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Drug Class Review: Atypical Antipsychotic Drugs: Final Update 3 Report [Internet]

Drug Class Review: Atypical Antipsychotic Drugs: Final Update 3 Report [Internet]

Drug Class Reviews - Oregon Health & Science University

Version: July 2010

Introduction

“Atypical” antipsychotic agents are used to treat the symptoms of schizophrenia and bipolar disorder (see Table 1 for details). In general, atypical antipsychotics produce antipsychotic responses with fewer acute extrapyramidal side effects than “conventional” antipsychotic drugs. Extrapyramidal side effects are a set of movement disorders such as akathisia, dystonia, and pseudoparkinsonism that resolve when the drug is discontinued or the dosage is lowered. Tardive dyskinesia is a movement disorder that can develop with more prolonged use and may persist even after cessation of the antipsychotic agent. Atypical antipsychotics are associated with lower rates of the development of this neurological side effect in comparison with the older, conventional agents. Atypical antipsychotics may also treat negative symptoms and improve cognitive functioning.

Overall Summary

The evidence summarizing our responses to the Key Questions is shown in Table 36. In addition to the limitations discussed above, the evidence is remarkable for its lack of real-world effectiveness outcomes important to patients, those relating to social success and economic independence. Inclusion of a large body of non-trial evidence did not improve the ability to answer questions in relation to these important effectiveness outcomes, as very few studies addressed such outcomes and most were limited by their design or implementation. There were 2 trials that were potentially includable but were published after the cut-off date of our second searches. They will be considered for inclusion in the next update.,

Results

A total of 7966 citations were identified from searching electronic databases, reviews of reference lists, pharmaceutical manufacturer dossier submissions, and public comments. By applying the eligibility and exclusion criteria to titles and abstracts of all identified citations, we identified 2776 potentially includable citations (571 for Update 3). After reapplying the criteria for inclusion to the full texts of these citations, we ultimately included 648 publications (223 for Update 3). Of these, 283 were primary trials (118 for Update 3), 186 were primary observational studies (45 for Update 3), 14 were systematic reviews (5 for Update 3), and 25 were pooled analysis, post-hoc analysis, and medical and/or statistical reviews (17 for Update 3). See Appendix E for a list of excluded studies and reasons for exclusion at full text. Figure 1 shows the flow of study selection.

Methods

To identify relevant citations, we searched the Cochrane Central Register of Controlled Trials (1st Quarter 2010), Cochrane Database of Systematic Reviews (4th quarter 2009), MEDLINE (1950 to week 4 January 2010), and PsycINFO (1806 to February week 1 2010) using terms for included drugs, indications, and study designs (see Appendix D for complete search strategies). We attempted to identify additional studies through searches of reference lists of included studies and reviews. In addition, we searched the US Food and Drug Administration Center for Drug Evaluation and Research website for medical and statistical reviews of individual drug products. Finally, we requested dossiers of published and unpublished information from the relevant pharmaceutical companies for this review. All received dossiers were screened for studies or data not found through other searches. All citations were imported into an electronic database (Endnote XI, Thomson Reuters).

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