Atrial Fibrillation - Limited efficacy and poor safety lead to bleak outlook
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 AF market - page 5
- The rapid increase in AF prevalence is driven by a number of factors, namely ageing population, the obesity epidemic, better prevention of strokes, and better survival of patients with cardiac disease. - page 6
- A change in the definition of AF used by epidemiologists - page 6
- The growing proportion of ageing population - page 7
- The current "obesity epidemic" - page 7
- Better prevention and treatment options for patients with heart disease - page 7
- Stroke prevention and treatment strategies - page 8
- Advanced technologies driving diagnosis rates - page 8
- There are numerous unmet needs associated with every treatment option available. The main unmet needs of pharmacological therapy are insufficient efficacy and poor safety. Non-pharmacological therapy has severe limitations, among them the cost of the procedures and the fact that a limited number of patients is eligible for it. - page 9
- Despite the desperate need for a new efficacious and safe antiarrhythmic, no new drug that would significantly impact the AF management is going to appear in the nearest future. - page 11
- The unresolved unmet needs put significant pressure on the more widespread use of non-pharmacological treatment options. The usage of electrical cardioversion is steadily growing, despite the guidelines, and due to several advantages of direct current cardioversion over pharmacological cardioversion. Also, pulmonary vein isolation as the only viable curative option, while not very widespread now, is becoming an attractive option for certain patient types, and may gain use, despite being still in development. - page 13
- The rapid increase in AF prevalence is driven by a number of factors, namely ageing population, the obesity epidemic, better prevention of strokes, and better survival of patients with cardiac disease. - page 6
- Key metrics - page 15
- CHAPTER 2 INTRODUCTION AND SCOPE - page 18
- Coverage of the Atrial Fibrillation Stakeholder Insight Survey - page 18
- CHAPTER 3 COUNTRY TREATMENT TREES - page 21
- Introduction to the treatment trees - page 21
- CHAPTER 4 EPIDEMIOLOGY & PATIENT SEGMENTATION - page 44
- Definition of the disease - page 44
- Classification of AF - page 46
- Epidemiology of disease - page 51
- Methodology - page 55
- US - page 55
- Japan - page 56
- Europe: UK - page 56
- Europe: France, Germany, Italy and Spain - page 56
- Methodology - page 55
- Lone atrial fibrillation - page 57
- Co-morbidities, complications and risk factors - page 58
- Hypertension and AF - page 59
- Heart failure and atrial fibrillation - page 60
- Complications - page 62
- Stroke - page 62
- CHAPTER 5 DIAGNOSIS & TREATMENT OPTIONS - page 64
- Diagnosis - page 64
- Untreated AF patients - page 67
- Treatment options - page 69
- Antiarrhythmic drugs - page 70
- Class I agents - page 73
- Class Ia - page 73
- Class Ic - page 74
- Class II agents - Beta blockers - page 76
- Class III agents - page 76
- Sotalol - page 76
- Amiodarone - page 78
- Dofetilide - page 81
- Diltiazem - page 82
- Verapamil - page 83
- Digoxin - page 84
- Class I agents - page 73
- CHAPTER 6 PRESCRIBING TRENDS AND INFLUENCING FACTORS - page 86
- Introduction to treatment guidelines - page 86
- Cardioversion - page 87
- Pharmacological cardioversion - page 87
- Electrical cardioversion - page 89
- Cardioversion: success rates - page 94
- Antiarrhythmic drug therapy strategies - page 96
- The rate versus rhythm debate - page 96
- Drug therapy for sinus rhythm control - page 106
- Outcome of antiarrhythmic drug therapy for rhythm control - page 109
- Drug therapy for rate control - page 112
- Outcome of rate control drugs - page 114
- Cardiac rhythm management (CRM) devices - page 117
- Pacemakers - page 120
- Overdrive atrial pacing - page 121
- Implantable cardioverter-defibrillators (ICDs) - page 122
- Shock intolerance issue with ICDs - page 123
- Pharmacoeconomics - page 124
- Adjunctive drug therapies used with devices - page 125
- Pacemakers - page 120
- Catheter ablation - page 130
- Atrioventricular node or junction ablation - page 134
- Pulmonary vein isolation/ablation - page 134
- Success rates of catheter ablation - page 137
- Success rates: catheter ablation versus drug therapy - page 140
- Surgical procedures - page 144
- Overview of AF treatment for all AF types - page 146
- Recent onset AF - page 147
- Paroxysmal AF - page 148
- Persistent and permanent AF - page 149
- Treatment guidelines for special cases - page 151
- Heart failure - page 151
- Coronary artery disease - page 151
- Hypertensive heart disease - page 152
- Post-operative therapy - page 153
- Prevention options - page 153
- Postoperative treatment options - page 153
- CHAPTER 7 IMPROVING TREATMENT OUTCOMES - page 155
- Treatment outcomes - page 156
- Rhythm versus rate control - page 159
- Cardioversion - page 160
- Ablation - page 160
- Cardiac rhythm devices - page 161
- Unmet needs in AF - page 162
- Efficacy - page 164
- Quality of life - page 164
- Treatment Options for AF patients with underlying heart disease - page 166
- Decreased mortality - page 167
- Safety - page 168
- New product development - Antiarrhythmics - page 169
- Dronedarone (Multaq) - page 170
- Azimilide - page 172
- RSD1235 (intravenous formulation) - page 174
- Pulzium (tedisamil) (intravenous formulation) - page 176
- Future focus - page 178
- Treatment outcomes - page 156
- APPENDIX A - page 180
- Bibliography - page 180
- Epidemiology - page 180
- General and clinical trial data - page 182
- Bibliography - page 180
- APPENDIX B - page 201
- QUESTIONNAIRE - page 201
- 1. Presentation And Diagnosis Rates - page 201
- 2. Cardioversion - page 206
- 3. Management Of Atrial Fibrillation - page 208
- 4 Antiarrhythmic Drug Therapy - page 210
- 5 Antiarrhythmic Drug Therapy For Sinus Rhythm Maintenance - page 213
- 6 Antiarrhythmic Drug Therapy For Ventricular Rate Control - page 216
- 7 Implantable Cardiac Rhythm Devices - page 220
- 8 Catheter Ablation Procedures - page 222
- 9 Unmet Needs in the Treatment of Atrial Fibrillation - page 224
- PHYSICIAN SAMPLE BREAKDOWN - page 226
- US - page 226
- Japan - page 226
- France - page 227
- Germany - page 227
- Spain - page 228
- Italy - page 228
- UK - page 229
- Disclaimer - page 230
- QUESTIONNAIRE - page 201
- List of Tables
- Table1: Prevalenceestimatesforatrialfibrillation,2006-2014 - page 15
- Table 2: Prevalence estimates for Atrial Fibrillation, 2006-2015, 000s - page 53
- Table 3: Proportion of AF patients with common co-morbidities and risk factors (%) - page 58
- Table 4: Percentage prevalence of co-morbidity in elderly AF patients - page 59
- Table 5: Major side effects of antiarrhythmic drugs - page 72
- Table 6: SAFE-T: median time to AF recurrence in days - page 80
- Table 7: Percentage of AF patients receiving the following antiarrhythmic classes or drugs for rhythm control - page 107
- Table 8: Factors effecting choice of first-line therapy for rhythm control (rated on the scale from 1 to 10, where 10 means most influential factor) - page 109
- Table 9: Percentage of AF patients receiving the following antiarrhythmic drugs for rate control - page 113
- Table 10: Factors effecting choice of first-line therapy for rate control - page 114
- Table 11: Average direct costs of care for pacemaker and ICD implantation in Canada, 1997-98 - page 125
- Table 12: The mean success rates for each type of catheter ablation (%) - page 137
- Table 13: A4: Primary and Secondary Endpoints at 12 Months - page 142
- Table 14: Treatment outcomes - page 156
- Table 15: US physician sample breakdown, 2006 - page 226
- Table 16: Japan physician sample breakdown, 2006 - page 226
- Table 17: France physician sample breakdown, 2006 - page 227
- Table 18: Germany physician sample breakdown, 2006 - page 227
- Table 19: Spain physician sample breakdown, 2006 - page 228
- Table 20: Italy physician sample breakdown, 2006 - page 228
- Table 21: UK physician sample breakdown, 2006 - page 229
- List of Figures
- Figure 1: Total AF population treated with antiarrhythmic drugs - page 16
- Figure 2: Diagrammatic overview of the coverage of the AF Stakeholder Insight Survey, 2006 - page 20
- Figure 3: A breakdown of AF population in the US by type, and method of diagnosis, 2006 - page 23
- Figure 4: A breakdown of AF population in the US by treatment and success rates, 2006 - page 24
- Figure 5: A breakdown of AF population in the US by treatment and strategy, 2006 - page 25
- Figure 6: A breakdown of AF population in Japan by type, and method of diagnosis, 2006 - page 26
- Figure 7: A breakdown of AF population in Japan by treatment and success rates, 2006 - page 27
- Figure 8: A breakdown of AF population in Japan by treatment and strategy, 2006 - page 28
- Figure 9: A breakdown of AF population France by type, and method of diagnosis, 2006 - page 29
- Figure 10: A breakdown of AF population in France by treatment and success rates, 2006 - page 30
- Figure 11: A breakdown of AF population in France by treatment and strategy, 2006 - page 31
- Figure 12: A breakdown of AF population in Germany by type, and method of diagnosis, 2006 - page 32
- Figure 13: A breakdown of AF population in Germany by treatment and success rates, 2006 - page 33
- Figure 14: A breakdown of AF population in Germany by treatment and strategy, 2006 - page 34
- Figure 15: A breakdown of AF population in Italy by type, and method of diagnosis, 2006 - page 35
- Figure 16: A breakdown of AF population in Italy by treatment and success rates, 2006 - page 36
- Figure 17: A breakdown of AF population in Italy by treatment and strategy, 2006 - page 37
- Figure 18: A breakdown of AF population in Spain by type, and method of diagnosis, 2006 - page 38
- Figure 19: A breakdown of AF population in Spain by treatment and success rates, 2006 - page 39
- Figure 20: A breakdown of AF population in Spain by treatment and strategy, 2006 - page 40
- Figure 21: A breakdown of AF population in the UK by type, and method of diagnosis, 2006 - page 41
- Figure 22: A breakdown of AF population in the UK by treatment and success rates, 2006 - page 42
- Figure 23: A breakdown of AF population in the UK by treatment and strategy, 2006 - page 43
- Figure 24: The structure of the human heart - page 45
- Figure 25: ECGs of normal heart rhythm and atrial fibrillation - page 46
- Figure 26: Classification of AF - page 49
- Figure 27: Prevalence of the different types of AF across the AF population - page 50
- Figure 28: Percentage of AF population with lone AF - page 57
- Figure 29: Percentage of severe HF patients within total AF population - page 61
- Figure 30: Percentage of AF patients diagnosed with each diagnostic method - page 65
- Figure 31: Percentage of AF population that remain untreated for AF - page 67
- Figure 32: Overview of treatment guidelines - page 69
- Figure 33: Antiarrhythmic drug classes and contraindications - page 70
- Figure 34: Guideline recommendations for drugs for pharmacological cardioversion - page 88
- Figure 35: Treatment guidelines for cardioversion in AF patients - page 91
- Figure 36: Percentage of AF patients undergoing each type of cardioversion - page 92
- Figure 37: Percentage of AF patients undergoing the following number of cardioversions during their arrhythmia lifetime - page 94
- Figure 38: Percentage of cardioversion patients maintaining sinus rhythm at one year - page 95
- Figure 39: Percentage of recent onset AF population treated with either rhythm or rate control therapy - page 99
- Figure 40: Percentage of paroxysmal AF population treated with either rhythm or rate control therapy - page 100
- Figure 41: Percentage of persistent AF population treated with either rhythm or rate control therapy - page 101
- Figure 42: Percentage of permanent AF population treated with either rhythm or rate control therapy - page 102
- Figure 43: Percentage of AF patients with each type of AF that receive rate control therapy - page 104
- Figure 44: Average ratings of each AF patient population benefiting from sinus rhythm maintenance (ranked from 1 to 13, where 1 means "great benefit") - page 105
- Figure 45: Average ratings of each AF patient population benefiting from ventricular rate control (ranked from 1 to 14, where 1 means "great benefit") - page 106
- Figure 46: Percentage of rhythm control patients not treated successfully at first line - page 110
- Figure 47: Percentage of AF patients treated for sinus rhythm maintenance that change therapy for the following reasons - page 111
- Figure 48: Percentage of rhythm patients that switch to rate control therapy - page 112
- Figure 49: Percentage of rate control patients not treated successfully at first line - page 115
- Figure 50: Percentage of AF patients treated for ventricular rate control that change therapy for the following reasons - page 116
- Figure 51: Percentage of all patients not treated successfully at first-line - page 117
- Figure 52: Percentage of AF population receiving CRM devices - page 118
- Figure 53: Percentage of AF population receiving each type of device - page 119
- Figure 54: Standard therapies given with Dual Chamber Pacemakers without AF Suppression Algorithms - page 126
- Figure 55: Standard therapies given with Dual Chamber Pacemakers with AF Suppression Algorithms - page 127
- Figure 56: Standard therapies given with Dual Chamber Implantable Cardioverter Defibrillator - page 128
- Figure 57: Standard therapies given with Single Chamber (Ventricular) Pacemakers - page 129
- Figure 58: Percentage of AF patients that have undergone catheter ablation - page 130
- Figure 59: Percentage of patients undergoing each type of catheter ablation - page 133
- Figure 60: Percentage of AF patients undergoing catheter and surgical ablation - page 144
- Figure 61: Percentage of AF patients receiving the following therapies - page 146
- Figure 62: Overview of treatment guidelines for recent onset AF - page 148
- Figure 63: Overview of treatment guidelines for paroxysmal AF - page 149
- Figure 64: Overview of treatment guidelines for persistent and permanent AF - page 150
- Figure 65: Treatment guidelines for patients with heart disease - page 151
- Figure 66: Unmet needs of AF (ranked from 1 to 15, where 1 means "most important") - page 162
- Figure 67: The most important unmet needs in AF - page 163
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