Long-term Treatment with Zyprexa(R) Demonstrated Significant Improvement Versus Risperidone in Treating Negative Symptoms in People with Schizophrenia NEW YORK, May 4 /PRNewswire-FirstCall/ -- A new study shows that long-term treatment with Zyprexa(R) (olanzapine) showed significant improvement versus long-term treatment with risperidone in improving the symptoms and social functioning of schizophrenia patients with prominent negative symptoms. Zyprexa was also shown to have significantly fewer treatment-emergent side effects, including significantly less sexual dysfunction. This study was presented at the annual meeting of the American Psychiatric Association in New York. "For people with schizophrenia, seemingly ordinary social endeavors such as sustaining relationships and keeping a job can be ambitious goals," said Dr. Jose M. Olivares, Psychiatry Department at the Complejo Hospitalario Universitario Xeral-Cies in Vigo, Spain. Negative symptoms, such as apathy, low levels of initiative and absence of emotional expression, are the prime cause of low social function in most people with schizophrenia. Patients who are poorly motivated cannot function adequately at school or work, and their personal relationships suffer due to unresponsiveness and inattention to social cues. (1) "The ultimate goal in treating people with schizophrenia is not only to get them well by reducing symptoms, but also to help them to achieve a satisfactory and meaningful level of social functioning," said Bruce Kinon, M.D., medical advisor, U.S. Medical Neurosciences, Eli Lilly and Company. "To that end, physicians need therapies that demonstrate long-term effectiveness especially in improving motivation to sustain social relationships and become engaged in vocational rehabilitation." Key Findings The study was a one-year, multi-center, randomized, open-label study of outpatients with schizophrenia with prominent negative symptoms. Patients were randomly assigned to treatment with Zyprexa (120 patients) or risperidone (115 patients). Results of the study are presented in two different posters, one focusing on negative, positive and overall symptomatology and safety and the second focusing on social functioning. Zyprexa vs. Risperidone: Response Rates and Improved Symptoms * At the end of the one-year study, the Zyprexa group had a significantly higher response rate (69.2 percent) than the risperidone group (48.7 percent). The response rate was defined as a 30 percent improvement in global score on the Scale for the Assessment of Negative Symptoms (SANS). * During the study, treatment-emergent extrapyramidal symptoms (such as muscle stiffness, tremors or rigidity), or worsening of the previous symptoms, occurred at a significantly lower rate among Zyprexa patients (28.9 percent) than in the risperidone group (50.4 percent). Negative symptoms may be, to some extent, related to extrapyramidal side effects. * Significantly fewer Zyprexa-treated patients (1.6 percent) experienced sexual dysfunction when compared to risperidone-treated patients (7.3 percent). Zyprexa vs. Risperidone: One-Year Results in Social Functioning * In the same study, Zyprexa treatment significantly improved overall social functioning compared to risperidone treatment. Social functioning improvements were determined by the total score and individual behavioral category scores on the Social Functioning Scale (SFS). * The mean improvement in SFS total scores was significantly higher in the Zyprexa group (7.75 in Zyprexa-treated patients and -0.92 in risperidone- treated patients). * Zyprexa treatment resulted in a greater numerical improvement than risperidone treatment in all SFS categories and reached statistically significant differences in such categories as social engagement or withdrawal, independence (performance), independence (competence), recreation activities, and employment. * The greatest difference between the Zyprexa and risperidone groups was found in the occupation/employment category (0.86 v. -3.06). Study Design This was a multi-center, randomized, open-label, parallel, dose-flexible study evaluating Zyprexa and risperidone in patients with prominent negative symptoms for one year. Patients were assigned to treatment with an initial dose of at least 10 mg/day of Zyprexa (N=120) or at least 3 mg/day of risperidone (N=115), with the mean doses of 12.2 mg/day for Zyprexa and 4.9 mg/day for risperidone during the studies. The study was conducted in Spain. 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. 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 IntraMuscular (olanzapine for injection), was approved by the FDA for the control of acute agitation associated with schizophrenia and bipolar mania. Since Zyprexa was introduced in 1996, it has been prescribed to more than 14 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/ . Certain of the matters discussed herein with respect to clinical studies and Lilly's products may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on current expectations, estimates and projections about the industry, management beliefs and certain assumptions made by management. Investors are cautioned that matters subject to forward- looking statements involve risks and uncertainties, including economic, competitive, governmental, technological and other factors discussed in the company's filings with the Securities and Exchange Commission, which may affect the business and prospects of the company. 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. (1) Tandon, R., M. Jibson. Negative Symptoms of Schizophrenia: How to Treat Them Most Effectively. Current Psychiatry, vol. 1, issue 9. September 2002. (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: Marni Lemons, +1-317-433-8990, cell: +1-317-997-5604, or Kindra Strupp, +1-317-277-5170, cell: +1-317-652-7571, both of Eli Lilly and Company

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