88
Views
1
CrossRef citations to date
0
Altmetric
Original Research

Safety and Effectiveness of Varenicline in Korean Smokers: A Nationwide Post-Marketing Surveillance Study

ORCID Icon, & ORCID Icon
Pages 413-426 | Published online: 15 Feb 2022

References

  • Iribarren C, Tekawa IS, Sidney S, Friedman GD. Effect of cigar smoking on the risk of cardiovascular disease, chronic obstructive pulmonary disease, and cancer in men. N Engl J Med. 1999;340(23):1773–1780. doi:10.1056/NEJM199906103402301
  • Reitsma MB, Fullman N, Ng M, et al. Smoking prevalence and attributable disease burden in 195 countries and territories, 1990–2015: a systematic analysis from the Global Burden of Disease Study 2015. Lancet. 2017;389(10082):1885–1906. doi:10.1016/S0140-6736(17)30819-X
  • Hong JW, Noh JH, Kim DJ. The prevalence of and factors associated with urinary cotinine-verified smoking in Korean adults: the 2008–2011 Korea National Health and Nutrition Examination Survey. PLoS One. 2018;13(6):e0198814. doi:10.1371/journal.pone.0198814
  • Prochaska JJ, Benowitz NL. The past, present, and future of nicotine addiction therapy. Annu Rev Med. 2016;67:467–486. doi:10.1146/annurev-med-111314-033712
  • Tonstad S, Tonnesen P, Hajek P, Williams KE, Billing CB, Reeves KR; for Varenicline Phase 3 Study Group. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA. 2006;296(1):64–71. doi:10.1001/jama.296.1.64
  • Treating tobacco use and dependence: 2008 update: clinical practice guideline. Rockville, MD: US Department of Health and Human Services, Public Health Service. Available from: https://www.ahrq.gov/professionals/clinicians-providers/guidelines-recommendations/tobacco/index.html. Accessed October 6, 2021.
  • Fagerström K, Hughes J. Varenicline in the treatment of tobacco dependence. Neuropsychiatr Dis Treat. 2008;4(2):353–363. doi:10.2147/NDT.S927
  • Garrison GD, Dugan SE. Varenicline: a first-line treatment option for smoking cessation. Clin Ther. 2009;31(3):463–491. doi:10.1016/j.clinthera.2009.03.021
  • Fagerström K, Nakamura M, Cho HJ, et al. Varenicline treatment for smoking cessation in Asian populations: a pooled analysis of placebo-controlled trials conducted in six Asian countries. Curr Med Res Opin. 2010;26(9):2165–2173. doi:10.1185/03007995.2010.505130
  • Wang C, Cho B, Xiao D, Wajsbrot D, Park PW. Effectiveness and safety of varenicline as an aid to smoking cessation: results of an inter-Asian observational study in real-world clinical practice. Int J Clin Pract. 2013;67(5):469–476. doi:10.1111/ijcp.12121
  • Anthenelli RM, Benowitz NL, West R, et al. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet. 2016;387(10037):2507–2520. doi:10.1016/S0140-6736(16)30272-0
  • Jordan CJ, Xi ZX. Discovery and development of varenicline for smoking cessation. Expert Opin Drug Discov. 2018;13(7):671–683. doi:10.1080/17460441.2018.1458090
  • Pasternak B, Svanstrom H, Hviid A. Use of varenicline versus bupropion and risk of psychiatric adverse events. Addiction. 2013;108(7):1336–1343. doi:10.1111/add.12165
  • Thomas KH, Martin RM, Knipe DW, Higgins JP, Gunnell D. Risk of neuropsychiatric adverse events associated with varenicline: systematic review and meta-analysis. BMJ. 2015;350:h1109. doi:10.1136/bmj.h1109
  • Vlahović-Palčevski V, Mentzer D. Postmarketing surveillance. Handb Exp Pharmacol. 2011;205:339–351.
  • Food and Drug Administration FDA Drug Safety Communication. Safety review update of Chantix (varenicline) and risk of neuropsychiatric adverse events. Available from: http://www.fda.gov/Drugs/DrugSafety/ucm276737.htm. Accessed October 6, 2021.
  • Food and Drug Administration FDA Drug Safety Communication. Safety review update of Chantix (varenicline) and risk of cardiovascular adverse events. Available from: http://www.fda.gov/Drugs/DrugSafety/ucm330367.htm. Accessed October 6, 2021.
  • Thomas KH, Martin RM, Davies NM, Metcalfe C, Windmeijer F, Gunnell D. Smoking cessation treatment and risk of depression, suicide, and self harm in the Clinical Practice Research Datalink: prospective cohort study. BMJ. 2013;347:f5704. doi:10.1136/bmj.f5704
  • Singh S, Loke YK, Spangler JG, Furberg CD. Risk of serious adverse cardiovascular events associated with varenicline: a systematic review and meta-analysis. CMAJ. 2011;183(12):1359–1366. doi:10.1503/cmaj.110218
  • Prochaska JJ, Hilton JF. Risk of cardiovascular serious adverse events associated with varenicline use for tobacco cessation: systematic review and meta-analysis. BMJ. 2012;344:e2856. doi:10.1136/bmj.e2856
  • Mills EJ, Thorlund K, Eapen S, Wu P, Prochaska JJ. Cardiovascular events associated with smoking cessation pharmacotherapies: a network meta-analysis. Circulation. 2014;129(1):28–41. doi:10.1161/CIRCULATIONAHA.113.003961
  • Xiao D, Chu S, Wang C. Smoking cessation in Asians: focus on varenicline. Patient Prefer Adherence. 2015;9:579–584. doi:10.2147/PPA.S60785
  • Williams KE, Reeves KR, Billing CB, Pennington AM, Gong J. A double-blind study evaluating the long-term safety of varenicline for smoking cessation. Curr Med Res Opin. 2007;23(4):793–801. doi:10.1185/030079907X182185
  • Evins AE, Cather C, Pratt SA, et al. Maintenance treatment with varenicline for smoking cessation in patients with schizophrenia and bipolar disorder: a randomized clinical trial. JAMA. 2014;311(2):145–154. doi:10.1001/jama.2013.285113
  • Hughes JR, Rennard SI, Fingar JR, Talbot SK, Callas PW, Fagerstrom KO. Efficacy of varenicline to prompt quit attempts in smokers not currently trying to quit: a randomized placebo-controlled trial. Nicotine Tob Res. 2011;13(10):955–964. doi:10.1093/ntr/ntr103
  • Ebbert JO, Hughes JR, West RJ, et al. Effect of varenicline on smoking cessation through smoking reduction: a randomized clinical trial. JAMA. 2015;313(7):687–694. doi:10.1001/jama.2015.280
  • Friend KB, Pagano ME. Smoking cessation and alcohol consumption in individuals in treatment for alcohol use disorders. J Addict Dis. 2005;24(2):61–75. doi:10.1300/J069v24n02_06
  • Pyo J, Ock M, Lee JW, Han YJ, Jo MW, Lee JA. Experience of smoking cessation treatment program in Korea: results from a qualitative study. Health Policy Manag. 2017;27(4):284–295.
  • Ioakeimidis N, Georgakopoulos C, Emmanouil E, et al. Effect of smoking cessation with varenicline on blood pressure control in hypertensive patients. Eur Heart J. 2020;41(Suppl 2):ehaa946.3019. doi:10.1093/ehjci/ehaa946.3019
  • Pezzuto A, Carico E. Effectiveness of smoking cessation in smokers with COPD and nocturnal oxygen desaturation: functional analysis. Clin Respir J. 2020;14(1):29–34. doi:10.1111/crj.13096
  • Pezzuto A, D’Ascanio M, Grieco A, Ricci A. Functional benefit of smoking cessation in severe COPD patients undergoing bronchial valve implantation. Eur J Intern Med. 2019;68:55–59. doi:10.1016/j.ejim.2019.07.032
  • Tashkin DP, Murray RP. Smoking cessation in chronic obstructive pulmonary disease. Respir Med. 2009;103(7):963–974. doi:10.1016/j.rmed.2009.02.013
  • Tonstad S, Lawrence D. Varenicline in smokers with diabetes: a pooled analysis of 15 randomized, placebo-controlled studies of varenicline. J Diabetes Investig. 2017;8(1):93–100. doi:10.1111/jdi.12543
  • Gonzales D, Rennard SI, Nides M, et al. Varenicline, an α4β2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006;296(1):47–55. doi:10.1001/jama.296.1.47
  • Jorenby DE, Hays JT, Rigotti NA, et al.; for Varenicline Phase 3 Study Group. Efficacy of varenicline, an α4β2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006;296(1):56–63. doi:10.1001/jama.296.1.56
  • Aubin HJ, Bobak A, Britton JR, et al. Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. Thorax. 2008;63(8):717–724. doi:10.1136/thx.2007.090647
  • Liberman JN, Lichtenfeld MJ, Galaznik A, et al. Adherence to varenicline and associated smoking cessation in a community-based patient setting. J Manag Care Pharm. 2013;19(2):125–131. doi:10.18553/jmcp.2013.19.2.125
  • Kim H, Oh JK, Lim MK, Jeong BY, Yun EH, Park EY. The national “smoking cessation clinics” program in the Republic of Korea: socioeconomic status and age matter. Asian Pac J Cancer Prev. 2013;14(11):6919–6924. doi:10.7314/APJCP.2013.14.11.6919