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Stakeholder Insight: Bipolar Disorders - Zyprexa Sets the Mood for Revenue GrowthPublished by: Datamonitor Published: Feb. 11, 2004 - 250 Pages Table of ContentsTABLE OF CONTENTS CHAPTER 1 EXECUTIVE SUMMARY 3 Scope of the analysis 3 Datamonitor insight into the bipolar market 4 Only 48% of the BD population are accurately diagnosed. As such, Datamonitor has highlighted a number of serious diagnostic issues, which infers that many of the patients currently diagnosed may receive incorrect BD categorization. Consequently, Datamonitor has identified a number of key areas, which, if exploited, have the propensity for increasing diagnosis and prescription rates 5 As the licensed bipolar market becomes increasingly crowded, efficacy in managing both bipolar symptoms and comorbidities will become a differentiating factor. With the high prevalence of migraine and anxiety, companies will have the opportunity to capitalize on the use of anticonvulsants and SSRIs, in the face of increasing antipsychotic usage 7 The BDII-migraine niche 7 Comorbid anxiety 7 Lilly’s Zyprexa (olanzapine) is currently leading the bipolar market in terms of revenue and lifecycle management. With recent EMEA and FDA approval for maintenance therapy and reformulation in a combination pill with Prozac as Symbyax. As such, Lilly appears to be making all the right moves for bipolar market dominance 8 Key metrics 9 CHAPTER 2 INTRODUCTION AND SCOPE 21 Coverage of the Stakeholder Insight survey - bipolar disorders 21 Epidemiology of bipolar disorders 21 Screening and diagnosis 21 Treatment of bipolar disorders 21 Clinical trial design 22 Miscellaneous 22 CHAPTER 3 COUNTRY TREATMENT TREES 23 US 23 Japan 28 France 31 Germany 34 Italy 37 Spain 40 UK 43 CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION OF BIPOLAR DISORDER 47 Bipolar disorder: definitions and classification 48 Types of BD 48 Mood episodes associated with BD 48 Bipolar I disorder 50 Bipolar II disorder 50 Bipolar III disorder (cyclothymia) 50 Rapid cycling bipolar disorder 50 Etiology of bipolar disorders 51 Causes of bipolar disorders 51 Genetics and neurotransmitters 52 Environmental factors 52 Circadian rhythm disturbances 53 Hypothyroidism 53 Substance abuse 54 Epidemiology of bipolar disorder 54 Prevalence of BD 54 Datamonitor comment 55 Segmentation of BD 58 Prevalence of BD types 58 Datamonitor comment 60 Average age of onset of BD 60 Datamonitor comment 61 Gender differences in BD 62 Episodes of BD 64 Datamonitor comment 65 Prevalence of different mania types in BD 67 Prevalence of different depressive types in BD 70 Datamonitor comment 72 Comorbidities of BD 73 Anxiety 73 Migraine 74 Substance abuse 74 Suicide 76 Living with BD 77 Economic burden of BD 78 CHAPTER 5 DIAGNOSIS AND TREATMENT OPTIONS 81 Introduction 82 Diagnostic tools in clinical trials 82 DSM-IV 82 ICD-10 82 Core Diagnostic Module 84 Complications with diagnostic criteria 84 Mania and hypomania 84 Mixed episodes 84 BDII and major depressive disorder 85 Differential diagnosis: ADHD 86 Diagnosis rate of BD 87 Datamonitor comment 87 Diagnostic unmet needs 88 Improvement of diagnostic algorithms 88 Introduction of novel diagnostic strategies 89 Time to diagnosis 90 Education 92 Treatment guidelines 94 Primary aims for the treatment of mania 95 Acute treatment of manic or mixed episodes (Hirschfeld et al., 2002) 97 Primary aims for the treatment of depression 98 Acute treatment of depressive episodes (Hirschfeld et al., 2002) 98 Variations in treatment guidelines 99 Treatment of RCBD (Hirschfeld et al., 2002) 101 Maintenance therapy (Hirschfeld et al., 2002) 101 Treatment options 102 Mania episodes: mood stabilizer monotherapy 102 Mania episodes: antipsychotic monotherapy 102 Mania episodes: combination therapy 104 Depressive episodes: mood stabilizer monotherapy 104 Depressive episodes: antidepressant monotherapy 105 Depressive episodes: combination therapy 106 Drug overview 108 Mood stabilizers 108 Lithium 110 Anticonvulsants used (and referred to) as mood stabilizers 111 Divalproex 111 Carbamazepine 113 Lamotrigine 113 Topiramate 114 Gabapentin 115 Antidepressants 116 Fluoxetine 117 Sertraline 118 Citalopram 118 Escitalopram 119 Fluvoxamine 120 Paroxetine 120 Venlafaxine 121 Mirtazapine 122 Bupropion 122 MAOIs and TCAs 123 Antipsychotics 123 Olanzapine 125 Risperidone 127 Quetiapine 129 Aripiprazole 130 Ziprasidone 130 Typical antipsychotics 131 Other drug classes used 132 Benzodiazepines 132 Non-pharmacological treatment 132 Psychosocial therapy 132 Electroconvulsive therapy 135 CHAPTER 6 CLINICAL TRIAL DESIGN 137 Introduction 138 Clinical trial assessment tools 138 Young mania rating scale 138 Hamilton Rating Scale for Depression 139 PANSS 139 Clinical trial features 139 Levels of drug approval 139 Problems of BD clinical trial design 140 BD clinical trial design 141 Double-blind, placebo-controlled 142 Study length 144 Treatment of mania 147 Treatment of depressive episodes 147 Prevention of mania and depression 148 Randomization, number of subjects, diversity and drop-out rate 148 Comparator usage 150 Comparator drug: mania episodes 151 Comparator drug: depressive episodes 152 Clinical trial design 153 CHAPTER 7 PRESCRIBING TRENDS AND INFLUENCING FACTORS 154 Treatment of mania episodes 155 First-line treatment strategy for mania episodes 155 Second-line treatment strategy for mania episodes 158 Mania treatment: drugs of choice 160 Treatment of depressive episodes 162 First-line treatment of depressive episodes 162 Second-line treatment of depressive episodes 165 Depression: drugs of choice 168 Treatment of RCBD 169 First-line treatment of RCBD 169 Second-line treatment of RCBD 172 Treatment of psychotic depression 175 First-line treatment of psychotic depression 175 Second-line treatment of psychotic depression 179 Psychotic depression: drugs of choice 181 Treatment of mixed episodes 182 First-line treatment of mixed episodes 182 Second-line treatment of mixed episodes 186 Mixed episode: drugs of choice 188 Factors influencing prescribing trends 189 Type of episode of BD/recognized and approved treatment algorithms 189 Clinical trial data supporting specific pharmacological treatment, combinations, efficacy and side-effect profiles 190 Patient drug history 190 Patient’s influence on treatment type 190 Patient lethality 191 Brand versus generic 191 Approved versus off-label prescribing 191 CHAPTER 8 IMPROVING TREATMENT OUTCOMES 193 Unmet needs 194 Maintenance therapy 194 Compliance 196 Onset of action 197 Side effects 198 Product development 198 Antidepressants 199 Mood stabilizers and anticonvulsants 200 Carbatrol (SPD-417) 200 Antipsychotics 201 Zyprexa 202 Symbyax 203 Novel bipolar treatments 205 Riluzole 205 Mifepristone (C-1073) 206 Tamoxifen 206 Pramipexole 206 Omega-3 fatty acids 207 APPENDIX A 208 APPENDIX B 225 AbstractIntroductionThe bipolar disorder market is experiencing a renewed expansion in product life-cycle management. Presently, mood stabilizers are the basis of treatment, although the antipsychotics led by Zyprexa, are evolving as a new therapeutic strategy. Companies will have to differentiate their products in the increasingly crowded market if they wish to protect their market share. Scope Analysis is based on a survey of 164 treating physicians in the seven major markets as well as in-depth interviews with Bipolar key opinion leaders Detailed treatment trees showing the prevalence, diagnosis and treatment rates of bipolar across the seven major markets Assessment of the use of mono- and combination-therapy in specific bipolar affective episodes Identification of therapeutic and diagnostic unmet needs, highlights areas where stakeholder investment is vital to drive patient identification Report Highlights Datamonitor primary research has identified variances in class and brand prescribing preferences among physicians, according to BD type and geography; although prescribing trends generally follow recognized national and international guidelines. However, there is concern over the use of tricyclic antidepressants in bipolar depression. Only 48% of the BD population are accurately diagnosed. Datamonitor has highlighted a number of serious diagnostic issues, which infers that many of the patients currently diagnosed may receive incorrect BD categorization. Lilly’s Zyprexa is currently leading the bipolar market in terms of revenue and life cycle management, with recent approval for maintenance therapy and reformulation in a combination pill with Prozac as Symbyax. Other atypical antipsychotics appear to be following suit, and could threaten anticonvulsant dominance of mood stabilization. Reasons to Purchase Understand differential treatment unmet needs in key patient populations identified by sex, co-morbidities and bipolar disorder type Gain expert insight into current diagnostic unmet needs and key growth areas in the public and healthcare sectors Target physicians more effectively, through an understanding of prescribing behavior Get Full Details About This Report >> |
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