Cardiovascular and neuropsychiatric risks of varenicline: A retrospective cohort study

The Lancet Respiratory Medicine

Volumn 3, Issue 10, 2015, Pages 761-768

  Kotz, Daniel ^a,b,c,d   Viechtbauer, Wolfgang ^e   Simpson, Colin ^c   van Schayck, Onno C P ^b,c   West, Robert ^d   Sheikh, Aziz ^b,c,f  

^a HEINRICH HEINE UNIVERSITY   (Germany)

^b MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

^c UNIVERSITY OF EDINBURGH   (United Kingdom)

^d UNIVERSITY COLLEGE LONDON   (United Kingdom)

^e MAASTRICHT UNIVERSITY   (Netherlands)

^f BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMFEBUTAMONE; VARENICLINE; DOPAMINE UPTAKE INHIBITOR; NICOTINE GUM; NICOTINIC AGENT;

ADULT; AGED; ARTICLE; AUTOMUTILATION; BRAIN INFARCTION; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; COHORT ANALYSIS; CONTROLLED STUDY; DEPRESSION; DISEASE ASSOCIATION; FEMALE; FOLLOW UP; HEART ARRHYTHMIA; HEART FAILURE; HUMAN; ISCHEMIC HEART DISEASE; MAJOR CLINICAL STUDY; MALE; MENTAL DISEASE; NICOTINE REPLACEMENT THERAPY; OUTCOME ASSESSMENT; PATIENT RISK; PERIPHERAL VASCULAR DISEASE; PRESCRIPTION; PRIORITY JOURNAL; RETROSPECTIVE STUDY; RISK ASSESSMENT; CHEMICALLY INDUCED; MIDDLE AGED; PROCEDURES; SMOKING CESSATION;

ADULT; BUPROPION; CARDIOVASCULAR DISEASES; DEPRESSION; DOPAMINE UPTAKE INHIBITORS; FEMALE; HUMANS; MALE; MENTAL DISORDERS; MIDDLE AGED; NICOTINIC AGONISTS; RETROSPECTIVE STUDIES; SMOKING CESSATION; TOBACCO USE CESSATION PRODUCTS; VARENICLINE;

EID: 84943418756     PISSN: 22132600     EISSN: 22132619     Source Type: Journal    
DOI: 10.1016/S2213-2600(15)00320-3     Document Type: Article

References (50)

1. WHO report on the global tobacco epidemic, 2011. Warning about the dangers of tobacco 2011, WHO, World Health Organization, Geneva.
2. Jha P, Ramasundarahettige C, Landsman V, et al. 21st-century hazards of smoking and benefits of cessation in the United States. N Engl J Med 2013, 368:341-350.
3. Hughes JR, Stead LF, Lancaster T Antidepressants for smoking cessation. Cochrane Database Syst Rev 2007, 1. CD000031.
4. Stead LF, Perera R, Bullen C, Mant D, Lancaster T Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev 2008, 1. CD000146.
5. Cahill K, Stead Lindsay F, Lancaster T Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev 2012, 4. CD006103.
6. Fiore MC, Jaén CR, Baker TB, et al. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am J Prev Med 2008, 35:158-176.
7. Smoking cessation services 2008, National Institute for Health and Care, NICE, London.
8. Tønnesen P, Carrozzi L, Fagerstrom KO, et al. Smoking cessation in patients with respiratory diseases: a high priority, integral component of therapy. Eur Respir J 2007, 29:390-417.
9. Cahill K, Stevens S, Lancaster T Pharmacological treatments for smoking cessation. JAMA 2014, 311:193-194.
10. Jorenby DE, Hays JT, Rigotti NA, et al. Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA 2006, 296:56-63. for the Varenicline Phase 3 Study Group.
11. Gonzales D, Rennard SI, Nides M, et al. Varenicline, an alpha4-beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA 2006, 296:47-55. for the Varenicline Phase 3 Study Group.
12. 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, 63:717-724.
13. Kotz D, Brown J, West R Prospective cohort study of the effectiveness of varenicline versus nicotine replacement therapy for smoking cessation in the "real world". BMC Public Health 2014, 14:1163.
14. Kotz D, Fidler JA, West R Did the introduction of varenicline in England substitute for or add to the use of other smoking cessation medications?. Nicotine Tob Res 2011, 13:793-799.
15. Ebbert JO, Hughes JR, West RJ, et al. Effect of varenicline on smoking cessation through smoking reduction: a randomized clinical trial. JAMA 2015, 313:687-694.
16. 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, 183:1359-1366.
17. European Medicines Agency confirms positive benefit-risk balance for Champix European Medicines, (accessed May 20, 2015). http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/07/news_detail_001314.jsp&mid=WC0b01ac058004d5c1.
18. 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.
19. Chantix (varenicline). Highlights of prescribing information US Food and Drug, (accessed May 20, 2015). http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s032s036s038lbl.pdf.
20. Harrison-Woolrych M, Maggo S, Tan M, Savage R, Ashton J Cardiovascular events in patients taking varenicline. Drug Safety 2012, 35:33-43.
21. Farrell M, Howes S, Bebbington P, et al. Nicotine, alcohol and drug dependence and psychiatric comorbidity: results of a national household survey. Br J Psychiatry 2001, 179:432-437.
22. Hughes Jr. Smoking and suicide: a brief overview. Drug Alcohol Depend 2008, 98:169-178.
23. Information for healthcare professionals: varenicline (marketed as Chantix) and bupropion (marketed as Zyban, Wellbutrin, and generics) US Food and Drug, (accessed May 20, 2015). http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm169986.htm.
24. European Medicines Agency concludes new advice to doctors and patients for Champix needed European Medicines, (accessed May 20, 2015). http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2009/11/news_detail_000085.jsp&mid=WC0b01ac058004d5c1.
25. 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.
26. 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.
27. 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, 347:1-9.
28. Meyer TE, Taylor LG, Xie S, et al. Neuropsychiatric events in varenicline and nicotine replacement patch users in the Military Health System. Addiction 2013, 108:203-210.
29. Pasternak B, Svanström H, Hviid A Use of varenicline versus bupropion and risk of psychiatric adverse events. Addiction 2013, 108:1336-1343.
30. Buggy Y, Cornelius V, Fogg C, Kasliwal R, Layton D, Shakir SW Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. Drug Safety 2013, 36:521-531.
31. Joint meeting of the Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. Chantix and serious neuropsychiatric adverse events US Food and Drug, (accessed May 20, 2015). http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM418705.pdf.
32. Hippisley-Cox J, Fielding K, Pringle M Depression as a risk factor for ischaemic heart disease in men: population based case-control study. BMJ 1998, 316:1714-1719.
33. Hippisley-Cox J, Coupland C, Vinogradova Y, Robson J, May M, Brindle P Derivation and validation of QRISK, a new cardiovascular disease risk score for the United Kingdom: prospective open cohort study. BMJ 2007, 335:136.
34. Hippisley-Cox J, Coupland C Effect of combinations of drugs on all cause mortality in patients with ischaemic heart disease: nested case-control analysis. BMJ 2005, 330:1059-1063.
35. Hippisley-Cox J, Coupland C Risk of myocardial infarction in patients taking cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs: population based nested case-control analysis. BMJ 2005, 330:1366.
36. Hippisley-Cox J, Coupland C, Brindle P Derivation and validation of QStroke score for predicting risk of ischaemic stroke in primary care and comparison with other risk scores: a prospective open cohort study. BMJ 2013, 346:f2573.
37. Reeves D, Springate DA, Ashcroft DM, et al. Can analyses of electronic patient records be independently and externally validated? The effect of statins on the mortality of patients with ischaemic heart disease: a cohort study with nested case-control analysis. BMJ Open 2014, 4:e004952.
38. Vinogradova Y, Coupland C, Hippisley-Cox J Exposure to bisphosphonates and risk of gastrointestinal cancers: series of nested case-control studies with QResearch and CPRD data. BMJ 2013, 346:f114.
39. Collins GS, Altman DG An independent and external validation of QRISK2 cardiovascular disease risk score: a prospective open cohort study. BMJ 2010, 340:c2442.
40. Kotz D, Simpson C, Viechtbauer W, van Schayck OC, West R, Sheikh A Cardiovascular and neuropsychiatric safety of varenicline and bupropion compared with nicotine replacement therapy for smoking cessation: study protocol of a retrospective cohort study using the QResearch general practice database. BMJ Open 2014, 4:e005281.
41. Townsend P, Phillimore P, Beattie A Health and deprivation: inequality and the north 1988, Croom Helm, London.
42. Khan N, Perera R, Harper S, Rose P Adaptation and validation of the Charlson Index for Read/OXMIS coded databases. BMC Fam Pract 2010, 11:1.
43. Lin DY, Psaty BM, Kronmal RA Assessing the sensitivity of regression results to unmeasured confounders in observational studies. Biometrics 1998, 54:948-963.
44. Mills EJ, Thorlund K, Eapen S, Wu P, Prochaska JJ Cardiovascular events associated with smoking cessation pharmacotherapies: a network meta-analysis. Circulation 2014, 129:28-41.
45. Toh S, Baker MA, Brown JS, Kornegay C, Platt R Rapid assessment of cardiovascular risk among users of smoking cessation drugs within the US Food and Drug Administration's Mini-Sentinel program. JAMA Intern Med 2013, 173:817-819. for the Mini-Sentinel.
46. Hughes Jr. Varenicline as a cause of suicidal outcomes. Nicotine Tob Res 2015, published online Jan 8. 10.1093/ntr/ntu275.
47. Risk of serious neuropsychiatric adverse events with Chantix (varenicline tartrate) Pfizer, Joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, (accessed May 20, 2015). http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM418706.pdf.
48. Kotz D, Brown J, West R Effectiveness of varenicline versus nicotine replacement therapy for smoking cessation with minimal professional support: evidence from an English population study. Psychopharmacology 2014, 231:37-42.
49. Joint meeting of the Psychopharmacologic Drugs and Drug Safety and Risk Management Advisory Committees US Food and Drug, (accessed July 9, 2015). http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM434007.pdf.
50. Doll R, Peto R, Boreham J, Sutherland I Mortality in relation to smoking: 50 years' observations on male British doctors. BMJ 2004, 328:1519.