Efficacy and comparative effectiveness of atypical antipsychotic medications for off-label uses in adults: a systematic review and meta-analysis.
Abstract | CONTEXT: 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:
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Authors | Alicia Ruelaz Maher, Margaret Maglione, Steven Bagley, Marika Suttorp, Jian-Hui Hu, Brett Ewing, Zhen Wang, Martha Timmer, David Sultzer, Paul G Shekelle |
Journal | JAMA
(JAMA)
Vol. 306
Issue 12
Pg. 1359-69
(Sep 28 2011)
ISSN: 1538-3598 [Electronic] United States |
PMID | 21954480
(Publication Type: Comparative Study, Journal Article, Research Support, U.S. Gov't, Non-P.H.S., Research Support, U.S. Gov't, P.H.S., Review, Systematic Review)
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Chemical References |
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Topics |
- Adult
- Aged
- Antipsychotic Agents
(pharmacology, therapeutic use)
- Anxiety Disorders
(drug therapy)
- Dementia
(complications, drug therapy)
- Humans
- Middle Aged
- Obsessive-Compulsive Disorder
(drug therapy)
- Off-Label Use
- Treatment Outcome
- United States
- United States Food and Drug Administration
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