Dyslipidemia - Statins Dominate Treatment Pathway
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the cardiovascular pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the dyslipidemia market - page 4
- Statins are the number one choice for first-line therapy - page 5
- Physicians predict that combination therapy will play an increasingly important role over the next three years - page 6
- New treatment options are required - page 7
- Datamonitor conclusions - page 7
- CHAPTER 2 INTRODUCTION AND SCOPE - page 16
- Coverage of the Stakeholder Insight Survey - page 17
- CHAPTER 3 COUNTRY TREATMENT TREES - page 21
- Introduction to the treatment trees - page 21
- US - page 24
- Japan - page 31
- France - page 38
- Germany - page 45
- Italy - page 52
- Spain - page 59
- UK - page 66
- CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION - page 73
- Definition of dyslipidemia - page 73
- What is dyslipidemia? - page 73
- Segmentation of dyslipidemia - page 74
- Markers for dyslipidemia - page 74
- Segmentation by type of dyslipidemia - page 74
- Hypercholesterolemia - page 75
- Mixed dyslipidemia - page 77
- Hypertriglyceridemia - page 77
- Familial hypertriglyceridemia - page 78
- Low HDL cholesterol - page 79
- Segmentation by disease severity - page 80
- Co-morbidities and risk factors - page 81
- Epidemiology of dyslipidemia - page 84
- Definition of dyslipidemia - page 73
- CHAPTER 5 DIAGNOSIS AND TREATMENT OPTIONS - page 88
- Presentation and diagnosis - page 88
- PCPs manage highest percentage of dyslipidemia patients - page 89
- Greatest percentage of patients managed with both drug therapy and lifestyle advice - page 90
- Influences on diagnosis and treatment rates - page 92
- Treatment guidelines - page 92
- NCEP treatment guidelines - page 92
- Treatment guidelines - page 92
- Presentation and diagnosis - page 88
- CHAPTER 6 OVERALL PRESCRIBING TRENDS - page 94
- Overall prescribing trend dominated by statins - page 94
- Statins - page 96
- Ezetimibe - page 96
- Caduet - page 97
- ASCOT - page 97
- AVALON - page 98
- Statin prescribing trends - page 99
- Breakdown of statin prescribing by type of statin - page 100
- Simvastatin most prescribed statin in six major markets - page 100
- Pitavastatin's rise to dominance in Japan - page 102
- TNT study - page 103
- CARDS study - page 105
- Breakdown of statin prescribing by line of therapy - page 106
- Breakdown of statin prescribing by daily dose - page 108
- Increased generic prescribing within three years - page 111
- Generic challenge to Lipitor's patent - page 112
- Limitations of statin therapy - page 113
- Patients unable to tolerate statin therapy - page 113
- Patients refusing to take statin therapy - page 114
- Patients refractory to statin therapy - page 116
- Breakdown of statin prescribing by type of statin - page 100
- Overall prescribing trend dominated by statins - page 94
- CHAPTER 7 ANALYSIS OF FIBRATE THERAPY - page 118
- Trends in fibrate therapy - page 118
- Breakdown of fibrate prescribing by type of fibrate - page 118
- Fenofibrate: leading fibrate in France and Germany - page 119
- Bezafibrate: leading fibrate in Japan and the UK - page 119
- Gemfibrozil: leading fibrate in the US, Italy and Spain - page 120
- Clofibrate: low use in all major markets - page 121
- Changes in fibrate usage over recent years - page 121
- Breakdown of fibrate prescribing by type of fibrate - page 118
- Trends in fibrate therapy - page 118
- CHAPTER 8 FIRST- TO SECOND-LINE THERAPY - page 122
- First-line therapy - page 122
- Breakdown of first-line therapy by drug class - page 122
- Second-line therapy - page 124
- Patients progressing to second-line therapy - page 124
- Breakdown of second-line therapy by drug class - page 125
- Patients progressing to third-line therapy and beyond - page 127
- Changes in antidyslipidemic therapy - page 128
- Patients having their drug therapy changed - page 128
- Reasons for changes in therapy - page 129
- Types of therapy changes - page 130
- First-line therapy - page 122
- CHAPTER 9 ANALYSIS OF COMBINATION THERAPY - page 132
- Proportion of patients receiving combination therapy - page 132
- Future prescribing of combination therapy - page 136
- Breakdown of combination therapy - page 136
- Statin + ezetimibe combination - page 138
- Statin + fibrate combination - page 140
- Factors influencing future use of new adjunctive therapies - page 142
- Additional LDL cholesterol-reducing benefits - page 143
- HDL cholesterol-raising benefits - page 143
- Ability to prescribe lower-dose statins without compromising efficacy - page 144
- Triglyceride-lowering effects - page 144
- Potential increase in side effects - page 144
- Limited mortality data for combination therapy - page 145
- Reduced compliance due to increase pill burden - page 145
- Increase in cost - page 145
- CHAPTER 10 IMPROVING TREATMENT OUTCOMES - page 146
- Treatment outcomes - page 146
- Patients failing to achieve target cholesterol goals - page 146
- Studies assessing treatment outcomes - page 147
- Factors influencing the prescribing of antidyslipidemics - page 149
- Patients failing to achieve target cholesterol goals - page 146
- The greatest unmet need in dyslipidemia according to key opinion leaders, is for drugs with the ability to prevent or reverse atherosclerosis - page 149
- Drugs need to prevent or even reverse the progression of atherosclerosis - page 150
- Drugs with novel mechanisms of action - page 151
- Drugs with increased efficacy in lowering LDL and increasing HDL - page 151
- More long-term data is required to support primary and secondary prevention of acute CVD event. - page 152
- More combination therapies are needed - page 152
- Additional statin safety studies not required - page 152
- Treatment outcomes - page 146
- CHAPTER 11 NEW PRODUCT AWARENESS - page 153
- Ezetimibe - page 153
- Physician awareness - page 153
- Percentage of patients prescribed - page 154
- Mean rating table - page 154
- Vytorin - page 155
- Physician awareness - page 155
- Percentage of patients prescribed - page 157
- The cost and reimbursement of Vytorin - page 158
- Crestor - page 159
- Atorvastatin + torcetrapib - page 160
- Physician awareness - page 161
- Percentage of patients prescribed - page 162
- Ezetimibe - page 153
- APPENDIX A BIBLIOGRAPHY - page 164
- Clinical trial data - page 164
- Epidemiology methodology - page 166
- Datamonitor forecast methodology - page 166
- Methodology - page 166
- US - page 166
- Japan - page 167
- France - page 168
- Germany - page 168
- Italy - page 169
- Spain - page 169
- UK - page 169
- APPENDIX B - page 170
- Physician research methodology - page 170
- Physician sample breakdown - page 170
- US - page 170
- Japan - page 171
- France - page 171
- Germany - page 172
- Italy - page 172
- Spain - page 173
- UK - page 173
- Stakeholder Insight Questionnaire - page 174
- Diagnosis - page 174
- Treatment overview - page 178
- First line therapy - page 187
- Therapy changes - page 188
- Second line therapy - page 189
- Combination therapy - page 191
- Treatment outcomes - page 195
- Future focus - page 197
- Disclaimer - page 204
- Physician research methodology - page 170
- List of Tables
- Table 1: Key changes to lipid levels between the NCEP II and NCEP III - page 76
- Table 2: Estimated proportion of dyslipidemia patients with co-morbid conditions and risk factors in the seven major markets, 2005 - page 82
- Table 3: Epidemiology overview of dyslipidemia, 2005-15 - page 85
- Table 4: Epidemiology figures by age for the seven major markets, 2005 - page 86
- Table 5: Estimated breakdown of the management of dyslipidemia in the general population by physician type, 2005 - page 89
- Table 6: Breakdown of dyslipidemia management across the different populations in the seven major markets, 2005 - page 90
- Table 7: Proportion of drug-treated patients prescribed each type of therapy in the seven major markets, 2005 - page 94
- Table 8: AVALON trial results - page 99
- Table 9: Generic price of simvastatin in the UK - page 101
- Table 10: TNT study results - page 104
- Table 11: CARDS study results - page 105
- Table 12: Breakdown of statin prescribing by line of therapy in the seven major markets, 2005 - page 107
- Table 13: Breakdown of statin prescribing by daily dose in the seven major markets, 2005 - page 109
- Table 14: Availability of generic statins in the seven major markets, 2005 - page 111
- Table 15: Proportion of overall drug-treated dyslipidemia patients prescribed each antidyslipidemic drug class as first-line therapy in the seven major markets, 2005 - page 123
- Table 16: Proportion of overall drug-treated dyslipidemia patients prescribed each antidyslipidemic drug class as second-line therapy in the seven major markets, 2005 - page 125
- Table 17: Average number of changes a patient undergoes over one year, 2005 - page 129
- Table 18: Change in combination therapy over the next three years in the seven major markets, 2005 - page 136
- Table 19: Breakdown of combination therapy by dyslipidemia sub-population in the seven major markets, 2005 - page 137
- 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 - page 143
- Table 21: Proportion of drug-treated dyslipidemia patients in each sub-population failing to reach target cholesterol goals in the seven major markets, 2005 - page 146
- Table 22: Average rating of factors influencing the prescribing of antidyslipidemic therapy in the seven major markets, 2005 - page 149
- Table 23: Mean ranking of preferred statin to use with ezetimibe, 2005 - page 155
- Table 24: Physician opinions of Vytorin, 2005 - page 158
- Table 25: Price comparison of Vytorin, 2005 - page 159
- Table 26: US physicians' opinion of Crestor, 2005 - page 160
- Table 27: US physician sample breakdown, 2005 - page 170
- Table 28: Japan physician sample breakdown, 2005 - page 171
- Table 29: France physician sample breakdown, 2005 - page 171
- Table 30: Germany physician sample breakdown, 2005 - page 172
- Table 31: Italy physician sample breakdown, 2005 - page 172
- Table 32: Spain physician sample breakdown, 2005 - page 173
- Table 33: UK physician sample breakdown, 2005 - page 173
- List of Figures
- Figure 1: Diagrammatic overview of the coverage of the dyslipidemia Stakeholder Insight survey, 2005 - page 20
- 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 - page 24
- Figure 3: Breakdown of drug therapy in the diagnosed dyslipidemia sub-populations in the US, 2005 - page 25
- 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 - page 26
- 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 - page 27
- 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 - page 28
- Figure 7: Breakdown of combination therapy by dyslipidemia sub-population in the US for the overall diagnosed and drug treated dyslipidemia population, 2005 - page 29
- Figure 8: Breakdown of treatment outcomes by dyslipidemia sub-population in the US, 2005 - page 30
- 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 - page 31
- Figure 10: Breakdown of drug therapy in the diagnosed dyslipidemia sub-populations in Japan, 2005 - page 32
- 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 - page 33
- 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 - page 34
- 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 - page 35
- Figure 14: Breakdown of combination therapy by dyslipidemia sub-population in Japan, 2005 - page 36
- Figure 15: Breakdown of treatment outcomes by dyslipidemia sub-population in Japan, 2005 - page 37
- 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 - page 38
- Figure 17: Breakdown of drug therapy in the diagnosed dyslipidemia sub-populations in France, 2005 - page 39
- 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 - page 40
- 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 - page 41
- 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 - page 42
- Figure 21: Breakdown of combination therapy by dyslipidemia sub-population in France, 2005 - page 43
- Figure 22: Breakdown of treatment outcomes by dyslipidemia sub-population in France, 2005 - page 44
- 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 - page 45
- Figure 24: Breakdown of drug therapy in the diagnosed dyslipidemia sub-populations in Germany, 2003 - page 46
- 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 - page 47
- 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 - page 48
- 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 - page 49
- Figure 28: Breakdown of combination therapy by dyslipidemia sub-population in Germany, 2005 - page 50
- Figure 29: Breakdown of treatment outcomes by dyslipidemia sub-population in Germany, 2005 - page 51
- 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 - page 52
- Figure 31: Breakdown of drug therapy in the diagnosed dyslipidemia sub-populations in Italy, 2005 - page 53
- 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 - page 54
- 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 - page 55
- 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 - page 56
- Figure 35: Breakdown of combination therapy by dyslipidemia sub-population in Italy, 2005 - page 57
- Figure 36: Breakdown of treatment outcomes by dyslipidemia sub-population in Italy, 2005 - page 58
- 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 - page 59
- Figure 38: Breakdown of drug therapy in the diagnosed dyslipidemia sub-populations in Spain, 2005 - page 60
- 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 - page 61
- 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 - page 62
- 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 - page 63
- Figure 42: Breakdown of combination therapy by dyslipidemia sub-population in Spain, 2005 - page 64
- Figure 43: Breakdown of treatment outcomes by dyslipidemia sub-population in Spain, 2005 - page 65
- 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 - page 66
- Figure 45: Breakdown of drug therapy in the diagnosed dyslipidemia sub-populations in the UK, 2005 - page 67
- 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 - page 68
- 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 - page 69
- 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 - page 70
- Figure 49: Breakdown of combination therapy by dyslipidemia sub-population in the UK, 2005 - page 71
- Figure 50: Breakdown of treatment outcomes by dyslipidemia sub-population in the UK, 2005 - page 72
- Figure 51: Proportion of diagnosed dyslipidemia patients with each type of dyslipidemia in the seven major markets, 2005 - page 75
- Figure 52: Proportion of diagnosed hypercholesterolemia patients with familial hypercholesterolemia in the seven major markets, 2005 - page 78
- Figure 53: Proportion of diagnosed dyslipidemia patients with low HDL cholesterol in the seven major markets, 2005 - page 79
- Figure 54: Breakdown of the diagnosed dyslipidemia population by disease severity in the seven major markets, 2005 - page 81
- Figure 55: Estimated proportion of dyslipidemia patients in the general population diagnosed in the seven major markets, 2005 - page 88
- Figure 56: Overview of NCEP ATP III guidelines - page 93
- Figure 57: Breakdown of statin prescribing by type of statin in overall dyslipidemia patients in the seven major markets, 2005 - page 100
- Figure 58: Brand versus generic prescribing of statins, currently and in three years, 2005 - page 112
- Figure 59: Proportion of drug-treated dyslipidemia patients unable to tolerate statin therapy in the seven major markets, 2005 - page 114
- Figure 60: Proportion of drug-treated dyslipidemia patients refusing to take statin therapy in the seven major markets, 2005 - page 115
- Figure 61: Proportion of dyslipidemia patients on statin therapy that are refractory to statins in the seven major markets, 2005 - page 117
- Figure 62: Breakdown of fibrate prescribing by compound in overall dyslipidemia patients in the seven major markets, 2005 - page 118
- Figure 63: Proportion of overall drug-treated dyslipidemia patients progressing to second-line therapy, 2005 - page 124
- Figure 64: Comparison of antidyslipidemic drug classes at first- versus second-line in the combined seven markets, 2005 - page 126
- Figure 65: Proportion of overall drug-treated dyslipidemia patients on second-line therapy progressing to third-line therapy and beyond, 2005 - page 127
- Figure 66: Proportion of overall drug-treated dyslipidemia patients having their therapy changed over a one-year period, 2005 - page 128
- Figure 67: Reasons for change in antidyslipidemic therapy in the seven major markets, 2005 - page 129
- Figure 68: Type of changes in antidyslipidemic therapy in the seven major markets, 2005 - page 131
- Figure 69: Proportion of overall drug-treated dyslipidemia patients receiving combination therapy in the seven major markets, 2005 - page 132
- Figure 70: Proportion of hypercholesterolemia drug-treated dyslipidemia patients receiving combination therapy in the seven major markets, 2005 - page 133
- Figure 71: Proportion of drug-treated mixed dyslipidemia patients receiving combination therapy in the seven major markets, 2005 - page 134
- Figure 72: Proportion of drug-treated diabetic dyslipidemia patients receiving combination therapy in the seven major markets, 2005 - page 135
- Figure 73: Proportion of drug-treated dyslipidemia patients in each sub-population receiving a statin + ezetimibe combination in the seven major markets, 2005 - page 138
- Figure 74: Proportion of drug-treated dyslipidemia patients in each sub-population receiving a statin + fibrate combination in the seven major markets, 2003 - page 140
- Figure 75: Unmet needs in the dyslipidemia market, 2005 - page 150
- Figure 76: Physician awareness of ezetimibe, 2005 - page 153
- Figure 77: Proportion of patients expected to be prescribed ezetimibe, 2005 - page 154
- Figure 78: Proportion of physicians aware of Vytorin, 2005 - page 156
- Figure 79: Proportion of patients estimated to receive Vytorin, 2005 - page 157
- Figure 80: Physician awareness of atorvastatin + torcetrapib, 2005 - page 162
- Figure 81: Proportion of patients expected to receive atorvastatin + torcetrapib when launched, 2005 - page 163
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