Stakeholder Insight: Diabetes

Published by: Datamonitor

Published: Dec. 26, 2007 - 185 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Cardiovascular pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Key Findings

CHAPTER 2 INTRODUCTION AND SCOPE

Scope of the analysis

Related reports

Common abbreviations used throughout this report:

CHAPTER 3 COUNTRY TREATMENT ALGORITHMS

Introduction

US

Japan

France

Germany

Italy

Spain

UK

5 European Markets Summary Algorithms

CHAPTER 4 DISEASE DEFINITION AND OVERVIEW

Definition of diabetes

Segmentation of diabetes

Type 1 diabetes

Type 1.5 diabetes

Type 2 diabetes

Etiology and Risk factors

Mechanisms of development of diabetes

Genetic or acquired causes

Risk factors

Obesity

T2 diabetes epidemic hand-in-hand with obesity epidemic

Race

T2 diabetes more prevalent in Hispanics and African Americans than in Caucasians

Family history

T2 diabetes in first-degree relatives is a strong prognostic indicator

Advanced age

Gender and other factors

Gestational diabetes mellitus

CHAPTER 5 EPIDEMIOLOGY OF DIABETES

Epidemiology of diabetes

Diabetes presents a worldwide public health problem

Current prevalence of type 1 and type 2 diabetes

Increasing prevalence of type 2 diabetes

Increase in prevalence to epidemic proportion

Datamonitor epidemiology forecast

Methodology

Epidemic rise in incidence of T2 diabetes

CHAPTER 6 DIAGNOSIS AND PATIENT MANAGEMENT

Patient management

The majority of diabetics are diagnosed and managed by primary care practitioners

Referral to a specialist

Diagnosis rates in type 2 diabetes

Reasons for the poor diagnosis rate

Insidious nature of the disease

Lack of screening

Awareness of guidelines

Validity of diagnostic tests

Misdiagnosis of T2 and T1 diabetes

Strategies to increase diagnosis rates

The need for a targeted screening program

Late stage of diagnosis

Disease indicators at presentation

CHAPTER 7 DIABETIC COMPLICATIONS

Complications of type 2 diabetes

Microvascular complications

Nephropathy

Retinopathy

Neuropathy

Macrovascular complications

Effect of macrovascular complications on type 2 diabetes treatment

End-stage disease considerations

Co-morbidities

Obesity

Effect of obesity on type 2 diabetes treatment

Hypertension

Dyslipidemia

CHAPTER 8 TREATMENT OPTIONS FOR TYPE 2 DIABETES

Treatment guidelines for type 2 diabetes

Clinical practice guidelines from the ADA/EASD

The AACE clinical practice guidelines

Lifestyle management for type 2 diabetes

Pharmacological treatment for type 2 diabetes

Oral antidiabetic (OAD) agents

Biguanides (metformin)

Sulfonylureas

Prandial glucose regulators (PGRs)

Thiazolidinediones

Alpha-glucosidase inhibitors (AGIs)

Incretin Mimetics

Glucagon-like peptide-1 agonists (GLP-1s)

Dipeptidyl peptidase-4 inhibitors (DPP-4s)

Insulins

Lantus

Levemir

Humalog

Novolog

NovoLin

Humulin

Apidra

CHAPTER 9 FIRST-LINE PHARMACOTHERAPY

Overview

First-line monotherapy

First-line combination therapy

CHAPTER 10 SECOND-LINE PHARMACOTHERAPY

Overview

Second-line monotherapy

Second-line combination therapy

CHAPTER 11 THIRD-LINE PHARMACOTHERAPY

Overview

Third-line monotherapy

Third-line combination therapy

CHAPTER 12 TRANSITION TO INSULIN THERAPY

History of insulin therapy

Indications for insulin use in type 2 diabetes

Time of initiation of insulin therapy

Drivers for insulin uptake

Improved of glycemic control

Earlier initiation of insulin therapy

Restraints for uptake of insulin

Weight gain

Risk of hypoglycemia

Patient education and compliance with subcutaneous injections

Cost and reimbursement issues

Use of insulin

Overall usage of insulin

Changes to insulin prescribing habits

Past, present and future use

Usage of different types of insulin

Physician perception of different types of insulin

Brand map overview

Interpreting a brand map

Long-acting insulins: Lantus (Glargine) and Levemir (Detemir)

Short-acting insulins: Humalog (Lispro) and Apidra (Glulisine)

Failure of inhaled insulin

CHAPTER 13 PRESCRIBING TRENDS IN THE TREATMENT OF TYPE 2 DIABETES

The evolution of the treatment regimen

Factors determining the alteration to a treatment regimen

Patient empowerment

Uptake of single-pill combination (SPC) therapies

The evolution of the treatment algorithm

Sulfonylureas and Metformin

Loss of confidence in TZDS

PGRs and AGIs

Insulin shifted down treatment algorithm by new classes of incretin mimetic

CHAPTER 14 PRESCRIBING INFLUENCES IN THE TREATMENT OF TYPE 2 DIABETES

Factors influencing prescribing decisions in T2 diabetes

Efficacy is the major prescribing influence in type 2 diabetes

Safety is also an important prescribing influence

Cost issues possibly not as important as for other indications

Beta cell salvage and time to secondary failure

Mode of administration

Dosing frequency

Physician perception of existing therapies in type 2 diabetes

Brand map overview

Interpreting a brand map

Physician perception of established classes of antidiabetic drugs

Physician perception of novel classes of antidiabetic drugs

CHAPTER 15 UNMET NEEDS IN TYPE 2 DIABETES

Overview

Each unmet need is ordered by relative importance, and discussed in more detail below:

Insulin response variability

Poor diagnosis

Routine screening programs to improve poor diagnosis rate

Guideline awareness

Non-invasive blood glucose measurement (BMG)

Tolerability

Incidence of hypoglycemic events

Delivery-related complications

Weight gain

Mode of administration (MoA)

Reluctance to self-inject

Patient compliance

Insulin secretion patterns

Patient awareness

Efficacy

APPENDIX A

Bibliography

APPENDIX B

Physician research methodology

Physician sample breakdown

US

Japan

France

Germany

Italy

Spain

UK

APPENDIX C

The survey questionnaire

List of Tables

Table 1: Prevalence of diabetes mellitus is forecast to increase by the International Diabetes Foundation (IDF), 2003-2025

Table 2: Prevalence rate of type 1 and type 2 diabetes in the seven major markets (%), 2006-2015

Table 3: Estimated absolute prevalence of diabetes in the seven major markets (millions), 2007-2017

Table 4: Framingham Heart Study data on lipid levels in men and women with and without diabetes

Table 5: ADA evidence grading system for clinical practice guidelines

Table 6: Comparator Insulins by onset of action, 2006

Table 7: US physician sample breakdown, 2007

Table 8: Japan physician sample breakdown, 2007

Table 9: France physician sample breakdown, 2007

Table 10: Germany physician sample breakdown, 2007

Table 11: Italy physician sample breakdown, 2007

Table 12: Spain physician sample breakdown, 2007

Table 13: UK physician sample breakdown, 2007

List of Figures

Figure 1: Population demographic for diagnosed type 2 diabetic patients in the US, 2007

Figure 2: Population, treatment and treatment outcome data for type 2 diabetic patients in US, 2007

Figure 3: Population demographic for diagnosed type 2 diabetic patients in Japan, 2007

Figure 4: Population, treatment and treatment outcome data for type 2 diabetic patients in Japan, 2007

Figure 5: Population demographic for diagnosed type 2 diabetic patients in France, 2007

Figure 6: Population, treatment and treatment outcome data for type 2 diabetic patients in France, 2007

Figure 7: Population demographic for diagnosed type 2 diabetic patients in Germany, 2007

Figure 8: Population, treatment and treatment outcome data for type 2 diabetic patients in Germany, 2007

Figure 9: Population demographic for diagnosed type 2 diabetic patients in Italy, 2007

Figure 10: Population, treatment and treatment outcome data for type 2 diabetic patients in Germany, 2007

Figure 11: Population demographic for diagnosed type 2 diabetic patients in Spain, 2007

Figure 12: Population, treatment and treatment outcome data for type 2 diabetic patients in Italy, 2007

Figure 13: Population demographic for diagnosed type 2 diabetic patients in the UK, 2007

Figure 14: Population, treatment and treatment outcome data for type 2 diabetic patients in the UK, 2007

Figure 15: Population, treatment and treatment outcome data for RCC in the 5EU, 2007 (continued)

Figure 16: Population, treatment and treatment outcome data for type 2 diabetic patients in the 5EU, 2007

Figure 17: Specialty of physician diagnosing and managing diabetic patients.

Figure 18: Estimated percentage of diagnosed type 2 diabetics in the seven major markets

Figure 19: Estimated percentage of diagnosed type 2 diabetics who are classified as either overweight or obese.

Figure 20: Estimated percentage of diagnosed type 2 diabetics who are classified as prehypertensive or hypertensive.

Figure 21: Estimated percentage of diagnosed type 2 diabetics with each degree of plasma cholesterol elevation

Figure 22: Proportion of type 2 diabetics in the seven major markets with complications

Figure 23: Proportion of type 2 diabetics with complications that suffer from microvascular and/or macrovascular complications in the seven major markets

Figure 24: Proportion of type 2 diabetics with different stages of nephropathy in the seven major markets

Figure 25: Average time from the diagnosis of diabetes required for the development of different stages of diabetic nephropathy in the seven major markets, 2007.

Figure 26: Proportion of type 2 diabetics with retinopathy in the seven major markets

Figure 27: Average time required for the development of diabetic retinopathy in the seven major markets

Figure 28: Proportion of type 2 diabetics with neuropathy in the seven major markets

Figure 29: Average time required for the development of diabetic neuropathy in the seven major markets

Figure 30: Proportion of type 2 diabetics with macrovascular complications in the seven major markets

Figure 31: Average time for the development of macrovascular complications in the seven major markets

Figure 32: Proportion of type 2 diabetics with serious complications (e.g. ESRD, acute MI, amputation)

Figure 33: Treatment algorithm for type 2 diabetes, recommended by the 2006 ADA/EASD clinical practice guidelines.

Figure 34: Percentage of diagnosed type 2 patients receiving drug therapy and/or lifestyle management in the seven major markets

Figure 35: Breakdown of patients by line of treatment in the seven major markets

Figure 36: Mechanism of action of sulfonylureas and prandial glucose regulators

Figure 37: Percentage of patients on monotherapy versus. combination therapy at first-line therapy, 2007.

Figure 38: Breakdown of overall drug class usage in patients on first-line therapy in the seven major markets

Figure 39: Breakdown of combination therapy at first-line in the seven major markets

Figure 40: Percentage of patients in monotherapy vs. combination therapy in second-line therapy

Figure 41: Breakdown of drug class use in patients on second-line monotherapy in the seven major markets

Figure 42: Breakdown of drug class use in patients on second-line monotherapy in the seven major markets

Figure 43: Percentage of patients on monotherapy versus combination therapy in third-line therapy, 2007.

Figure 44: Breakdown of drug class use in patients on third-line monotherapy in the seven major markets, 2007.

Figure 45: Breakdown of drug regimen use in patients on third-line combination therapy in the seven major markets

Figure 46: Common insulin regimens

Figure 47: When to start insulin therapy in type 2 diabetes?

Figure 48: Time to the inititation of insulin therapy

Figure 49: Specialists' rankings of the factors influencing insulin prescribing in the seven major markets (1 = most influencing, 5 = least influencing)

Figure 50: Uptake of insulin across the seven major markets, 2007.

Figure 51: Proportion of drug-treated type 2 diabetes patients prescribed insulin either alone or in combination therapy, by line of therapy, across the seven major markets, 2007

Figure 52: Comparison of current (2007) insulin prescription pattern with that in 2004, and 2010.

Figure 53: Brand map for the different types of insulin

Figure 54: Factors influencing therapy changes, 2007

Figure 55: Therapy changes across the seven major markets, 2007

Figure 56: Factors influencing the uptake of SPCs across the seven major markets, 2007

Figure 57: Uptake of SPCs across the seven major markets, 2007

Figure 58: Physicians' changing prescribing trends 2004-2010

Figure 59: Evolution of the treatment algorithm

Figure 60: Evolution of the treatment algorithm

Figure 61: Evolution of the treatment algorithm

Figure 62: Relative weighting given to each prescribing influence for type 2 diabetes drug therapy across the seven major markets, 2007

Figure 63: Brand map of established antidiabetic drugs in 7MM, 2007

Figure 64: Brand map of novel classes of antidiabetic drugs in 7MM, 2007

Figure 65: Unmet need for antidiabetic drugs in 7MM, 2007

Figure 66: Unmet need in blood glucose measurement (BMG)

Abstract

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