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Rates of 5 Common Antidepressant Side Effects Among New Adult and Adolescent Cases of Depression: a Retrospective US Claims Study

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Rates of 5 Common Antidepressant Side Effects Among New Adult and Adolescent Cases of Depression: a Retrospective US Claims Study Clinical Therapeutics/Volume 34, Number 1, 2012 Rates of 5 Common Antidepressant Side Effects Among New Adult and Adolescent Cases of Depression: A Retrospective US Claims Study Heather D. Anderson, PhD 1,2,3; Wilson D. Pace, MD 2,4; Anne M. Libby, PhD 1,2; David R. West, PhD 2; and Robert J. Valuck, PhD, RPh 1,2 1University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Denver, Colorado; 2University of Colorado School of Medicine, Denver, Colorado; 3University of Colorado School of Public Health, Denver, Colorado; and 4American Academy of Family Physicians, Leawood, Kansas ABSTRACT a new episode of depression who were initiated on anti- Background: Antidepressants are the first-line treat- depressant monotherapy within 30 days of diagnosis ment for depression, yet medication-related side effects (SSRI [66%], bupropion [14%], SNRI [12%], other may be associated with antidepressant discontinuation [8%]). The most common side effects were headache (up before reaching a period of exposure believed to result in to 17/1000 person-months of therapy in adults and ado- effectiveness. There is a gap in knowledge of the preva- lescents) and nausea (up to 7.2/1000 in adults, 9.3/1000 lence of side effects across commonly prescribed antide- in adolescents). Relative to adults receiving SSRIs, adults pressants and the effect of the type of antidepressant on receiving SNRIs had a higher risk of nausea (hazard ratio the likelihood of side effects in real-world clinical [HR] ϭ 1.26; 95%CI,1.05–1.51). Adults (HR ϭ 0.78; practice. 95% CI, 0.62–0.96) and adolescents (HR ϭ 0.43; 95% Objective: The aim of this study was to estimate and CI, 0.21–0.87) taking bupropion were less likely to ex- compare the prevalence of headaches, nausea or vomit- perience headaches compared with adults and adoles- ing, agitation, sedation, and sexual dysfunction among cents, respectively, taking an SSRI. Adolescents receiving patients diagnosed with depression who initiated mono- a tetracyclic were more likely to experience headaches therapy across different classes of antidepressants and to than adolescents receiving an SSRI (HR ϭ 3.16; 95%CI, estimate the effect of the type of antidepressant on the 1.13–8.84). likelihood of each of the 5 side effects. Conclusions: Prevalence and risk of the 5 side effects Methods: A retrospective cohort of patients aged Ն13 varied across types of antidepressants for both adults and who were newly diagnosed with depression and began adolescents. Results from this study were consistent with antidepressant monotherapy was created using LifeLink prior clinical trials, suggesting that variation in side effect managed care claims from 1998 to 2008. Antidepressant profiles exists in a more generalized managed care groups included selective serotonin reuptake inhibitors population. ( Clin Ther. 2012;34:113–123) © 2012 (SSRIs), serotonin-norepinephrine reuptake inhibitors Elsevier HS Journals, Inc. All rights reserved. (SNRIs), tricyclic antidepressants (TCAs), monoamine Key words: antidepressants, depression, side ef- oxidase inhibitors (MAOIs), bupropion, phenylpipera- fects, tolerability. zine, and tetracyclic antidepressants. Prevalence of headache, nausea or vomiting, agitation, sedation, and sexual dysfunction were compared across antidepres- INTRODUCTION sant groups. Propensity-adjusted Cox proportional haz- Major depressive disorder (MDD) is common in the ards regression was used to estimate the likelihood of United States, with lifetime prevalence estimated at each of the 5 side effects for each antidepressant group 16% for adults and 14% for adolescents, and 1-year compared with SSRIs, adjusted for demographic, clinical, and treatment characteristics. Accepted for publication November 16, 2011. Results: The study cohort included 40,017 patients doi:10.1016/j.clinthera.2011.11.024 (3617 adolescents, aged 13–18 years, and 36,400 adults, 0149-2918/$ - see front matter aged Ն19 years; mean age ϭ 45 years; 67% female) with © 2012 Elsevier HS Journals, Inc. All rights reserved. January 2012 113 Clinical Therapeutics prevalence estimated at 7% for adults and 13% for tients newly diagnosed with depression who were new adolescents.1,2 The disease is burdensome, evidenced users of antidepressants. Data were drawn from a large by its ranking as one of the leading causes of disability national database of integrated medical and pharmacy worldwide.3 The most common treatment for MDD is claims. Prevalence estimates and adjusted effects of an- a second-generation antidepressant medication, such tidepressant group on each of the 5 side effects were as selective serotonin reuptake inhibitors (SSRIs). 4–6 A stratified by adults and adolescents. recent study of depression diagnoses and treatment patterns reported that 86% to 90% of adult patients PATIENTS AND METHODS diagnosed with a new or recurrent episode of depres- Data Source and Study Population sion filled a prescription for an antidepressant within A new-user, open cohort design was implemented 30 days of their diagnoses; SSRIs were the most com- by searching 11 years of data (1998–2008) from a 7 monly filled antidepressant (54%–66%). large, commercially available national data source Antidepressant therapy is considered first-line treat- (IMS LifeLink Health Plan Claims Database) to iden- ment in the acute phase of depression in both adolescents tify a retrospective cohort of patients receiving an an- and adults, yet up to 68% of patients stop taking antide- tidepressant to treat a new episode of MDD. The Life- pressants within 3 months of their initiation and 54% do Link data source includes medical, specialty, facility, 8–11 not reach remission. Side effects are an important and pharmacy paid claims for Ͼ68 million covered 12–15 reason for discontinuing antidepressants. One lives from Ͼ102 managed care plans nationally. Pa- study conducted telephone surveys among 672 pa- tients in LifeLink are representative of the US commer- tients at 3 and 6 months after starting an SSRI for new cially insured population with regard to age and gen- or recurrent depression and reported that 43% discon- der; the distributions of age and gender among patients tinued their SSRI within 3 months because of an ad- in the LifeLink database are not significantly different verse effect; 27% discontinued using the SSRI by 6 from distributions in the 2000 US census. 21 Using months. Other studies have estimated that 15% to claims from the LifeLink database, adolescent (aged 30% of patients discontinue using their SSRI because 13–18 years) and adult (age Ն19 years) patients with 12,13 of side effects. new episodes of MDD were identified according to the There is evidence that various antidepressants have following criteria: (1) a claim indicating a primary or 16–20 differential tolerability profiles. One systematic secondary International Classification of Diseases, review reported that users of the SSRI fluvoxamine Ninth Revision, Clinical Modification (ICD-9-CM) di- experienced more gastrointestinal side effects than us- agnostic code of 296.2 or 296.3; (2) at least 90 days 20 ers of tricyclic antidepressants (TCAs). The same sys- without taking antidepressants before the MDD claim tematic review, however, reported no differences date; (3) at least 120 days without an MDD diagno- across antidepressants with respect to trial dropout sis(es) or receipt of psychotherapy services (2 or more due to side effects. Another meta-analysis of random- visits) before the MDD claim date; and (4) at least 180 ized, controlled trials reported fewer side effects days of continuous health plan eligibility before and among patients treated with fluoxetine compared with 210 days after the MDD claim date. These criteria are TCAs but not compared with other SSRIs.17 The ma- based on the Healthplan Employer Data Information jority of these studies comparing the tolerability of dif- System (HEDIS) criteria for defining and measuring ferent agents are based on efficacy trials or small clin- new episodes of depression, employed by the National ical studies, neither of which is generalizable to Committee for Quality Assurance (NCQA),22,23 and broader, nonspecific populations of depressed people. have been used by the authors in prior published Because the majority of what is known about anti- work.24–26 depressant side effect profiles comes from randomized For patients with Ͼ1 MDD episode during the study trials,6,17,18 little is known about how different antide- period, only the earliest episode was selected. Patients pressants compare with respect to side effect rates in who did not receive an antidepressant within 30 days real-world clinical practice. The objective of the cur- of their episode diagnosis date were excluded from the rent study was to measure and compare the prevalence study cohort. This resulted in a cohort of 40,017 pa- of 5 specific side effects (headache, nausea or vomiting, tients (36,400 adults, 3617 adolescents). The study agitation, sedation, and sexual dysfunction) among pa- was approved by the Colorado Multiple Institutional 114 Volume 34 Number 1 H.D. Anderson et al. Review Board and granted a waiver of consent owing therefore not treatment-emergent. For each patient to the unidentified and anonymous data. with a treatment-emergent side effect reported during the follow-up period, the first occurrence was identi- Antidepressant Treatment Groups fied and days to event were calculated. A composite The 6 antidepressant groups of interest for this variable indicating the occurrence of Ն1 of the 5 side study were based on the Agency for Healthcare Re- effects was also created. search and Quality (AHRQ) Comparative Effective- Demographic characteristics included age (in years, ness Report on Second-Generation Antidepressant at time of start of MDD episode), gender, region (West, Treatment of Adult Depression 8: SSRI, serotonin-nor- Midwest, East, and South), health plan type (HMO vs epinephrine reuptake inhibitor (SNRI), TCA, bupro- non-HMO), and Medicaid status (yes/no). Baseline pion, monoamine oxidase inhibitor (MAOI), phe- clinical characteristics included the Chronic Disease nylpiperazine (PP), and tetracyclic antidepressant.
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