 Eiichi Araki,5 Dapagli ozin in Patients With Marcus Lind,6,7 Stephen C. Bain,8 Serge Jabbour,9 Niki Arya,10 Lars Hansen,11 EMERGING THERAPIES: DRUGS AND REGIMENS Inadequately Controlled Type 1 Fredrik Thoren,´ 12 and Anna Maria Langkilde,12 on behalf of the Diabetes (the DEPICT-2 Study): DEPICT-2 Investigators* 24-Week Results From a Randomized Controlled Trial Diabetes Care 2018;41:1938–1946 | https://doi.org/10.2337/dc18-0623 1Clinical and Experimental Endocrinology, Uni- versity of Leuven, Leuven, Belgium 2Department of Medicine, State University of New York at Buffalo, Buffalo, NY 3Division of Endocrinology, University of Alberta, Edmonton, Canada 4Diabetesinstitut Heidelberg, Heidelberg, Germany 5Department of Metabolic Medicine, Faculty of OBJECTIVE Life Sciences, Kumamoto University, Kumamoto, Japan This 24-week, double-blinded, phase 3 clinicaltrial (DEPICT-2; ClinicalTrials.gov, 6Institute of Medicine, University of Gothenburg, NCT02460978) evaluated efficacy and safety of dapagliflozin as adjunct therapy to Gothenburg, Sweden 7 adjustable insulin in patients with inadequately controlled type 1 diabetes (HbA Department of Medicine, NU Hospital Group, 1c Uddevalla, Sweden 7.5–10.5%). 8Diabetes Research Unit, Swansea University, Swansea, Wales, U.K. RESEARCH DESIGN AND METHODS 9Division of Endocrinology, Diabetes and Met- Patients were randomized 1:1:1 to dapagliflozin 5 mg (n = 271), dapagliflozin abolic Diseases, Sidney Kimmel Medical College 10 mg (n = 270), or placebo (n = 272) plus insulin. Insulin dose was adjusted by at Thomas Jefferson University, Philadelphia, PA 10AstraZeneca, Gaithersburg, MD investigators according to self-monitored glucose readings, local guidance, and 11MedImmune, Gaithersburg, MD individual circumstances. 12AstraZeneca, Gothenburg, Sweden Corresponding author: Chantal Mathieu, RESULTS [email protected]. Baseline characteristics were balanced between treatment groups. At week 24, Received 21 March 2018 and accepted 18 June dapagliflozin significantly decreased HbA1c (primary outcome; difference vs. 2018. placebo: dapagliflozin 5 mg 20.37% [95% CI 20.49, 20.26], dapagliflozin Clinical trial reg. no. NCT02460978, clinicaltrials 10 mg –0.42% [20.53, 20.30]), total daily insulin dose (210.78% [213.73, .gov. 27.72] and 211.08% [214.04, 28.02], respectively), and body weight (23.21% This article contains Supplementary Data online [23.96, 22.45] and 23.74% [24.49, 22.99], respectively) (P < 0.0001 for all). at http://care.diabetesjournals.org/lookup/suppl/ doi:10.2337/dc18-0623/-/DC1. Mean interstitial glucose, amplitude of glucose excursion, and percent of readings This article is featured in a podcast available at within target glycemic range (>70 to £180 mg/dL) versus placebo were signifi- http://www.diabetesjournals.org/content/diabetes- cantly improved. More patients receiving dapagliflozin achieved a reduction in core-update-podcasts. HbA1c ‡0.5% without severe hypoglycemia compared with placebo. Adverse events At the time of the study, L.H. worked at Bristol- were reported for 72.7%, 67.0%, and 63.2% of patients receiving dapagliflozin 5 mg, Myers Squibb, Princeton, NJ. dapagliflozin 10 mg, and placebo, respectively. Hypoglycemia, including severe *A completelist of the DEPICT-2Investigatorscan hypoglycemia, was balanced between groups. There were more adjudicated def- be found in the Supplementary Data online. inite diabetic ketoacidosis (DKA) events with dapagliflozin: 2.6%, 2.2%, and 0% © 2018 by the American Diabetes Association. fl fl Readers may use this article as long as the work for dapagli ozin 5 mg, dapagli ozin 10 mg, and placebo, respectively. is properly cited, the use is educational and not for profit, and the work is not altered. More infor- CONCLUSIONS mation is available at http://www.diabetesjournals Dapagliflozin as adjunct therapy to adjustable insulin in patients with type 1 .org/content/license. diabetes was well tolerated and improved glycemic control with no increase in See accompanying articles, pp. 1970 hypoglycemia versus placebo but with more DKA events. and 1981. care.diabetesjournals.org Mathieu and Associates 1939 Less than one-third of patients with adjustable insulin, providing further sup- or malignancy (within 5 years) or had type 1 diabetes achieve optimal glycemic portive evidence for its use in the treat- previously used any SGLT2 inhibitor. A control (HbA1c ,7% [,53 mmol/mol]) ment of type 1 diabetes. comprehensive list of inclusion and exclu- (1,2). Even when target HbA1c levels sion criteria is provided in Supplementary are achieved, there is still evidence RESEARCH DESIGN AND METHODS Table 1. for excess mortality in patients with Study Design type 1 diabetes (3). Insulin therapy is DEPICT-2 was the second of two random- Study Medications and Procedures the mainstay of treatment (4); however, Eligible patients entered an 8-week lead- ized, double-blind, parallel-controlled, it is associated with hypoglycemia (5–7) in period to optimize diabetes manage- three-arm, multicenter, phase 3 stud- and weight gain (8), both of which are ment. On completing the lead-in period, ies evaluating the efficacy and safety important cardiovascular risk factors patients with an HbA of 7.5–10.5% of dapagliflozin 5 mg and 10 mg as 1c (9,10). Occurrence of hypoglycemia hin- (58–91 mmol/mol) were randomized adjunct therapy to adjustable insulin ders the achievement of glycemic tar- 1:1:1 using an interactive voice/web in adult patients with type 1 diabetes gets and affects the quality of life of response system to oral dapagliflozin and inadequate glycemic control. The patients (11–13), and severe hypoglyce- 5 mg, dapagliflozin 10 mg, or placebo methodology has been published pre- mia is a potentially serious event. Other once daily. Patients were stratified by use viously (16). The study was conducted challenges for patients with type 1 di- of continuous glucose monitoring (CGM) at 148 sites in the following countries: abetes include excessive glycemic vari- at baseline (in which case they would Argentina, Belgium, Canada, Chile, Germany, ability and hypoglycemia unawareness continue to use their own device dur- Japan, the Netherlands, Poland, the (11). Thus, strategies to improve glyce- ing the study in addition to the masked Russian Federation, Sweden, Switzerland, mic control, without increasing hypo- study CGM), use of CSII or MDI for insulin the U.K., and the U.S., in accordance glycemia or weight gain, would fulfill an administration at baseline, and baseline with the Declaration of Helsinki and unmet need. HbA (7.5 to ,9.0% [58 to ,75 mmol/ Good Clinical Practice Guidelines as 1c Sodium–glucose cotransporter 2 mol] or 9.0–10.5% [75–91 mmol/mol]). defined by the International Council (SGLT2) inhibitors are insulin-independent, The lead-in period was followed by a for Harmonisation. It was approved by glucose-dependent antihyperglycemic 24-week, short-term, double-blind treat- the institutional review boards and in- agents that have demonstrated poten- ment period and a 28-week, long-term dependent ethics committees for all tial for use as adjunct therapy to insulin subject- and site-blinded extension phase participating centers. All participants in the treatment of type 1 diabetes, assessing safety, followed by a 4-week provided written informed consent. For providing additional treatment benefits follow-up period. The 24-week results Japanese patients $18 to ,20 years old, such as weight loss and decreased gly- are reported here. informed consent was obtained from cemic variability. Dapagliflozin, an SGLT2 Glycemic control (including self- their parents/guardians. The DEPICT-2 inhibitor approved for the treatment of monitoring of blood glucose [SMBG]) study is registered on ClinicalTrials.gov type 2 diabetes, and sotagliflozin, a non- and home ketone (b-hydroxybutyrate (NCT02460978). selective SGLT2/SGLT1 inhibitor, have [BOHB]) measurements were assessed shown promise as adjunct treatments Study Participants at each study visit. Insulin doses were for type 1 diabetes in previous studies This study included adult patients with adjusted as deemed appropriate by the (14–17). The recent randomized, placebo- inadequately controlled type 1 diabetes investigator, based on SMBG readings controlled, phase 3, 24-week DEPICT-1 (HbA1c 7.7–11.0% [61–97 mmol/mol] at (recommended four times per day at a (Efficacy and safety of dapagliflozin in screening/enrollment; 7.5–10.5% [58–91 minimum and six times per day during patients with inadequately controlled mmol/mol] at randomization) receiv- protocol-specified periods of intense type 1 diabetes [16]) study demonstrated ing adjustable insulin via multiple daily glucose monitoring), local guidance, that when used as adjunct therapy to injections (MDI) or continuous subcutane- and individual circumstances. The pro- adjustable insulin in patients with inad- ous insulin infusion (CSII) for $12 months tocol did not specify uniform insulin equately controlled type 1 diabetes, prior to screening (total insulin dose titration algorithms. After the first dapagliflozin significantly decreased $0.3 IU/kg/day for $3 months prior dose of the study drug, the daily insulin HbA1c, body weight, total insulin dose, to screening), and with C-peptide ,0.7 dose was recommended to be reduced and glycemic variability. Treatment ng/mL and BMI $18.5 kg/m2.Patients by up to 20% to balance the risk of was generally well tolerated, with simi- were excluded if they had type 2 diabe- hypoglycemia and DKA due to excessive lar levels of hypoglycemia compared tes, a history of pancreatic surgery, insulin dose reduction (14,18,19), be- with placebo (16). The overall adverse chronic pancreatitis, or other pancre- fore subsequently attempting to titrate event (AE) profile was consistent with that atic disorders resulting in decreased it back as far as possible to baseline observed in patients with type 2 diabe- b-cell capacity, signs of poorly controlled levels. Events of potential DKA were tes. There were few events of diabetic diabetes (including DKA requiring medi- monitored throughout the study.
Load more

Recommended publications
  • First-Year Experience of Medical Emergency Care, a New Healthcare Chain for Acute Life-Threatening Medical Conditions at the ED
    Research Article Published: 13 Dec, 2018 Journal of Cardiology Forecast First-Year Experience of Medical Emergency Care, a New Healthcare Chain for Acute Life-Threatening Medical Conditions at the ED Bergh N2,3*, Hellberg J1,3, Rehnström K1, Karlsson T4, Ekerstad N5,6 and Karlson BW1,2 1Department of Acute and Internal Medicine, NU (NÄL-Uddevalla) Hospital Group, Trollhättan-Uddevalla- Vänersborg, Sweden 2Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden 3Department of Cardiology, Sahlgrenska University Hospital, Sahlgrenska, Gothenburg, Sweden 4Health Metrics Unit, Institution of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden 5Department of Cardiology, NU (NÄL-Uddevalla) Hospital Group, Trollhättan-Uddevalla-Vänersborg, Sweden 6Department of Medical and Health Sciences, Division of Health Care Analysis, Linköping University, Linköping, Sweden Abstract Background: There is a high inflow of patients at most medical emergency departments (ED). In 2013 the Medical Emergency Care (MEC) healthcare chain was introduced at the NU-hospital group, Sweden, in order to better identify, alerting and treat the critically ill adult medical patients. Aim: The primary aim of this retrospective study was to characterize medical patients who were judged and handled as critically ill according to the concept of MEC during the first year following its introduction. OPEN ACCESS Methods: This is a single-center, consecutive cohort study of all patients initially taken care of at the ED using the concept of MEC at the NU Hospital group, Västra Götaland health care region, * Correspondence: Sweden, between February 26 2013 and February 28 2014. Niklas Bergh, Department of Molecular and Clinical Medicine, Department Results: A total of 856 patients were registered as MEC patients, representing 3.2% of all adult medical ED patients.
    [Show full text]
  • Preserved Physical Fitness Is Associated with Lower 1-Year Mortality in Frail Elderly Patients with a Severe Comorbidity Burden
    Journal name: Clinical Interventions in Aging Article Designation: Original Research Year: 2019 Volume: 14 Clinical Interventions in Aging Dovepress Running head verso: Åhlund et al Running head recto: Åhlund et al open access to scientific and medical research DOI: 198591 Open Access Full Text Article ORIGINAL RESEARCH Preserved physical fitness is associated with lower 1-year mortality in frail elderly patients with a severe comorbidity burden This article was published in the following Dove Medical Press journal: Clinical Interventions in Aging Kristina Åhlund1,2 Introduction: Physical deterioration in connection with a care episode is common. The aim Niklas Ekerstad3,4 of this study was, in frail elderly patients with a severe comorbidity burden, to analyze 1) the Maria Bäck2,5 association between physical fitness measurements and 1-year mortality and 2) the association Björn W Karlson6,7 between preserved physical fitness during the first three months after discharge from emergency Birgitta Öberg2 hospital care and 1-year prognosis. Methods: Frail elderly patients ($75 years) in need of inpatient emergency medical care were 1Department of Physiotherapy, NU included. Aerobic capacity (six-minute walk test, 6MWT) and muscle strength (handgrip strength Hospital Group, Trollhättan, Sweden; 2Department of Medical and Health test, HS) were assessed during the hospital stay and at a three-month follow-up. The results Sciences, Division of Physiotherapy, were analyzed using multivariate Cox regression; 1) 0–12-month analysis and 2) 0–3-month Linköping University, Linköping, For personal use only. Sweden; 3Department of Research and change in physical fitness in relation to 1-year mortality. The analyses were adjusted for age, Development, NU Hospital Group, gender, comorbidity and frailty.
    [Show full text]
  • Are Frail Elderly Patients Treated in a CGA Unit More Satisfied with Their Hospital Care Than Those Treated in Conventional Acute Medical Care?
    Journal name: Patient Preference and Adherence Article Designation: Original Research Year: 2018 Volume: 12 Patient Preference and Adherence Dovepress Running head verso: Ekerstad et al Running head recto: Comparison of acute treatment in CGA units and in conventional wards open access to scientific and medical research DOI: http://dx.doi.org/10.2147/PPA.S154658 Open Access Full Text Article ORIGINAL RESEARCH Are frail elderly patients treated in a CGA unit more satisfied with their hospital care than those treated in conventional acute medical care? Niklas Ekerstad1,2 Objectives: Our aim was to study whether the acute care of frail elderly patients directly Göran Östberg3 admitted to a comprehensive geriatric assessment (CGA) unit is superior to the care in a con- Maria Johansson3 ventional acute medical care unit in terms of patient satisfaction. Björn W Karlson3,4 Design: TREEE (Is the TReatment of frail Elderly patients Effective in an Elderly care unit?) is a clinical, prospective, controlled, one-center intervention trial comparing acute treatment in 1Department of Cardiology, NU (NÄL-Uddevalla) Hospital Group, CGA units and in conventional wards. Trollhättan-Uddevalla-Vänersborg, Setting: This study was conducted in the NÄL-Uddevalla county hospital in western Sweden. 2 Department of Medical and Health Participants: In this follow-up to the TREEE study, 229 frail patients, aged $75 years, in need Sciences, Division of Health Care Analysis, Linköping University, of acute in-hospital treatment, were eligible. Of these patients, 139 patients were included in 3 For personal use only. Linköping, Division of Internal and the analysis, 72 allocated to the CGA unit group and 67 to the conventional care group.
    [Show full text]
  • A Roadmap for Improving Wikipedia 29/08 2017
    Embargo Tuesday 29th August at 00:05 [UK time] Press release 29/08 A roadmap for improving Wikipedia The evolution of Wikipedia’s medical content: past, present and future 2017 Shafee T, Masukume G, Kipersztok L, Das D, Häggström M, Heilman J. (2017) Journal of Epidemiology & Community Health 71(10) Wikipedia is a key source of public health information Wikipedia needs expert input Health professionals need Wikipedia’s reach Image: Blausen medical CC BY-SA, via WikiJournal of Medicine (full res version) doi:10.15347/wjm/2014.010. Given its prominence as a source of scientific and medical information, improving Wikipedia is a public health “Wikipedia has over 44 million necessity. How can the medical and scientific community articles across 295 languages work towards enhancing the quality and quantity of its and climbing, but contributor medical articles? An international group of doctors and numbers are pretty flat.” researchers have outlined their recommendations in the Journal of Epidemiology and Community Health. The encyclopedia’s content, community and collaborations have changed a lot over the last 16 years. Now is also the time to plan improvements for its future. The Wikimedia Foundation, the charity that supports Wikipedia, is currently updating their strategy through to 2030. It’s therefore an ideal “At 16 years old, Wikipedia is opportunity for those with an interest in disseminating a teenager, and going through biomedical information to become involved in some changes.” Wikipedia. The authors identify four main areas that can be used to improve the encyclopedia. doi.org/10.1136/jech-2016-208601 Embargo Tuesday 29th August at 00:05 [UK time] Individual Wikipedia is built entirely by volunteers.
    [Show full text]
  • Polymyalgia Rheumatica Mimicking an Iliopsoas Abscess
    Central Annals of Orthopedics & Rheumatology Case Report *Corresponding author Lennart Dimberg, Department of Public Health and Community Medicine, the Sahlgrenska Academy, University of Gothenburg, Box 454, SE-405 30 Polymyalgia Rheumatica Gothenburg, Sweden, Email: [email protected] Submitted: 30 November 2020 Mimicking an Iliopsoas Abscess Accepted: 12 December 2020 Published: 15 December 2020 Lennart Dimberg1* and Fredrik Wennerberg2 Copyright 1Department of Public Health and Community Medicine, the Sahlgrenska Academy, © 2020 Dimberg L, et al. University of Gothenburg, Sweden OPEN ACCESS 2Radiology Resident Physician/MD, NU Hospital Group/NU-sjukvården, Sweden Keywords • Case report Abstract • Polymyalgia rheumatic Background: Polymyalgia Rheumatica (PMR) is a clinical condition characterized • Iliopsoas abscess by pain and stiffness of proximal muscles of shoulders and hips. We here present an unusual case initially believed to be an abscess of the iliopsoas muscle. Case presentation: An elderly man visited our clinic with symptoms of left hip pain and stiffness and an elevated erythrocyte sedimentation rate (ESR) at 96 mm/h, but no fever. An MRI of the left hip and proximal femur suggested an iliopsoas abscess, which was aspirated with clear yellow fluid and no bacteria. A few weeks later, additional pain and stiffness of the muscles of both shoulders made a diagnosis of PMR suspicious. A prompt response to high doses of Prednisolone confirmed the diagnosis. Conclusion: PMR may present with hip-pain due to a unilateral iliopsoas bursitis. BACKGROUND An iliopsoas abscess is a rare condition, often appearing with vague clinical features. In a review article by Lee et al, during 1988-1998 a major Taiwanese hospital registered about one case per year Lee et al, [1] The affected individual typically presents with fever, back-pain and limp.
    [Show full text]
  • SUPPLEMENTARY APPENDIX Mutation Status of Essential Thrombocythemia and Primary Myelofibrosis Defines Clinical Outcome
    SUPPLEMENTARY APPENDIX Mutation status of essential thrombocythemia and primary myelofibrosis defines clinical outcome Julia Asp, 1,2 Björn Andréasson, 3,4 Ulrika Hansson, 5 Carina Wasslavik, 2 Johanna Abelsson, 3 Peter Johansson, 3,4 and Lars Palmqvist 1,2 1Department of Clinical Chemistry and Transfusion Medicine, Institute of Biomedicine, the Sahlgrenska Academy, University of Gothenburg; 2Department of Clinical Chemistry, Sahlgrenska University Hospital, Gothenburg; 3Haematology and Coagulation Section, Department of Medicine, Sahlgrenska University Hospital, Gothenburg; 4Hematology Section, Department of Medicine, NU Hospital Group, Uddevalla; and 5Department of Clinical Pathology and Genetics, Sahlgrenska University Hospital, Gothenburg, Sweden Correspondence: [email protected] doi:10.3324/haematol.2015.138958 Online supplement Mutation Status of Essential Thrombocythemia and Primary Myelofibrosis Defines Clinical Outcome Julia Asp, Björn Andréasson, Ulrika Hansson, Carina Wasslavik, Johanna Abelsson, Peter Johansson, and Lars Palmqvist Methods Patients The study was performed in accordance to the Declaration of Helsinki after ethical approval by the Research Ethics Board at the University of Gothenburg and the Sahlgrenska Academy, Gothenburg, Sweden. All patients diagnosed with ET or PMF according to the WHO 2008 classification between 2008 and 2013 in Western Sweden at the Sahlgrenska University Hospital or NU Hospital Group and reported to the Swedish national cancer register, INCA, were selected (n=186). 170 patients were included; 129 ET patients (73 females and 56 males, median age 67 years, range 27–90 years) and 41 PMF patients (21 females and 20 males, median age 70 years, range 32–85 years). 16 patients did not answer the request to participate in the study. Clinical, laboratory and outcome data was available for all patients.
    [Show full text]
  • An Antenatal Health Care Intervention Can Reduce Gestational Weight Gain in Women with Obesity
    Midwifery ∎ (∎∎∎∎) ∎∎∎–∎∎∎ Contents lists available at ScienceDirect Midwifery journal homepage: www.elsevier.com/midw Mighty Mums – An antenatal health care intervention can reduce gestational weight gain in women with obesity Karin Haby, RD, MSc (Maternal health care dietitian)a,n, Anna Glantz, MD, Ph D (Senior Consultant in Obstetrics and Gynecology, Head of Antenatal Health Care)b, Ragnar Hanas, MD, Ph D (Assoc Prof, Senior Consultant)c, Åsa Premberg, RNM, Ph D (Senior lecturer)d a Antenatal Health Care, Primary Health Care, Research and Development Unit, Närhälsan, Gothenburg, Region of Västra Götaland, Sweden b Primary Health Care, Närhälsan, Gothenburg, Region of Västra Götaland, Sweden c The Sahlgrenska Academy, University of Gothenburg, Institute of Clinical Sciences and Department of Pediatrics, NU Hospital Group, Uddevalla Hospital, Uddevalla, Region of Västra Götaland, Sweden d The Sahlgrenska Academy, University of Gothenburg, Primary Health Care, Research and Development Unit, Närhälsan, Gothenburg, Region of Västra Götaland, Sweden article info abstract Article history: Background: overweight and obesity are growing public health problems and around 13% of women Received 15 November 2014 assigned to antenatal health care (AHC) in Sweden have obesity (Body Mass Index, BMI Z30). The risk of Received in revised form complications during pregnancy and childbirth increase with increasing BMI. Excessive gestational 22 March 2015 weight gain (GWG) among obese women further increases the risks of adverse pregnancy outcomes. Accepted 29 March 2015 In this pilot-study from AHC in Gothenburg, a co-ordinated project with standardised care, given by midwives and supported by dietitian and aiming at reducing weight gain in obese pregnant women, is Keywords: evaluated.
    [Show full text]
  • Acute Care of Severely Frail Elderly Patients in a CGA-Unit Is Associated with Less Functional Decline Than Conventional Acute Care
    Journal name: Clinical Interventions in Aging Article Designation: Original Research Year: 2017 Volume: 12 Clinical Interventions in Aging Dovepress Running head verso: Ekerstad et al Running head recto: CGA for acutely ill frail elderly patients open access to scientific and medical research DOI: http://dx.doi.org/10.2147/CIA.S139230 Open Access Full Text Article ORIGINAL RESEARCH Acute care of severely frail elderly patients in a CGA-unit is associated with less functional decline than conventional acute care Niklas Ekerstad1,2 Background: A high percentage of individuals treated in specialized acute care wards are Synneve Dahlin Ivanoff3 frail and elderly. Our aim was to study whether the acute care of such patients in a compre- Sten Landahl4 hensive geriatric assessment (CGA) unit is superior to care in a conventional acute medical Göran Östberg5 care unit when it comes to activities of daily living (ADLs), frailty, and use of municipal help Maria Johansson5 services. David Andersson6 Patients and methods: A clinical, prospective, controlled trial with two parallel groups was conducted in a large county hospital in West Sweden and included 408 frail elderly patients, age Magnus Husberg2 75 or older (mean age 85.7 years; 56% female). Patients were assigned to the intervention group Jenny Alwin2 (n=206) or control group (n=202). Primary outcome was decline in functional activity ADLs Björn W Karlson7 For personal use only. assessed by the ADL Staircase 3 months after discharge from hospital. Secondary outcomes 1Department of Cardiology,
    [Show full text]
  • ISPAD Clinical Practice Consensus Guidelines 2018: Diabetic Ketoacidosis and the Hyperglycem
    Received: 11 April 2018 Accepted: 31 May 2018 DOI: 10.1111/pedi.12701 ISPAD CLINICAL PRACTICE CONSENSUS GUIDELINES ISPAD Clinical Practice Consensus Guidelines 2018: Diabetic ketoacidosis and the hyperglycemic hyperosmolar state Joseph I. Wolfsdorf1 | Nicole Glaser2 | Michael Agus1,3 | Maria Fritsch4 | Ragnar Hanas5 | Arleta Rewers6 | Mark A. Sperling7 | Ethel Codner8 1Division of Endocrinology, Boston Children's Hospital, Boston, Massachusetts 2Department of Pediatrics, Section of Endocrinology, University of California, Davis School of Medicine, Sacramento, California 3Division of Critical Care Medicine, Boston Children's Hospital, Boston, Massachusetts 4Department of Pediatric and Adolescent Medicine, Medical University of Vienna, Vienna, Austria 5Department of Pediatrics, NU Hospital Group, Uddevalla and Sahlgrenska Academy, Gothenburg University, Uddevalla, Sweden 6Department of Pediatrics, School of Medicine, University of Colorado, Aurora, Colorado 7Division of Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, New York 8Institute of Maternal and Child Research, School of Medicine, University of Chile, Santiago, Chile Correspondence Joseph I. Wolfsdorf, Division of Endocrinology, Boston Children's Hospital, 300 Longwood Avenue, Boston, MA. Email: [email protected] 1 | SUMMARY OF WHAT IS Risk factors for DKA in newly diagnosed patients include younger NEW/DIFFERENT age, delayed diagnosis, lower socioeconomic status, and residence in a country with a low prevalence of type 1 diabetes mellitus (T1DM). Recommendations concerning fluid management have been modified Risk factors for DKA in patients with known diabetes include to reflect recent findings from a randomized controlled clinical trial omission of insulin for various reasons, limited access to medical ser- showing no difference in cerebral injury in patients rehydrated at dif- vices, and unrecognized interruption of insulin delivery in patients ferent rates with either 0.45% or 0.9% saline.
    [Show full text]
  • Minna Johansson
    Minna Johansson 0733-106170 / Hedegatan 38, 45152 Uddevalla / [email protected] General Practitioner and PhD student. ResearCh topics include methodological aspects when evaluating benefits and harms of screening, informed choice, overdiagnosis/too much medicine and evidenCe-based medicine. EDUCATION 2012 – present PhD student University of Gothenburg 2017 Medical statistics II University of Gothenburg (5 credits) 2016 Medical statistics I University of Gothenburg (5 Credits) 2015 How to practice evidence-based health care Norwegian Institute of Public Health (1.5 credits) 2014 Scientific communication National Research SChool for General Practice (4.5 credits) 2002 – 2007 School of Medicine University of Umeå PROFESSIONAL EXPERIENCE 2017 – present General Practitioner Herrestad HCC, Region Västra Götaland 2010 – 2017 Resident Physician Herrestad HCC, Region Västra Götaland 2008 – 2010 Medical Intern NU hospital group, Region Västra Götaland 1999 – 2002 Care Assistant Karlskrona Municipality, blekinge TEACHING 2014 – present Evidence-based medicine, 12 h, Research Methodology in Primary Care (SM00016), PhD Course, University of Gothenburg 2016 – present Evidence-based medicine, 9 h, IntroduCtion to research for resident physicians, FoUU Centre Fyrbodal, Region Västra Götaland 2016 Evaluation of screening programmes, 2 h, Screening and Prevention in Primary Health Care (43VT11), PhD course, University of Gothenburg OTHER 2017 – present Member of the Junior Research Committee, Preventing Overdiagnosis conference 2017 – present Chair of the Council for Sustainable Medicine, the Swedish College of General PractiCe 2015 – 2017 Peer-review for The Lancet, four papers Minna Johansson 0733-106170 / Hedegatan 38, 45152 Uddevalla / [email protected] PUBLICATIONS Peer-reviewed Analysis papers 1. Johansson M, Hansson A, brodersen J. Estimating overdiagnosis in screening for Abdominal Aortic Aeurysm: could a Change in smoking habits and lowered aortiC diameter tip the balance of AAA screening towards harm? BMJ 2015;350:h825.
    [Show full text]
  • Guidelines for the Management of Diverticular Disease of the Colon
    Original Article doi:10.1111/codi.15140 European Society of Coloproctology: guidelines for the management of diverticular disease of the colon J. K. Schultz* , N. Azhar†,‡ , G. A. Binda§, G. Barbara¶ , S. Biondo** , M. A. Boermester††, A. Chabok‡‡ , E. C. J. Consten§§,¶¶, S. T. van Dijk††, A. Johanssen*, W. Kruis***, D. Lambrichts††† , S. Post‡‡‡ , F. Ris§§§ , T. A. Rockall¶¶¶, A. Samuelsson****,††††, S. Di Saverio‡‡‡‡,§§§§ , D. Tartaglia¶¶¶¶ , A. Thorisson*****,††††† , D. C. Winter‡‡‡‡‡, W. Bemelman†† and E. Angenete§§§§§,†††† *Department of Gastrointestinal Surgery, Akershus University Hospital, Lørenskog, Norway, †Colorectal Unit, Department of Surgery, Skane University Hospital Malmo,€ Malmo,€ Sweden, ‡Department of Clinical Sciences, Lund University, Malmo,€ Sweden, §Colorectal Surgery, BioMedical Institute, Genova, Italy, ¶Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy, **Department of General and Digestive Surgery – Colorectal Unit, Bellvitge University Hospital, University of Barcelona and IDIBELL, Barcelona, Spain, ††Department of Surgery, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands, ‡‡Colorectal Unit, Department of Surgery, Centre for Clinical Research Uppsala University, V€astmanlands Hospital V€asteras, V€asteras, Sweden, §§Department of Surgery, Meander Medical Centre, Amersfoort, The Netherlands, ¶¶Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands, ***Faculty of Medicine,
    [Show full text]
  • Periprosthetic Hip Infections in a Swedish Regional Hospital Between
    Original full-length article J. Bone Joint Infect., 6, 219–228, 2021 https://doi.org/10.5194/jbji-6-219-2021 JBJI © Author(s) 2021. This work is distributed under Journal of Bone the Creative Commons Attribution 4.0 License. and Joint Infection Open Access Periprosthetic hip infections in a Swedish regional hospital between 2012 and 2018: is there a relationship between Cutibacterium acnes infections and uncemented prostheses? Urban Hedlundh1, Michail Zacharatos1, Jonas Magnusson1, Magnus Gottlander1, and Johanna Karlsson2,3 1Department of Orthopedic Surgery, Uddevalla Hospital, SE 451 80, Uddevalla, Sweden 2Department of Infectious Diseases, NU Hospital Group, Trollhättan/Uddevalla, Sweden 3Department of Infectious Diseases, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden Correspondence: Urban Hedlundh ([email protected]) Received: 19 January 2021 – Revised: 18 May 2021 – Accepted: 24 May 2021 – Published: 4 June 2021 Abstract. The purpose of this study was to evaluate patients requiring in-patient care due to a periprosthetic joint infection (PJI), with respect to bacterial agents, surgical treatment, antibiotics, and outcome. We retrospec- tively identified all infected total hip arthroplasties (THAs) in a Swedish regional hospital during a 7-year period (2012–2018) and reviewed medical records and microbiological data. A total of 89 infected THAs in 87 patients were identified. Standardized treatment with debridement with retention of the implant and antibiotics (DAIR) was initially performed in 53 cases (60 %), one or two stage revisions in 33 cases (37 %), and an immediate Girdlestone in 3 cases (3 %). Infection eradication was seen in 77 PJIs (87 %) in addition to six patients (7 %) ending up with a permanent but uninfected Girdlestone.
    [Show full text]