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High Throughput Pharmacovigilance Screening for Roflumilast Adverse Effects in Real-World Settings: A Sequence Symmetry Analysis
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  • Abdullah Abdelaziz,
  • Charles E. Gaber,
  • Preeti Gupta,
  • Todd A. Lee
Abdullah Abdelaziz
University of Illinois Chicago College of Pharmacy

Corresponding Author:[email protected]

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Charles E. Gaber
University of Illinois Chicago College of Pharmacy
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Preeti Gupta
University of Illinois Chicago College of Medicine
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Todd A. Lee
University of Illinois Chicago College of Pharmacy
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Abstract

Background Roflumilast is an add-on therapy for COPD following exacerbations, but real-world safety data in the U.S. is limited. Objective This study aimed to identify safety signals associated with roflumilast use through a high-throughput signal detection algorithm. Methods Using sequence symmetry analysis (SSA), we analyzed Marketscan databases for new roflumilast users (2011–2021). We screened for adverse effects across 211 therapeutic classes within 365 days of initiation. Sensitivity analyses were conducted by sex, age, and observation period. Crude and adjusted sequence ratios (cSR, aSR) were reported with 95% confidence intervals (CIs). Results Among 11,091 patients (53% aged 65+, 52% female), 19 safety signals were identified. Strong associations were observed with anti-thyroid agents (aSR, 3.62; 95% CI: 1.44–10.36), parathyroid hormones (aSR, 2.65; 95% CI: 1.33–5.51), and meglitinides (aSR, 2.43; 95% CI: 1.15–5.35). While many signals aligned with prior clinical trial data, novel associations with anti-thyroid and parathyroid agents were discovered. Conclusion In our study, we detected 19 safety signals for roflumilast, including notable associations with anti-thyroid agents and parathyroid hormones. Future investigations using more robust study designs are warranted to evaluate those signals.
09 Sep 2024Submitted to Basic & Clinical Pharmacology & Toxicology
10 Sep 2024Submission Checks Completed
10 Sep 2024Assigned to Editor
10 Sep 2024Review(s) Completed, Editorial Evaluation Pending
12 Sep 2024Reviewer(s) Assigned
21 Oct 2024Editorial Decision: Revise Major