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Drug Class Scan: Atypical Antipsychotics

History. Date of the Last Update: July 2010. . 2. Inclusion Criteria. PopulationsSchizophrenia: Adults and adolescentsBipolar disorder: Adults and youthsMajor depressive disorder in adultsBehavioral and psychological symptoms of dementiaYouths with pervasive developmental disorders, including

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Drug Class Scan: Atypical Antipsychotics

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    1. Drug Class Scan: Atypical Antipsychotics

    2. History Date of the Last Update: July 2010 2

    3. Inclusion Criteria Populations Schizophrenia: Adults and adolescents Bipolar disorder: Adults and youths Major depressive disorder in adults Behavioral and psychological symptoms of dementia Youths with pervasive developmental disorders, including autism Youths with disruptive behavior disorders, including conduct disorder and oppositional defiant disorder (Includes inpatients and outpatients) 3

    4. Inclusion Criteria 4

    5. Inclusion Criteria Effectiveness/ efficacy outcomes Mortality Quality of life Functional capacity Hospitalization, emergency department visits, etc. Efficacy as measured by symptom response: response rates, duration of response, remission, relapse, speed of response, time to discontinuation of medication, etc. Adherence Persistence Caregiver burden 5

    6. Inclusion Criteria Harms Overall adverse effects Withdrawals due to adverse events Specific adverse events, major and general 6

    7. Methods MEDLINE (Ovid) search for randomized controlled trials (RCTs) from February 2010 to August week two 2011 Search for Cochrane and AHRQ systematic reviews (SRs) FDA website search 7

    8. Results 1 AHRQ Systematic Review identified: Warren et al (2011) – Therapies for children with autism spectrum disorders Agency for Healthcare Research and Quality 4 AHRQ Systematic Review Protocols identified: AHRQ Protocol (Posted 2010) – Efficacy and Comparative Effectiveness of Off-Label Use of Atypical Antipsychotics – Update AHRQ Protocol (Posted 2010) – Comparative Effectiveness of First and Second Generation Antipsychotics in the Adult Population AHRQ Protocol (Posted 2010) – Comparative Effectiveness of First and Second Generation Antipsychotics in the Pediatric and Young Adult Populations AHRQ Protocol (Posted 2010) – Depression Treatment after Unsatisfactory Response to SSRIs when used as First-line Therapy 8

    9. Results 1 Cochrane Systematic Review Protocol identified: Preda et al (Posted 2010) – Asenapine versus other atypical antipsychotics for schizophrenia. Cochrane Database of Systematic Reviews, Issue 12. 4 Cochrane Systematic Reviews identified: Komossa et al (2010). Olanzapine vs. other atypical antipsychotics for schizophrenia. Cochrane Database of Systematic Reviews, Issue 3. Komossa et al (2010). Quetiapine vs. other atypical antipsychotics. Cochrane Database of Systematic Reviews, Issue 1. Komossa et al (2011). Risperidone vs. other atypical antipsychotics. Cochrane Database of Systematic Reviews, Issue 1. Lobos et al (2010). Clozapine vs. other atypical antipsychotics. Cochrane Database of Systematic Reviews, Issue 11. 9

    10. Results MEDLINE search identified 341 full citations 5 new SRs identified and 5 SR protocols identified Multiple FDA safety warnings No box warnings 4 warnings, 5 precautions, 6 adverse reactions, 3 drug interactions 10

    11. New FDA Approved Drugs and Indications New Drugs Latuda (lurasidone HCI) tablets 40mg and 80mg – indicated for the treatment of patients with schizophrenia Approved October 2010 No new indications identified 11

    12. New Literature 24 new potentially relevant head-to-head trials: 19 head-to-head RCTs identified for schizophrenia Includes two secondary analyses from CATIE 2 head-to-head RCTs for bipolar disorder 3 head-to-head RCTs for psychosis 12

    13. New Literature Atypical vs. Atypicals (6 studies) Olanzapine orodispersible vs. oral conventional (1 study) Risperidone vs. olanzapine (5 studies) Risperidone vs. quietiapine (3 studies) Ziprasidone vs. olanzapine (3 studies) Lurasidone vs. ziprasidone (1 study) Clozapine in combo with ziprasidone vs. risperidone (1 study) Asenapine vs. placebo vs. olanzapine (2 studies) Paliperidone vs. risperidone (1 study) Paliperidone vs. quetiapine (1 study) 13

    14. New Literature 47 RCTs identified that compared an atypical antipsychotic(s) to placebo or a drug other than an atypical antipsychotic. Two Cochrane reviews and one Cochrane protocol that compared an atypical antipsychotic(s) to placebo, were identified but not included in this scan. 14

    15. Acknowledgements This report was prepared by: Kathryn Clark, BA Alison Little, MD, MPH Valerie King, MD, MPH Medline search performed by: Andrew Hamilton, MS, MLS 15

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