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Report and Evidence Tables Drug Class Review on Second Generation Antidepressants Final Report Update 1 July 2005 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. Gerald Gartlehner, M.D., M.P.H. Richard A. Hansen, Ph.D. Leila Kahwati, M.D., M.P.H. Kathleen N. Lohr, Ph.D. Bradley Gaynes, M.D., M.P.H. Tim Carey, M.D., M.P.H. RTI-UNC Evidence-based Practice Center Cecil G. Sheps Center for Health Services Research University of North Carolina at Chapel Hill 725 Airport Road, CB# 7590 Chapel Hill, NC 27599-7590 Tim Carey, M.D., M.P.H., Director Copyright © 2005 by Oregon Health & Science University Portland, Oregon 97201. All rights reserved Final Report Update 1 Drug Effectiveness Review Project Table of Contents Introduction........................................................................................................................ 4 Overview................................................................................................................. 4 Scope and Key Questions ....................................................................................... 7 Methods............................................................................................................................... 9 Literature Search..................................................................................................... 9 Study Selection ....................................................................................................... 9 Data Abstraction ................................................................................................... 10 Quality Assessment............................................................................................... 11 Data Synthesis....................................................................................................... 11 Results ............................................................................................................................... 13 Overview............................................................................................................... 13 Key Question 1 ..................................................................................................... 15 Key Question 2: Adverse Events .......................................................................... 60 Key Question 3: Subgroups. ................................................................................. 71 References......................................................................................................................... 80 In-Text Tables Table 1: Approved Second-Generation Antidepressants........................................ 6 Table 2: Dosing Range and Frequency ................................................................... 7 Table 3: Outcomes and Eligibility Criteria............................................................. 8 Table 4: Abbreviations of Diagnostic Scales........................................................ 14 Table 5: Included Studies for Major Depressive Disorder ................................... 28 Table 6: Studies Indicating a Faster Onset of Mirtazapine................................... 30 Table 7: Studies Indicating Fewer Sexual Adverse Events with Bupropion ........ 31 Table 8: Studies Indicating a Better Sleep Profile with Nefazadone.................... 32 Table 9: Included Studies for Dysthymia ............................................................. 34 Table 10: Included Studies for Major Depressive Disorder in Children .............. 39 Table 11: Included Studies for Generalized Anxiety Disorder............................. 43 Table 12: Included Studies for Obsessive Compulsive Disorder ......................... 46 Table 13: Included Studies for Panic Disorder ..................................................... 49 Table 14: Included Studies for Post-Traumatic Stress Disorder........................... 51 Table 15: Included Studies for Social Anxiety Disorder ...................................... 56 Table 16: Included Studies for Premenstrual Dysphoric Disorder ....................... 59 Table 17: Mean Incidence of Specific Adverse Events ........................................ 63 Table 18: Included Studies for Adverse Events.................................................... 70 Table 19: Included Studies for Subgroups............................................................ 79 Exhibits Exhibit 1: Meta-analysis Fluoxetine-Paroxetine................................................. 100 Exhibit 2: Meta-analysis Fluoxetine-Sertraline .................................................. 102 Antidepressants: Second Generation Page 2 of 449 Final Report Update 1 Drug Effectiveness Review Project Exhibit 3: Meta-analysis Fluoxetine-Venlafaxine .............................................. 104 Exhibit 4: Meta-analysis of Discontinuation Rates............................................. 106 Figures Figure 1: Results of Literature Search ................................................................ 113 Evidence Tables Evidence Table 1: Major Depressive Disorder Adults ....................................... 115 Evidence Table 2: Dysthymia............................................................................. 221 Evidence Table 3: Major Depressive Disorder Pediatrics .................................. 229 Evidence Table 4: General Anxiety Disorder..................................................... 241 Evidence Table 5: Obsessive Compulsive Disorder........................................... 251 Evidence Table 6: Panic Disorder....................................................................... 269 Evidence Table 7: Post-Traumatic Stress Disorder ............................................ 281 Evidence Table 8: Social Anxiety Disorder........................................................ 293 Evidence Table 9: Premenstrual and Late Luteal Phase Dysphoric Disorder .... 317 Evidence Table 10: Adverse Events ................................................................... 329 Evidence Table 11: Subgroups ........................................................................... 378 Appendices Appendix A: Search Strategy.............................................................................. 416 Appendix B: Quality Criteria.............................................................................. 418 Appendix C: Excluded Studies ........................................................................... 422 Appendix D: Pharmacokinetic Properties and Drug Interactions....................... 425 Appendix E: Placebo-controlled trials (not included)......................................... 430 Appendix F: Abstract-only Studies (not included) ............................................. 448 Appendix G: Acknowledgements ....................................................................... 449 Many thanks to our abstractors Heather Himburg and Michaela Jones and to our supporting staff Leah Randolph, Laura Morgan, Diane Greer, and Susan Goulet. Antidepressants: Second Generation Page 3 of 449 Final Report Update 1 Drug Effectiveness Review Project INTRODUCTION A. Overview Axis I psychiatric disorders such as depressive disorder, anxiety disorder, adjustment disorder, and premenstrual disorders are serious disabling illnesses. Combined, they affect approximately one in five Americans.1 Major depressive disorder is the most prevalent, affecting more than 16 percent (lifetime) of US adults.2 In 2000, the economic burden of depressive disorders was estimated to be $83.1 billion.3 More than 30 percent of these costs were attributable to direct medical expenses. Pharmacotherapy dominates the medical management of Axis I psychiatric disease. Before the late 1980s, pharmacologic treatment was limited to tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs) (with the exception of premenstrual disorder, which historically was untreated). The TCAs and MAOIs sometimes are referred to as traditional or first-generation antidepressants. These drugs are often accompanied by multiple side effects that many patients find intolerable;e.g., TCAs tend to cause anticholinergic effects including dry mouth and eyes, urinary hesitancy, and sometimes retention and constipation and MAOIs have the potential to produce hypertensive crisis if taken along with certain foods or dietary supplements containing excessive amounts of tyramine. Thus, first-generation antidepressants are no longer agents of choice in many circumstances. Newer treatments include selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and other second-generation drugs. The first of the second-generation drugs was introduced to the US market in 1985, when bupropion was approved for the treatment of major depressive disorders. In 1987, the US Food and Drug Administration (FDA) approved the first SSRI, fluoxetine. Since then, five other SSRIs have been introduced: sertraline (1991), paroxetine (1992), citalopram (1999), fluvoxamine (2000), and escitalopram (2002). The SNRIs were first introduced to the market in 1993 with the approval of venlafaxine. In 1994, nefazodone, which is
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