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Management of Type 2 Diabetes Mellitus - a Pharmacoepidemiological Review

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Management of Type 2 Diabetes Mellitus - a Pharmacoepidemiological Review MANAGEMENT OF TYPE 2 DIABETES MELLITUS - A PHARMACOEPIDEMIOLOGICAL REVIEW ANUSOOYA SAUGUR 2011 MANAGEMENT OF TYPE 2 DIABETES MELLITUS - A PHARMACOEPIDEMIOLOGICAL REVIEW By Anusooya Saugur Submitted in fulfilment of the requirements for the degree of Magister Pharmaciae at the Nelson Mandela Metropolitan University November 2011 Supervisor: Ms Lia Kritiotis Co-supervisor: Ms Susan Burton DECLARATION I, Anusooya Saugur (206080380), hereby declare that the dissertation for Magister Pharmaciae is my own work and that it has not been previously submitted for assessment or completion of any postgraduate qualification to another university or for another qualification. Anusooya Saugur ACKNOWLEDGEMENTS During the course of this masters‟ degree, I have encountered numerous people who have helped and supported me in different ways. I would like to genuinely acknowledge their contribution to this journey and they are: My supervisors, Ms Lia Kritiotis and Mrs Susan Burton for their support. The Nelson Mandela Metropolitan University for providing the financial assistance over the two years of the postgraduate degree. Mr Danie Venter from the Statistics Department and Mrs Hayley Irvine from the Computing Sciences Department who both played a major role in the initial phase of the research. Dr Jacques Pietersen who helped me extensively with statistical assistance. My friends for their support in this endeavour. My family for encouraging me to pursue a postgraduate degree, for being supportive of my decisions and for their patience with me. Their support and encouragement have allowed me to pursue my dreams. i TABLE OF CONTENTS ABSTRACT .............................................................................................................. ix Chapter One 1.1 INTRODUCTION .............................................................................................. 1 1.2 BACKGROUND TO THE STUDY ..................................................................... 1 1.3 PROBLEM STATEMENT .................................................................................. 3 1.4 AIM AND OBJECTIVES .................................................................................... 3 1.5 DIVISION OF CHAPTERS ................................................................................ 4 Chapter Two 2.1 TYPE 2 DIABETES MELLITUS ........................................................................ 7 2.1.1 Definition of diabetes mellitus and types of diabetes mellitus .................... 7 2.1.2 Complications of diabetes mellitus ............................................................ 8 2.1.3 International Classification of Diseases and diabetes mellitus ..................10 2.2 OVERVIEW OF THE EPIDEMIOLOGY OF DIABETES MELLITUS .................11 2.2.1 Age ..........................................................................................................11 2.2.2 Ethnicity ...................................................................................................14 2.2.3 Gender .....................................................................................................15 2.3 DEATH STATISTICS IN SOUTH AFRICA AND DIABETES MELLITUS ..........16 2.4 OVERVIEW OF THE AETIOLOGY OF TYPE 2 DIABETES MELLITUS ..........17 2.5 CLINICAL FINDINGS FOR THE DIAGNOSIS OF DIABETES MELLITUS .......22 2.6 RISK FACTORS ..............................................................................................24 2.7 TYPE 2 DIABETES MELLITUS AND COMORBID DISEASE STATES ............25 2.7.1 Metabolic Syndrome ................................................................................25 2.7.2 Hypertension ............................................................................................27 2.7.3 Dyslipidaemia...........................................................................................28 2.7.4 Coronary Artery Disease ..........................................................................29 2.8 MANAGEMENT OF TYPE 2 DIABETES MELLITUS .......................................30 2.8.1 Non-pharmacological management approaches ......................................33 2.8.1.1 Dietary Changes ..................................................................................33 2.8.1.2 Exercise ...............................................................................................34 2.8.2 Pharmacological treatments .....................................................................35 ii 2.9 INSULIN USE IN TYPE 2 DIABETES MELLITUS PATIENTS..........................39 2.9.1 Background on insulin ..............................................................................39 2.9.2 The United Kingdom Prospective Diabetes Study ....................................41 2.9.3 Insulin use ................................................................................................42 2.9.4 Available insulin preparations ...................................................................44 2.9.4.1 Insulin Colour Code ..............................................................................45 2.9.4.2 Pharmacokinetic properties of insulin preparations ..............................46 2.9.5 Factors affecting insulin use .....................................................................47 2.9.6 Disadvantages and risks of insulin use ....................................................48 2.9.7 Barriers to initiating insulin therapy ...........................................................49 2.9.7.1 Fear of needles ....................................................................................50 2.9.7.2 Sense of failure in the patient and stigmatisation ..................................50 2.9.7.3 Fear of gaining weight ..........................................................................50 2.9.7.4 Fear of hypoglycaemic episode ............................................................51 2.9.7.5 Fear of complications ...........................................................................51 2.9.7.6 Perceived complexity of insulin regimen ...............................................52 2.9.7.7 Cost implications ..................................................................................52 2.9.8 Side effects of insulin therapy ..................................................................52 2.9.8.1 Potential allergic reaction and hypoglycaemic episode ...........................53 2.9.8.2 Weight gain ..........................................................................................53 2.9.8.3 Lipohypertrophy and Lipoatrophy .........................................................53 2.9.8.4 Insulin oedema .....................................................................................53 2.9.9 Starting insulin therapy .............................................................................54 2.9.9.1 Insulin devices and innovations in insulin drug delivery ........................54 2.9.9.2 Syringe and needle ..............................................................................55 2.9.9.3 Pens .....................................................................................................55 2.9.9.4 Insulin pumps .......................................................................................55 2.9.9.5 Inhaled insulin ......................................................................................55 2.10 SOUTH AFRICAN GUIDELINES .....................................................................56 2.10.1 SEMDSA Guidelines for Diagnosis and Management of type 2 diabetes mellitus for Primary Health Care – 2009 ...............................................57 2.10.2 Standard Treatment Guidelines and Essential Medicines List for Primary Health Care (2008) ...............................................................................60 2.11 INTERNATIONAL GUIDELINES ......................................................................62 2.11.1 Canada ................................................................................................63 2.11.2 New Zealand ........................................................................................63 iii 2.11.3 United Kingdom ....................................................................................64 2.12 PHARMACOEPIDEMIOLOGICAL REVIEWS AND DRUG UTILISATION RESEARCH .....................................................................................................65 2.12.1 Overview of pharmacoepidemiological review and drug utilisation research ...............................................................................................66 2.12.2 Purpose of drug utilisation research .....................................................66 2.12.3 Types of drug utilisation research .........................................................67 2.12.4 Terminologies used in pharmacoepidemiological reviews ....................69 2.12.5 Summary of pharmacoepidemiological studies already concluded .......71 2.12.5.1 Study researching the beneficial effects of insulin compared to sulphonylureas on insulin secretion and metabolic control in recently diagnosed type 2 diabetic patients .......................................................71 2.12.5.2 Initiation of insulin therapy in elderly patients taking oral hypoglycaemic agents ..................................................................................................75 Chapter Three 3.1 INTRODUCTION .............................................................................................80 3.2 STUDY DESIGN ..............................................................................................80
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