Contents:

CHAPTER 1 - EXECUTIVE SUMMARY 3. Scope of the analysis 3 Insight into the stroke market 4 Stroke is the third leading cause of death in the US and the second leading cause of death in Europe. Incidence of stroke is predicted to increase to 1.5 million by 2012 within the seven major markets. According to the American Stroke Association, the estimated direct and indirect cost of stroke in the US in 2004 will be $53.6 billion. 4 Increasing awareness of the symptoms and urgency of stroke is essential for patient outcomes to improve. Our research reveals that one of the biggest delays in patients receiving treatment is late presentation to hospital, as patients often perceive symptoms as not serious or do not recognize they are having a stroke. To improve patient outcomes radically for ischemic stroke patients, “time to treatment” needs to be improved so that more eligible patients can receive tPA therapy. 5 Ideally patients should be taken straight to stroke unit/centers by Medical Emergency Services. This would greatly improve treatment times as facilities such as diagnostic machinery are located conveniently and specialists are at hand to differentiate between stroke types and initiate treatment. However, we also found that resources available to stroke units vary across countries and this can greatly influence the care that patients receive. Stroke units/centers need to have a standard definition across countries. 6 Our research shows that no one pharmacological treatment protocol produces better outcomes than another. However, even with the lack of pharmacological therapies, death rates and recurrence figures are better in Japan, so maybe countries should look to Japan for best practice strategies. 7 Recommendations 8 CHAPTER 2 - INTRODUCTION AND SCOPE 16. 2.1 Coverage of the Stakeholder Insight Survey 16 2.1.1 Country level ‘treatment trees’ 19 2.1.2 Supporting data sets 19 CHAPTER 3 - COUNTRY TREATMENT TREES 20. Introduction to the treatment trees 20 US 21 Japan 23 France 25 Germany 27 Italy 29 Spain 31 UK 33 CHAPTER 4 - EPIDEMIOLOGY AND PATIENT SEGMENTATION 35. 4.1 Disease definition and classification 35 Symptoms 35 Ischemic stroke 36 Hemorrhagic stroke 37 Transient ischemic attack 39 4.2 Epidemiology of stroke 40 4.3 Key patient segmentations 41 Patient gender 41 Patient age 44 4.4 Comorbidities, complications and risk factors 46 CHAPTER 5 - DIAGNOSIS AND TREATMENT OPTIONS 48. 5.1 Presentation and diagnosis 48 Time to presentation 48 Diagnosis 49 Healthcare professionals involved in the diagnosis of stroke 49 Tests in emergency diagnosis of stroke 50 Secondary tests performed after initial diagnosis 52 5.3 Influences on diagnosis and treatment rates 55 The Stroke Association 55 The National Stroke Association 55 STOP Stroke Act 56 5.5 Treatment guidelines 56 5.6 Treatment pathways 62 CHAPTER 6 - PRESCRIBING TRENDS AND INFLUENCING FACTORS 64. 6.1 Prescribing trends 64 Ischemic stroke treatment 64 Time to treatment 64 Drug therapy 65 Hemorrhagic stroke treatment 75 CHAPTER 7 - IMPROVING TREATMENT OUTCOMES 80. 7.1 Treatment outcomes 80 Length of stay 81 Mortality 82 Recovery 83 7.2 Unmet needs 88 Patient awareness 88 Rapid diagnosis 89 Adequately equipped stroke units 89 Physician education 90 Safe acute treatment options with greater therapeutic window 90 7.3 New product development 92 Ancrod 92 Desmoteplase 93 Novoseven 93 APPENDIX A BIBLIOGRAPHY 95 Epidemiology methodology 95 Epidemiology 95 Clinical trial data 96 Bibliography 97 General and clinical trial data 97 Key associations and conferences 97 APPENDIX B 99 Physician research methodology 99 Physician sample breakdown 99 US 99 Japan 100 France 100 Germany 101 Italy 101 Spain 102 UK 102 APPENDIX C 103 The survey questionnaire 103 1. Epidemiology and patient segmentation 103 2. Diagnosis of stroke 107 3. Treatment of acute stroke 112 Treatment of Ischemic stroke 117 4. Surgical procedures 126 5. Patient outcomes 128 Key Opinion Leader discussion guide 131 Epidemiology and patient segmentation 131 Diagnosis and treatment options 133 Prescribing trends and influencing factors 138 Improving treatment outcomes 147 Unmet needs 151 New product awareness 152 Regulatory issues 153 Disclaimer 154