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Current Drug Safety

Editor-in-Chief

ISSN (Print): 1574-8863
ISSN (Online): 2212-3911

Research Article

Pharmacovigilance Assessment of Cardiac Implications of Nicotine Replacement Therapy Among Smokers

Author(s): Oluwafemi Olawuyi * and Kathleen Mathieson

Volume 15, Issue 3, 2020

Page: [173 - 180] Pages: 8

DOI: 10.2174/1574886315666200611135800

Price: $65

Abstract

Purpose: The purpose of this quantitative comparative study was to examine the possible relationship between nicotine replacement therapy (NRT) and cardiac disorder risk by comparing the rates of cardiac disorder risk of NRT with cardiac disorder risk of non-replacement drugs among smokers seeking smoking cessation.

Methods: The study used retrospective quantitative design, which involved the collection of secondary data from the adverse event reporting system (FAERS) database of the U.S Food and Drug Administration (FDA). Rates of cardiac disorder were compared between the NRT group and non- NRT (varenicline and bupropion) group. Statistical analyses involved using a 2x2 contingency table and logistic regression to calculate odds ratio (reporting odds ratio (ROR)).

Results and Discussion: Unadjusted ROR was 0.45 (95% confidence interval [CI] 0.28, 0.70). With age and sex as confounding factors, the smokers in the NRT group still had lower odds of having cardiac disorder risk than the non-NRT group (adjusted ROR=0.44, 95% CI 0.28, 0.70).

Conclusion: Our study findings showed lower cardiac disorder risk with the NRT group compared to the non-NRT (varenicline and bupropion) group. While the study did not aim to undermine either using NRT or non-NRT for smoking cessation therapy to prevent smoking illness, the study results offer informed findings that could potentially improve current smoking cessation management using NRT intervention among smokers and enhance smokers’ health outcome. Despite the negative signal detection of cardiac disorder risk with NRT as compared to non-NRT in final findings, we still recommend further research on the causal relationship between NRT and non-NRT and cardiac disorder risk.

Keywords: Nicotine replacement therapy, nicotine, varenicline, bupropion, Non-NRT, smoking cessation, cardiac disorder.

Graphical Abstract

[1]
Nicotine replacement therapy for quitting tobacco. American Cancer Society 2017. Jan 12 [cited: 10 September 2019 Available from: https://www.cancer.org/healthy/stay-away-from-tobacco/guide-quitting-smoking/nicotine-replacement-therapy.html
[2]
Apelberg BJ, Onicescu G, Avila-Tang E, Samet JM. Estimating the risks and benefits of nicotine replacement therapy for smoking cessation in the United States. Am J Public Health 2010; 100(2): 341-8.
[http://dx.doi.org/10.2105/AJPH.2008.147223] [PMID: 20019322]
[3]
Baker TB, Piper ME, Stein JH, et al. Effects of nicotine patch vs. varenicline vs. combination nicotine replacement therapy on smoking cessation at 26 weeks: A randomized clinical trial. JAMA 2016; 315(4): 371-9.
[http://dx.doi.org/10.1001/jama.2015.19284] [PMID: 26813210]
[4]
Benowitz NL, Burbank AD. Cardiovascular toxicity of nicotine: Implications for electronic cigarette use. Trends Cardiovasc Med 2016; 26(6): 515-23.
[http://dx.doi.org/10.1016/j.tcm.2016.03.001] [PMID: 27079891]
[5]
Böhm R, von Hehn L, Herdegen T, et al. OpenVigil FDA - Inspection of U.S. American adverse drug events pharmacovigilance data and novel clinical applications. PLoS One 2016; 11(6)e0157753
[http://dx.doi.org/10.1371/journal.pone.0157753] [PMID: 27326858]
[6]
Heart disease facts. Centers for disease control and prevention 2017. [cited: 10 September 2019 Available from: https://www.cdc.gov/heartdisease/facts.htm
[7]
Using nicotine replacement therapy. Centers for disease control and prevention 2018. Sep 17; [cited: 10 September 2019]. Available from: https://www.cdc.gov/tobacco/campaign/tips/quit-smoking/guide/explore-medications.html
[8]
Dollerup J, Vestbo J, Murray-Thomas T, et al. Cardiovascular risks in smokers treated with nicotine replacement therapy: A historical cohort study. Clin Epidemiol 2017; 9: 231-43.
[http://dx.doi.org/10.2147/CLEP.S127775] [PMID: 28490903]
[9]
Find Drugs & Conditions. Available from: https://www.drugs.com/
[10]
Elizabeth P, Myra S. Effective ways of supporting patients to stop smoking. Prescriber 2017; 2: 14-20.
[11]
Filion KB, Dell’Aniello S, Eberg M, et al. Varenicline and the risk of adverse cardiovascular events: A population-based cohort study. Circulation 2014; 129(Suppl. 1): 1-2.
[12]
Comparison of pharmacokinetic profiles of two nicotine gum formulations. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). Identifier NCT01847443 2014. [cited: 10 September 2019]. Available from: https://ClinicalTrials.gov/show/NCT01847443
[13]
Hartmann-Boyce J, Chepkin SC, Ye W, Bullen C, Lancaster T. Nicotine replacement therapy versus control for smoking cessation Cochrane Database Syst Rev 2018; 5CD000146
[http://dx.doi.org/10.1002/14651858.CD000146.pub5] [PMID: 29852054]
[14]
Ibrahim H, Saad A, Abdo A, Sharaf Eldin A. Mining association patterns of drug-interactions using post marketing FDA’s spontaneous reporting data. J Biomed Inform 2016; 60: 294-308.
[http://dx.doi.org/10.1016/j.jbi.2016.02.009] [PMID: 26903152]
[15]
Keto J, Ventola H, Jokelainen J, et al. Cardiovascular disease risk factors in relation to smoking behaviour and history: A population-based cohort study. Open Heart 2016; 3(2)e000358
[http://dx.doi.org/10.1136/openhrt-2015-000358] [PMID: 27493759]
[16]
Kotz D, Viechtbauer W, Simpson C, van Schayck OC, West R, Sheikh A. Cardiovascular and neuropsychiatric risks of varenicline: A retrospective cohort study. Lancet Respir Med 2015; 3(10): 761-8.
[http://dx.doi.org/10.1016/S2213-2600(15)00320-3] [PMID: 26355008]
[17]
Kress CM, Obi NU, Prochazka AV. In smokers with COPD, neither varenicline nor bupropion was linked to increased CV or neuropsychiatric risk vs. NRT. Ann Intern Med 2017; 167(6): JC31.
[http://dx.doi.org/10.7326/ACPJC-2017-167-6-031] [PMID: 28975321]
[18]
Lee PN, Fariss MW. A systematic review of possible serious adverse health effects of nicotine replacement therapy. Arch Toxicol 2017; 91(4): 1565-94.
[http://dx.doi.org/10.1007/s00204-016-1856-y] [PMID: 27699443]
[19]
ClinicalTrials.gov. [Internet]. Bethesda (MD): National Library of Medicine (US). 2014 May 19 - . Identifier NCT00939029. High dose nicotine patch therapy for smokeless tobacco use 2014. [cited: 10 September 2019]. Available from: https://ClinicalTrials.gov/show/NCT00939029
[20]
Mathew TP, Herity NA. Acute myocardial infarction soon after nicotine replacement therapy. QJM 2001; 94(9): 503-4.
[http://dx.doi.org/10.1093/qjmed/94.9.503] [PMID: 11528015]
[21]
Meigs J. Approach to evaluating nicotine replacement therapies 2018. [cited: 10 September 2019]. Available from: https://www.aafp.org/dam/AAFP/documents/advocacy/prevention/tobacco/LT-FDA-NRT-020718.pdf
[22]
ClinicalTrials.gov. [Internet]. Bethesda (MD): National Library of Medicine (US). 2017 May 19 - . Identifier NCT01791803, Smoking cessation after hospitalization for a cardiopulmonary illness 2017. [cited: 10 September 2019]. Available from: https://ClinicalTrials.gov/show/NCT01791803
[23]
Ong JC, Crawford MR. Insomnia and obstructive sleep apnea. Sleep Med Clin 2013; 8(3): 389-98.
[http://dx.doi.org/10.1016/j.jsmc.2013.04.004] [PMID: 24015117]
[24]
Ottervanger JP, Festen JM, de Vries AG, Stricker BH. Acute myocardial infarction while using the nicotine patch. Chest 1995; 107(6): 1765-6.
[http://dx.doi.org/10.1378/chest.107.6.1765] [PMID: 7781384]
[25]
Peace KE, Okwuokenye M. Monitoring for adverse events post marketing approval of a drug Int J Allergy Med 2015; 1(2)
[http://dx.doi.org/10.23937/2572-3308.1510010]
[26]
Ryan MP, Hinojosa JJ. Conceptual obstacles to making use of four smoking-cessation strategies: What reasons do light smokers give for rejecting strategies? Health Psychol Open 2015; 2(2)2055102915624928
[http://dx.doi.org/10.1177/2055102915624928] [PMID: 28070381]
[27]
Sakaeda T, Tamon A, Kadoyama K, Okuno Y. Data mining of the public version of the FDA adverse event reporting system. Int J Med Sci 2013; 10(7): 796-803.
[http://dx.doi.org/10.7150/ijms.6048] [PMID: 23794943]
[28]
Samet JM. Smoking cessation: Benefits versus risks of using pharmacotherapy to quit. Circulation 2014; 129(1): 8-10.
[http://dx.doi.org/10.1161/CIRCULATIONAHA.113.006928] [PMID: 24323794]
[29]
Sharma S, Culebras A. Sleep apnoea and stroke. Stroke Vasc Neurol 2016; 1(4): 185-91.
[http://dx.doi.org/10.1136/svn-2016-000038] [PMID: 28959482]
[30]
Sobieraj DM, White WB, Baker WL. Cardiovascular effects of pharmacologic therapies for smoking cessation. J Am Soc Hypertens 2013; 7(1): 61-7.
[http://dx.doi.org/10.1016/j.jash.2012.11.003] [PMID: 23266101]
[31]
ClinicalTrials.gov. [Internet]. Bethesda (MD): National Library of Medicine (US). Identifier NCT01048944, Nicotine replacement therapy (NRT) and bupropion mechanisms of effectiveness in smokers 2014. [cited: 10 September 2019]. Available from: https://ClinicalTrials.gov/show/NCT01048944
[32]
Swank KA, Wu E, Kortepeter C, McAninch J, Levin RL. Adverse event detection using the FDA post-marketing drug safety surveillance system: Cardiotoxicity associated with loperamide abuse and misuse. J Am Pharm Assoc (2003) 2017; 57(2S): S63-7.
[http://dx.doi.org/10.1016/j.japh.2016.11.011] [PMID: 28073687]
[33]
ClinicalTrials.gov. [Internet]. Bethesda (MD): National Library of Medicine (US). Identifier NCT02148445, Smoking cessation versus long-term nico tine replacement among high-risk smokers 2017. [cited: 10 September 2019]. Available from: https://ClinicalTrials.gov/show/NCT02148445
[34]
ClinicalTrials.gov. [Internet]. Bethesda (MD): National Library of Medicine (US). Identifier NCT00956943, Assessment of high dose transdermal nicotine for fast metabolizers of nicotine 2014. [cited: 10 September 2019]. Available from: https://ClinicalTrials.gov/show/NCT00956943
[35]
The health consequences of smoking—50 years of progress: A report of the surgeon gen-eral. U.S. Department of health and human services 2014. [cited: 10 September 2019]. Available from: https://www.surgeongeneral.gov/library/reports/50-years-of-progress/full-report.pdf
[36]
Potential signals of serious risks/new safety information identified by the FDA Adverse Event Reporting System (FAERS). Food and Drug Administration 2017. [cited: 10 September 2019]. Available from: https://www.fda.gov/drugs/fda-adverse-event-reporting-system-faers/potential-signals-serious-risksnew-safety-information-identified-fda-adverse-event-reporting-system-14
[37]
How consumers can report an adverse event or serious problem to FDA. U.S. Food and Drug Administration 2018. Jan 10. [cited: 10 September 2019]. Available from: https://www.fda.gov/safety/reporting-serious-problems-fda/how-consumers-can-report-adverse-event-or-serious-problem-fda
[38]
RxNav. US National Library of Medicine [cited: 10 September 2019]. Available from: https://mor.nlm.nih.gov/RxNav/
[39]
Wadgave U, Nagesh L. Nicotine replacement therapy: An overview. Int J Health Sci (Qassim) 2016; 10(3): 425-35.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5003586/
[http://dx.doi.org/10.12816/0048737] [PMID: 27610066]
[40]
Zhao‐Wong A. Applying MedDRA in clinical safety and pharmacovigilance. 5th DIA China annual meeting patient safety - A sustained focus from scientific ideas to innovative Medicines 2013. Available from: https://www.meddra.org/sites/default/files/page/documents_insert/dia_china_meddra_workshop_zhao-wong_20130412.pdf

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