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BERLIN--(BUSINESS WIRE)--Nov. 20, 2003

Cumulative Olanzapine Benefits vs. Other Atypicals May Lead to

Better Patient Outcomes Over Time

Twelve-month results from the world's largest real-world schizophrenia study show that people receiving atypical, or newer generation, antipsychotics benefited more than those receiving the older typicals across a range of efficacy and safety parameters. The data also indicated that patients treated with olanzapine (Zyprexa(R)) experienced a range of modest but identifiable advantages when compared to those treated with other leading antipsychotics. The 12-month results of the ongoing Schizophrenia Outpatient Health Outcomes (SOHO) study were presented during the annual meeting of the German Association of Psychiatrists, Psychotherapists and Neurologists (DGPPN).

"First-year results of this study clearly indicate that atypicals provide advantages across a range of efficacy and safety parameters, including the management of positive, negative, depressive and cognitive symptoms, when compared to typicals," said Dieter Naber, MD, Professor and Chairman, Department of Psychiatry, University of Hamburg.

"Among the first-line atypicals, patients remained longer on olanzapine than on other drug therapies during the first year of the SOHO study. In clinical practice, we see that a therapy's enduring efficacy helps patients and physicians work together toward realizing a patients individual potential", said Professor Dr. Naber.

As a study of schizophrenia treatments, SOHO is unprecedented in size and scope, evaluating a total of more than 17,750 patients in two studies in 37 countries. Ten countries in Western Europe and 27 countries throughout Asia, Central and Eastern Europe, Latin America and the Middle East are involved in the study. The observational trial is collecting data in the real-world setting of physicians' offices over three years. By evaluating patients who seek treatment in typical outpatient settings, SOHO differs from traditional clinical trials, which often have rigid exclusion criteria that limit the kinds of patients who participate. The SOHO study complements this traditional approach by providing data on people's daily experiences with antipsychotics.

SOHO: 12-Month Findings

Atypicals vs. Typicals

-- Patients taking atypicals had superior outcomes to those

taking typicals in the management of positive (delusions and

hallucinations), negative (diminished emotion, lack of

interest), depressive, cognitive and overall symptoms.

-- Patients taking atypicals had a lower incidence of

extrapyramidal symptoms (EPS) of shaking, spasms, or

restlessness, when compared with patients on typicals.

-- Patients taking atypicals required anticholinergic drugs less

often to control tremors than those treated with typicals.

Olanzapine vs. Other Treatments

-- Patients treated with olanzapine showed clinical improvement

in positive, negative, depressive, cognitive and overall

symptoms compared to patients on risperidone (Risperdal(R)),

quetiapine (Seroquel(R)), oral typical and depot typical

antipsychotics. No significant differences were found between

olanzapine and clozapine (Clozaril(R)), which is typically

used as a second-line antipsychotic.

-- Olanzapine-treated patients were more likely to continue

therapy throughout the first year of the study without

changing medications when compared to those taking other

first-line atypical antipsychotics.

-- Olanzapine-treated patients had the lowest overall rate of EPS

compared with patients on all other studied drugs.

-- Fewer patients treated with olanzapine required the use of an

anticholinergic drug.

-- Weight gain was highest in patients treated with olanzapine

and clozapine as compared with other drugs.

SOHO Study Design

The study is collecting long-term data on several antipsychotic treatments, including typicals, depot formulations and atypicals such as olanzapine, clozapine, quetiapine, risperidone and amisulpride (Solian(R)). The study is sponsored by Eli Lilly and Company.

The SOHO study will look at more than 30 areas over the course of three years to assess how treatment patterns affect patients' living conditions, clinical status, health-related quality of life, and ability to work and socialize. It will also assess treatment tolerability, compliance, victimization, violence and resource use.

Patients undergoing treatment in the outpatient setting for schizophrenia were enrolled if, at the direction of the treating psychiatrist, they started or changed antipsychotic medication. Three treatment groups were established post hoc: olanzapine, risperidone and 'other antipsychotics' (non-olanzapine including risperidone) treatment. Measures of treatment effectiveness (overall, positive, negative, cognitive and depressive domains), safety (incidence of EPS or tardive dyskinesia), side effects (sexual dysfunction and weight gain) and functional status (social and work functioning) were taken at the start of the study (baseline) and at three, six and 12-months.

About Schizophrenia

Schizophrenia is a severe and debilitating psychosis often characterized by acute episodes of delusions (false beliefs that cannot be corrected by reason), hallucinations (usually in the form of non-existent voices) and long-term impairments such as diminished emotion, lack of interest and depressive signs and symptoms. It is usually associated with a disruption in social and family relationships.

Schizophrenia is the most common severe mental illness. There are as many as 50 million people with schizophrenia worldwide, more than 33 million of them in developing countries. Symptoms of schizophrenia usually begin to appear in the teenage years or early to mid-twenties.

Olanzapine Background

Olanzapine is currently indicated in the European Union (EU), the United States, Australia, and Canada for the acute and long-term treatment of schizophrenia, and the short-term treatment of acute manic episodes associated with bipolar disorder. In addition, olanzapine is indicated in the EU and Australia for the prevention of recurrence in patients with bipolar disorder whose manic episode has responded to olanzapine treatment, making it the first atypical antipsychotic to be approved as a mood stabilizing medication. Olanzapine was also the first atypical antipsychotic to prove its long-term effectiveness in patients with schizophrenia. Since olanzapine was introduced in 1996, it has been prescribed to more than 12.5 million people worldwide.

In clinical trials, olanzapine was generally well tolerated. However, as with all medications, olanzapine is associated with some side effects, the most common being somnolence and weight gain. Other common treatment-emergent adverse events may include dry mouth, dizziness, asthenia (muscle weakness), akathisia (restlessness), constipation, increased appetite, modest elevations of prolactin, postural hypotension, parkinsonism, oedema, asymptomatic elevations of hepatic transaminase, and tremor. Hyperglyceamia and/or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported very rarely (less than 0.01%). As with other atypicals, appropriate clinical monitoring is advisable particularly in diabetic patients and in patients with risk factors for the development of diabetes mellitus.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers--through medicines and information--for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

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