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Atypical antipsychotics appear to be effective for only few off-label uses, study suggests

Date:
September 28, 2011
Source:
JAMA and Archives Journals
Summary:
A review of previous studies suggests that even though atypical antipsychotic medications are commonly used for off-label conditions such as behavioral symptoms of dementia, anxiety, and obsessive-compulsive disorder, these medications are effective for only a few off-label conditions, and that the benefits and harms of these medications for these uses vary, according to a new article.

A review of previous studies suggests that even though atypical antipsychotic medications are commonly used for off-label conditions such as behavioral symptoms of dementia, anxiety, and obsessive-compulsive disorder, these medications are effective for only a few off-label conditions, and that the benefits and harms of these medications for these uses vary, according to an article in the Sept. 28 issue of JAMA.

"Atypical antipsychotic medications are approved for marketing and labeling by the U.S. Food and Drug Administration (FDA) for treating schizophrenia, bipolar disorder, and depression under drug-specific circumstances. The use of atypical antipsychotic medications is rapidly increasing in the United States, with 1 study estimating an increase from 6.2 million to 14.3 million treatment visits between 1995 and 2008. The estimated use of these drugs for off-label indications, meaning those without FDA approval for these indications, doubled during this period," according to background information in the article.

Alicia Ruelaz Maher, M.D., of RAND Health, Santa Monica, Calif., and colleagues conducted a systemic review and meta-analysis to examine the efficacy and adverse events associated with off-label use of atypical antipsychotic medications for behavioral symptoms in dementia, anxiety, obsessive-compulsive disorder (OCD), eating disorders, posttraumatic stress disorder (PTSD), insomnia, personality disorders, depression, and substance abuse. The authors searched the medical literature for controlled trials comparing an atypical antipsychotic medication (risperidone, olanzapine, quetiapine, aripiprazole, ziprasidone, asenapine, iloperidone, or paliperidone) with placebo, another atypical antipsychotic medication, or other pharmacotherapy for adult off-label conditions. Observational studies with sample sizes of greater than 1,000 patients were included to assess adverse events.

For this study, the researchers identified and included 162 trials with efficacy outcomes and 231 trials or large observational studies with adverse events. Among the findings of the authors, aripiprazole, olanzapine, and risperidone were associated with small but statistically significant benefits for the treatment in elderly patients of behavioral symptoms of dementia, such as psychosis, mood alterations, and aggression. For generalized anxiety disorder, a pooled analysis of 3 trials showed that quetiapine was associated with a 26 percent increase in the chance of a favorable response at 8 weeks compared with placebo. For obsessive-compulsive disorder, three pooled studies of risperidone resulted in an approximate 4-fold increase in the chance of responding compared with placebo. Evidence did not support using atypical medications for substance abuse or eating disorders.

"In elderly patients, adverse events included an increased risk of death (number needed to harm [NNH] = 87), stroke (NNH = 53 for risperidone), extrapyramidal symptoms [movement disorders; NNH = 10 for olanzapine; NNH = 20 for risperidone], and urinary tract symptoms (NNH range-16-36). In nonelderly adults, adverse events included weight gain (particularly with olanzapine), fatigue, sedation, akathisia [inability to remain motionless] (for aripiprazole), and extrapyramidal symptoms," the authors write.

"The benefits and harms vary among atypical antipsychotic medications for off-label use," the authors write. "This evidence should prove useful for clinicians considering off-label prescribing of atypical antipsychotic medications, and should contribute to optimal treatment decision making for individual patients with specific clinical symptoms and unique risk profiles."


Story Source:

The above story is based on materials provided by JAMA and Archives Journals. Note: Materials may be edited for content and length.


Journal Reference:

  1. Alicia Ruelaz Maher, Margaret Maglione, Steven Bagley, Marika Suttorp, Jian-Hui Hu, Brett Ewing, Zhen Wang, Martha Timmer, David Sultzer, Paul G. Shekelle. Efficacy and Comparative Effectiveness of Atypical Antipsychotic Medications for Off-Label Uses in Adults: A Systematic Review and Meta-analysis. JAMA, 2011; 306 (12): 1359-1369 DOI: 10.1001/jama.2011.1360

Cite This Page:

JAMA and Archives Journals. "Atypical antipsychotics appear to be effective for only few off-label uses, study suggests." ScienceDaily. ScienceDaily, 28 September 2011. <www.sciencedaily.com/releases/2011/09/110927161649.htm>.
JAMA and Archives Journals. (2011, September 28). Atypical antipsychotics appear to be effective for only few off-label uses, study suggests. ScienceDaily. Retrieved September 2, 2014 from www.sciencedaily.com/releases/2011/09/110927161649.htm
JAMA and Archives Journals. "Atypical antipsychotics appear to be effective for only few off-label uses, study suggests." ScienceDaily. www.sciencedaily.com/releases/2011/09/110927161649.htm (accessed September 2, 2014).

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Atypical Antipsychotics May Aid Symptons for Some Off-Label Uses, but Not Others

Sep. 27, 2011 Atypical antipsychotic medications, developed to treat schizophrenia and bipolar disorder, are frequently prescribed for many off-label uses. A new study finds that medical evidence suggests the ... read more
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