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Treatment With Olanzapine Results in Less Hospitalization When Compared to Risperidone

INDIANAPOLIS, In. -- November 5, 2003 -- People with schizophrenia treated with olanzapine are less likely to be hospitalized and also spend significantly fewer days in the hospital than patients treated with risperidone, new data show. Furthermore, fewer hospitalized days resulted in an annual hospitalization cost savings of $2,500 per olanzapine-treated patient, per year. The findings were presented at the 55th Institute on Psychiatric Services meeting in Boston. The data were collected as part of a landmark three-year "real world" study of people with schizophrenia, called the Schizophrenia Care and Assessment Program (SCAP) that evaluated available schizophrenia treatments.

"Hospitalization represents by far the largest expenditure associated with the treatment of schizophrenia, and it's usually something patients want to avoid if they possibly can. A medication that can help clinicians keep people out of the hospital offers a big advantage to patients, as well as caregivers," said Jeff Swanson, Ph.D., associate professor of psychiatry & behavioral sciences at Duke University Medical Center, and a SCAP investigator.

Unlike a traditional clinical trial, SCAP was a longitudinal observational study designed to understand and improve the treatments currently provided to schizophrenia patients in usual care settings (e.g., employment, mental and physical functioning, housing and substance abuse). Sponsored by Eli Lilly and Company, SCAP is one of the largest naturalistic studies ever to be conducted in the United States, consisting of 2,400 patients located at multiple centers across the country.

Key Findings
- Olanzapine-treated patients had lower hospitalization rates compared to patients treated with risperidone (14.4 percent vs. 24.1 percent).

- Olanzapine-treated patients were hospitalized for significantly fewer days compared to patients treated with risperidone (9.9 days vs. 14.5 days).

- In terms of economic cost, the mean annual group difference of 4.6 days in the olanzapine group translates to a cost savings of $2,502 per patient in hospitalization costs (at $556 per day).

- The median time to first psychiatric hospitalization for patients treated with olanzapine was 1.8 times longer than for patients treated with risperidone (94 days vs. 173 days).

- During the first six months of treatment, patients treated with olanzapine had 3.9 fewer hospitalization days than the risperidone group.

Study Design
In this non-randomized prospective study, patients who were initiated on olanzapine (N=159) were compared with patients who were initiated on risperidone (N=112) on the one-year risk of psychiatric hospitalization. Patients who were diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder, received olanzapine or risperidone for at least one year following initiation, and did not receive either treatment in the 60 days prior to initiation. The primary outcome measure was the number of psychiatric hospitalization days during the year. A generalized Linear Model was used to compare medication groups on the average number of hospitalization days after log transformation. A Logistic Model was used for comparing medication groups on the percent of patients who were hospitalized during the one year following initiation. Kaplan-Meier survival analysis was used to compare medication groups on the time to first psychiatric hospitalization.

"An observational study such as SCAP provides an innovative research model because it evaluates and demonstrates the effectiveness of a treatment in a real-world setting," said Marvin Swartz, M.D., professor and head of the division of social and community psychiatry at Duke University Medical Center, and a SCAP investigator. "This type of outcomes data offers unique advantages that differentiate it from data that are based on randomized clinical trials."

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 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.

Olanzapine Background
Olanzapine 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. Since olanzapine was introduced in 1996, it has been prescribed to 12 million people worldwide.

The most common treatment-emergent adverse event associated with olanzapine 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, akathisia, postural hypotension, dry mouth, asthenia, dyspepsia, increased appetite and tremor.

A small number of patients in premarketing trials experienced asymptomatic elevations of hepatic transaminase; none of these patients developed jaundice. Periodic assessment of transaminases is recommended in patients with significant hepatic disease.

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

Hyperglycemia and diabetes mellitus - Hyperglycemia, in some cases associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics including olanzapine. 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. The available data are insufficient to provide reliable estimates of differences in hyperglycemia-related adverse event risk among the marketed atypical antipsychotics.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.

Source: Lilly

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