Diabetes Drug Notes

Description

DIABETES DRUG NOTES Diabetes is becoming more common in both older and younger generations and in keeping with this escalation in cases, there are an ever increasing number of drugs and drug classes that are suitable to treat hyperglycaemia. In a unique blend of diabetes practice, clinical pharmacology, and cardiovascular medicine, Diabetes Drug Notes describes the principles of clinical pharmacology with regards to diabetes prescribing. Each drug class for the treatment of diabetes is covered in detail, along with the effect on the cardiovascular and renal systems caused by each drug. Building upon the success of their “Drug Notes” series for Practical Diabetes and their “Drugs for Diabetes” series in the British Journal of Cardiology, the team of experts focuses on the glycaemic management of type 1 and type 2 diabetes, with other effects of antidiabetic drugs covered as well. Diabetes Drug Notes also includes: Comprehensive and up-to-date coverage of the drugs for the glycaemic management of patients with type 1 or type 2 diabetesExpert reflection on prescribing considerations for special groups, as well as common pitfalls in prescribingDetailed case histories to illustrate relevant informationSummaries of recent guidelines related to diabetic intervention Diabetes Drug Notes is a user-friendly guide for a general diabetes medical, nursing, and pharmacology readership, as well as those who support them. Diabetes Drug Notes Contents FOREWORD PREFACE EDITORS AND C ONTRIBUTORS Introduction 1 Clinical Pharmacology of Antidiabetic Drugs Introduction Clinical Pharmacology Introduction Pharmacodynamics Action on a Receptor Action on an Enzyme Membrane Channels Cytotoxic Dose–Response Relationship Pharmacokinetics Absorption Distribution/Plasma Protein Binding Clearance Drug Metabolism and Elimination Enzyme Induction and Inhibition Renal Excretion Drug Development and Clinical Trials Introduction Preclinical Development Regulatory Approval Clinical Trials Microdosing Phase 1 Trials Phase 2 Trials Phase 3 Trials Phase 4 Trials Drug Licensing of Antidiabetic Drugs Cardiovascular Outcome Trials Marketing Authorisation Development and Licensing of Insulin Insulin Regulatory Approval Development and Approval of Biosimilar Insulin Introduction Insulin Production Biosimilar vs. Generic Drugs Regulatory Considerations for Biosimilars Safety of Biosimilars Interchangeability and Substitution Prescribing Considerations for Biosimilars Pharmacovigilance Passive Pharmacovigilance Active Pharmacovigilance Pharmacoeconomics Introduction Utility Values Health Economic Modelling Sensitivity Analysis Discounting Indirect Comparison and Network Meta-analysis Future Developments in Diabetes Clinical Pharmacology Drug Development Pharmacovigilance Pharmacoeconomics 2 Metformin Introduction History of Biguanides Phenformin and Lactic Acidosis Pharmacology Mechanism of Action Inhibition of Hepatic Glucose Production Reduced Insulin Resistance Intestinal Effects Pharmacokinetics Prescribing in Renal Impairment Prescribing in Liver Disease Prescribing in Heart Failure Prescribing in Pregnancy Glycaemic Efficacy Safety and Side Effects Lactic Acidosis Outcome Trials Cardiovascular Outcome Trials UKPDS HOME Study SPREAD-DIMCAD Renal Effects Prevention of Type 2 Diabetes DPP IDPP CANOE Metformin in Type 1 Diabetes REMOVAL Place of Metformin in Current and Future Practice 3 Sulfonylureas and Meglitinides Introduction History of Sulfonylureas Pharmacology Insulin Secretion from Beta Cells Mechanism of Action Insulin Secretion Extra-pancreatic Actions Pharmacokinetics Gliclazide Glimepiride Glycaemic Efficacy ADOPT UKPDS GRADE Study Safety and Side Effects Weight Gain Hypoglycaemia Other Side Effects Outcome Trials Cardiovascular Safety and Sulfonylureas UGDP UKPDS ADVANCE CAROLINA TOSCA. IT Meglitinides Nateglinide Repaglinide Outcome Trials NAVIGATOR Place of Sulfonylureas and Meglitinides in Current and Future Practice 4 DPP-4 Inhibitors Introduction Pharmacology Structure and Function of Dipeptidyl Peptidase-4 Mechanism of Action Pharmacodynamics and Pharmacokinetics Sitagliptin Saxagliptin Vildagliptin Alogliptin Linagliptin Other DPP-4 Inhibitors Glycaemic Efficacy VERIFY GRADE Safety and Side Effects Side Effects Pancreatitis and Pancreatic Cancer Hepatic Side Effects of Alogliptin Outcome Trials Cardiovascular Outcome Trials SAVOR-TIMI 53 EXAMINE TECOS CARMELINA and CAROLINA Vildagliptin Meta-analysis Summary of Cardiovascular Outcome Trials Renal Outcomes Saxagliptin Alogliptin Sitagliptin Linagliptin Summary of Renal Effects The Place of DPP-4 Inhibitors in Current and Future Practice 5 SGLT2 Inhibitors Introduction Pharmacology Physiology of Sodium-dependent Glucose Transporters Mechanism of Action Pharmacodynamics and Pharmacokinetics Dapagliflozin Canagliflozin Empagliflozin Ertugliflozin Sotagliflozin Other SGLT2 Inhibitors Glycaemic Efficacy Comparisons of SGLT2 Inhibitors with GLP-1 Receptor Agonists Additional Effects of SGLT2 Inhibitors Body Weight Blood Pressure Side Effects and Safety Genitourinary Infections Diabetic Ketoacidosis Amputation Other Adverse Effects Outcome Trials Cardiovascular Outcome Trials in Diabetes EMPA-REG OUTCOME The CANVAS Program DECLARE-TIMI 58 VERTIS CV Meta-analysis of Cardiovascular Outcome Trials Real-world Evidence of Cardiovascular Benefits Renal Outcome Trials CREDENCE DAPA-CKD SCORED Empagliflozin Ertugliflozin Meta-analysis of Renal Outcomes Real-world Evidence of Renal Benefit Heart Failure Outcome Trials DAPA-HF The EMPEROR Trials Program SOLOIST-WHF Canagliflozin and Ertugliflozin Meta-analysis of DAPA-HF and EMPEROR-Reduced SGLT2 Inhibitors in Type 1 Diabetes Dapagliflozin in Type 1 Diabetes Sotagliflozin in Type 1 Diabetes Efficacy and Safety of Other SGLT2 Inhibitors in Type 1 Diabetes Diabetic Ketoacidosis Regulatory Approval in Type 1 Diabetes Use of SGLT2 Inhibitors in Other Diseases DARE-19 Place of SGLT2 Inhibitors in Current and Future Practice Type 2 Diabetes Chronic Kidney Disease and Heart Failure Type 1 Diabetes 6 GLP-1 Receptor Agonists Introduction Pharmacology Glucagon-like Peptide-1 and the Incretin Effect Mechanism of Action Pancreatic Actions Extra-pancreatic Actions Pharmacodynamics and Pharmacokinetics Exenatide Lixisenatide Liraglutide Dulaglutide Semaglutide Other GLP-1 Receptor Agonists Glycaemic Efficacy and Effect on Weight Comparisons within Class Comparisons with Other Antidiabetic Drugs DPP-4 Inhibitors SGLT2 Inhibitors Insulin Other Antidiabetic Drugs Efficacy of Combinations of GLP-1 Receptor Agonists with Insulin Other Effects of GLP-1 Receptor Agonists Cardiovascular System Lipids Side Effects and Safety Side Effects Safety Thyroid Cancer Pancreatitis and Pancreatic Cancer Cholelithiasis Outcome Trials Cardiovascular Outcome Trials ELIXA LEADER SUSTAIN-6 EXSCEL REWIND Harmony Outcomes PIONEER 6 AMPLITUDE-O Meta-analysis of Cardiovascular Outcome Trials Summary of Cardiovascular Outcome Trials Renal Outcomes Renal Outcomes from Cardiovascular Outcome Trials Meta-analysis of Renal Outcomes from Cardiovascular Outcome Trials Use of GLP-1 Receptor Agonists in Other Diseases Overweight and Obesity Nonalcoholic Fatty Liver Disease Place of GLP-1 Receptor Agonists in Current and Future Practice 7 Animal and Human Insulins Introduction Insulin Structure Insulin Receptors Insulin Physiology Production and Pharmacokinetic Modifications Improved Purification Time Action Prolongation Insulin Zinc Suspension Protamine Zinc Insulin Isophane or Neutral Protamine Hagedorn Insulin Biphasic Insulins Unified Formulation Sources of Insulin Beef Insulin Pork Insulin Human Insulin Hypoglycaemia and Human Insulin Limitations of Older Insulins Short-acting Insulins Intermediate and Long-acting Insulins Time–Action Profile Morning (Fasting) Hyperglycaemia Variability Intensified Insulin Therapy DCCT and EDIC UKPDS Side Effects of Intensified Insulin Therapy Hypoglycaemia Weight Gain Place of Human Insulin in Current and Future Therapy Insulin Therapy in Type 1 Diabetes Insulin Therapy in Type 2 Diabetes 8 Short-acting Insulin Analogues Introduction Factors Affecting Absorption and Metabolism of Short-acting Insulin Manufacturing Insulin Analogues Short-acting Insulin Analogues Insulin Lispro Insulin Aspart Insulin Glulisine Meta-analysis of Short-acting Insulin Analogues Biosimilar Short-acting Insulin Analogues Second-generation Ultrafast-acting Insulin Analogues Fast-acting Insulin Aspart Ultra-rapid Insulin Lispro Other Attempts to Improve Insulin Absorption and Inhaled Insulin Technosphere Inhaled Insulin Place of Short-acting Insulin Analogues in Current and Future Practice Intensive Insulin Therapy Structured Education Alternative Routes of Insulin Delivery 9 Long-acting Insulin Analogues Introduction Older Strategies to Extend the Action of Insulin Factors Affecting the Absorption and Action of Insulin Development of Long-acting Insulin Analogues Strategies to Modify the Action of Long-acting Insulin Analogues Long-acting Insulin Analogues Insulin Glargine Glycaemic Efficacy and Risk of Hypoglycaemia with Glargine ORIGIN Insulin Detemir Glycaemic Efficacy and Risk of Hypoglycaemia with Detemir 4-T Insulin Degludec Glycaemic Efficacy and Risk of Hypoglycaemia with Degludec DEVOTE U300 Glargine Glycaemic Efficacy and Risk of Hypoglycaemia with U300 Glargine Biosimilar Long-acting Insulin Analogues Other Long-acting Insulin Analogues Combinations of Long- and Short-acting Insulin Analogues Meta-analysis of Glycaemic Efficacy of Long-acting Insulin Analogues Type 1 Diabetes Type 2 Diabetes Safety of Long-acting Insulin Analogues The Place of Long-acting Insulin Analogues in Current and Future Practice Advantages of Insulin Analogues Patterns of Insulin Administration Future Long-acting Insulin Analogues 10 Devices Introduction Insulin Pens History Modern Insulin Pens Insulin Pumps History Modern Insulin Pumps Glycaemic Efficacy of Insulin Pumps Safety of Insulin Pumps Potential Disadvantages of Pump Therapy Self-monitoring of Blood Glucose Blood Glucose Monitors Continuous Glucose Monitoring Intermittently Scanned (Flash) Continuous Glucose Monitoring Real-time Continuous Glucose Monitoring Accuracy of Continuous Glucose Monitoring Ambulatory Glucose Profiles Time in Range Efficacy of Continuous Glucose Monitoring Linkage of Continuous Glucose Monitoring to Insulin Pumps Low-glucose Suspend Hybrid Closed Loop Efficacy of Closed Loop Systems DIY Closed Loop Guidelines on the Use of Devices Insulin Pumps Continuous Glucose Monitoring Place of Devices in Current and Future Practice 11 Acarbose and Alpha Glucosidase Inhibitors Introduction Pharmacology Mechanism of Action Acarbose Other Alpha Glucosidase Inhibitors Glycaemic Efficacy Safety and Side Effects Outcome Trials Prevention of Type 2 Diabetes STOP-NIDDM Voglibose Ph-3 Study Cardiovascular Outcome Trials Meta-analysis of Cardiovascular Events with Acarbose ACE Meta-analysis of Cardiovascular Events with Alpha Glucosidase Inhibitors Place of Alpha Glucosidase Inhibitors in Current and Future Practice 12 Glitazones and Glitazars Introduction Pharmacology Mechanism of Action Pharmacokinetics Pioglitazone Glycaemic Efficacy ADOPT Other Effects of Glitazones Safety and Side Effects Side Effects Safety Cardiovascular Safety Heart Failure Bone Fractures Bladder Cancer Outcome Trials Cardiovascular Outcome Trials RECORD TIDE PROactive IRIS TOSCA. IT Prevention of Type 2 Diabetes DREAM Other Trials on the Prevention of Diabetes Glitazars Aleglitazar Saroglitazar Place of Glitazones and in Current and Future Practice Type 2 Diabetes Prevention of Diabetes 13 Other Antidiabetic Drugs Introduction Pramlintide Pharmacology Glycaemic Efficacy Efficacy in Type 1 Diabetes Efficacy in Type 2 Diabetes Safety Colesevelam Pharmacology Glycaemic Efficacy Cardiovascular Safety Bromocriptine Pharmacology Glycaemic Efficacy Cylcoset Safety Trial Hydroxychloroquine Pharmacology Glycaemic Efficacy Antiobesity Drugs Orlistat Pharmacology Glycaemic Efficacy XENDOS Naltrexone/Bupropion Pharmacology Efficacy Cardiovascular Safety Phentermine and Phentermine/Topiramate Pharmacology Efficacy Cardiovascular Safety Place of Other Drugs in Current and Future Practice Type 1 Diabetes Type 2 Diabetes 14 Future Antidiabetic Drugs Introduction Dual and Triple Agonists Physiology GLP-1 GIP Glucagon Pharmacology of Multiagonist Therapies GLP-1/GIP Receptor Dual Agonists Tirzepatide NNC0090-2746 GLP-1/Glucagon Receptor Dual Agonists Cotadutide Bamadutide GLP-1/Glucagon Receptor Dual Agonists in Non-alcoholic Fatty Liver Disease Triple Agonists Imeglimin Pharmacology Mechanism of Action Pharmacokinetics Glycaemic Efficacy and Safety Regulatory Status Place of New Antidiabetic Drugs in Future Practice 15 Guidelines on Antidiabetic Drugs Introduction Evidence-based Guidelines Consensus Reports Common Approaches and HbA1c Targets Guidelines on the Use of Antidiabetic Drugs in Type 2 Diabetes NICE SIGN ICGP EASD and ADA Consensus Reports ESC IDF Guidelines on the Management of Type 1 Diabetes NICE SIGN ADA ADA/ESD Consensus Report on the Management of Type 1 Diabetes in Adults Special Patient Groups Use of Antidiabetic Drugs in Pregnancy Use of Antidiabetic Drugs in Patients with Kidney Disease KDIGO ABCD Use of Antidiabetic Drugs during Ramadan Place of Guidelines in Current and Future Practice 16 Prescribing Antidiabetic Drugs Introduction Why Prescribe? Therapeutic Inertia Introduction Causes of Therapeutic Inertia Clinician-related Factors Patient-related Factors Healthcare System Factors Overcoming Inertia Polypharmacy Introduction Detecting and Managing Polypharmacy Nonadherence Introduction Improving Adherence The Patient with Problematic Hypoglycaemia Introduction Problematic Hypoglycaemia Management of Problematic Hypoglycaemia Identify and Characterise Hypoglycaemia Review Risk Factors for Problematic Hypoglycaemia Review Patient Education and Behaviour Review Insulin Prescribing in Renal Impairment Introduction Reduced Absorption Increased Bioavailability Reduced Renal Clearance Metformin Pioglitazone Acarbose Sulfonylureas and Meglitinides Incretin-based Therapies SGLT2 Inhibitors Insulin Prescribing in Liver Disease Introduction Liver Disease and Diabetes Reduced Drug Absorption Increased Volume of Distribution Altered Protein Binding Reduced Metabolism Hepatic Blood Flow Reduced Excretion Metformin Pioglitazone Sulfonylureas and Meglitinides Incretin-based Therapies SGLT2 Inhibitors Insulin Acarbose Prescribing in Cardiovascular Disease Diabetes and Coronary Artery Disease Glycaemic Control Choosing Antidiabetic Drugs with Cardiovascular Benefit Management of Other Cardiovascular Risk Factors Blood Pressure Management Lipid Management Antiplatelet Therapy Acute Coronary Syndromes Diabetes and Heart Failure Pioglitazone Saxagliptin GLP-1 Receptor Agonists SGLT2 Inhibitors Prescribing in Pregnancy Introduction Antidiabetic Drugs in Pregnancy Other Drugs Used in Pregnancy Breastfeeding Prescribing in the Young Prescribing in the Elderly Introduction Hypoglycaemia in the Elderly The Patient with Type 1 Diabetes: a Therapeutic Journey (an Illustrative Case) The Patient with Type 2 Diabetes: a Therapeutic Journey (an Illustrative Case) Future Developments in Prescribing in Diabetes APPENDIX INDEX EULA