異常脂質血症の治療動向

Overview

Introduction

Datamonitor estimates that there are 267m people in the seven major markets with total cholesterol >200mg/dL which is set to rise to 287m in 2015. Despite this vast patient potential, low diagnosis rates limit the market size, and with the launch of generic statins, and the maturing of the market, it is increasingly important for companies to target the under-treated dyslipidemia sub-populations.

Scope

• 180 physician interviews carried out across the seven major pharmaceutical markets, plus the views of key industry opinion leaders
• Examination of dyslipidemia patient potential, detailing the current and future prevalence of high total cholesterol
• Detailed treatment trees to show dyslipidemia patient flows at country levels (US, Japan, France, Germany, Italy, Spain and the UK)
• Expected future prescribing rates for combination therapy and new agents, such as Vytorin (ezetimibe + simvastatin) and atorvastatin and torcetrapib

Highlights

Dyslipidemia patients are often plagued with risk factors and co-morbidities that increase their relative risk considerably. Datamonitor research found that a high percentage of patients with dyslipidemia also suffer from obesity, hypertension and type 2 diabetes, representing a potentially lucrative target.

The more aggressive approach to LDL lowering, and lower treatment thresholds recommended in updated guidelines means a greater patient population. However, increasing awareness in physicians and in the general population is essential to increase diagnosis and thus treatment rates.

Physicians predict that combination therapy will play an increasingly important role over the next three years. Given the highly competitive nature of the antidyslipidemic market, companies that can position novel products as effective treatments for use in combination therapy are likely to be the most successful.

Reasons to Purchase

• Gain independent insight into the management of dyslipidemia and understand what factors influence physicians prescribing practices
• Assess the future direction of dyslipidemia therapy, and the remaining unmet needs in order to successfully manage your developmental products
• Identify lucrative new target populations in order to create new opportunities in this market

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

• About the cardiovascular pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

• Scope of the analysis
• Datamonitor insight into the dyslipidemia market
  • Statins are the number one choice for first-line therapy
  • Physicians predict that combination therapy will play anincreasingly important role over the next three years
  • New treatment options are required
  • Datamonitor conclusions

CHAPTER 2 INTRODUCTION AND SCOPE

• Coverage of the Stakeholder Insight Survey

CHAPTER 3 COUNTRY TREATMENT TREES

• Introduction to the treatment trees
• US
• Japan
• France
• Germany
• Italy
• Spain
• UK

CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION

• Definition of dyslipidemia
  • What is dyslipidemia?
• Segmentation of dyslipidemia
  • Markers for dyslipidemia
  • Segmentation by type of dyslipidemia
    • Hypercholesterolemia
    • Mixed dyslipidemia
    • Hypertriglyceridemia
  • Familial hypertriglyceridemia
  • Low HDL cholesterol
  • Segmentation by disease severity
• Co-morbidities and risk factors
• Epidemiology of dyslipidemia

CHAPTER 5 DIAGNOSIS AND TREATMENT OPTIONS

• Presentation and diagnosis
  • PCPs manage highest percentage of dyslipidemia patients
  • Greatest percentage of patients managed with both drugtherapy and lifestyle advice
• Influences on diagnosis and treatment rates
  • Treatment guidelines
    • NCEP treatment guidelines

CHAPTER 6 OVERALL PRESCRIBING TRENDS

• Overall prescribing trend dominated by statins
  • Statins
  • Ezetimibe
  • Caduet
    • ASCOT
    • AVALON
• Statin prescribing trends
  • Breakdown of statin prescribing by type of statin
    • Simvastatin most prescribed statin in six major markets
    • Pitavastatins rise to dominance in Japan
    • TNT study
    • CARDS study
  • Breakdown of statin prescribing by line of therapy
  • Breakdown of statin prescribing by daily dose
  • Increased generic prescribing within three years
    • Generic challenge to Lipitors patent
  • Limitations of statin therapy
    • Patients unable to tolerate statin therapy
    • Patients refusing to take statin therapy
    • Patients refractory to statin therapy

CHAPTER 7 ANALYSIS OF FIBRATE THERAPY

• Trends in fibrate therapy
  • Breakdown of fibrate prescribing by type of fibrate
    • Fenofibrate: leading fibrate in France and Germany
    • Bezafibrate: leading fibrate in Japan and the UK
    • Gemfibrozil: leading fibrate in the US, Italy and Spain
    • Clofibrate: low use in all major markets
  • Changes in fibrate usage over recent years

CHAPTER 8 FIRST- TO SECOND-LINE THERAPY

• First-line therapy
  • Breakdown of first-line therapy by drug class
• Second-line therapy
  • Patients progressing to second-line therapy
  • Breakdown of second-line therapy by drug class
  • Patients progressing to third-line therapy and beyond
• Changes in antidyslipidemic therapy
  • Patients having their drug therapy changed
  • Reasons for changes in therapy
  • Types of therapy changes

CHAPTER 9 ANALYSIS OF COMBINATION THERAPY

• Proportion of patients receiving combination therapy
• Future prescribing of combination therapy
• Breakdown of combination therapy
  • Statin + ezetimibe combination
  • Statin + fibrate combination
• Factors influencing future use of new adjunctivetherapies
  • Additional LDL cholesterol-reducing benefits
  • HDL cholesterol-raising benefits
  • Ability to prescribe lower-dose statins withoutcompromising efficacy
  • Triglyceride-lowering effects
  • Potential increase in side effects
  • Limited mortality data for combination therapy
  • Reduced compliance due to increase pill burden
  • Increase in cost

CHAPTER 10 IMPROVING TREATMENT OUTCOMES

• Treatment outcomes
  • Patients failing to achieve target cholesterol goals
    • Studies assessing treatment outcomes
  • Factors influencing the prescribing of antidyslipidemics
• The greatest unmet need in dyslipidemia according to keyopinion leaders, is for drugs with the ability to prevent or reverseatherosclerosis
  • Drugs need to prevent or even reverse the progression ofatherosclerosis
  • Drugs with novel mechanisms of action
  • Drugs with increased efficacy in lowering LDL andincreasing HDL
  • More long-term data is required to support primary andsecondary prevention of acute CVD event.
  • More combination therapies are needed
  • Additional statin safety studies not required

CHAPTER 11 NEW PRODUCT AWARENESS

• Ezetimibe
  • Physician awareness
  • Percentage of patients prescribed
  • Mean rating table
• Vytorin
  • Physician awareness
  • Percentage of patients prescribed
  • The cost and reimbursement of Vytorin
• Crestor
• Atorvastatin + torcetrapib
  • Physician awareness
  • Percentage of patients prescribed

• APPENDIX A BIBLIOGRAPHY
  • Clinical trial data
• Epidemiology methodology
  • Datamonitor forecast methodology
  • Methodology
  • US
  • Japan
  • France
  • Germany
  • Italy
  • Spain
  • UK
• APPENDIX B
  • Physician research methodology
    • Physician sample breakdown
    • US
    • Japan
    • France
    • Germany
    • Italy
    • Spain
    • UK
  • Stakeholder Insight Questionnaire
    • Diagnosis
    • Treatment overview
    • First line therapy
    • Therapy changes
    • Second line therapy
    • Combination therapy
    • Treatment outcomes
    • Future focus
    • Disclaimer

List of Tables

• Table 1: Key changes to lipid levels between the NCEPII and NCEP III
• Table 2: Estimated proportion of dyslipidemia patientswith co-morbid conditions and risk factors in the seven major markets,2005
• Table 3: Epidemiology overview of dyslipidemia,2005-15
• Table 4: Epidemiology figures by age for the sevenmajor markets, 2005
• Table 5: Estimated breakdown of the management ofdyslipidemia in the general population by physician type, 2005
• Table 6: Breakdown of dyslipidemia management acrossthe different populations in the seven major markets, 2005
• Table 7: Proportion of drug-treated patientsprescribed each type of therapy in the seven major markets, 2005
• Table 8: AVALON trial results
• Table 9: Generic price of simvastatin in the UK
• Table 10: TNT study results
• Table 11: CARDS study results
• Table 12: Breakdown of statin prescribing by line oftherapy in the seven major markets, 2005
• Table 13: Breakdown of statin prescribing by dailydose in the seven major markets, 2005
• Table 14: Availability of generic statins in the sevenmajor markets, 2005
• Table 15: Proportion of overall drug-treateddyslipidemia patients prescribed each antidyslipidemic drug class asfirst-line therapy in the seven major markets, 2005
• Table 16: Proportion of overall drug-treateddyslipidemia patients prescribed each antidyslipidemic drug class assecond-line therapy in the seven major markets, 2005
• Table 17: Average number of changes a patientundergoes over one year, 2005
• Table 18: Change in combination therapy over the nextthree years in the seven major markets, 2005
• Table 19: Breakdown of combination therapy bydyslipidemia sub-population in the seven major markets, 2005
• Table 20: Physician ratings of factors providingincentives/disincentives for the future prescribing of new therapies asadjuncts to statins in the seven major markets, 2005
• Table 21: Proportion of drug-treated dyslipidemiapatients in each sub-population failing to reach target cholesterolgoals in the seven major markets, 2005
• Table 22: Average rating of factors influencing theprescribing of antidyslipidemic therapy in the seven major markets, 2005
• Table 23: Mean ranking of preferred statin to use withezetimibe, 2005
• Table 24: Physician opinions of Vytorin, 2005
• Table 25: Price comparison of Vytorin, 2005
• Table 26: US physicians opinion of Crestor, 2005
• Table 27: US physician sample breakdown, 2005
• Table 28: Japan physician sample breakdown, 2005
• Table 29: France physician sample breakdown, 2005
• Table 30: Germany physician sample breakdown, 2005
• Table 31: Italy physician sample breakdown, 2005
• Table 32: Spain physician sample breakdown, 2005
• Table 33: UK physician sample breakdown, 2005

List of Figures

• Figure 1: Diagrammatic overview of the coverage of thedyslipidemia Stakeholder Insight survey, 2005
• Figure 2: Breakdown of the overall dyslipidemiapopulation in the US by diagnosis, type of dyslipidemia, diseaseseverity and prevalence of risk factors and co-morbidities, 2005
• Figure 3: Breakdown of drug therapy in the diagnoseddyslipidemia sub-populations in the US, 2005
• Figure 4: Breakdown of statin therapy by compound,line of therapy, daily dose and use of brands versus generics in the US,for the overall drug treated dyslipidemia population, 2005
• Figure 5: Breakdown of first- and second-line therapyby antidyslipidemic drug class in the US for the overall diagnosed anddrug treated dyslipidemia population, 2005
• Figure 6: Segmentation of drug-treated overalldyslipidemia population having therapy changed over a one-year period inthe US for the overall diagnosed and drug treated dyslipidemiapopulation, 2005
• Figure 7: Breakdown of combination therapy bydyslipidemia sub-population in the US for the overall diagnosed and drugtreated dyslipidemia population, 2005
• Figure 8: Breakdown of treatment outcomes bydyslipidemia sub-population in the US, 2005
• Figure 9: Breakdown of the overall dyslipidemiapopulation in Japan by diagnosis, type of dyslipidemia, disease severityand prevalence of risk factors and co-morbidities, 2005
• Figure 10: Breakdown of drug therapy in the diagnoseddyslipidemia sub-populations in Japan, 2005
• Figure 11: Breakdown of statin therapy by compound,line of therapy, daily dose and use of brands versus generics in Japan,for the overall drug treated dyslipidemia population, 2005
• Figure 12: Breakdown of first- and second-line therapyby antidyslipidemic drug class in Japan for the overall diagnosed anddrug treated dyslipidemia population, 2005
• Figure 13: Segmentation of drug-treated overalldyslipidemia population having therapy changed over a one-year period inJapan for the overall diagnosed and drug treated dyslipidemiapopulation, 2005
• Figure 14: Breakdown of combination therapy bydyslipidemia sub-population in Japan, 2005
• Figure 15: Breakdown of treatment outcomes bydyslipidemia sub-population in Japan, 2005
• Figure 16: Breakdown of the overall dyslipidemiapopulation in France by diagnosis, type of dyslipidemia, diseaseseverity and prevalence of risk factors and co-morbidities, 2005
• Figure 17: Breakdown of drug therapy in the diagnoseddyslipidemia sub-populations in France, 2005
• Figure 18: Breakdown of statin therapy by compound,line of therapy, daily dose and use of brands versus generics in France,for the overall drug treated dyslipidemia population, 2005
• Figure 19: Breakdown of first- and second-line therapyby antidyslipidemic drug class in France for the overall diagnosed anddrug treated dyslipidemia population, 2005
• Figure 20: Segmentation of drug-treated overalldyslipidemia population having therapy changed over a one-year period inFrance for the overall diagnosed and drug treated dyslipidemiapopulation, 2005
• Figure 21: Breakdown of combination therapy bydyslipidemia sub-population in France, 2005
• Figure 22: Breakdown of treatment outcomes bydyslipidemia sub-population in France, 2005
• Figure 23: Breakdown of the overall dyslipidemiapopulation in Germany by diagnosis, type of dyslipidemia, diseaseseverity and prevalence of risk factors and co-morbidities, 2005
• Figure 24: Breakdown of drug therapy in the diagnoseddyslipidemia sub-populations in Germany, 2003
• Figure 25: Breakdown of statin therapy by compound,line of therapy, daily dose and use of brands versus generics inGermany, for the overall drug treated dyslipidemia population, 2005
• Figure 26: Breakdown of first- and second-line therapyby antidyslipidemic drug class in Germany for the overall diagnosed anddrug treated dyslipidemia population, 2005
• Figure 27: Segmentation of drug-treated overalldyslipidemia population having therapy changed over a one-year period inGermany for the overall diagnosed and drug treated dyslipidemiapopulation, 2005
• Figure 28: Breakdown of combination therapy bydyslipidemia sub-population in Germany, 2005
• Figure 29: Breakdown of treatment outcomes bydyslipidemia sub-population in Germany, 2005
• Figure 30: Breakdown of the overall dyslipidemiapopulation in Italy by diagnosis, type of dyslipidemia, disease severityand prevalence of risk factors and co-morbidities, 2005
• Figure 31: Breakdown of drug therapy in the diagnoseddyslipidemia sub-populations in Italy, 2005
• Figure 32: Breakdown of statin therapy by compound,line of therapy, daily dose and use of brands versus generics in Italy,for the overall drug treated dyslipidemia population, 2005
• Figure 33: Breakdown of first- and second-line therapyby antidyslipidemic drug class in Italy for the overall diagnosed anddrug treated dyslipidemia population, 2005
• Figure 34: Segmentation of drug-treated overalldyslipidemia population having therapy changed over a one-year period inItaly for the overall diagnosed and drug treated dyslipidemiapopulation, 2005
• Figure 35: Breakdown of combination therapy bydyslipidemia sub-population in Italy, 2005
• Figure 36: Breakdown of treatment outcomes bydyslipidemia sub-population in Italy, 2005
• Figure 37: Breakdown of the overall dyslipidemiapopulation in Spain by diagnosis, type of dyslipidemia, disease severityand prevalence of risk factors and co-morbidities, 2005
• Figure 38: Breakdown of drug therapy in the diagnoseddyslipidemia sub-populations in Spain, 2005
• Figure 39: Breakdown of statin therapy by compound,line of therapy, daily dose and use of brands versus generics in Spain,for the overall drug treated dyslipidemia population, 2005
• Figure 40: Breakdown of first- and second-line therapyby antidyslipidemic drug class in Spain for the overall diagnosed anddrug treated dyslipidemia population, 2005
• Figure 41: Segmentation of drug-treated overalldyslipidemia population having therapy changed over a one-year period inSpain for the overall diagnosed and drug treated dyslipidemiapopulation, 2005
• Figure 42: Breakdown of combination therapy bydyslipidemia sub-population in Spain, 2005
• Figure 43: Breakdown of treatment outcomes bydyslipidemia sub-population in Spain, 2005
• Figure 44: Breakdown of the overall dyslipidemiapopulation in the UK by diagnosis, type of dyslipidemia, diseaseseverity and prevalence of risk factors and co-morbidities, 2005
• Figure 45: Breakdown of drug therapy in the diagnoseddyslipidemia sub-populations in the UK, 2005
• Figure 46: Breakdown of statin therapy by compound,line of therapy, daily dose and use of brands versus generics in the UK,for the overall drug treated dyslipidemia population, 2005
• Figure 47: Breakdown of first- and second-line therapyby antidyslipidemic drug class in the UK for the overall diagnosed anddrug treated dyslipidemia population, 2005
• Figure 48: Segmentation of drug-treated overalldyslipidemia population having therapy changed over a one-year period inthe UK for the overall diagnosed and drug treated dyslipidemiapopulation, 2005
• Figure 49: Breakdown of combination therapy bydyslipidemia sub-population in the UK, 2005
• Figure 50: Breakdown of treatment outcomes bydyslipidemia sub-population in the UK, 2005
• Figure 51: Proportion of diagnosed dyslipidemiapatients with each type of dyslipidemia in the seven major markets, 2005
• Figure 52: Proportion of diagnosedhypercholesterolemia patients with familial hypercholesterolemia in theseven major markets, 2005
• Figure 53: Proportion of diagnosed dyslipidemiapatients with low HDL cholesterol in the seven major markets, 2005
• Figure 54: Breakdown of the diagnosed dyslipidemiapopulation by disease severity in the seven major markets, 2005
• Figure 55: Estimated proportion of dyslipidemiapatients in the general population diagnosed in the seven major markets,2005
• Figure 56: Overview of NCEP ATP III guidelines
• Figure 57: Breakdown of statin prescribing by type ofstatin in overall dyslipidemia patients in the seven major markets, 2005
• Figure 58: Brand versus generic prescribing ofstatins, currently and in three years, 2005
• Figure 59: Proportion of drug-treated dyslipidemiapatients unable to tolerate statin therapy in the seven major markets,2005
• Figure 60: Proportion of drug-treated dyslipidemiapatients refusing to take statin therapy in the seven major markets,2005
• Figure 61: Proportion of dyslipidemia patients onstatin therapy that are refractory to statins in the seven majormarkets, 2005
• Figure 62: Breakdown of fibrate prescribing bycompound in overall dyslipidemia patients in the seven major markets,2005
• Figure 63: Proportion of overall drug-treateddyslipidemia patients progressing to second-line therapy, 2005
• Figure 64: Comparison of antidyslipidemic drug classesat first- versus second-line in the combined seven markets, 2005
• Figure 65: Proportion of overall drug-treateddyslipidemia patients on second-line therapy progressing to third-linetherapy and beyond, 2005
• Figure 66: Proportion of overall drug-treateddyslipidemia patients having their therapy changed over a one-yearperiod, 2005
• Figure 67: Reasons for change in antidyslipidemictherapy in the seven major markets, 2005
• Figure 68: Type of changes in antidyslipidemic therapyin the seven major markets, 2005
• Figure 69: Proportion of overall drug-treateddyslipidemia patients receiving combination therapy in the seven majormarkets, 2005
• Figure 70: Proportion of hypercholesterolemiadrug-treated dyslipidemia patients receiving combination therapy in theseven major markets, 2005
• Figure 71: Proportion of drug-treated mixeddyslipidemia patients receiving combination therapy in the seven majormarkets, 2005
• Figure 72: Proportion of drug-treated diabeticdyslipidemia patients receiving combination therapy in the seven majormarkets, 2005
• Figure 73: Proportion of drug-treated dyslipidemiapatients in each sub-population receiving a statin + ezetimibecombination in the seven major markets, 2005
• Figure 74: Proportion of drug-treated dyslipidemiapatients in each sub-population receiving a statin + fibrate combinationin the seven major markets, 2003
• Figure 75: Unmet needs in the dyslipidemia market,2005
• Figure 76: Physician awareness of ezetimibe, 2005
• Figure 77: Proportion of patients expected to beprescribed ezetimibe, 2005
• Figure 78: Proportion of physicians aware of Vytorin,2005
• Figure 79: Proportion of patients estimated to receiveVytorin, 2005
• Figure 80: Physician awareness of atorvastatin +torcetrapib, 2005
• Figure 81: Proportion of patients expected to receiveatorvastatin + torcetrapib when launched, 2005