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Adverse Effects of First-Line Pharmacologic Treatments of Major Depression in Older Adults

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Adverse Effects of First-Line Pharmacologic Treatments of Major Depression in Older Adults Draft Comparative Effectiveness Review Number xx Adverse Effects of First-line Pharmacologic Treatments of Major Depression in Older Adults Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857 www.ahrq.gov This information is distributed solely for the purposes of predissemination peer review. It has not been formally disseminated by the Agency for Healthcare Research and Quality. The findings are subject to change based on the literature identified in the interim and peer-review/public comments and should not be referenced as definitive. It does not represent and should not be construed to represent an Agency for Healthcare Research and Quality or Department of Health and Human Services (AHRQ) determination or policy. Contract No. 290-2015-00012I Prepared by: Will be included in the final report Investigators: Will be included in the final report AHRQ Publication No. xx-EHCxxx <Month, Year> ii Purpose of the Review To assess adverse events of first-line antidepressants in the treatment of major depressive disorder in adults 65 years or older. Key Messages • Acute treatment (<12 weeks) with o Serotonin norepinephrine reuptake inhibitors (SNRIs) (duloxetine, venlafaxine), but not selective serotonin reuptake inhibitors (SSRIs) (escitalopram, fluoxetine) led to a greater number of adverse events compared with placebo. o SSRIs (citalopram, escitalopram and fluoxetine) and SNRIs (duloxetine and venlafaxine) led to a greater number of patients withdrawing from studies due to adverse events compared with placebo o Details of the contributing adverse events in RCTs were rarely reported to more clearly characterize what adverse events to expect. • Acute and continuation treatment (24 weeks) with the SNRI duloxetine most likely increases the risk of falls. • Observational evidence suggested increased risk of adverse events (SSRIs), falls (SSRIs, SNRI venlafaxine, mirtazapine, trazadone), fractures (SSRIs, SNRI venlafaxine, mirtazapine), and mortality (SSRIs, SNRI venlafaxine, mirtazapine, trazadone), compared to no antidepressant. • RCT data is limited due to short duration and being underpowered. Observational studies were non-placebo comparison. Long term, rigorous comparative studies are needed. iii This report is based on research conducted by an Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. xxx-xxxx-xxxxx). 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. None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report. 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 is made available to the public under the terms of a licensing agreement between the author and the Agency for Healthcare Research and Quality. This report may be used and reprinted without permission except those copyrighted materials that are clearly noted in the report. Further reproduction of those copyrighted materials is prohibited without the express permission of copyright holders. AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies may not be stated or implied. This report may periodically be assessed for the currency of conclusions. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site at www.effectivehealthcare.ahrq.gov. Search on the title of the report. Persons using assistive technology may not be able to fully access information in this report. For assistance contact [email protected]. Suggested citation: Will be included in the final report iv Preface The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based Practice Centers (EPCs), sponsors the development of systematic reviews to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. These reviews provide comprehensive, science-based information on common, costly medical conditions, and new health care technologies and strategies. 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 can help clarify whether assertions about the value of the intervention are based on strong evidence from clinical studies. For more information about AHRQ EPC systematic reviews, see www.effectivehealthcare.ahrq.gov/reference/purpose.cfm AHRQ expects that these systematic reviews will be helpful to health plans, providers, purchasers, government programs, and the health care system as a whole. 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 e- mail list to learn about new program products and opportunities for input. If you have comments on this systematic review, they may be sent by mail to the Task Order Officer named below at: Agency for Healthcare Research and Quality, 5600 Fishers Lane, Rockville, MD 20857, or by email to [email protected]. Gopal Khanna MBA Arlene Bierman, M.D., M.S. Director Director Agency for Healthcare Research and Quality Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality Stephanie Chang, M.D., M.P.H. Aysegul Gozu, M.D., M.P.H. Director Task Order Officer Evidence-based Practice Center Program Center for Evidence and Practice Improvement Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality v Investigator Affiliations Will be added for the final report Acknowledgments The authors gratefully acknowledge the following individuals for their contributions to this project: will be added for the final report. Key Informants In designing the study questions, the EPC consulted several Key Informants who represent the end-users of research. The EPC sought the Key Informant input on the priority areas for research and synthesis. Key Informants are not involved in the analysis of the evidence or the writing of the report. Therefore, in the end, study questions, design, methodological approaches, and/or conclusions do not necessarily represent the views of individual Key Informants. Key Informants must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their role as end-users, individuals with potential conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any conflicts of interest. The list of Key Informants who provided input to this report follows: Will be added for the final report Technical Expert Panel In designing the study questions and methodology at the outset of this report, the EPC consulted several technical and content experts. Broad expertise and perspectives were sought. Divergent and conflicted opinions are common and perceived as healthy scientific discourse that results in a thoughtful, relevant systematic review. Therefore, in the end, study questions, design, methodologic approaches, and/or conclusions do not necessarily represent the views of individual technical and content experts. Technical Experts must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their unique clinical or content expertise, individuals with potential conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any potential conflicts of interest identified. The list of Technical Experts who provided input to this report follows: Will be added for the final report Peer Reviewers Prior to publication of the final evidence report, EPCs sought input from independent Peer Reviewers without financial conflicts of interest. However, the conclusions and synthesis of the scientific literature presented in this report does not necessarily represent the views of individual reviewers. Peer Reviewers must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their unique clinical or content vi
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