Study Demonstrated Long-Term Treatment with Zyprexa(R) Reduced Violent Behavior in People with Schizophrenia Compared to Risperi

Study Demonstrated Long-Term Treatment with Zyprexa(R) Reduced
Violent Behavior in People with Schizophrenia Compared to Risperidone 


INDIANAPOLIS, Dec. 14  /PRNewswire-FirstCall/ -- Long-term treatment with
Zyprexa(R) (olanzapine) significantly lowered risk of violent behavior in
people with schizophrenia versus risperidone (Risperdal(R), Janssen), according
to a study published in the December issue of the Journal of Clinical
Psychiatry.  The three-year naturalistic or "real world" study, the
Schizophrenia Care and Assessment Program (SCAP), also showed that improved
medication adherence was an important element that contributed to the reduced
violence risk in patients treated with Zyprexa.

"Violent behavior, even in a small proportion of people with schizophrenia, can
stigmatize all those with the disease, preventing acceptance of people with
psychiatric disabilities in society, disrupting continuity of care, and
limiting the effectiveness of community-based mental health services," said
Jeff Swanson, Ph.D., associate professor of Psychiatry and Behavioral Sciences
at Duke University Medical Center and SCAP investigator.

Unlike a traditional clinical trial, SCAP is a longitudinal observational study
designed to understand the treatment provided to schizophrenia patients in
community care settings.  SCAP is one of the largest naturalistic studies ever
conducted in the United States, consisting of 2,400 patients treated at centers
across the country.  SCAP investigators from Duke University Medical Center
studied violent behavior in a smaller group of patients in North Carolina, one
of the six states where SCAP was carried out.

Key Findings

In this non-randomized prospective study, 124 adults with schizophrenia-
spectrum disorders receiving services in public-sector mental health systems in
North Carolina were followed for three years.  Rates of violence among people
who were initiated on Zyprexa (N=59) were compared with people who were
initiated on risperidone (N=65) at six-month intervals. 

  -- Remaining on Zyprexa for one year or more significantly lowered the
     risk of violent behavior
     - No significant change in violence risk was found for subjects
       remaining on risperidone for one year or more
  -- More violence-prone patients were initially switched to Zyprexa
  -- The reduction in violent behavior associated with Zyprexa treatment was
     attributed to higher rates of medication adherence


Given the observational design of this study and the absence of random
assignment to treatment conditions, it is possible that selection bias could
affect these results.  A patient was classified as a Zyprexa patient if he or
she was prescribed Zyprexa for more than half of each six-month period during
the study.  Likewise a patient was classified as a risperidone patient if he or
she was prescribed risperidone for more than half of each six-month period
during the study.

"Data such as these can be important to healthcare professionals treating
patients in community settings where nonadherence and substance abuse often
further compound the risk of violent behavior," said Marvin Swartz, M.D.,
professor and head of the Division of Social and Community Psychiatry at Duke
University Medical Center, and SCAP investigator.

Study Design

All study participants had been diagnosed with schizophrenia-spectrum
disorders.  The SCAP research design is naturalistic and observational;
therefore, no experimental intervention or interference with usual patterns of
treatment took place.  Violent behavior was measured using the MacArthur
Community Violence Interview, review of outpatient and inpatient medical
records, and review of arrest records for violent offenses documented in the
North Carolina Department of Justice database.  Medication adherence, certain,
designated adverse events, patient sociodemographic characteristics and
clinical variables (hospitalization history, substance abuse, psychotic
symptoms and functional impairment) were assessed at six-month intervals using
a patient-reported validated measure, the SCAP Health Questionnaire.  Results
were obtained using multivariable time series analysis controlling for selected
demographic and clinical covariates.  The study was sponsored by Eli Lilly and
Company.

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 a common severe mental illness.  More than two million
American 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.

Important Information About Zyprexa

Zyprexa is indicated in the United States for the short-term and long-term
treatment of schizophrenia, for maintenance in the treatment of bipolar
disorder, and either alone or in combination with lithium or valproate
(Depakote(R), Abbott) for the short-term treatment of acute mixed or manic
episodes associated with bipolar disorder.  In addition, on March 29, 2004,
Zyprexa for injection was approved by the FDA for the control of acute
agitation associated with schizophrenia and bipolar mania.  Since its
introduction in 1996, Zyprexa has been prescribed to more than 16 million
people worldwide.

The most common treatment-emergent adverse event associated with Zyprexa in
placebo-controlled, short-term schizophrenia and bipolar mania trials was
drowsiness.  Other common events were dizziness, weight gain, personality
disorder (COSTART term for nonaggressive objectionable behavior), constipation,
restlessness, episodes of low blood pressure, dry mouth, weakness, upset
stomach, increased appetite, and tremor.  A small number of patients
experienced asymptomatic elevations of certain liver enzymes; none of these
patients experienced jaundice.

Hyperglycemia, in some cases associated with ketoacidosis, coma, or death, has
been reported in patients treated with atypical antipsychotics including
Zyprexa.  Assessment of the relationship between atypical antipsychotic use and
glucose abnormalities is complicated by the possibility of an increased
background risk of diabetes mellitus in patients with schizophrenia and the
increasing incidence of diabetes mellitus in the general population.  All
patients taking atypicals should be monitored for symptoms of hyperglycemia.
Persons with diabetes who are started on atypicals should be monitored
regularly for worsening of glucose control; those with risk factors for
diabetes should undergo baseline and periodic fasting blood glucose testing.
Patients who develop symptoms of hyperglycemia during treatment should undergo
fasting blood glucose testing.

Prescribing should be consistent with the need to minimize the risk of
neuroleptic malignant syndrome, tardive dyskinesia, seizures and low blood
pressure.

In short-term (six-week) acute bipolar mania trials in combination with lithium
or valproate, the most common treatment emergent adverse event associated with
Zyprexa and lithium or valproate was dry mouth.  Other common events were
weight gain, increased appetite, dizziness, back pain, constipation, speech
disorder, increased salivation, amnesia and abnormal burning or tingling of the
skin.

Although the efficacy of Zyprexa in elderly patients with dementia has not been
established in clinical trials and Zyprexa is not approved for use in this
patient population, it is important to note the label for Zyprexa includes a
warning for elderly patients with dementia.  The warning states that strokes or
mini-strokes (also called transient ischemic attacks or TIAs), including
fatalities were reported in elderly patients with dementia-related psychosis
participating in Zyprexa clinical trials.  In addition, Lilly has completed a
medical review of five placebo-controlled trials in elderly patients with
dementia, and found an increased incidence of mortality from any cause in the
Zyprexa group compared to patients who took placebo (3.5% vs. 1.5%).  In this
review, risk factors that predisposed Zyprexa patients to increased mortality
included age greater than 80 years, sedation, simultaneous use of certain
sedative and anti-anxiety medications (called benzodiazepines) or presence of
pulmonary conditions such as pneumonia.  Lilly is currently addressing this
mortality data with the FDA.

  Full prescribing information is available at http://www.zyprexa.com/ .

  About Eli Lilly and Company


Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and 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 http://www.lilly.com/ .

LillyAnswers ensures that low-income Medicare enrollees with the greatest need
have complete access to the Lilly products they require.  The centerpiece of
the patient assistance program, the LillyAnswers card, allows seniors and
people with disabilities under Medicare to pay a flat $12 fee for a 30-day
supply of certain retail distributed Lilly drugs, including Zyprexa.  Since
Lilly implemented LillyAnswers in 2002, hundreds of thousands of people without
prescription drug insurance have received more than a half million Lilly
products.  LillyAnswers enrollment applications are available by calling the
toll-free number: 1-877-RX-LILLY (1-877-795-4559) or online at
http://www.lillyanswers.com/ . P-LLY

This press release contains forward-looking statements about the potential of
Zyprexa for the treatment of schizophrenia, including the associated risk of
violent behavior in some patients, and reflects Lilly's current beliefs.
However, as with any pharmaceutical product, there are substantial risks and
uncertainties in the process of development and commercialization.  There is no
guarantee that the product will continue to be commercially successful. For
further discussion of these and other risks and uncertainties, see Lilly's
filings with the United States Securities and Exchange Commission.  Lilly
undertakes no duty to update forward-looking statements.

(Logo:  http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO ) 

http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO

DATASOURCE: Eli Lilly and Company



CONTACT:  Kerry Dixon of GCI Group, [phone]; or Marni Lemons

of Eli Lilly and Company, [phone]

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