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First-Generation Versus Second-Generation Antipsychotics in Adults: Comparative Effectiveness

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Objectives:To compare individual first-generation antipsychotics (FGAs) with individual second-generation antipsychotics (SGAs) in adults (18 to 64 years) with schizophrenia, schizophrenia-related psychoses, or bipolar disorder, with a focus on core
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  Comparative Effectiveness Review Number 63 First-Generation Versus Second-Generation Antipsychotics in Adults: Comparative Effectiveness Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 540 Gaither Road Rockville, MD 20850 www.ahrq.gov Contract No. 290-2007-10021 Prepared by: University of Alberta Evidence-based Practice Center Edmonton, Alberta, Canada Investigators: Ahmed M. Abou-Setta, M.D., Ph.D. Shima S. Mousavi, M.D. Carol Spooner, B.Sc.N., M.Sc. Janine R. Schouten, B.Sc. Dion Pasichnyk, B.Sc. Susan Armijo-Olivo, B.Sc.P.T., M.Sc., Ph.D. Amy Beaith, B.A., M.I.St. Jennifer C. Seida, M.P.H. Serdar Dursun, M.D. Amanda S. Newton, R.N., Ph.D. Lisa Hartling, B.Sc.P.T., M.Sc., Ph.D. AHRQ Publication No. 12-EHC054-EF August 2012 Errata – On August 20, 2012, Appendix O was updated to clarify that the route of administration for INVEGA SUSTENNA is IM injection (dosage 39 mg - 234 mg) and the route of administration for RISPERIDOL CONSTA is IM injection (dosage 25 mg).  ii This report is based on research conducted by the University of Alberta Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10021). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to  be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients. This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage  policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied. This document is in the public domain and may be used and reprinted without special  permission. Citation of the source is appreciated. Persons using assistive technology may not be able to fully access information in this report. For assistance contact EffectiveHealthCare@ahrq.hhs.gov.  None of the investigators has any affiliations or financial involvement that conflicts with the material presented in this report. Suggested citation:  Abou-Setta AM, Mousavi SS, Spooner C, Schouten JR, Pasichnyk D, Armijo-Olivo S, Beaith A, Seida JC, Dursun S, Newton AS, Hartling L. First-Generation Versus Second-Generation Antipsychotics in Adults: Comparative Effectiveness. Comparative Effectiveness Review No. 63. (Prepared by the University of Alberta Evidence-based Practice Center under Contract No. 290-2007-10021.) AHRQ Publication No. 12-EHC054-EF. Rockville, MD: Agency for Healthcare Research and Quality; August 2012. www.effectivehealthcare.ahrq.gov/reports/final.cfm.  iii Preface The Agency for Healthcare Research and Quality (AHRQ) conducts the Effective Health Care Program as part of its mission to organize knowledge and make it available to inform decisions about health care. As part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Congress directed AHRQ to conduct and support research on the comparative outcomes, clinical effectiveness, and appropriateness of pharmaceuticals, devices, and health care services to meet the needs of Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP). AHRQ has an established network of Evidence-based Practice Centers (EPCs) that produce Evidence Reports/Technology Assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care. The EPCs now lend their expertise to the Effective Health Care Program by conducting Comparative Effectiveness Reviews (CERs) of medications, devices, and other relevant interventions, including strategies for how these items and services can best be organized, managed, and delivered. Systematic reviews are the building blocks underlying evidence-based practice; they focus attention on the strength and limits of evidence from research studies about the effectiveness and safety of a clinical intervention. In the context of developing recommendations for practice, systematic reviews are useful because they define the strengths and limits of the evidence, clarifying whether assertions about the value of the intervention are based on strong evidence from clinical studies. For more information about systematic reviews, see www.effectivehealthcare.ahrq.gov/reference/purpose.cfm. AHRQ expects that CERs will be helpful to health plans, providers, purchasers, government  programs, and the health care system as a whole. In addition, AHRQ is committed to presenting information in different formats so that consumers who make decisions about their own and their family’s health can benefit from the evidence. Transparency and stakeholder input are essential to the Effective Health Care Program. Please visit the Web site (www.effectivehealthcare.ahrq.gov) to see draft research questions and reports or to join an email list to learn about new program products and opportunities for input. Comparative Effectiveness Reviews will be updated regularly. We welcome comments on this CER. They may be sent by mail to Beth Collins Sharp at: Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850, or by email to epc@ahrq.hhs.gov. Carolyn M. Clancy, M.D. Director Agency for Healthcare Research and Quality Stephanie Chang, M.D., M.P.H. Director, EPC Program Center for Outcomes and Evidence Agency for Healthcare Research and Quality Sonia Tyutyulkova, M.D., Ph.D. Task Order Officer Center for Outcomes and Evidence Agency for Healthcare Research and Quality Jean Slutsky, P.A., M.S.P.H. Director, Center for Outcomes and Evidence Agency for Healthcare Research and Quality Beth A. Collins Sharp, Ph.D., R.N. Task Order Officer, Center for Outcomes and Evidence Senior Advisor, Women's Health and Gender Research Agency for Healthcare Research and Quality   iv Acknowledgments The authors gratefully acknowledge the following individuals for their contributions to this  project: Ms. Annabritt Chisholm (article retrieval), Ms. Teodora Radisic (article retrieval), Mr. Ben Vandermeer (data analysis), and Ms. Andrea Milne (literature searching). We acknowledge Ms. Christine Ha, Ms. Elizabeth Sumamo Schellenberg, and Mr. Kai Wong for help in screening the gray literature. Technical Expert Panel John Davis, M.D. Research Professor, Gillman Professor Department of Psychiatry University of Illinois at Chicago Chicago, IL Lisa Dixon, M.D. Division Head, Department of Psychiatry University of Maryland School of Medicine Baltimore, MD Ken Duckworth, M.D. Medical Director  National Alliance on Mental Illness Arlington, VA Peter Jones, M.D. Head, Department of Psychiatry University of Cambridge Cambridge, UK Julie A. Kreyenbuhl, Pharm.D., Ph.D. Associate Professor Department of Psychiatry University of Maryland School of Medicine Baltimore, MD John H. Krystal, M.D. Chair, Department of Psychiatry Yale University School of Medicine  New Haven, CT  Peer Reviewers Jaime Hallak, M.D. Department of Neurology, Psychiatry and Psychological Medicine Ribeirão Preto Medical School University of São Paulo São Paulo, Brazil Stephen Marder, M.D. Professor Psychiatry and Biobehavioral Sciences University of California Los Angeles Los Angeles, CA David Osser, M.D. Associate Professor Department of Psychiatry Harvard Medical School Boston, MA Scot E. Purdon, Ph.D. Clinical Professor Department of Psychiatry University of Alberta Edmonton, Canada George Simpson, M.D. Department of Psychiatry and the Behavioral Sciences Keck School of Medicine University of Southern California Los Angeles, CA Donald M. Steinwachs, Ph.D. Professor, Health Policy and Management School of Hygiene and Public Health Johns Hopkins University Baltimore, MD   v First-Generation Versus Second-Generation Antipsychotics in Adults: Comparative Effectiveness Structured Abstract Objectives.  To compare individual first-generation antipsychotics (FGAs) with individual second-generation antipsychotics (SGAs) in adults (18 to 64 years) with schizophrenia, schizophrenia-related psychoses, or bipolar disorder, with a focus on core illness symptoms, functional outcomes, health care system utilization, and adverse events. Data Sources.  We conducted comprehensive searches in 10 electronic databases up to July 2011. We hand-searched conference proceedings, clinical trials registers, and reference lists of relevant studies. We contacted content experts and authors of relevant studies. Methods.  Two reviewers independently conducted study selection, assessed methodological quality, extracted data, and graded the strength of evidence. We conducted a descriptive analysis and performed meta-analyses when appropriate. Results.   We included 113 studies of schizophrenia (22 comparisons) and 11 studies of bipolar disorder (6 comparisons), and 1 study included both. Trials (n = 123) had an unclear (63 percent) or high (37 percent) risk of bias. Cohort studies (n = 2) had good methodological quality. Core illness symptoms (global ratings and total scores). For schizophrenia, clozapine was more efficacious than chlorpromazine based on the one reported scale. Results for haloperidol versus olanzapine were discordant, with olanzapine favored for one scale but no differences based on two other scales. Haloperidol was favored over quetiapine based on one of four scales reported.  No differences were found for haloperidol versus aripiprazole, clozapine, risperidone, and ziprasidone. For bipolar disorder, haloperidol was favored over ziprasidone on the one scale reported. No differences were observed for haloperidol versus aripiprazole, olanzapine, or risperidone. Functional outcomes and health care system utilization. Evidence came primarily from single studies and showed no differences between groups.  Adverse events.  No differences were found in mortality for chlorpromazine versus clozapine and haloperidol versus aripiprazole, or in metabolic syndrome for haloperidol versus olanzapine. The most frequently reported adverse events with significant differences were extrapyramidal symptoms; in most cases, the SGA had fewer extrapyramidal symptoms than haloperidol. Other outcomes. For schizophrenia, few differences were found across comparisons and outcomes. No differences were observed in health-related quality of life. For bipolar disorder, there were few comparisons or differences. Subgroups. The most common subgroups were race and treatment resistance. No notable differences were found compared with overall results. Conclusion.  Few differences of clinical importance for outcomes of effectiveness were found. Patient-important outcomes were rarely assessed. Data were sparse for the four key adverse events deemed a priori to be most clinically important. 

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