Clinical Usefulness of Olanzapine in Bipolar Disorder—A Developer’s Insight

Clinical Usefulness of Olanzapine in Bipolar Disorder—A Developer’s Insight

Tohen Mauricio, Treuer Tamas

US Psychiatry 2009;2(1):32-6

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Abstract
This article provides a unique insight into the research program for the development of olanzapine in the treatment of bipolar disorder from the developer’s perspective. Olanzapine was the first atypical antipsychotic to obtain regulatory approval in the US and the EU for the treatment of acute bipolar mania and bipolar maintenance/relapse prevention. It also obtained regulatory approval for bipolar depression in combination with fluoxetine in the US by the US Food and Drug Administration (FDA). Olanzapine has the largest amount of clinical trial data available compared with any other agent used for the treatment of any phase of bipolar disorder, with perhaps the exception of lithium, which has been in use for over 50 years. The research program and the double-blind, randomized, controlled trials that have evaluated the efficacy of olanzapine monotherapy and combination therapy in the treatment of bipolar I disorder and the data from observational studies are briefly reviewed here. This is the richest and most thorough clinical plan in bipolar disorder undertaken by the pharmaceutical industry or academia. This development plan introduced a new paradigm to the treatment of bipolar disorder, and the role of atypical antipsychotics is still evolving as recently updated treatment guidelines reflect an expanded importance of these drugs among treatment options in bipolar disorder.

Keywords
Olanzapine, bipolar disorder, drug development, clinical trials, treatment

Disclosure: Mauricio Tohen, MD, DrPH, MBA, is a former Eli Lilly employee. He has consulted or received honoraria from AstraZeneca, BMS, GlaxoSmithKline, Eli Lilly, Johnson & Johnson, and Wyeth. His spouse is a current employee and stockholder at Eli Lilly. Tamas Treuer, MD, PhD, is an employee of Eli Lilly and Company, the manufacturer of olanzapine. Acknowledgement: The authors thank Jolanta Salburg and Thomas T Wagner for their technical and editorial assistance.
Received: April 12, 2008 Accepted: August 3, 2008
Correspondence: Mauricio Tohen, MD, DrPH, MBA, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229. E: tohen@uthscsa.edu

Bipolar I disorder (BPD) is a serious mental illness with a lifetime prevalence of approximately 1–3%.1–3 The treatment of bipolar disorder is often complicated by co-occurring substance use disorders (SUDs). In fact, BPD has the highest prevalence of co-occurring SUDs among all psychiatric conditions except antisocial personality disorder.4 In this article we examine the epidemiology, outcome, etiology, and treatment of patients with BPD and co-occurring SUDs. This review extends two previous reviews of this topic by the authors.5,6

Epidemiology
Evidence for the general prevalence of BPD and co-occurring SUDs comes from several large population-based studies (see Table 1). The National Epidemiologic Survey on Alcohol and Related Conditions (NESARC)2 examined the prevalence and co-occurrence of the Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV) substance disorders in a representative sample of 43,093 respondents in the US. Subjects with BPD had a 58% lifetime prevalence of co-occurring alcohol use disorders and a 38% lifetime prevalence of any drug use disorder. The National Institutes of Mental Health Epidemiologic Catchment Area Program4 examined the prevalence and co-occurrence of DSM IV substance and mood disorders in a representative sample of 20,291 persons from community and institutional settings. Subjects with BPD had a 61% lifetime prevalence of any drug or alcohol use disorder.4

Epidemiological data on the co-occurrence of SUDs also come from studies examining the clinical characteristics of large populations of subjects with BPD (see Table 1). Cassidy et al.7 surveyed 392 patients with BPD and found a lifetime prevalence of 48.5% for alcohol abuse, 36% for cannabis abuse, 24.2% for cocaine abuse, and 4.6% for opioid abuse. The point prevalence for each SUD was 28.5% for alcohol abuse, 22.2% for cannabis abuse, 10.2% for cocaine abuse, and 1.0% for opioid abuse. McElroy et al.8 evaluated 239 BPD outpatients and found a lifetime prevalence of 36% for alcohol use disorders, 40% for cannabis use disorders, 10% for cocaine use disorders, and 8% for opioid use disorders.

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