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Stakeholder Insight: Dyslipidemia - Statins Dominate Treatment Pathway - For Now

Published by: Datamonitor

Published: Oct. 5, 2005 - 204 Pages


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 an increasingly 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 drug therapy 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

Pitavastatin's 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 Lipitor's 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 adjunctive therapies


Additional LDL cholesterol-reducing benefits

HDL cholesterol-raising benefits

Ability to prescribe lower-dose statins without compromising 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 key opinion leaders, is for drugs with the ability to prevent or reverse atherosclerosis


Drugs need to prevent or even reverse the progression of atherosclerosis

Drugs with novel mechanisms of action

Drugs with increased efficacy in lowering LDL and increasing HDL

More long-term data is required to support primary and secondary 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 NCEP II and NCEP III

Table 2: Estimated proportion of dyslipidemia patients with 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 seven major markets, 2005

Table 5: Estimated breakdown of the management of dyslipidemia in the general population by physician type, 2005

Table 6: Breakdown of dyslipidemia management across the different populations in the seven major markets, 2005

Table 7: Proportion of drug-treated patients prescribed 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 of therapy in the seven major markets, 2005

Table 13: Breakdown of statin prescribing by daily dose in the seven major markets, 2005

Table 14: Availability of generic statins in the seven major markets, 2005

Table 15: Proportion of overall drug-treated dyslipidemia patients prescribed each antidyslipidemic drug class as first-line therapy in the seven major markets, 2005

Table 16: Proportion of overall drug-treated dyslipidemia patients prescribed each antidyslipidemic drug class as second-line therapy in the seven major markets, 2005

Table 17: Average number of changes a patient undergoes over one year, 2005

Table 18: Change in combination therapy over the next three years in the seven major markets, 2005

Table 19: Breakdown of combination therapy by dyslipidemia sub-population in the seven major markets, 2005

Table 20: Physician ratings of factors providing incentives/disincentives for the future prescribing of new therapies as adjuncts to statins in the seven major markets, 2005

Table 21: Proportion of drug-treated dyslipidemia patients in each sub-population failing to reach target cholesterol goals in the seven major markets, 2005

Table 22: Average rating of factors influencing the prescribing of antidyslipidemic therapy in the seven major markets, 2005

Table 23: Mean ranking of preferred statin to use with ezetimibe, 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 the dyslipidemia Stakeholder Insight survey, 2005

Figure 2: Breakdown of the overall dyslipidemia population in the US by diagnosis, type of dyslipidemia, disease severity and prevalence of risk factors and co-morbidities, 2005

Figure 3: Breakdown of drug therapy in the diagnosed dyslipidemia 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 therapy by antidyslipidemic drug class in the US for the overall diagnosed and drug treated dyslipidemia population, 2005

Figure 6: Segmentation of drug-treated overall dyslipidemia population having therapy changed over a one-year period in the US for the overall diagnosed and drug treated dyslipidemia population, 2005

Figure 7: Breakdown of combination therapy by dyslipidemia sub-population in the US for the overall diagnosed and drug treated dyslipidemia population, 2005

Figure 8: Breakdown of treatment outcomes by dyslipidemia sub-population in the US, 2005

Figure 9: Breakdown of the overall dyslipidemia population in Japan by diagnosis, type of dyslipidemia, disease severity and prevalence of risk factors and co-morbidities, 2005

Figure 10: Breakdown of drug therapy in the diagnosed dyslipidemia 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 therapy by antidyslipidemic drug class in Japan for the overall diagnosed and drug treated dyslipidemia population, 2005

Figure 13: Segmentation of drug-treated overall dyslipidemia population having therapy changed over a one-year period in Japan for the overall diagnosed and drug treated dyslipidemia population, 2005

Figure 14: Breakdown of combination therapy by dyslipidemia sub-population in Japan, 2005

Figure 15: Breakdown of treatment outcomes by dyslipidemia sub-population in Japan, 2005

Figure 16: Breakdown of the overall dyslipidemia population in France by diagnosis, type of dyslipidemia, disease severity and prevalence of risk factors and co-morbidities, 2005

Figure 17: Breakdown of drug therapy in the diagnosed dyslipidemia 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 therapy by antidyslipidemic drug class in France for the overall diagnosed and drug treated dyslipidemia population, 2005

Figure 20: Segmentation of drug-treated overall dyslipidemia population having therapy changed over a one-year period in France for the overall diagnosed and drug treated dyslipidemia population, 2005

Figure 21: Breakdown of combination therapy by dyslipidemia sub-population in France, 2005

Figure 22: Breakdown of treatment outcomes by dyslipidemia sub-population in France, 2005

Figure 23: Breakdown of the overall dyslipidemia population in Germany by diagnosis, type of dyslipidemia, disease severity and prevalence of risk factors and co-morbidities, 2005

Figure 24: Breakdown of drug therapy in the diagnosed dyslipidemia sub-populations in Germany, 2003

Figure 25: Breakdown of statin therapy by compound, line of therapy, daily dose and use of brands versus generics in Germany, for the overall drug treated dyslipidemia population, 2005

Figure 26: Breakdown of first- and second-line therapy by antidyslipidemic drug class in Germany for the overall diagnosed and drug treated dyslipidemia population, 2005

Figure 27: Segmentation of drug-treated overall dyslipidemia population having therapy changed over a one-year period in Germany for the overall diagnosed and drug treated dyslipidemia population, 2005

Figure 28: Breakdown of combination therapy by dyslipidemia sub-population in Germany, 2005

Figure 29: Breakdown of treatment outcomes by dyslipidemia sub-population in Germany, 2005

Figure 30: Breakdown of the overall dyslipidemia population in Italy by diagnosis, type of dyslipidemia, disease severity and prevalence of risk factors and co-morbidities, 2005

Figure 31: Breakdown of drug therapy in the diagnosed dyslipidemia 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 therapy by antidyslipidemic drug class in Italy for the overall diagnosed and drug treated dyslipidemia population, 2005

Figure 34: Segmentation of drug-treated overall dyslipidemia population having therapy changed over a one-year period in Italy for the overall diagnosed and drug treated dyslipidemia population, 2005

Figure 35: Breakdown of combination therapy by dyslipidemia sub-population in Italy, 2005

Figure 36: Breakdown of treatment outcomes by dyslipidemia sub-population in Italy, 2005

Figure 37: Breakdown of the overall dyslipidemia population in Spain by diagnosis, type of dyslipidemia, disease severity and prevalence of risk factors and co-morbidities, 2005

Figure 38: Breakdown of drug therapy in the diagnosed dyslipidemia 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 therapy by antidyslipidemic drug class in Spain for the overall diagnosed and drug treated dyslipidemia population, 2005

Figure 41: Segmentation of drug-treated overall dyslipidemia population having therapy changed over a one-year period in Spain for the overall diagnosed and drug treated dyslipidemia population, 2005

Figure 42: Breakdown of combination therapy by dyslipidemia sub-population in Spain, 2005

Figure 43: Breakdown of treatment outcomes by dyslipidemia sub-population in Spain, 2005

Figure 44: Breakdown of the overall dyslipidemia population in the UK by diagnosis, type of dyslipidemia, disease severity and prevalence of risk factors and co-morbidities, 2005

Figure 45: Breakdown of drug therapy in the diagnosed dyslipidemia 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 therapy by antidyslipidemic drug class in the UK for the overall diagnosed and drug treated dyslipidemia population, 2005

Figure 48: Segmentation of drug-treated overall dyslipidemia population having therapy changed over a one-year period in the UK for the overall diagnosed and drug treated dyslipidemia population, 2005

Figure 49: Breakdown of combination therapy by dyslipidemia sub-population in the UK, 2005

Figure 50: Breakdown of treatment outcomes by dyslipidemia sub-population in the UK, 2005

Figure 51: Proportion of diagnosed dyslipidemia patients with each type of dyslipidemia in the seven major markets, 2005

Figure 52: Proportion of diagnosed hypercholesterolemia patients with familial hypercholesterolemia in the seven major markets, 2005

Figure 53: Proportion of diagnosed dyslipidemia patients with low HDL cholesterol in the seven major markets, 2005

Figure 54: Breakdown of the diagnosed dyslipidemia population by disease severity in the seven major markets, 2005

Figure 55: Estimated proportion of dyslipidemia patients 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 of statin in overall dyslipidemia patients in the seven major markets, 2005

Figure 58: Brand versus generic prescribing of statins, currently and in three years, 2005

Figure 59: Proportion of drug-treated dyslipidemia patients unable to tolerate statin therapy in the seven major markets, 2005

Figure 60: Proportion of drug-treated dyslipidemia patients refusing to take statin therapy in the seven major markets, 2005

Figure 61: Proportion of dyslipidemia patients on statin therapy that are refractory to statins in the seven major markets, 2005

Figure 62: Breakdown of fibrate prescribing by compound in overall dyslipidemia patients in the seven major markets, 2005

Figure 63: Proportion of overall drug-treated dyslipidemia patients progressing to second-line therapy, 2005

Figure 64: Comparison of antidyslipidemic drug classes at first- versus second-line in the combined seven markets, 2005

Figure 65: Proportion of overall drug-treated dyslipidemia patients on second-line therapy progressing to third-line therapy and beyond, 2005

Figure 66: Proportion of overall drug-treated dyslipidemia patients having their therapy changed over a one-year period, 2005

Figure 67: Reasons for change in antidyslipidemic therapy in the seven major markets, 2005

Figure 68: Type of changes in antidyslipidemic therapy in the seven major markets, 2005

Figure 69: Proportion of overall drug-treated dyslipidemia patients receiving combination therapy in the seven major markets, 2005

Figure 70: Proportion of hypercholesterolemia drug-treated dyslipidemia patients receiving combination therapy in the seven major markets, 2005

Figure 71: Proportion of drug-treated mixed dyslipidemia patients receiving combination therapy in the seven major markets, 2005

Figure 72: Proportion of drug-treated diabetic dyslipidemia patients receiving combination therapy in the seven major markets, 2005

Figure 73: Proportion of drug-treated dyslipidemia patients in each sub-population receiving a statin + ezetimibe combination in the seven major markets, 2005

Figure 74: Proportion of drug-treated dyslipidemia patients in each sub-population receiving a statin + fibrate combination in 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 be prescribed ezetimibe, 2005

Figure 78: Proportion of physicians aware of Vytorin, 2005

Figure 79: Proportion of patients estimated to receive Vytorin, 2005

Figure 80: Physician awareness of atorvastatin + torcetrapib, 2005

Figure 81: Proportion of patients expected to receive atorvastatin + torcetrapib when launched, 2005

Abstract

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


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