Risk of hospitalized depression and intentional self-harm with brand and authorized generic sertraline.

Autor: Pennap DD; U.S. Food and Drug Administration Center for Drug Evaluation and Research, Division of Epidemiology I, Silver Spring MD, United States. Electronic address: dinci.pennap@fda.hhs.gov., Swain RS; U.S. Food and Drug Administration Center for Drug Evaluation and Research, Division of Epidemiology I, Silver Spring MD, United States., Welch EC; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston MA, United States., Bohn J; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston MA, United States., Lyons JG; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston MA, United States., Dutcher S; U.S. Food and Drug Administration Center for Drug Evaluation and Research, Regulatory Science Staff, Silver Spring MD, United States., Mosholder AD; U.S. Food and Drug Administration Center for Drug Evaluation and Research, Division of Epidemiology I, Silver Spring MD, United States.
Jazyk: angličtina
Zdroj: Journal of affective disorders [J Affect Disord] 2022 Jan 01; Vol. 296, pp. 635-641. Date of Electronic Publication: 2021 Oct 05.
DOI: 10.1016/j.jad.2021.09.088
Abstrakt: Background: Recent suggestions of therapeutic inequivalence of brand and generic sertraline have raised concerns about disproportionately higher adverse events among generic users.
Objective: To assess the impact of confounding in a comparison of the risks of worsening depression and intentional self-harm (ISH) between users of brand name sertraline and its pharmaceutically equivalent authorized generic (AG).
Methods: Using a retrospective new-user cohort design, we identified patients with a diagnosis code for depression aged ≥12 years who were continuously enrolled in a Sentinel Data Partner health plan for ≥180 days before their first sertraline dispensing between June 30, 2006 and September 30, 2015. New use was defined as no evidence of sertraline dispensing in the 180 days before index date. We matched each brand name user to up to 10 AG users using propensity scores (PS) and conducted case-centered logistic regression to assess the risks of hospitalized depression and ISH.
Results: Before PS matching, brand name users were significantly less likely to be hospitalized for depression [Hazard Ratio (HR) = 0.70 (95% confidence interval (CI): 0.53-0.94)]. However, in the matched analysis, we observed no statistical difference between brand and AG users [HR = 0.84 (95% CI: 0.59-1.21)]. The risk of ISH did not significantly differ between the exposure groups in unmatched (HR = 0.99 (95% CI: 0.60-1.62) and matched analyses [HR = 0.91 (95% CI: 0.49-1.70).
Conclusion: In depressed patients receiving brand versus AG sertraline, patient characteristics confounded the association with hospitalization. Baseline differences were ameliorated by PS matching resulting in no statistical difference between brand and AG sertraline users.
(Copyright © 2021. Published by Elsevier B.V.)
Databáze: MEDLINE
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