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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Chapter 57 Drugs for Diabetes Mellitus
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Diabetes Mellitus: Overview of the Disease and Its Treatment Disorder of carbohydrate metabolism Deficiency of insulin Resistance to action of insulin Sustained hyperglycemia, polyuria, polydipsia, ketonuria, and weight loss 2
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Types of Diabetes Mellitus Type 1 diabetes (T1DM) As a rule, type 1 diabetes develops during childhood or adolescence, and symptom onset is relatively abrupt Can develop during adulthood Accounts for 5% of all cases of diabetes mellitus Primary defect is destruction of pancreatic beta cells due to autoimmune process Trigger for this immune response is not entirely known, but genetic, environmental, and infectious factors likely play a role 3
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Types of Diabetes Mellitus Type 2 diabetes (T2DM) Most prevalent form of diabetes Accounts for 90% to 95% of all cases of diabetes Affects approximately 22 million Americans Insulin resistance and impaired insulin secretion Hyperinsulinemia Insulin resistance Strong family association 4
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Complications of Diabetes Short-Term Hyperglycemia Ketoacidosis Hypoglycemia Long-Term Macrovascular damage Heart disease Hypertension Stroke Hyperglycemia Altered lipid metabolism Microvascular damage Retinopathy Nephropathy: Angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) Sensory and motor neuropathy Gastroparesis Amputation secondary to infection Erectile dysfunction 5
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Diabetes and Pregnancy Before insulin: Virtually all babies born to severely diabetic women died during infancy Factors during pregnancy Placenta produces hormones that antagonize the actions of insulin Production of cortisol increases threefold Glucose can pass freely from the maternal to the fetal circulation (fetal hyperinsulinemia) 6
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Diabetes and Pregnancy Proper glucose levels are needed in the pregnant patient and in the fetus to prevent teratogenic effects Fetal death frequently occurs near term Earlier delivery is desirable 7
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Diabetes and Pregnancy Gestational diabetes Appears in the mother during pregnancy and subsides rapidly after delivery Managed in much the same manner as any other diabetic pregnancy Blood glucose should be monitored and controlled with diet and insulin Diabetic state usually disappears almost immediately after delivery If diabetic state persists beyond delivery, it is no longer considered gestational and should be rediagnosed and treated accordingly 8
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Diagnosis of Diabetes Hemoglobin A 1c Tests based on glucose: Fasting plasma glucose (FPG) test Casual plasma glucose test Oral glucose tolerance test (OGTT) 9
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Prediabetes Impaired fasting plasma glucose between 100 mg/dL and 125 mg/dL Impaired glucose tolerance test Increased risk for developing type 2 diabetes May reduce risk with diet changes and exercise and possibly with certain oral antidiabetic drugs Many people who meet criteria for “prediabetes” never develop diabetes, even if they do not take precautions against diabetes 10
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Overview of Diabetes Treatment Primary goal is to prevent long-term complications Tight control of blood glucose level is important Controlling blood pressure and blood lipids also is important 11
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Type 1 Diabetes Requires a comprehensive plan Integrated program of diet, self-monitoring of blood glucose, exercise, and insulin replacement 12
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Type 1 Diabetes Dietary measures Evidence suggests no ideal percentage of calories that should be ingested from carbohydrate, fat, or protein Macronutrient distribution for any given individual is based on the person’s current eating patterns, preferences, and goals Glycemic index Substituting low-glycemic-load foods for higher- glycemic-load foods may modestly improve glycemic control 13
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Type 1 Diabetes Physical activity Insulin replacement Management of hypertension An ACE inhibitor (for example, lisinopril) or an ARB (for example, losartan) can reduce the risk of diabetic nephropathy Dyslipidemia Statins (for example, atorvastatin ) 14
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Type 2 Diabetes Similar to type 1, requires comprehensive plan Patient should be screened and treated for: Hypertension, nephropathy, retinopathy, neuropathy, dyslipidemias Glycemic control with: Modified diet and physical activity Drug therapy 15
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Tight Glycemic Control Inappropriate Long-standing type 2 diabetes Advanced microvascular or macrovascular complications Extensive comorbid conditions History of severe hypoglycemia Limited life expectancy 16
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Monitoring Treatment Self-monitoring of blood glucose (SMBG) Common target values for blood glucose 70-130 mg/dL before meals 100-140 mg/dL at bedtime 17
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Monitoring Treatment Hemoglobin A 1c Also called glycosylated hemoglobin or glycated hemoglobin Provides an index of average glucose levels over the prior 2 to 3 months A 1c goal of below 7% is good for most patients Goal below 8% may be appropriate for patients with a history of severe hypoglycemia, limited life expectancy, or advanced microvascular or macrovascular complications 18
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Insulin Preparations: “High alert” agents Sources of insulin Recombinant DNA technology Human insulin: Identical to insulin produced by the human pancreas Human insulin analogs: Modified forms of human insulin that have the same pharmacologic actions as human insulin but different time courses 19
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Types of Insulin Short duration: Rapid acting Insulin lispro [Humalog] Insulin aspart [NovoLog] Insulin glulisine [Apidra] Short duration: Slower acting Regular insulin [Humulin R, Novolin R] Intermediate duration Neutral protamine Hagedorn (NPH) insulin Insulin detemir [Levemir] Long duration Insulin glargine 20
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Insulin Appearance Except for NPH insulins, all insulins made in the United States are formulated as clear, colorless solutions NPH insulin is a cloudy suspension Patients should inspect their insulin before using it and should discard the vial if the insulin looks abnormal 21
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Insulin Concentration 100 units/mL (U-100) 500 units/mL (U-500) Mixing insulins NPH with short-acting insulins Short-acting insulin drawn first 22
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Administration Subcutaneous injection Syringe and needle Pen injectors Jet injectors Subcutaneous infusion Portable insulin pumps Implantable insulin pumps Intravenous infusion Inhalation (approved but not used) 23
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Storage Unopened vials should be stored under refrigeration until needed Insulin should not be frozen Insulin can be used until the expiration date if kept in the refrigerator After opening, insulin can be kept up to 1 month without significant loss of activity Insulin should be kept out of direct sunlight and extreme heat 24
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Storage Mixtures of insulin in vials are stable for 1 month at room temperature and for 3 months under refrigeration Mixtures in prefilled syringes should be stored in a refrigerator for at least 1 week; they should be stored vertically with the needle pointing up 25
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Insulin: Therapeutic Use Indications Principal: Diabetes mellitus Required by all patients with T1DM and by many patients with T2DM Most insulin sold is used by people with type 2 diabetes, largely because T2DM accounts for 90% to 95% of all cases of diabetes IV insulin for diabetic ketoacidosis Gestational diabetes Hyperkalemia: Can promote uptake of potassium Aids in the diagnosis of growth hormone (GH) deficiency 26
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Insulin Therapy of Diabetes Dosage Dosing schedules Three dosing schedules Twice daily premixed insulin regimen Intensive basal/bolus strategy Continuous subcutaneous insulin 27
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Achieving Optimal Glucose Control Careful attention to all elements of the treatment program (diet, exercise, insulin replacement therapy) A defined glycemic target Self-monitoring of blood glucose according to the patient’s individualized management plan A high degree of patient motivation Extensive patient education The responsibility for managing diabetes rests with the patient 28
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Complications of Insulin Treatment Hypoglycemia: Blood glucose below 70 mg/dL Drug interactions Blood glucose below 70 mg/dL Rapid treatment mandatory Conscious patients: Fast-acting oral sugar (for example, glucose tablets, orange juice, sugar cubes, nondiet soda) If swallowing reflex or gag reflex is suppressed: Nothing should be given by mouth IV glucose or parenteral glucagon is the preferred treatment 29
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Complications of Insulin Treatment Lipohypertrophy Allergic reactions Hypokalemia Drug interactions Hypoglycemic agents Hyperglycemic agents Beta-adrenergic blocking agents 30
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Oral Hypoglycemics Biguanides Metformin [Glucophage] Sulfonylureas Thiazolidinediones (also known as glitazones) Rosiglitazone [Avandia] Pioglitazone [Actos] Meglitinides (also known as glinides) Repaglinide [Prandin] Nateglinide [Starlix] 31
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Non-Insulin Injectable Drugs Pramlintide Amylin mimetic 32
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Non-Insulin Injectable Drugs GLP-1 receptor agonists (also called incretin mimetics) Slow gastric emptying, stimulate glucose- dependent release of insulin, inhibit postprandial release of glucagon, and suppress appetite Exenatide [Byetta] Adverse effects: Hypoglycemia and gastrointestinal effects, including pancreatitis Drug interactions 33
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Non-Insulin Injectable Drugs GLP-1 receptor agonists (incretin mimetics) (Cont.) Liraglutide [Victoza] May cause medullary thyroid carcinoma (MTC) Amylin mimetics Pramlintide [Symlin] Reduces postprandial levels of glucose by delaying gastric emptying and suppressing glucagon secretion Adverse effects: Hypoglycemia and nausea, injection site reactions Drug interactions 34
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Acute Complications of Poor Glycemic Control Diabetic ketoacidosis (DKA) Hyperosmolar hyperglycemic state (HHS) Cardinal features of both conditions: Hyperglycemic crisis and associated loss of fluid and electrolytes Both conditions can be life-threatening Differences Hyperglycemia more severe in HHS Ketoacidosis characteristic of DKA, absent in HHS Treatment of the two disorders is similar 35
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Diabetic Ketoacidosis Severe manifestation of insulin deficiency Symptoms evolve quickly within hours or days Most common complication in pediatric patients and leading cause of death Characteristics Hyperglycemia Ketoacids Hemoconcentration Acidosis Coma 36
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Diabetic Ketoacidosis Altered glucose metabolism Hyperglycemia Water loss Hemoconcentration Altered fat metabolism Production of ketoacids 37
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Diabetic Ketoacidosis Treatment Insulin replacement Bicarbonate for acidosis Water and sodium replacement Potassium replacement Normalization of glucose levels 38
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Hyperosmolar Hyperglycemic State (HHS) Also called hyperglycemic hyperosmolar nonketotic syndrome (HHNS) Large amount of glucose excreted in urine Results in dehydration and loss of blood volume Increases blood concentrations of electrolytes and nonelectrolytes (particularly glucose); also increases hematocrit Blood “thickens” and becomes sluggish 39
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. HHS Little or no change in ketoacid levels Little or no change in blood pH No sweet or acetone-like smell to urine or breath Occurs most frequently with type 2 diabetes with acute infection, acute illness, or some other stress 40
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. HHS Can evolve slowly Metabolic changes begin a month or two before signs and symptoms become apparent If left untreated, can lead to coma, seizures, and death Management Correct hyperglycemia and dehydration with IV insulin, fluids, and electrolytes 41
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Copyright © 2016, 2013, 2010 by Saunders, an imprint of Elsevier Inc. All rights reserved. Glucagon for Treatment of Severe Hypoglycemia Preferred treatment is IV glucose Immediately raises blood glucose level Glucagon can be used if IV glucose is not available Delayed elevation of blood glucose Cannot correct hypoglycemia resulting from starvation Promotes glycogen breakdown, and the malnourished have little glycogen left 42
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