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Drug Class Review Atypical Antipsychotic Drugs

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Drug Class Review Atypical Antipsychotic Drugs Drug Class Review Atypical Antipsychotic Drugs Final Report Update 2 June 2008 Original Report Date: January 2005 Update 1 Report Date: April 2006 A literature scan of this topic is done periodically The purpose of this report is to make available information regarding the comparative effectiveness and safety profiles of different drugs within pharmaceutical classes. Reports are not usage guidelines, nor should they be read as an endorsement of or recommendation for any particular drug, use, or approach. Oregon Health & Science University does not recommend or endorse any guideline or recommendation developed by users of these reports. Marian S. McDonagh, PharmD Kim Peterson, MS Susan Carson, MPH Benjamin Chan, MS Sujata Thakurta, MPA:HA Oregon Evidence-based Practice Center Oregon Health & Science University Mark Helfand, MD, MPH, Director Copyright © 2008 by Oregon Health & Science University Portland, Oregon 97239. All rights reserved. Final Report Update 2 Drug Effectiveness Review Project TABLE OF CONTENTS INTRODUCTION.............................................................................................................8 Scope and Key Questions ......................................................................................................15 METHODS .................................................................................................................... 18 Literature Search ....................................................................................................................18 Study Selection .......................................................................................................................18 Data Abstraction .....................................................................................................................18 Quality Assessment ................................................................................................................18 Data Synthesis........................................................................................................................19 Statistical Analysis ..................................................................................................................20 Peer Review............................................................................................................................21 RESULTS ..................................................................................................................... 22 Overview ................................................................................................................................22 Schizophrenia and Related Psychoses ..............................................................................24 Summary of Evidence for Comparative Effectiveness and Short Term Adverse Events of Atypical Antipsychotics in Patients with Schizophrenia………………………………………. 24 Effect of Subgroups.........................................................................................................27 Detailed Assessment for Key Questions 1 and 2……………………………………………... 27 Effectiveness…………………………………………………………………………………….. 32 Suicidality ........................................................................................................................32 Relapse and Hospitalization............................................................................................33 Relapse rate and time to relapse ................................................................................33 Hospitalization.............................................................................................................33 Quality of Life ..................................................................................................................34 Persistence .....................................................................................................................35 Rate of discontinuation................................................................................................35 Time to discontinuation ...............................................................................................39 Social Function................................................................................................................41 Inpatient Outcomes .........................................................................................................42 Aggressive behavior....................................................................................................42 Length of stay..............................................................................................................42 Time to onset of efficacy .............................................................................................43 Discontinuation of treatment........................................................................................43 Discharge rates ...........................................................................................................44 Nursing burden in inpatient setting..............................................................................46 Efficacy…………………………………………………………………………………………… 46 Response Rates..............................................................................................................47 Relationship between Adherence and Long-term Outcomes..........................................49 First Episode Schizophrenia ...........................................................................................50 Alternative Dosage Forms of Atypical Antipsychotics .....................................................50 Paliperidone extended release....................................................................................50 Quetiapine extended release ......................................................................................51 Long-acting risperidone injectable...............................................................................51 Short-acting injectables: aripiprazole, olanzapine, ziprasidone...................................52 Tolerability and Adverse Events……………………………………………………………….. 53 Discontinuations from Studies Due to Adverse Events...................................................53 AAP Page 2 of 206 Final Report Update 2 Drug Effectiveness Review Project Extrapyramidal Symptoms ..............................................................................................54 Weight Gain under Trial Conditions ................................................................................56 Sexual Dysfunction .........................................................................................................58 Metabolic Effects.............................................................................................................59 Other Adverse Events .....................................................................................................60 Detailed Assessment for Key Question 3……………………………………………………….61 Age..................................................................................................................................62 Ethnicity...........................................................................................................................62 Substance Use................................................................................................................63 Bipolar Disorder....................................................................................................................64 Summary of Evidence for Comparative Effectiveness and Short-term Adverse Events of Atypical Antipsychotics in Patients with Bipolar Disorder……………………………………..64 Direct Comparisons.........................................................................................................64 Indirect Comparisons ......................................................................................................64 Detailed Assessment for Key Questions 1 and 2………………………………………………65 Effectiveness…………………………………………………………………………………….. 65 Hospitalization.................................................................................................................65 Direct comparisons......................................................................................................65 Indirect comparisons ...................................................................................................65 Persistence .....................................................................................................................66 Efficacy and Safety……………………………………………………………………………… 66 Direct Comparisons.........................................................................................................66 Indirect Comparisons ......................................................................................................67 Manic and mixed episodes..........................................................................................67 Depressive episodes...................................................................................................73 Rapid cycling...............................................................................................................75 Immediate control of acute agitation associated with bipolar I disorder ......................76 Detailed Assessment for Key Question 3……………………………………………………….76 Behavioral and Psychological Symptoms of Dementia ....................................................77 Summary…………………………………………………………………………………………... 77 Comparative Effectiveness
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