Table A17Studies Reporting Adverse Event Rates

Author, YearStudy Type; Study
Objective; Study
Population
AAP TreatmentSafety Outcomes
Stroup et al. 2009 CATIE III294RCT; continuation trial to compare the effectiveness of AAP treatment; 270 patients with schizophrenia.Combination AAP treatment 40 patients (mostly those who had stopped previous treatment due to inefficacy)Any serious AE: 6 (15%)

Any moderate to severe AE: 26 (65%)
Clozapine at therapeutic doses, 37 patients (mostly those who had stopped previous treatment due to inefficacy)Any serious AE: 7 (19%)

Any moderate to severe AE: 29 (78%)
Citrome 2009329Review; to review the efficacy and safety of asenapine for tx of schizophrenia and bipolar disorder; patients with an acute exacerbation of schizophrenia, schizophrenia, schizoaffective disorder, or bipolar disorderAsenapine 10–20 mg per day (versus standard doses of olanzapine, risperidone, haloperidol, placebo)16% serious adverse event rate

(olanzapine: 12%, risperidone: 18%, haloperidol: 11%, placebo: 10%)
Goodnick 2005331Review; expert opinion on higher than recommended doses of AAPs; patients with schizophreniaZiprasidone
240 mg/d, ≥
320 mg/day
No differences in AE rates between the two doses.

AAP = atypical antipsychotic; AE = adverse event; mg/d = milligrams per day; SAE = serious adverse event.

From: APPENDIX 17, SUPPLEMENTAL SAFETY REVIEW

Cover of A Systematic Review of Combination and High-Dose Atypical Antipsychotic Therapy in Patients with Schizophrenia
A Systematic Review of Combination and High-Dose Atypical Antipsychotic Therapy in Patients with Schizophrenia [Internet].
CADTH Optimal Use Report, No. 1.1B.
Copyright © 2011 Canadian Agency for Drugs and Technologies in Health.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial- NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

PubMed Health. A service of the National Library of Medicine, National Institutes of Health.