Treatment with bupropion and varenicline for smoking cessation and the risk of acute cardiovascular events and injuries: A Swedish case-crossover study

Nicotine and Tobacco Research

Volumn 20, Issue 5, 2018, Pages 606-613

  Monárrez Espino, Joel ^a   Galanti, Maria Rosaria ^a,b   Hansson, Jenny ^a   Janszky, Imre ^c,d   Söderberg Löfdal, Karin ^a,e   Möller, Jette ^a  

^a KAROLINSKA INSTITUTE   (Sweden)

^b STOCKHOLM COUNTY COUNCIL   (Sweden)

^c NORWEGIAN UNIVERSITY OF SCIENCE AND TECHNOLOGY   (Norway)

^d TRONDHEIM UNIVERSITY HOSPITAL   (Norway)

^e KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

AMFEBUTAMONE; VARENICLINE;

ADULT; AGED; ARTICLE; BRAIN ISCHEMIA; CASE CONTROL STUDY; CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG SAFETY; FALLING; FEMALE; HEART INFARCTION; HIGH RISK POPULATION; HUMAN; MAJOR CLINICAL STUDY; MALE; POPULATION RESEARCH; PRACTICE GUIDELINE; PRESCRIPTION; PRIORITY JOURNAL; SIDE EFFECT; SMOKING CESSATION; SUICIDE; SUICIDE ATTEMPT; SWEDEN; TRAFFIC ACCIDENT; ADVERSE EVENT; CARDIOVASCULAR DISEASE; INJURY; PROCEDURES; TOBACCO DEPENDENCE; WITHDRAWAL SYNDROME;

ACCIDENTAL FALLS; ACCIDENTS, TRAFFIC; ADULT; BUPROPION; CARDIOVASCULAR DISEASES; CROSS-OVER STUDIES; HUMANS; SMOKING CESSATION; SMOKING CESSATION AGENTS; SUBSTANCE WITHDRAWAL SYNDROME; SUICIDE, ATTEMPTED; SWEDEN; TOBACCO USE DISORDER; VARENICLINE; WOUNDS AND INJURIES;

EID: 85045523892     PISSN: 14622203     EISSN: 1469994X     Source Type: Journal    
DOI: 10.1093/ntr/ntx131     Document Type: Article

References (50)

1. Benowitz NL. Pharmacology of nicotine: addiction, smoking-induced disease, and therapeutics. Annu Rev Pharmacol Toxicol. 2009;49:57-71.
2. Xi ZX. Preclinical Pharmacology, Efficacy and Safety of Varenicline in Smoking Cessation and Clinical Utility in High Risk Patients. Drug Healthc Patient Saf. 2010;2010(2):39-48.
3. Richmond R, Zwar N. Review of bupropion for smoking cessation. Drug Alcohol Rev. 2003;22(2):203-220.
4. Wilkes S. The use of bupropion SR in cigarette smoking cessation. Int J Chron Obstruct Pulmon Dis. 2008;3(1):45-53.
5. Ebbert JO, Wyatt KD, Hays JT, Klee EW, Hurt RD. Varenicline for smoking cessation: efficacy, safety, and treatment recommendations. Patient Prefer Adherence. 2010;4:355-362.
6. Cahill K, Stevens S, Perera R, Lancaster T. Pharmacological interventions for smoking cessation: an overview and network meta-analysis. Cochrane Database Syst Rev. 2013;5:CD009329.
7. Farmaceutiska Specialiteter i Sverige (Medicines Compendium for healthcare professionals). Zyban.http://www.fass.se/LIF/product?userType=2&nplId=20000519000014. Accessed February 15, 2017.
8. Rollema H, Chambers LK, Coe JW, et al. Pharmacological profile of the alpha4beta2 nicotinic acetylcholine receptor partial agonist varenicline, an effective smoking cessation aid. Neuropharmacology. 2007;52(3):985-994.
9. Farmaceutiska Specialiteter i Sverige (Medicines Compendium for healthcare professionals). Champix. www.fass.se/LIF/product?userType=2&nplId=20060105000057. Accessed February 15, 2017.
10. Mills EJ, Thorlund K, Eapen S, Wu P, Prochaska JJ. Cardiovascular events associated with smoking cessation pharmacotherapies: a network metaanalysis. Circulation. 2014;129(1):28-41.
11. United States Food and Drug Administration. FDA Drug Safety Communication: Safety Review Update of Chantix (Varenicline) and Risk of Cardiovascular Adverse Events; 2012.http://www.fda.gov/Drugs/DrugSafety/ucm330367.htm. Accessed: June 7, 2017.
12. 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.
13. Boshier A, Wilton LV, Shakir SA. Evaluation of the safety of bupropion (Zyban) for smoking cessation from experience gained in general practice use in England in 2000. Eur J Clin Pharmacol. 2003;59(10):767-773.
14. Hubbard R, Lewis S, West J, et al. Bupropion and the risk of sudden death: a self-controlled case-series analysis using The Health Improvement Network. Thorax. 2005;60(10):848-850.
15. Beyens MN, Guy C, Mounier G, Laporte S, Ollagnier M. Serious adverse reactions of bupropion for smoking cessation: analysis of the French Pharmacovigilance Database from 2001 to 2004. Drug Saf. 2008;31(11):1017-1026.
16. Medicines and Healthcare Products Regulatory Agency. Varenicline: adverse psychiatric reactions, including depression. Drug Saf. Updat. 2008;2(4):2-3.
17. United States Food and Drug Administration. Information for healthcare professionals: varenicline and bupropion. FDA Drug Saf. Newsl. 2009;2:1.
18. 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.
19. Gibbons RD, Mann JJ. Varenicline, smoking cessation, and neuropsychiatric adverse events. Am J Psychiatry. 2013;170(12):1460-1467.
20. Gunnell D, Irvine D, Wise L, Davies C, Martin RM. Varenicline and suicidal behaviour: a cohort study based on data from the General Practice Research Database. BMJ. 2009;339:b3805.
21. Kasliwal R, Wilton LV, Shakir SA. Safety and drug utilization profile of varenicline as used in general practice in England: interim results from a prescription-event monitoring study. Drug Saf. 2009;32(6):499-507.
22. Harrison-Woolrych M, Ashton J. Psychiatric adverse events associated with varenicline: an intensive postmarketing prospective cohort study in New Zealand. Drug Saf. 2011;34(9):763-772.
23. United States Food and Drug Administration. FDA Drug Safety Communication: Safety review update of Chantix (varenicline) and risk of neuropsychiatric adverse events. US FDA 2011. www.fda.gov/Drugs/DrugSafety/ucm276737.htm. Accessed June 7, 2017.
24. Maclure M. The case-crossover design: a method for studying transient effects on the risk of acute events. Am J Epidemiol. 1991;133(2):144-153.
25. Maclure M, Mittleman MA. Should we use a case-crossover design? Annu Rev Public Health. 2000;21:193-221.
26. Delaney JA, Suissa S. The case-crossover study design in pharmacoepidemiology. Stat Methods Med Res. 2009;18(1):53-65.
27. Maclure M, Fireman B, Nelson JC, et al. When should case-only designs be used for safety monitoring of medical products? Pharmacoepidemiol Drug Saf. 2012;21 Suppl 1:50-61.
28. Ludvigsson JF, Andersson E, Ekbom A, et al. External review and validation of the Swedish national inpatient register. BMC Public Health. 2011;11:450.
29. Swedish Transport Agency. STRADA-Swedish Traffic Accident Data Acquisition.https://www.transportstyrelsen.se/en/road/statistik-och-register/STRADA/. Accessed February 15, 2017.
30. Wettermark B, Hammar N, Fored CM, et al. The new Swedish Prescribed Drug Register-opportunities for pharmacoepidemiological research and experience from the first six months. Pharmacoepidemiol Drug Saf. 2007;16(7):726-735.
31. Consiglio GP, Burden AM, Maclure M, McCarthy L, Cadarette SM. Case-crossover study design in pharmacoepidemiology: systematic review and recommendations. Pharmacoepidemiol Drug Saf. 2013;22(11):1146-1153.
32. Björkenstam C, Möller J, Ringbäck G, Salmi P, Hallqvist J, Ljung R. An association between initiation of selective serotonin reuptake inhibitors and suicide-a nationwide register-based case-crossover study. PLoS One. 2013;8(9):e73973.
33. Möller J, Laflamme L, Söderberg Löfdal K. CYP2D6-inhibiting drugs and the increased risk of fall-related injuries due to newly initiated opioid treatment-a Swedish, register-based case-crossover study. Basic Clin Pharmacol Toxicol. 2015;116(2):134-139.
34. Kuehn BM. Varenicline gets stronger warnings about psychiatric problems, vehicle crashes. JAMA. 2009;302(8):834.
35. Molero Y, Lichtenstein P, Zetterqvist J, Gumpert CH, Fazel S. Varenicline and risk of psychiatric conditions, suicidal behaviour, criminal offending, and transport accidents and offences: population based cohort study. BMJ. 2015;350:h2388.
36. Appelros P, Terént A. Validation of the Swedish inpatient and causeof-death registers in the context of stroke. Acta Neurol Scand. 2011;123(4):289-293.
37. 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.
38. Hughes JR, Stead LF, Hartmann-Boyce J, Cahill K, Lancaster T. Antidepressants for smoking cessation. In: Cochrane Database of Systematic Reviews.; 2014:CD000031.
39. Baker TB, Piper ME, Stein JH, Smith SS, Bolt DM, Fraser DL, Fiore MC. Effects of Nicotine Patch vs Varenicline vs Combination Nicotine Replacement Therapy on Smoking Cessation at 26 Weeks. JAMA. 2016;315(4):371-379.
40. 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.
41. Pasternak B, Svanström H, Hviid A. Use of varenicline versus bupropion and risk of psychiatric adverse events. Addiction. 2013;108(7):1336-1343.
42. 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.
43. Graham DJ, By K, McKean S, et al. Cardiovascular and mortality risks in older Medicare patients treated with varenicline or bupropion for smoking cessation: an observational cohort study. Pharmacoepidemiol Drug Saf. 2014;23(11):1205-1212.
44. Svanström H, Pasternak B, Hviid A. Use of varenicline for smoking cessation and risk of serious cardiovascular events: nationwide cohort study. BMJ. 2012;345:e7176.
45. 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):761-768.
46. Hallas J, Pottegård A. Use of self-controlled designs in pharmacoepidemiology. J Intern Med. 2014;275(6):581-589.
47. Nollen NL, Cox LS, Nazir N, et al. A pilot clinical trial of varenicline for smoking cessation in black smokers. Nicotine Tob Res. 2011;13(9):868-873.
48. Concato J. Observational versus experimental studies: what's the evidence for a hierarchy? NeuroRx. 2004;1(3):341-347.
49. Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000;342(25):1887-1892.
50. Benson K, Hartz AJ. A comparison of observational studies and randomized, controlled trials. N Engl J Med. 2000;342(25):1878-1886.