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Diabetes: Opinion Leader Forum - Experts Views and Perspectives on Diagnosis, Treatment, Product Performance, and Closing the Need Gap

DateJan, 2001
Pages362
Price / format€13643 / Hard Copy

€10 000 

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Abstract:
 The subject of this report is the management of diabetes in the United States. More specifically, however, the subject has been approached primarily through in-depth interviews with clinical and academic authorities, managed care medical and disease management executives, and pharmaceutical and diagnostics industry executives, so as to produce an audit of the current opinions and attitudes of the thought leaders in the user segments of the pharmaceutical and diagnostic marketplace.

The report addresses diabetes Type I, Diabetes Type II, and the complications of diabetes, retinopathy, neuropathy, and nephropathy.








Table of contents:
 DIABETES: OPINION LEADER FORUM EXPERT’S VIEWS AND PERSPECTIVE ON DIAGNOSIS, TREATMENT, PRODUCT PERFORMANCE…AND CLOSING THE NEED GAP

TABLE OF CONTENTS

EXECUTIVE SUMMARY......................................................................................................................................... i
SECTION 1 INTRODUCTION................................................................................................................................ 1
1.1 SCOPE AND OBJECTIVES OF RESEARCH INVESTIGATION........................................................... 1
1.2 METHODOLOGY OF INVESTIGATION................................................................................................ 2
1.3 LIMITATIONS OF INVESTIGATION ..................................................................................................... 5
SECTION 2 GENERAL ISSUES IN THE MANAGEMENT OF DIABETES..................................................... 7
2.1 THE FUNDAMENTALS OF DIABETES................................................................................................. 7
2.2 TYPE I DIABETES................................................................................................................................... 7
2.2.1 Epidemiology .................................................................................................................................. 8
2.2.2 Etiology ........................................................................................................................................... 8
2.2.3 Genetic Predisposition..................................................................................................................... 9
2.2.4 Pathophysiology ............................................................................................................................... 9
2.2.5 Environmental Viruses ................................................................................................................... 10
2.2.6 Adhesion Molecules ....................................................................................................................... 11
2.2.7 Glutamic Acid Decarboxylase (GAD) ........................................................................................... 11
2.2.8 Diagnosis of Type I Diabetes ......................................................................................................... 12
2.2.9 The Hyperglycemic Condition ....................................................................................................... 12
2.2.10 Biochemical Markers ..................................................................................................................... 13
2.2.11 Tests for Predicting Evolving (Early Stage) Diabetes Before Symptoms Appear.......................... 14
2.3 TYPE II DIABETES................................................................................................................................ 15
2.3.1 Risk Factors for Type II diabetes ................................................................................................... 15
2.3.2 Insulin Resistance.......................................................................................................................... 16
2.3.3 Role of Insulin Resistance in Diabetes ........................................................................................... 17
2.3.4 Pregnancy/Gestational Diabetes ..................................................................................................... 17
2.3.5 HNKS-Hyperosmoler Nonketotic Syndrome ................................................................................. 17
2.3.6 Epidemiology ................................................................................................................................ 18
2.3.7 Prevalence ..................................................................................................................................... 18
2.3.8 Etiology ......................................................................................................................................... 19
2.3.9 Insulin Secretion............................................................................................................................ 19
2.3.10 Insulin Action/Resistance............................................................................................................... 21
2.3.11 Genetics......................................................................................................................................... 21
2.3.12 Obesity .......................................................................................................................................... 22
2.3.13 Pathophysiology ............................................................................................................................. 22
2.3.14 Sorbitol and the Polyol Pathway .................................................................................................... 22
2.3.15 Advanced Glycation End (AGE) Products ..................................................................................... 23
2.3.16 Vascular Hemodynamic Dysfunction............................................................................................. 23
2.3.17 Diagnosis of Type II Diabetes........................................................................................................ 24
2.3.18 Treatment Goals ............................................................................................................................. 24
2.3.19 Innovative Therapy for Diabetes .................................................................................................... 25
2.3.20 Complexity of Treatment ............................................................................................................... 26
2.3.21 Quality of Life ............................................................................................................................... 26
2.3.22 Mortality........................................................................................................................................ 26
2.3.23 Current Therapy: Value And Limitations....................................................................................... 27
2.3.24 Exercise ......................................................................................................................................... 28
2.3.25 Dietary Control.............................................................................................................................. 28
2.4 DIABETES DRUGS OF THE ‘90S.......................................................................................................... 29
2.5 DIABETIC RETINOPATHY................................................................................................................... 31
2.5.1 Angiogenesis ................................................................................................................................. 33
2.5.2 Neovascular Diseases of the Eye.................................................................................................... 34
2.5.3 Epidemiology ................................................................................................................................ 35
2.5.4 Nonproliferative Diabetic Retinopathy........................................................................................... 36
2.5.5 Proliferative Diabetic Retinopathy ................................................................................................. 36
2.5.6 Etiology and Pathophysiology........................................................................................................ 37
2.5.7 Diagnosis....................................................................................................................................... 39
2.5.8 Treatment ...................................................................................................................................... 39
2.6 DIABETIC NEUROPATHY.................................................................................................................... 40
2.6.1 Definition ...................................................................................................................................... 40
2.6.2 Types of Neuropathy ...................................................................................................................... 41
2.6.3 Epidemiology ................................................................................................................................ 42
2.6.4 Etiology ......................................................................................................................................... 43
2.6.5 Pathophysiology ............................................................................................................................. 43
2.6.6 Diagnosis....................................................................................................................................... 44
2.6.7 Conventional Treatment ................................................................................................................. 44
2.7 DIABETIC NEPHROPATHY.................................................................................................................. 46
2.7.1 Definition ...................................................................................................................................... 46
2.7.2 Genetics of Nephropathy................................................................................................................ 47
2.7.3 Epidemiology ................................................................................................................................ 48
2.7.4 Etiology ......................................................................................................................................... 48
2.7.5 Pathophysiology ............................................................................................................................. 49
2.7.6 Modification of Cardiovascular Risk ............................................................................................. 51
2.7.7 Diagnosis....................................................................................................................................... 51
2.7.8 Conventional Treatment ................................................................................................................. 51
2.8 THE PUBLIC HEALTH BURDEN OF DIABETES MELLITUS IN THE UNITED STATES ............. 53
SECTION 3 CLINICAL MANAGEMENT OF DIABETES ................................................................................ 63
3.1 PHARMACEUTICAL STRATEGIES FOR MANAGING DIABETES ................................................. 63
3.2 PATIENT CARE STRATEGIES.............................................................................................................. 68
3.2.1 Patient and Physician Responsibilities for Effective Diabetes Care............................................... 68
3.2.2 Challenges in the Management of Diabetes ................................................................................... 70
3.2.3 Intensive Treatment Of Comorbid Conditions ............................................................................... 73
3.2.4 Young People with Type II diabetes .............................................................................................. 79
3.2.5 Diabetic Wound Care ..................................................................................................................... 81
SECTION 4 ISSUES IN CURRENT PHARMACEUTICAL APPROACHES TO THE MANAGEMENT OF
DIABETES................................................................................................................................... 85
4.1 CURRENT PRODUCT TECHNOLOGY FOR DIABETES TYPE I ...................................................... 85
4.2 CURRENT PRODUCT TECHNOLOGY FOR DIABETES TYPE II..................................................... 88
4.3 GLUCOVANCE ...................................................................................................................................... 89
4.4 OTHER ORAL HYPOGLYCEMIC DRUGS .......................................................................................... 90
4.5 COMBINATION THERAPY................................................................................................................... 91
SECTION 5 PHARMACEUTICAL TECHNOLOGIES IN DEVELOPMENT FOR THE MANAGEMENT
OF DIABETES ............................................................................................................................. 95
5.1 PRODUCT TECHNOLOGY FOR TYPE I DIABETES.......................................................................... 95
5.2 PRODUCT TECHNOLOGY FOR TYPE II DIABETES ........................................................................ 96
5.3 EXPERT COMMENTARY ON PHARMACEUTICAL TECHNOLOGIES UNDER DEVELOPMENT
FOR THE MANAGEMENT OF DIABETES .......................................................................................... 97
5.3.1 Inhaled Insulin............................................................................................................................... 99
5.3.2 Alternative Delivery Systems for Insulin ..................................................................................... 102
5.3.3 Insulin Pump Therapy .................................................................................................................. 105
5.3.4 Experts Comments on Insulin Pump Therapy .............................................................................. 107
5.3.5 The Role of Genetics in Managing Diabetes................................................................................ 111
5.3.6 Diabetic Retinopathy and Macular Edema ................................................................................... 114
SECTION 6 RECENT AND ONGOING DIAGNOSTIC DEVELOPMENTS IN THE MANAGEMENT OF
DIABETES AND ITS COMPLICATIONS ............................................................................. 117
6.1 AUTONOMIC DYSFUNCTION/HEART RATE VARIABILITY....................................................... 117
6.2 GLUCOWATCH ................................................................................................................................... 119
6.3 LASER GLUCOSE MONITOR............................................................................................................. 125
6.4 NEAR-INFRA (NIR) GLUCOSE MONITORING................................................................................ 127
6.5 MINIMALLY INVASIVE CONTINUOUS SUBCUTANEOUS GLUCOSE MONITOR ................... 129
SECTION 7 THE DIABETES MARKET: DELIVERY SYSTEM ISSUES..................................................... 133
7.1 AMERICA’S ASSAULT ON DIABETES AND CARDIOVASCULAR DISEASE LAUNCHED...... 133
7.2 DISEASE MANAGEMENT GUIDELINES FOR MANAGING DIABETES...................................... 136
7.3 LIFESTYLE ISSUES............................................................................................................................. 138
7.4 OBESITY............................................................................................................................................... 139
7.5 SELECTED EXPERT COMMENTS ON DISEASE MANAGEMENT................................................ 142
SECTION 8 NEEDS/GAPS ANALYSIS OF THE MANAGEMENT OF DIABETES.................................... 149
8.1 OVERVIEW .......................................................................................................................................... 149
8.2 EXPERTS’ VIEWS ON THE NEED/GAPS IN THE MANAGEMENT OF DIABETES .................... 149
8.3 POSTPRANDIAL GLUCOSE LEVELS................................................................................................ 152
ADDENDUM A THE PUBLIC HEALTH BURDEN OF DIABETES MELLITUS IN THE UNITED STATES
..................................................................................................................................................... 157
ADDENDUM B ECONOMIC IMPACT OF DIABETES JONATHAN C. JAVITT, MD, MPH, AND YENPIN
CHIANG, PHD ................................................................................................................... 167
B.1 SUMMARY........................................................................................................................................... 167
B.2 INTRODUCTION ................................................................................................................................. 167
B.3 METHODOLOGICAL ISSUES IN ESTIMATING THE COSTS OF AN ILLNESS........................... 168
B.4 METHODS FOR ATTRIBUTING COSTS TO THE UNDERLYING CONDITION........................... 168
B.5 METHODS FOR VALUING HUMAN LIFE AND HEALTH.............................................................. 169
B.6 METHODS FOR ESTIMATING VOLUME OF MEDICAL SERVICES............................................. 170
B.7 DIRECT AND INDIRECT COSTS OF DIABETES ............................................................................. 171
B.8 DIRECT COSTS.................................................................................................................................... 173
B.9 INDIRECT COSTS................................................................................................................................ 174
B.10 THE COSTS OF SYSTEMIC MORBIDITY AND MORTALITY ATTRIBUTABLE TO DIABETES
175
B.11 ECONOMIC IMPACT OF DIABETES ON AFFECTED INDIVIDUALS........................................... 176
B.12 INTERNATIONAL COMPARISONS OF DIABETES COSTS ........................................................... 179
B.13 CONLUSIONS ...................................................................................................................................... 180
B.14 REFERENCES....................................................................................................................................... 181
ADDENDUM C DIABETES QUALITY IMPROVEMENT PROJECT: INITIAL MEASURE SET (FINAL
VERSION) AUGUST 14, 1998.................................................................................................. 183
ADDENDUM D SUMMARY OF VHA/DOD CLINICAL PRACTICE GUIDELINE FOR THE
MANAGEMENT OF DIABETES MELLITUS IN THE PRIMARY CARE SETTING .... 197
ADDENDUM E AMERICAN ASSOCIATION OF ENDOCRINOLOGISTS GUIDELINES DIABETES
MANAGEMENT STANLEY FELD, MD, FACP, MACE CHAIRMAN, DIABETES
MEDICAL GUIDELINES TASK FORCE AACE DIABETES GUIDELINE..................... 209
ADDENDUM F CONQUERING DIABETES: A STRATEGIC PLAN FOR THE 21ST CENTURY........... 251
ADDENDUM G PRODUCT TECHNOLOGIES IMPACTING DIABETES THERAPEUTICS................... 269
ADDENDUM H PROFILES OF LEADING FIRMS DEVELOPING AND/OR MARKETING DIABETES
MEDICINES.............................................................................................................................. 301
ADDENDUM I SELECTED RECENT EVENTS IN THE MANAGEMENT OF DIABETES ...................... 341

Table 1 Estimates of the Economic Costs of Diabetes in the United States Dollars in Billions............... 172
Table 2 Estimates of the Direct Costs of Diabetes in the United States Dollars in Billions..................... 172
Table 3 Total Economic Cost of Diabetes in the United States (1992) ..................................................... 176
Table 4 Total and Out-Of-Pocket Medical Expenses: Diabetic Patients Versus the General Population . 177
Table 5 Direct Medical Care Expenditures for Persons with Confirmed Diabetes and for Persons with
Diabetes or High Blood Sugar...................................................................................................... 179
Table 6 Evidence Grading System ............................................................................................................ 200
Table 7 Comparison of VHA/DoD Diabetes Clinical Guidelines to Existing National Guidelines
Relevant to Diabetes..................................................................................................................... 201
Table 8 VHA’s External Peer Review Specific Measures for Diabetes Mellitus...................................... 203
Table 9 General Preventive Measures Pertinent for Persons with Diabetes Preventive Measures........... 204
Table 10 Classification of Blood Pressure in DM(a) .................................................................................... 205
Table 11 Target Value for Hemoglobin A1c (HbA1c)................................................................................ 205
Table 12 Recommended Treatment Options for Type II Diabetes.............................................................. 206
Table 13 Oral Hypoglycemic Agents .......................................................................................................... 207
Table 14 Commonly Used Sulfonylureas: Dosage Data ............................................................................ 221
Table 15 Metformin: Dosage Data ............................................................................................................. 221
Table 16 a-Glucosidase Inhibitors: Dosage Data ....................................................................................... 221
Table 17 Thiazolidinediones: Dosage Data................................................................................................ 222
Table 18 Meglitinides: Dosage Data .......................................................................................................... 223
Table 19 Insulins: Available Types, Strengths and Duration of Action* ................................................... 224
Table 20 Fasting and Postprandial Blood Glucose and Glycosylated Hemoglobin Responses to
Pharmacologic Treatment in Patients with Type 2 Diabetes* ...................................................... 224
Table 21 Effect of Pharmacologic Treatment of Type 2 Diabetes on Insulin Secretion and Glucose
Production and Uptake ................................................................................................................. 224
Table 22 Summary of Patient and Physician Responsibilities in Intensive Diabetes Self-Management
System......................................................................................................................................... 232
Table 23 Diabetes Drug Development Programs ........................................................................................ 334




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