sábado, 1 de octubre de 2011

Off-Label Use of Atypical Antipsychotics: An Update - Research Review - Final | AHRQ Effective Health Care Program

1. Report finds off-label use of atypical antipsychotic drugs not supported by evidence for some conditions
AHRQ’s Effective Health Care Program has released a new report that found there is little evidence to support the use of atypical antipsychotic drugs for some treatments other than their officially approved purposes, even though many clinicians continue to commonly prescribe these drugs for of- label uses. Atypical antipsychotic medications, which are approved by the FDA for treatment of schizophrenia, bipolar disorder and, in some cases, depression, are commonly prescribed to treat other behavioral conditions. The report, which is an update of a 2007 report, found limited evidence to support the off-label use of certain atypical antipsychotic medications. Evidence was strongest, for example, for the off-label use of risperidone, olanzapine and aripiprazole to treat symptoms of dementia; quetiapine to treat generalized anxiety disorder; and risperidone to treat obsessive-compulsive disorder. However, evidence was lacking to justify the use of these and other atypical antipsychotic drugs to treat substance abuse problems, eating disorders or insomnia. These findings and future research needs are summarized in the review, Off-Label Use of Atypical Antipsychotics: An Update. Select to read our press release and select to access the abstract on PubMed.®

open here please to see/read/learn and download the Guideline:
Off-Label Use of Atypical Antipsychotics: An Update - Research Review - Final AHRQ Effective Health Care Program

JAMA. 2011 Sep 28;306(12):1359-69.

Efficacy and comparative effectiveness of atypical antipsychotic medications for off-label uses in adults: a systematic review and meta-analysis.

Maher AR, Maglione M, Bagley S, Suttorp M, Hu JH, Ewing B, Wang Z, Timmer M, Sultzer D, Shekelle PG.

Source

RAND Health, Southern California Evidence-Based Practice Center, 1776 Main St, Santa Monica, CA 90401, USA. Alicia.Ruelaz@cshs.org

Abstract

CONTEXT:

Atypical antipsychotic medications are commonly used for off-label conditions such as agitation in dementia, anxiety, and obsessive-compulsive disorder.

OBJECTIVE:

To perform a systematic review on the efficacy and safety of atypical antipsychotic medications for use in conditions lacking approval for labeling and marketing by the US Food and Drug Administration.

DATA SOURCES AND STUDY SELECTION:

Relevant studies published in the English language were identified by searches of 6 databases (PubMed, EMBASE, CINAHL, PsycInfo, Cochrane DARE, and CENTRAL) from inception through May 2011. 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 were included. Observational studies with sample sizes of greater than 1000 patients were included to assess adverse events.

DATA EXTRACTION:

Independent article review and study quality assessment by 2 investigators.

DATA SYNTHESIS:

Of 12 228 citations identified, 162 contributed data to the efficacy review. Among 14 placebo-controlled trials of elderly patients with dementia reporting a total global outcome score that includes symptoms such as psychosis, mood alterations, and aggression, small but statistically significant effects sizes ranging from 0.12 and 0.20 were observed for aripiprazole, olanzapine, and risperidone. For generalized anxiety disorder, a pooled analysis of 3 trials showed that quetiapine was associated with a 26% greater likelihood of a favorable response (defined as at least 50% improvement on the Hamilton Anxiety Scale) compared with placebo. For obsessive-compulsive disorder, risperidone was associated with a 3.9-fold greater likelihood of a favorable response (defined as a 25% improvement on the Yale-Brown Obsessive Compulsive Scale) compared with placebo. In elderly patients, adverse events included an increased risk of death (number needed to harm [NNH] = 87), stroke (NNH = 53 for risperidone), extrapyramidal symptoms (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 (for aripiprazole), and extrapyramidal symptoms.

CONCLUSIONS:

Benefits and harms vary among atypical antipsychotic medications for off-label use. For global behavioral symptom scores associated with dementia in elderly patients, small but statistically significant benefits were observed for aripiprazole, olanzapine, and risperidone. Quetiapine was associated with benefits in the treatment of generalized anxiety disorder, and risperidone was associated with benefits in the treatment of obsessive-compulsive disorder; however, adverse events were common.