PMID- 34112520
OWN - NLM
STAT- MEDLINE
DCOM- 20210722
LR  - 20210922
IS  - 1942-5546 (Electronic)
IS  - 0025-6196 (Linking)
VI  - 96
IP  - 7
DP  - 2021 Jul
TI  - Frequently Reported Adverse Events With Smoking Cessation Medications: Post Hoc 
      Analysis of a Randomized Trial.
PG  - 1801-1811
LID - S0025-6196(20)31387-2 [pii]
LID - 10.1016/j.mayocp.2020.10.046 [doi]
AB  - 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.
CI  - Copyright (c) 2020 Mayo Foundation for Medical Education and Research. Published by 
      Elsevier Inc. All rights reserved.
FAU - Ebbert, Jon
AU  - Ebbert J
AD  - Department of Medicine, Mayo Clinic, Rochester, MN.
FAU - Jimenez-Ruiz, Carlos
AU  - Jimenez-Ruiz C
AD  - Smoking Cessation Service, Madrid, Spain.
FAU - Dutro, Michael P
AU  - Dutro MP
AD  - Medical Affairs, Pfizer Inc, New York, NY.
FAU - Fisher, Matt
AU  - Fisher M
AD  - Medical Affairs, Pfizer Inc, Madison, NJ.
FAU - Li, Jing
AU  - Li J
AD  - Biostatistics, Pfizer Inc, Madison, NJ.
FAU - Hays, J Taylor
AU  - Hays JT
AD  - Department of Medicine, Mayo Clinic, Rochester, MN. Electronic address: 
      hays.taylor@mayo.edu.
LA  - eng
SI  - ClinicalTrials.gov/NCT01456936
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210608
PL  - England
TA  - Mayo Clin Proc
JT  - Mayo Clinic proceedings
JID - 0405543
RN  - 0 (Smoking Cessation Agents)
RN  - 01ZG3TPX31 (Bupropion)
RN  - W6HS99O8ZO (Varenicline)
SB  - IM
CIN - Mayo Clin Proc. 2021 Sep;96(9):2494-2495. PMID: 34481604
CIN - Mayo Clin Proc. 2021 Sep;96(9):2495. PMID: 34481605
MH  - Adult
MH  - *Bupropion/administration & dosage/adverse effects
MH  - Drug Tapering/methods
MH  - *Drug-Related Side Effects and Adverse 
      Reactions/classification/diagnosis/etiology
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Outcome and Process Assessment, Health Care
MH  - Smoking/*drug therapy
MH  - Smoking Cessation/*methods
MH  - *Smoking Cessation Agents/administration & dosage/adverse effects
MH  - Tobacco Use Cessation Devices/*adverse effects
MH  - *Varenicline/administration & dosage/adverse effects
EDAT- 2021/06/12 06:00
MHDA- 2021/07/23 06:00
CRDT- 2021/06/11 05:50
PHST- 2020/04/21 00:00 [received]
PHST- 2020/09/23 00:00 [revised]
PHST- 2020/10/21 00:00 [accepted]
PHST- 2021/06/12 06:00 [pubmed]
PHST- 2021/07/23 06:00 [medline]
PHST- 2021/06/11 05:50 [entrez]
AID - S0025-6196(20)31387-2 [pii]
AID - 10.1016/j.mayocp.2020.10.046 [doi]
PST - ppublish
SO  - Mayo Clin Proc. 2021 Jul;96(7):1801-1811. doi: 10.1016/j.mayocp.2020.10.046. Epub 
      2021 Jun 8.