Zyprexa Demonstrates Superior Long-Term Efficacy In Treating Schizophrenia, New Data Show.

Business Editors/Health/Medical Writers

COLORADO SPRINGS, Colo.--(BUSINESS WIRE)--April 1, 2003

Head-to-Head Zyprexa(R) vs. Geodon(R) Study Provides Additional

Evidence That All Antipsychotics Are Not the Same

In a head-to-head study comparing two atypical antipsychotic treatments for schizophrenia, Zyprexa(R) (olanzapine, Lilly) was shown to have greater efficacy than Geodon(R) (ziprasidone, Pfizer). The results of the 28-week, double-blind, flexible-dose study were presented this week at a major international psychiatric congress(a).

"Prevailing sentiment which suggests that all antipsychotics have similar efficacy can be misleading, so it is important to perform these types of studies to help us understand more about the differences in efficacy of various medications," said Stephen M. Stahl, M.D., Chairman of the Neuroscience Education Institute and professor of psychiatry, University of California at San Diego (UCSD). "Long-term efficacy and tolerability are key issues in the treatment of schizophrenia and some medications work better than others in different patients. It is important that patients have all of these medications available to them because they are not the same," he added.

Key Findings

After 28 weeks of randomized, double-blind treatment, the study showed that Zyprexa was superior for the treatment of schizophrenia:

-- Long-term treatment with Zyprexa resulted in significantly

better improvement in treating positive symptoms (delusions

and hallucinations), as well as negative symptoms (diminished

emotion, lack of interest and depressive signs), on all

efficacy measures. Clear separation on positive and negative

symptoms began as early as week 3 and was sustained out to 28

weeks on the Positive and Negative Syndrome Scale (PANSS)

total and subscales.

-- Significantly more Zyprexa patients completed the study (59.6%

vs. 42.4%).

-- Significantly more Zyprexa patients responded positively to

treatment (58.6% vs. 42.5%).

-- For those patients who responded at 8 weeks, Zyprexa patients

were significantly more likely to maintain their response

throughout the 28 weeks without relapse than Geodon patients

(81.6% vs. 62.8%).

-- Zyprexa was significantly better on the CGI-I scale (Clinical

Global Impression-Improvement) at week 3 and most other time

points, including week 28. The CGI-I scale is the clinician's

assessment of improvement in a patient's symptoms.

-- A significantly greater proportion of Geodon patients required

a dose reduction due to side effects during the trial than

Zyprexa patients (26.9% vs. 14.8%).

-- Geodon patients required significantly more benzodiazepines 

(53.5%) and anticholinergics (15.5%) than Zyprexa patients

(40.4% and 7.2%, respectively). Benzodiazepines are additional

medications that may be given to people with schizophrenia to

treat agitation or anxiety; anticholinergics may also be added

to treatment to control tremors or other movement disorders.

"This study gives hope, not only to people who suffer from schizophrenia, but to their caregivers, as well," said Alan Breier, MD, Vice President, Pharmaceutical Products, Eli Lilly and Company. "The tolerability and superior efficacy of Zyprexa, as shown in this study, contributes to the development of a stronger therapeutic alliance that supports doctors in helping their patients reach their individual potential."

Study Design

The study enrolled 548 patients with DSM-IV-defined schizophrenia, with 277 patients receiving Zyprexa in a flexible dose range of 10 to 20 mg/day and 271 patients receiving Geodon in a flexible dose range of 80 to 160 mg/day. The primary efficacy measure was the patients' mean change from beginning of the study to endpoint on the Positive and Negative Syndrome Scale (PANSS) total score. Response to treatment was defined as a 30 percent improvement in the PANSS total at week 8. Safety was evaluated by recording treatment-emergent adverse events and measuring vital signs and weight.

Several adverse events were reported more frequently by patients treated with Geodon than by patients treated with Zyprexa, including aggravated psychosis (4.4 percent vs. 1.4 percent), insomnia (22.1 percent vs. 6.9 percent), vomiting (9.2 percent vs. 4.0 percent), anorexia (2.6 percent vs. 0.4 percent), painful muscle contractions called dystonia (2.2 percent vs. 0.0 percent) and hypotension, or low blood pressure. (1.8 percent vs. 0.0 percent). The most common adverse events reported more frequently during Zyprexa treatment than during Geodon treatment were increased appetite (7.2 percent vs. 2.6 percent for Geodon) and increased weight (12.6 percent vs. 1.8 percent).

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. More than 2 million Americans adults have the disease, with more than 100,000 new cases reported each year. Symptoms of schizophrenia usually begin to appear in the teenage years or early to mid-twenties.

Zyprexa Background

Zyprexa is indicated in the United States for the treatment of schizophrenia, the short-term treatment of acute manic episodes associated with bipolar disorder and for the long-term therapy and maintenance of treatment response of schizophrenia. Zyprexa was the first atypical antipsychotic to prove its long-term effectiveness in patients with schizophrenia. Since Zyprexa was introduced in 1996, it has been prescribed to 11 million people worldwide.

In the original schizophrenia registration trials, Zyprexa was generally well tolerated. However, as with all medications, Zyprexa was associated with some side effects. In the original six-week, acute-phase schizophrenia trials, the most common treatment-emergent adverse event associated with Zyprexa was somnolence. Other common events were dizziness, weight gain, constipation, akathisia (restlessness) and postural hypotension. Modest elevations of prolactin were also seen, although mean changes from baseline to endpoint were not statistically significantly different between Zyprexa and placebo. A small number of patients experienced asymptomatic elevations of hepatic transaminase; none of these patients developed jaundice or drug-induced hepatitis.

In short-term (three- and four-week) acute bipolar mania trials, the most common treatment emergent adverse event associated with Zyprexa was somnolence. Other common events were dry mouth, dizziness, asthenia, constipation, dyspepsia, increased appetite, and tremor.

Full prescribing information is available at www.zyprexa.com.

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.

(a) Kane JM, Berg PH, Thakore J, Naber D, Gattaz WF, Cavazzoni P, Walker DJ, Roychowdhury SM, Earley W, Breier A. Olanzapine versus Ziprasidone: Results of the 28-Week Double-Blind Study in Patients with Schizophrenia. Poster presentation at the International Congress on Schizophrenia Research (ICOSR) meeting March, 2003 in Colorado Springs, Colorado.