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Psychiatric Times. Vol. 26 No. 3
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News 

Lilly Off-Label Promotion

By Arline Kaplan | February 23, 2009

“Ours is an NIMH-funded 5-year study of the effects of 4 different atypical antipsychotics (aripiprazole [Abilify], olanzapine(Drug information on olanzapine), quetiapine, and risperidone(Drug information on risperidone)) in middle-aged and older people with psychotic disorders, for whom atypical antipsychotics are prescribed by the individual patients’ own treating physicians,” said Dilip Jeste, MD, distinguished professor of psychiatry and neurosciences at the University of California, San Diego, and director of the Sam and Rose Stein Institute for Research on Aging. “We use equipoise-stratified randomization, which allows the patients and their doctors to exclude up to 2 of the 4 medications from the list.”

The purpose of the study, Jeste said, is to compare the therapeutic and adverse effects of these atypical agents in patients 40 years and older. The researchers have completed two-thirds of the study but have not published any findings yet.

A recently published retrospective study funded by Department of Health and Human Services’ Agency for Healthcare Research and Quality looked at the effects of antipsychotics on the heart.4

Lead researcher Wayne A. Ray, PhD, of Vanderbilt University and his colleagues reviewed medical records from Tennessee’s Medicaid program, involving patients aged 30 to 74 years. The preliminary analysis included 44,218 users of typical antipsychotics, 46,089 users of atypical antipsychotics, and 186,000 matched nonusers. Current users of atypical antipsychotics, such as risperidone, quetiapine(Drug information on quetiapine), olanzapine, or clozapine(Drug information on clozapine) (Clozaril), had a rate of sudden cardiac death twice that of nonusers of antipsychotic drugs and similar to the death rate for patients taking typical antipsychotics. For both classes of antipsychotics, the risk for current users increased significantly with an increasing dose, but there was an absence of significantly increased risk among former users of antipsychotic drugs.

Commenting on this study, Schneeweiss and Avorn5 asked whether the use of antipsychotic medications should be restricted on the basis of these data. “Much of their use is in vulnerable populations and outside the labeled indications, including the use in children and in the elderly with dementia, and there is much less evidence of efficacy in these populations,” they said. “For these patients, the use of antipsychotic medications should be reduced sharply, perhaps by requiring an age-dependent justification for their use.”

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