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| | | | CATIE Phase 2 Data Confirm Patients Stay on Treatment Longer Because of Symptom Improvement More... Apr 1st 2006
So Than Tolerability. Zyprexa Was Among Most Effective Atypical Antipsychotics Studied. 
Eli Lilly and Company today commented on findings of the phase 2 CATIE (Clinical Antipsychotic Trial of Intervention Effectiveness) trial and provided perspective on Zyprexa s
overall results. The findings from phase 2 were published in the April issue of the American Journal of Psychiatry.
CATIE phase 2 focused on the use of atypical antipsychotics to treat chronic schizophrenia and was designed to evaluate which ones were better rescue treatments for patients who required a medication switch in phase 1 either because the prior medication didn t work well enough or they were not able to tolerate it. This was measured by medication discontinuation for any
cause.
Results indicated that patients continue medication treatment longer when given a medication that effectively controls their psychotic symptoms, and that when patients switch medications, it is more often due to the drug s lack of efficacy rather than the patient s ability to tolerate the drug.
Results from CATIE phase 1 and 2 challenge the notion that patients discontinue their medication mainly due to side effects, said J. Steven Lamberti, M.D., associate chair for clinical programs, department of psychiatry, University of Rochester Medical Center and CATIE investigator. These findings further demonstrate the need for doctors to fully evaluate the
benefit/risk profiles of atypical antipsychotics and why individualized treatment is so important to consider when treating chronic schizophrenia.
Zyprexa(R) (olanzapine) was among the most effective atypical
antipsychotics studied in the second phase of CATIE for those patients who required a medication change in Phase 1.
In the efficacy arm, clozapine performed best in terms of all-cause discontinuation, followed by Zyprexa(i). In the tolerability arm, risperidone and Zyprexa performed best in terms of all-cause discontinuation, which was contrary to the study s hypothesis that ziprasidone would be the most effective atypical because it caused little or no weight gain(ii). In
addition, a secondary analysis in the tolerability arm of the study showed a statistically significant reduction in positive psychotic symptoms (such as paranoid ideas or hearing voices) for patients taking Zyprexa. Zyprexa patients also had the lowest rate of hospitalizations (11 percent) among the other atypicals studied (risperidone (15 percent), ziprasidone (16 percent), and quetiapine (20 percent)(iii)). These findings are consistent with CATIE phase 1.
While there were no statistical differences among those who discontinued treatment because of intolerability among the four atypical antipsychotics studied in this arm, there were variations in the types of adverse events reported. Zyprexa patients in phase 2 experienced greater weight gain and
increases in total cholesterol and triglyceride levels versus patients using the other atypical antipsychotics studied. These results are similar to data reported in phase 1. (Information about adverse events related to increases in blood glucose levels, lipid metabolism and weight gain is included in the
Zyprexa product label.)
Results of this landmark study confirm that efficacy matters when treating this devastating illness, said Robert Baker, M.D., medical director, U.S. neuroscience, Eli Lilly and Company. Studies such as CATIE are important for both doctors and patients as they provide insights about why patients continue or discontinue their medication treatment. This is
important because patients who stay on their treatment longer may have a lower risk of relapse as well as experience fewer hospitalizations.
Schizophrenia is a very complex neurological disorder, he added. For reasons we do not yet fully understand, a medication that works in one person with schizophrenia may not work in another. It s important for doctors and patients to have access to a variety of medications, and it s crucial for
patients to stay on the medication that works best for them.
Eli Lilly and Company http://www.lilly.com/index.html
Apr 1st 2006
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