DOCSLIB.ORG

Protocol for Non-Interventional Studies Based on Existing Data TITLE PAGE Document Number: C30445781-01

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text

Load more

ABCD Protocol for non-interventional studies based on existing data TITLE PAGE Document Number: c30445781-01 BI Study Number: 1237-0090 BI Investigational Stiolto® Respimat® Product(s): The Role of Inhaler Device in the Treatment Persistence with Dual Title: Bronchodilators in Patients with COPD Protocol version 1.0 identifier: Date of last version of N/A protocol: PASS: No EU PAS register Study not registered number: Olodaterol and Tiotropium Bromide (ATC R03AL06) Active substance: Umeclidinium and Vilanterol (ATC R03AL03) Medicinal product: Stiolto® Respimat®; Anoro® Ellipta® Product reference: N/A Procedure number: N/A Joint PASS: No The primary objective of the study is to use US data to determine relative persistence between Olodaterol/Tiotropium Bromide delivered with the Respimat soft mist inhaler and Umeclidinium/Vilanterol delivered with the Ellipta dry powder inhaler using a 1:2 propensity score matched analysis. The secondary objectives of the study are as follows: Research question and - Characterize new users of Olodaterol/Tiotropium Bromide objectives: and Umeclidinium/Vilanterol in terms of demographics, medication use, comorbidities, and other variables, before and after propensity score matching. - Determine the incidence rate and proportion of patients discontinuing or switching among new users of Olodaterol/Tiotropium Bromide and Umeclidinium/ Vilanterol. - Determine the relative rate and proportion of patients discontinuing between Olodaterol/ Tiotropium Bromide and 001-MCG-102_RD-02 (1.0) / Saved on: 22 Oct 2015 Boehringer Ingelheim Page 2 of 69 Protocol for non-interventional studies based on existing data BI Study Number 1237-0090 c30445781-01 Proprietary confidential information © 2019 Boehringer Ingelheim International GmbH or one or more of its affiliated companies Umeclidinium/Vilanterol. using a standard multivariate analysis (If feasible). Country(-ies) of study: United States T: Email: Author: T: Email: BI contact person: Marketing authorisation holder(s): MAH contact person: In case of PASS, add: N/A In case of PASS, add: N/A Date: 22 November 2019 Page 1 of 69 Proprietary confidential information © 2019 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved. This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission 001-MCG-102_RD-02 (1.0) / Saved on: 22 Oct 2015 Boehringer Ingelheim Page 3 of 69 Protocol for non-interventional studies based on existing data BI Study Number 1237-0090 c30445781-01 Proprietary confidential information © 2019 Boehringer Ingelheim International GmbH or one or more of its affiliated companies 1. TABLE OF CONTENTS TITLE PAGE.............................................................................................................................1 1. TABLE OF CONTENTS...............................................................................................3 2. LIST OF ABBREVIATIONS........................................................................................5 3. RESPONSIBLE PARTIES ............................................................................................6 4. ABSTRACT...................................................................................................................7 5. AMENDMENTS AND UPDATES.............................................................................15 6. MILESTONES.............................................................................................................15 7. RATIONALE AND BACKGROUND........................................................................15 8. RESEARCH QUESTION AND OBJECTIVES..........................................................16 9. RESEARCH METHODS ............................................................................................17 9.1 STUDY DESIGN..........................................................................................17 9.2 SETTING ......................................................................................................17 9.2.1 Definitions.....................................................................................................17 9.2.2 Study population............................................................................................19 9.3 VARIABLES.................................................................................................20 9.3.1 Exposures ......................................................................................................20 9.3.2 Outcomes.......................................................................................................20 9.3.2.1 Primary outcome..........................................................................................20 9.3.2.2 Secondary outcomes ....................................................................................21 9.3.3 Covariates......................................................................................................21 9.4 DATA SOURCES.........................................................................................23 9.5 STUDY SIZE ................................................................................................23 9.6 DATA MANAGEMENT..............................................................................23 9.7 DATA ANALYSIS .......................................................................................24 9.7.1 Main analysis.................................................................................................24 9.7.1.1 Descriptive Analysis ....................................................................................24 9.7.1.2 Rates and Risks............................................................................................24 9.7.1.3 Comparative Persistence..............................................................................25 9.7.2 Sensitivity Analysis.......................................................................................26 9.8 QUALITY CONTROL .................................................................................27 9.9 LIMITATIONS OF THE RESEARCH METHODS ....................................28 001-MCG-102_RD-02 (1.0) / Saved on: 22 Oct 2015 Boehringer Ingelheim Page 4 of 69 Protocol for non-interventional studies based on existing data BI Study Number 1237-0090 c30445781-01 Proprietary confidential information © 2019 Boehringer Ingelheim International GmbH or one or more of its affiliated companies 9.10 OTHER ASPECTS........................................................................................28 9.11 SUBJECTS....................................................................................................28 9.11.1 Cases..............................................................................................................28 9.11.2 Controls .........................................................................................................29 9.12 BIAS..............................................................................................................29 10. PROTECTION OF HUMAN SUBJECTS ..................................................................29 11. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE REACTIONS ...............................................................................................................30 12. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS..30 13. REFERENCES.............................................................................................................31 13.1 PUBLISHED REFERENCES.......................................................................31 13.2 UNPUBLISHED REFERENCES .................................................................32 ANNEX 1. LIST OF STAND-ALONE DOCUMENTS.........................................................33 ANNEX 2. ENCEPP CHECKLIST FOR STUDY PROTOCOLS .........................................34 ANNEX 3: LIST OF MEDICATION MEASURE DEFINITIONS........................................35 ANNEX 4. LIST OF COMORBIDITY, SYMPTOMS AND OTHER MEASURE DEFINITIONS.............................................................................................................38 ANNEX 5. TABLE SHELLS AND PROPOSED FIGURES .................................................60 001-MCG-102_RD-02 (1.0) / Saved on: 22 Oct 2015 Boehringer Ingelheim Page 5 of 69 Protocol for non-interventional studies based on existing data BI Study Number 1237-0090 c30445781-01 Proprietary confidential information © 2019 Boehringer Ingelheim International GmbH or one or more of its affiliated companies 2. LIST OF ABBREVIATIONS ACE Angiotensin Converting Enzyme AIDS Acquired Immune Deficiency Syndrome CCAE Commercial Claims and Encounters CDCI Charlson Deyo Comorbidity Index CI Confidence Interval COB Coordination of Benefits COBRA Consolidated Omnibus Budget Reconciliation Act COPD Chronic Obstructive Pulmonary Disease CT Computed Tomography DPI Dry Powder Inhaler ENCEPP European Network of Centres for Pharmacoepidemiology and Pharmacovigilance ESRD End Stage Renal Disease FDC Fixed Dose Combination GLP-1 Glucagon-like Peptide-1 GOLD Global Initiative for Chronic Obstructive Lung Disease HIV Human Immunodeficiency Virus ICD International Classification of Diseases ICS Inhaled Corticosteroid IP Inpatient IQR Interquartile Range IRB Institutional Review Board LABA Long-Acting Beta-Agonists LAMA Long-Acting Muscarinic Antagonists NDC National Drug Code NSAID Nonsteroidal Anti-inflammatory Drug
Recommended publications
  • PROZAC Product Monograph Page 1 of 49 Table of Contents

    PROZAC Product Monograph Page 1 of 49 Table of Contents

    PRODUCT MONOGRAPH PrPROZAC® fluoxetine hydrochloride 10 mg and 20 mg Capsules Antidepressant / Antiobsessional / Antibulimic © Eli Lilly Canada Inc. Date of Revision: January, 25 Exchange Tower 2021 130 King Street West, Suite 900 PO Box 73 Toronto, Ontario M5X 1B1 1-888-545-5972 www.lilly.ca Submission Control No: 192639 PROZAC Product Monograph Page 1 of 49 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION .......................................................3 SUMMARY PRODUCT INFORMATION...........................................................................3 INDICATIONS AND CLINICAL USE ................................................................................3 CONTRAINDICATIONS .....................................................................................................4 WARNINGS AND PRECAUTIONS ....................................................................................5 ADVERSE REACTIONS ...................................................................................................13 DRUG INTERACTIONS....................................................................................................22 DOSAGE AND ADMINISTRATION ................................................................................27 OVERDOSAGE..................................................................................................................28 ACTION AND CLINICAL PHARMACOLOGY ...............................................................30 STORAGE AND STABILITY............................................................................................32
  • Allosteric Drug Transport Mechanism of Multidrug Transporter Acrb

    Allosteric Drug Transport Mechanism of Multidrug Transporter Acrb

    ARTICLE https://doi.org/10.1038/s41467-021-24151-3 OPEN Allosteric drug transport mechanism of multidrug transporter AcrB ✉ Heng-Keat Tam 1,3,4 , Wuen Ee Foong 1,4, Christine Oswald1,2, Andrea Herrmann1, Hui Zeng1 & ✉ Klaas M. Pos 1 Gram-negative bacteria maintain an intrinsic resistance mechanism against entry of noxious compounds by utilizing highly efficient efflux pumps. The E. coli AcrAB-TolC drug efflux pump + 1234567890():,; contains the inner membrane H /drug antiporter AcrB comprising three functionally inter- dependent protomers, cycling consecutively through the loose (L), tight (T) and open (O) state during cooperative catalysis. Here, we present 13 X-ray structures of AcrB in inter- mediate states of the transport cycle. Structure-based mutational analysis combined with drug susceptibility assays indicate that drugs are guided through dedicated transport chan- nels toward the drug binding pockets. A co-structure obtained in the combined presence of erythromycin, linezolid, oxacillin and fusidic acid shows binding of fusidic acid deeply inside the T protomer transmembrane domain. Thiol cross-link substrate protection assays indicate that this transmembrane domain-binding site can also accommodate oxacillin or novobiocin but not erythromycin or linezolid. AcrB-mediated drug transport is suggested to be allos- terically modulated in presence of multiple drugs. 1 Institute of Biochemistry, Goethe-University Frankfurt, Frankfurt am Main, Germany. 2 Sosei Heptares, Steinmetz Building, Granta Park, Great Abington, Cambridge, UK. 3Present
  • Treatment of 51 Pregnancies with Danaparoid Because of Heparin

    Treatment of 51 Pregnancies with Danaparoid Because of Heparin

    ©2005 Schattauer GmbH,Stuttgart Blood Coagulation, Fibrinolysis and CellularHaemostasis Treatment of 51 pregnancies withdanaparoidbecause of heparin intolerance EdelgardLindhoff-Last1 ,Hans-Joachim Kreutzenbeck2 ,Harry N. Magnani3 1 Division ofVascular Medicine,Department of Internal Medicine,University Hospital Frankfurt, Germany 2 MedicalDepartment, Celltech, Essen, Germany 3 Clinical Consultant Marketing, OrganonBV, Oss,The Netherlands Summary Pregnant patients withacute venous thrombosis or ahistoryof required (3/14) or an adverse eventled to atreatment discon- thrombosis mayneed alternative anticoagulation, when heparin tinuation (11/14).Four maternal bleeding events were recorded intolerance occurs. Onlylimited dataonthe useofthe hepari- during pregnancy, deliveryorpostpartum, twoofthemwere noiddanaparoid areavailable in literature.We reviewedthe use fatal duetoplacental problems.Three fetal deathswererec- of danaparoid in 51 pregnancies of 49 patients identified in litera- orded,all associated with maternal complications antedating da- turebetween 1981 and 2004.All patients had developed hepa- naparoiduse.Danaparoid cross-reactivity was suspectedin4 rin intolerance (32 duetoheparin-induced thrombocytopenia, HITpatientsand 5non-HITpatientswith skin reactions and was 19 mainlydue to heparin-induced skin rashes)and had acurrent confirmedserologicallyinone of the twoHIT patients tested.In and/or pasthistoryofthromboembolic complications.The initial none of fivefetal cordblood- andthree maternal breast milk- danaparoid doseregimens ranged
  • (12) Patent Application Publication (10) Pub. No.: US 2006/0110428A1 De Juan Et Al

    (12) Patent Application Publication (10) Pub. No.: US 2006/0110428A1 De Juan Et Al

    US 200601 10428A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0110428A1 de Juan et al. (43) Pub. Date: May 25, 2006 (54) METHODS AND DEVICES FOR THE Publication Classification TREATMENT OF OCULAR CONDITIONS (51) Int. Cl. (76) Inventors: Eugene de Juan, LaCanada, CA (US); A6F 2/00 (2006.01) Signe E. Varner, Los Angeles, CA (52) U.S. Cl. .............................................................. 424/427 (US); Laurie R. Lawin, New Brighton, MN (US) (57) ABSTRACT Correspondence Address: Featured is a method for instilling one or more bioactive SCOTT PRIBNOW agents into ocular tissue within an eye of a patient for the Kagan Binder, PLLC treatment of an ocular condition, the method comprising Suite 200 concurrently using at least two of the following bioactive 221 Main Street North agent delivery methods (A)-(C): Stillwater, MN 55082 (US) (A) implanting a Sustained release delivery device com (21) Appl. No.: 11/175,850 prising one or more bioactive agents in a posterior region of the eye so that it delivers the one or more (22) Filed: Jul. 5, 2005 bioactive agents into the vitreous humor of the eye; (B) instilling (e.g., injecting or implanting) one or more Related U.S. Application Data bioactive agents Subretinally; and (60) Provisional application No. 60/585,236, filed on Jul. (C) instilling (e.g., injecting or delivering by ocular ion 2, 2004. Provisional application No. 60/669,701, filed tophoresis) one or more bioactive agents into the Vit on Apr. 8, 2005. reous humor of the eye. Patent Application Publication May 25, 2006 Sheet 1 of 22 US 2006/0110428A1 R 2 2 C.6 Fig.
  • Kengrexal, INN-Cangrelor Tetrasodium

    Kengrexal, INN-Cangrelor Tetrasodium

    ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Kengrexal 50 mg powder for concentrate for solution for injection/infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains cangrelor tetrasodium corresponding to 50 mg cangrelor. After reconstitution 1 mL of concentrate contains 10 mg cangrelor. After dilution 1 mL of solution contains 200 micrograms cangrelor. Excipient with known effect Each vial contains 52.2 mg sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for injection/infusion. White to off-white lyophilised powder. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Kengrexal, co-administered with acetylsalicylic acid (ASA), is indicated for the reduction of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable. 4.2 Posology and method of administration Kengrexal should be administered by a physician experienced in either acute coronary care or in coronary intervention procedures and is intended for specialised use in an acute and hospital setting. Posology The recommended dose of Kengrexal for patients undergoing PCI is a 30 micrograms/kg intravenous bolus followed immediately by 4 micrograms/kg/min intravenous infusion. The bolus and infusion should be initiated prior to the procedure and continued for at least two hours or for the duration of the procedure, whichever is longer. At the discretion of the physician, the infusion may be continued for a total duration of four hours, see section 5.1.
  • Characterising the Risk of Major Bleeding in Patients With

    Characterising the Risk of Major Bleeding in Patients With

    EU PE&PV Research Network under the Framework Service Contract (nr. EMA/2015/27/PH) Study Protocol Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU Version 3.0 1 June 2018 EU PAS Register No: 16014 EMA/2015/27/PH EUPAS16014 Version 3.0 1 June 2018 1 TABLE OF CONTENTS 1 Title ........................................................................................................................................... 5 2 Marketing authorization holder ................................................................................................. 5 3 Responsible parties ................................................................................................................... 5 4 Abstract ..................................................................................................................................... 6 5 Amendments and updates ......................................................................................................... 7 6 Milestones ................................................................................................................................. 8 7 Rationale and background ......................................................................................................... 9 8 Research question and objectives .............................................................................................. 9 9 Research methods ....................................................................................................................
  • Eptifibatide Is Noninferior to Abciximab: Implications for Clinical Practice

    Eptifibatide Is Noninferior to Abciximab: Implications for Clinical Practice

    RESEARCH HIGHLIGHTS ANTIPLATELET THERAPY Eptifibatide is noninferior to abciximab: implications for clinical practice he glycoprotein IIb/IIIa (GPIIb/ randomized, open, parallel-group January 2004 and December 2007, IIIa) inhibitors eptifibatide and comparison of eptifibatide and abciximab and eptifibatide was used in 2,355 Tabciximab have comparable efficacy in 427 patients presenting within 12 h such procedures over this time frame. and safety in patients with ST-segment of STEMI onset and who underwent During the 1-year follow-up period, elevation myocardial infarction (STEMI) primary PCI. Enrolled patients were from no significant difference was reported undergoing primary percutaneous 22 centers in France and Germany. The for the incidence of death (8.0% and coronary intervention (PCI). These two study drugs were administered in 7.6%), myocardial infarction (9.0% and findings, from a randomized trial and a combination with background therapy 8.4%), or bleeding (2.7% and 3.2%) registry study, are reported in two papers comprising clopidogrel, aspirin, and between abciximab and eptifibatide, published in the Journal of the American heparin or enoxaparin. This study used respectively. Multivariable analysis College of Cardiology (JACC). the surrogate primary end point of showed that eptifibatide was noninferior Platelet aggregation and thrombus complete electrocardiographic ST-segment to abciximab for the prevention of death formation can be inhibited by blocking resolution (STR) 60 min after completion or myocardial infarction (odds ratio 0.94, the GPIIb/IIIa receptor on the platelet of PCI. 95% CI 0.82–1.09). membrane, thereby preventing the binding In the intention-to-treat analysis, These findings “fuel an already much of fibrinogen.
  • Tetracycline and Sulfonamide Antibiotics in Soils: Presence, Fate and Environmental Risks

    Tetracycline and Sulfonamide Antibiotics in Soils: Presence, Fate and Environmental Risks

    processes Review Tetracycline and Sulfonamide Antibiotics in Soils: Presence, Fate and Environmental Risks Manuel Conde-Cid 1, Avelino Núñez-Delgado 2 , María José Fernández-Sanjurjo 2 , Esperanza Álvarez-Rodríguez 2, David Fernández-Calviño 1,* and Manuel Arias-Estévez 1 1 Soil Science and Agricultural Chemistry, Faculty Sciences, University Vigo, 32004 Ourense, Spain; [email protected] (M.C.-C.); [email protected] (M.A.-E.) 2 Department Soil Science and Agricultural Chemistry, Engineering Polytechnic School, University Santiago de Compostela, 27002 Lugo, Spain; [email protected] (A.N.-D.); [email protected] (M.J.F.-S.); [email protected] (E.Á.-R.) * Correspondence: [email protected] Received: 30 October 2020; Accepted: 13 November 2020; Published: 17 November 2020 Abstract: Veterinary antibiotics are widely used worldwide to treat and prevent infectious diseases, as well as (in countries where allowed) to promote growth and improve feeding efficiency of food-producing animals in livestock activities. Among the different antibiotic classes, tetracyclines and sulfonamides are two of the most used for veterinary proposals. Due to the fact that these compounds are poorly absorbed in the gut of animals, a significant proportion (up to ~90%) of them are excreted unchanged, thus reaching the environment mainly through the application of manures and slurries as fertilizers in agricultural fields. Once in the soil, antibiotics are subjected to a series of physicochemical and biological processes, which depend both on the antibiotic nature and soil characteristics. Adsorption/desorption to soil particles and degradation are the main processes that will affect the persistence, bioavailability, and environmental fate of these pollutants, thus determining their potential impacts and risks on human and ecological health.
  • Deliverable 5.A Interim Report on the Study Results APPENDIX 2

    Deliverable 5.A Interim Report on the Study Results APPENDIX 2

    Deliverable 5.a Interim report on the study results APPENDIX 2: Algorithms used to identify study variables for service contract EMA/2011/38/CN ‐ PIOGLITAZONE November 28th 2012 D5.a Interim report on the study results (Appendix 2) for Service Contract EMA/2011/38/CN PIOGLITAZONE Author(s): Vera Ehrenstein (AUH‐AS) APPENDIX 2. ALGORITHMS USED TO IDENTIFY STUDY VARIABLES Algorithms for AU Database DISEASE/CONDITION ICD-8 CODE (1977-1993) ICD-10 CODE (1994-) Diabetes type 2 250.00; 250.06; 250.07; 250.09 E11.0; E11.1; E11.9 Cancer of bladder 188 C67 Haematuria N/A R31 Haematuria, unspecified B18, K70.0–K70.3, K70.9, K71, K73, Mild hepatic impairment 571, 573.01, 573.04 K74, K76.0 Moderate to severe hepatic 070.00, 070.02, 070.04, 070.06, B15.0, B16.0, B16.2, B19.0, K70.4, impairment 070.08, 573.00, 456.00–456.09 K72, K76.6, I85 Acute myocardial infarction 410 I21-I23 Acute coronary syndrome 410, 413 I20-I24 Ischemic heart disease 410-414 I20-I25 427.09, 427.10, 427.11, 427.19, Congestive heart failure I50, I11.0, I13.0,I13.2 428.99, 782.49; Acute renal failure N/A N17 Diabetic coma N/A E10.0, E11.0, E12.0,E13.0, E14.0 Diabetic acidosis N/A E10.1, E11.1, E12.1,E13.1, E14.1 F10.1-F10.9, G31.2, G62.1, G72.1, Alcoholism 291, 303, 577.10, 571.09, 571.10 I42.6, K29.2, K86.0, Z72.1 Obesity 277.99 E65-E66 D5.a Interim report on the study results (Appendix 2) for Service Contract EMA/2011/38/CN PIOGLITAZONE Author(s): Vera Ehrenstein (AUH‐AS) Algorithms for defining acute events in Denmark, ICD-10 code Event ICD-10 code I21.x, I23.x http://apps.who.int/classifications/icd10/browse/2010/en#/I21
  • Antimicrobial Resistance Benchmark 2020 Antimicrobial Resistance Benchmark 2020

    Antimicrobial Resistance Benchmark 2020 Antimicrobial Resistance Benchmark 2020

    First independent framework for assessing pharmaceutical company action Antimicrobial Resistance Benchmark 2020 Antimicrobial Resistance Benchmark 2020 ACKNOWLEDGEMENTS The Access to Medicine Foundation would like to thank the following people and organisations for their contributions to this report.1 FUNDERS The Antimicrobial Resistance Benchmark research programme is made possible with financial support from UK AID and the Dutch Ministry of Health, Welfare and Sport. Expert Review Committee Research Team Reviewers Hans Hogerzeil - Chair Gabrielle Breugelmans Christine Årdal Gregory Frank Fatema Rafiqi Karen Gallant Nina Grundmann Adrián Alonso Ruiz Hans Hogerzeil Magdalena Kettis Ruth Baron Hitesh Hurkchand Joakim Larsson Dulce Calçada Joakim Larsson Marc Mendelson Moska Hellamand Marc Mendelson Margareth Ndomondo-Sigonda Kevin Outterson Katarina Nedog Sarah Paulin (Observer) Editorial Team Andrew Singer Anna Massey Deirdre Cogan ACCESS TO MEDICINE FOUNDATION Rachel Jones The Access to Medicine Foundation is an independent Emma Ross non-profit organisation based in the Netherlands. It aims to advance access to medicine in low- and middle-income Additional contributors countries by stimulating and guiding the pharmaceutical Thomas Collin-Lefebvre industry to play a greater role in improving access to Alex Kong medicine. Nestor Papanikolaou Address Contact Naritaweg 227-A For more information about this publication, please contact 1043 CB, Amsterdam Jayasree K. Iyer, Executive Director The Netherlands [email protected] +31 (0) 20 215 35 35 www.amrbenchmark.org 1 This acknowledgement is not intended to imply that the individuals and institutions referred to above endorse About the cover: Young woman from the Antimicrobial Resistance Benchmark methodology, Brazil, where 40%-60% of infections are analyses or results.
  • Drug Consumption in 2017 - 2020

    Drug Consumption in 2017 - 2020

    Page 1 Drug consumption in 2017 - 2020 2020 2019 2018 2017 DDD/ DDD/ DDD/ DDD/ 1000 inhab./ Hospital 1000 inhab./ Hospital 1000 inhab./ Hospital 1000 inhab./ Hospital ATC code Subgroup or chemical substance day % day % day % day % A ALIMENTARY TRACT AND METABOLISM 322,79 3 312,53 4 303,08 4 298,95 4 A01 STOMATOLOGICAL PREPARATIONS 14,28 4 12,82 4 10,77 6 10,46 7 A01A STOMATOLOGICAL PREPARATIONS 14,28 4 12,82 4 10,77 6 10,46 7 A01AA Caries prophylactic agents 11,90 3 10,48 4 8,42 5 8,45 7 A01AA01 sodium fluoride 11,90 3 10,48 4 8,42 5 8,45 7 A01AA03 olaflur 0,00 - 0,00 - 0,00 - 0,00 - A01AB Antiinfectives for local oral treatment 2,36 8 2,31 7 2,31 7 2,02 7 A01AB03 chlorhexidine 2,02 6 2,10 7 2,09 7 1,78 7 A01AB11 various 0,33 21 0,21 0 0,22 0 0,24 0 A01AD Other agents for local oral treatment 0,02 0 0,03 0 0,04 0 - - A01AD02 benzydamine 0,02 0 0,03 0 0,04 0 - - A02 DRUGS FOR ACID RELATED DISORDERS 73,05 3 71,13 3 69,32 3 68,35 3 A02A ANTACIDS 2,23 1 2,22 1 2,20 1 2,30 1 A02AA Magnesium compounds 0,07 22 0,07 22 0,08 22 0,10 19 A02AA04 magnesium hydroxide 0,07 22 0,07 22 0,08 22 0,10 19 A02AD Combinations and complexes of aluminium, 2,17 0 2,15 0 2,12 0 2,20 0 calcium and magnesium compounds A02AD01 ordinary salt combinations 2,17 0 2,15 0 2,12 0 2,20 0 A02B DRUGS FOR PEPTIC ULCER AND 70,82 3 68,91 3 67,12 3 66,05 4 GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) A02BA H2-receptor antagonists 0,17 7 0,74 4 1,10 4 1,11 5 A02BA02 ranitidine 0,00 1 0,63 3 0,99 3 0,99 4 A02BA03 famotidine 0,16 7 0,11 8 0,11 10 0,12 9 A02BB Prostaglandins 0,04 62
  • Heparin-Induced Thrombocytopenia (Hit)

    Heparin-Induced Thrombocytopenia (Hit)

    HEPARIN‐INDUCED THROMBOCYTOPENIA (HIT) OBJECTIVE: To assist clinicians with the diagnosis and initial management of heparin‐induced thrombocytopenia (HIT) and suspected HIT. BACKGROUND: HIT is a transient, immune‐mediated adverse drug reaction in patients recently exposed to heparin that generally produces thrombocytopenia and often results in venous and/or arterial thrombosis. HIT occurs in up to 5% of patients receiving unfractionated heparin (UFH) and in <1% who receive low molecular weight heparin (LMWH). HIT is characterised by immunoglobulin G (IgG) antibodies that recognize an antigen complex of platelet factor 4 (PF4) bound to heparin. These antibodies trigger a highly prothrombotic state by causing intravascular platelet aggregation, intense platelet, monocyte and endothelial cell activation and excessive thrombin generation. CLINICAL FEATURES: HIT typically presents with a fall in platelet count with or without venous and/or arterial thrombosis. Thrombocytopenia: A platelet count fall >30% beginning 5‐10 days after heparin exposure, in the absence of other causes of thrombocytopenia, should be considered to be HIT, unless proven otherwise. A more rapid onset of platelet count fall (often within 24 hours of heparin exposure) can occur when there is a history of heparin exposure within the preceding 3 months. Bleeding is very infrequent. Thrombosis: HIT is associated with a high risk (30‐50%) of new venous or arterial thromboembolism. Thrombosis may be the presenting clinical manifestation of HIT or can occur during or shortly after the thrombocytopenia. Other clinical manifestations of HIT: Less frequent manifestations include heparin‐induced skin lesions, adrenal hemorrhagic infarction, transient global amnesia, and acute systemic reactions (e.g. chills, dyspnea, cardiac or respiratory arrest following IV heparin bolus).