Frequently Reported Adverse Events With Smoking Cessation Medications: Post Hoc Analysis of a Randomized Trial.

Item request has been placed! ×
Item request cannot be made. ×
loading   Processing Request
Read More Add to Saved list
  • Additional Information
    • Source:
      Publisher: [Oxford, England] Country of Publication: England NLM ID: 0405543 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1942-5546 (Electronic) Linking ISSN: 00256196 NLM ISO Abbreviation: Mayo Clin Proc Subsets: MEDLINE
    • Publication Information:
      Publication: Jan. 2012- : [Oxford, England] : Elsevier
      Original Publication: Rochester, MN : Mayo Foundation for Medical Education and Research
    • Subject Terms:
      Bupropion*/administration & dosage ; Bupropion*/adverse effects ; Drug-Related Side Effects and Adverse Reactions*/classification ; Drug-Related Side Effects and Adverse Reactions*/diagnosis ; Drug-Related Side Effects and Adverse Reactions*/etiology ; Smoking Cessation Agents*/administration & dosage ; Smoking Cessation Agents*/adverse effects ; Varenicline*/administration & dosage ; Varenicline*/adverse effects; Smoking/*drug therapy ; Smoking Cessation/*methods ; Tobacco Use Cessation Devices/*adverse effects; Adult ; Drug Tapering/methods ; Female ; Humans ; Male ; Middle Aged ; Outcome and Process Assessment, Health Care
    • Abstract:
      Objective: To compare the incidence, severity, and clinical course of frequently reported adverse events (AEs) after treatment with smoking cessation pharmacotherapies.
      Methods: This was a multinational, multicenter, post hoc analysis of frequently reported treatment-emergent AEs from a large, phase 4, double-blind, randomized, triple-dummy, placebo-controlled trial (EAGLES), conducted between November 30, 2011, and January 13, 2015, that included smokers with and without psychiatric disorders (N=8144). Treatments were varenicline 1 mg twice daily, bupropion sustained-release 150 mg twice daily, and nicotine patch 21 mg once daily with tapering (12-week treatment, 12-week nontreatment follow-up), with incidence, time to onset, and duration of frequently reported AEs (≥5% of participants in any treatment group) measured. Risk differences for AEs for varenicline and bupropion vs nicotine patch were compared.
      Results: Across frequently reported AEs, nausea, insomnia, abnormal dreams, anxiety, irritability, dry mouth, fatigue, and application site pruritus differed significantly in active treatment vs placebo groups. Risk differences were as follows: for nausea with varenicline vs nicotine patch, 15.50% (95% CI, 13.20% to 17.80%); for insomnia with bupropion vs nicotine patch, 2.58% (CI, 0.65% to 4.51%); and for abnormal dreams with varenicline and bupropion vs nicotine patch, -2.49% (CI, -4.35% to -0.64%) and -5.60% (CI, -7.27% to -3.93%), respectively. Frequently reported AEs of severe intensity and treatment discontinuation were experienced by less than 1.5% and less than 3% of participants across all groups, respectively.
      Conclusion: Active treatments were well tolerated with comparable AE profiles. Most AEs are not clinically important, and prescribers can reassure patients that those experienced will be manageable.
      Trial Registration: Clinicaltrials.gov Identifier: NCT01456936.
      (Copyright © 2020 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)
    • Comments:
      Comment in: Mayo Clin Proc. 2021 Sep;96(9):2494-2495. (PMID: 34481604)
      Comment in: Mayo Clin Proc. 2021 Sep;96(9):2495. (PMID: 34481605)
    • Molecular Sequence:
      ClinicalTrials.gov NCT01456936
    • Accession Number:
      0 (Smoking Cessation Agents)
      01ZG3TPX31 (Bupropion)
      W6HS99O8ZO (Varenicline)
    • Publication Date:
      Date Created: 20210611 Date Completed: 20210722 Latest Revision: 20210922
    • Publication Date:
      20221213
    • Accession Number:
      10.1016/j.mayocp.2020.10.046
    • Accession Number:
      34112520