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Stakeholder Insight: Bipolar Disorders - Zyprexa Sets the Mood for Revenue Growth
Datamonitor, Feb 2004, Pages: 250
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
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