drug class review on atypical antipsychotic drugs “atypicalâ€‌ antipsychotic agents...

Download Drug Class Review on Atypical Antipsychotic Drugs “Atypicalâ€‌ antipsychotic agents (AAPs) are used

If you can't read please download the document

Post on 15-Aug-2020

0 views

Category:

Documents

0 download

Embed Size (px)

TRANSCRIPT

  • Drug Class Review on

    Atypical Antipsychotic Drugs

    Final Report

    January 2005

    Marian S. McDonagh, PharmD Kim Peterson, MS Michele Freeman, MPH Susan Carson, MPH Oregon Evidence-based Practice Center Oregon Health & Science University Mark Helfand, MD, MPH, Director

  • TABLE OF CONTENTS Introduction....................................................................................................................................6 Scope and Key Questions ..................................................................................................13 Methods.........................................................................................................................................15 Literature Search................................................................................................................15 Study Selection ..................................................................................................................16 Data Abstraction ................................................................................................................16 Quality Assessment............................................................................................................16 Data Synthesis....................................................................................................................17 Peer Review .......................................................................................................................18 Results ...........................................................................................................................................18 Overview ...........................................................................................................................18 Schizophrenia and Related Psychoses............................................................................19 Summary: Schizophrenia and Related Psychoses..................................................19 Key Question 1. Efficacy......................................................................................21 Key Question 2. Safety .........................................................................................49 Key Question 3. Subgroups ..................................................................................60 Bipolar I Disorder ............................................................................................................67 Summary: Bipolar I Disorder.................................................................................67 Key Question 1. Efficacy......................................................................................68 Key Question 2. Safety .........................................................................................78 Key Question 3. Subgroups .................................................................................82 Behavioral and Psychological Symptoms of Dementia (BPSD)...................................82 Summary: Behavioral and Psychological Symptoms of Dementia .......................82 Key Question 1. Efficacy......................................................................................83 Key Question 2. Safety .........................................................................................88 Key Question 3. Subgroups ..................................................................................91 Youths with Autism, Disruptive Behavior Disorder, or Attention Deficit

    Hyperactivity Disorder ....................................................................................................91 Summary: Youths .................................................................................................91 Key Question 1. Efficacy......................................................................................92 Key Question 2. Safety .........................................................................................94 Key Question 3. Subgroups ..................................................................................95 Long-term Safety .............................................................................................................96 Overall Summary.......................................................................................................................110 References ...................................................................................................................................115

    Final Report Drug Effectiveness Review Project

    Atypical Antipsychotic Drugs Page 2 of 187

  • Tables Table 1. AAP drug indications, doses, and mechanisms of action ...........................................8 Table 2. Eligible Outcomes ....................................................................................................15 Table 3. Summary of differences in benefits and harms among AAPS .................................21 Table 4. Total numbers of head-to-head trials of atypical antipsychotics ..............................22 Table 5. Mean change on PANSS and BPRS in Effectiveness versus Efficacy Studies........23 Table 6. Clozapine vs olanzapine: mean change (baseline to 18 weeks) ...............................27 Table 7. Clozapine vs risperidone: mean change (baseline to endpoint)................................28 Table 8. Clozapine vs risperidone: PANSS endpoint scores ..................................................28 Table 9. Olanzapine vs risperidone: mean change (baseline to endpoint).............................30 Table 10. Clozapine vs olanzapine: response rates.................................................................33 Table 11. Response rates: PANSS >20% ...............................................................................33 Table 12. Patients leaving study early ....................................................................................35 Table 13. Treatment comparisons in active control studies of AAPs.....................................42 Table 14. Aripiprazole vs haloperidol ....................................................................................43 Table 15. Clozapine vs typical APs (mean change scores) ....................................................44 Table 16. Olanzapine versus typical APs (mean change scores)............................................45 Table 17. Quetiapine vs haloperidol (mean change scores) ...................................................46 Table 18. Quetiapine vs haloperidol: Cognitive Outcomes ....................................................46 Table 19. Risperidone vs typical APs in patients with schizophrenia, mean change scores .47 Table 20. Risperidone vs haloperidol: rates of relapse ...........................................................48 Table 21. Ziprasidone vs haloperidol......................................................................................48 Table 22. Extrapyramidal symptoms assessments..................................................................52 Table 23. Clozapine vs olanzapine adverse events.................................................................53 Table 24. Clozapine vs risperidone adverse events ................................................................53 Table 25. Olanzapine vs risperidone adverse events ..............................................................54 Table 26. Quetiapine vs risperidone adverse events...............................................................55 Table 27. EPS in studies of clozapine versus haloperidol ......................................................55 Table 28. EPS in trials of olanzapine compared to haloperidol..............................................56 Table 29. EPS in studies of quetiapine versus haloperidol.....................................................56 Table 30. EPS in trials comparing disparate dosages of risperidone and haloperidol............57 Table 31. Table of adverse events in haloperidol-controlled trials.........................................58 Table 32. Mean change in psychopathology scales: Olanzapine vs Risperidone (age 50-65) ........................................................................................................................61 Table 33. Extrapyramidal symptoms: olanzapine vs risperidone (age 50-65)........................61 Table 34. Summary of systematic reviews .............................................................................66 Table 35. Unpublished research..............................................................................................69 Table 36. Placebo-controlled trial characteristics...................................................................70 Table 37. YMRS outcomes in 3-week trials using > mid-range mean doses .........................71 Table 38. Outcomes in 3-week trials using > mid-range mean doses ....................................71 Table 39. YMRS outcomes in trials using mid-range mean doses .........................................72 Table 40. Summary of other outcomes in monotherapy trials for manic/mixed episodes .....73 Table 41. Total withdrawals in patients with manic/mixed episodes .....................................73 Table 42. Summary of outcomes in quetiapine trials .............................................................74 Table 43. YMRS outcomes in adjunctive treatment trials (mid-range mean dose)................75 Table 44. Tohen 2002 outcomes (adjunctive therapy)............................................................76

    Final Report Drug

Recommended

View more >