Cardiovascular and mortality risks in older Medicare patients treated with varenicline or bupropion for smoking cessation: An observational cohort study

Pharmacoepidemiology and Drug Safety

Volumn 23, Issue 11, 2014, Pages 1205-1212

  Graham, David J ^a   By, Kunthel ^a   Mckean, Stephen ^b   Mosholder, Andrew ^a   Kornegay, Cynthia ^a   Racoosin, Judith A ^a   Young, Jessica ^b   Levenson, Mark ^a   Macurdy, Thomas E ^b,c   Worrall, Chris ^d   Kelman, Jeffrey A ^d  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b Acumen LLC   (United States)

^c STANFORD UNIVERSITY   (United States)

^d CENTERS FOR MEDICARE AND MEDICAID SERVICES   (United States)

Author keywords

Bupropion; Cardiovascular risk; Mortality; Pharmacoepidemiology; Varenicline

Indexed keywords

AMFEBUTAMONE; VARENICLINE; BENZAZEPINE DERIVATIVE; NICOTINIC AGENT; QUINOXALINE DERIVATIVE;

ACUTE HEART INFARCTION; AGED; ARTICLE; CARDIOVASCULAR RISK; CEREBROVASCULAR ACCIDENT; COHORT ANALYSIS; CONTROLLED STUDY; DIABETES MELLITUS; FEMALE; HEART MUSCLE REVASCULARIZATION; HUMAN; ISCHEMIC HEART DISEASE; MAJOR CLINICAL STUDY; MALE; MEDICARE; MORTALITY; OBSERVATIONAL STUDY; PRESCRIPTION; PRIORITY JOURNAL; PROPENSITY SCORE; SMOKING CESSATION; TREATMENT OUTCOME; UNSTABLE ANGINA PECTORIS; CARDIOVASCULAR DISEASE; CHEMICALLY INDUCED; COMORBIDITY; INCIDENCE; PROCEDURES; STATISTICS AND NUMERICAL DATA; UNITED STATES; VERY ELDERLY;

AGED; AGED, 80 AND OVER; BENZAZEPINES; BUPROPION; CARDIOVASCULAR DISEASES; COHORT STUDIES; COMORBIDITY; FEMALE; HUMANS; INCIDENCE; MALE; MEDICARE; NICOTINIC AGONISTS; QUINOXALINES; SMOKING CESSATION; UNITED STATES;

EID: 84937199819     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3678     Document Type: Article

References (39)

1. Mihalak KB, Carroll FI, Luetje CW. Varenicline is a partial agonist at alpha 4 beta 2 and full agonist at alpha 7 neuronal nicotinic receptors. Mol Pharmacol 2006; 70: 801-805.
2. Foulds J. The neurobiological basis for partial agonist treatment of nicotine dependence: varenicline. Int J Clin Pract 2006; 60: 571-576.
3. Hays JT, Ebbert JO. Varenicline for tobacco dependence. N Engl J Med 2008; 359: 2018-2024.
4. Product labeling for Chantix (varenicline) tablets. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021928s030lbl.pdf [10 June 2013].
5. Cahill K, Stead LF, Lancaster T. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev 2012; 4: CD006103. doi:10.1002/14651858.CD006103.pub6.
6. FDA Drug Safety Communication. Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease, June 16, 2011. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm259161.htm [10 June 2013].
7. 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. doi:10.1503/cmaj.110218.
8. 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.
9. FDA Drug Safety Communication. Safety review update of Chantix (varenicline) and risk of cardiovascular adverse events, December 12, 2012. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm330367.htm [10 June 2013].
10. Svanström H, Pasternak B, Hviid A. Use of varenicline for smoking cessation and risk of serious cardiovascular events: nationwide cohort study. BMJ 2012: e7176. doi:10.1136/bmj.e7176.
11. Centers for Disease Control and Prevention. Smoking-attributable mortality, years of potential life lost, and productivity losses-United States, 2000-2004. MMWR Morb Mortal Wkly Rep 2008; 57: 1226-1228.
12. Critchley JA, Capewell S. Mortality risk reduction associated with smoking cessation in patients with coronary heart disease: a systematic review. JAMA 2003; 290: 86-97.
13. Centers for Medicare and Medicaid Services. Medicare program general information. Available at: http://www.cms.hhs.gov/MedicareGenInfo/ [26 June 2012].
14. Centers for Medicare and Medicaid Services. Prescription drug coverage-general information. Available at: http://www.cms.hhs.gov/PrescriptionDrugCovGenIn/ [26 June 2012].
15. Ray WA. Evaluating medication effects outside of clinical trials: new-user designs. Am J Epidemiol 2003; 158: 915-920.
16. Mamdani M, Sykora K, Li P, et al. Reader's guide to critical appraisal of cohort studies: 2. Assessing potential for confounding. BMJ 2005; 330(7497): 960-962.
17. Austin PC. Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples. Stat Med 2009; 28: 3083-3107.
18. Rosenbaum PR, Rubin DB. The central role of the propensity score in observational studies for causal effects. Biometrika 1983; 79: 516-524.
19. Rosenbaum PR, Rubin DB. Reducing bias in observational studies using subclassification on the propensity score. J Am Stat Assoc 1984; 79: 516-524.
20. Greenland S, Robins JM, Pearl J. Confounding and collapsibility in causal inference. Stat Sci 1999; 14: 29-46.
21. Sato T, Matsuyama Y. Marginal structural models as a tool for standardization. Epidemiology 2003; 14: 680-686.
22. Stuart EA. Matching methods for causal inference: a review and a look forward. Stat Sci 2010; 25(1): 1-21.
23. Petersen LA, Wright S, Normand ST, Daley J. Positive predictive value of the diagnosis of acute myocardial infarction in an administrative database. J Gen Intern Med 1999; 14(9): 555-558.
24. Levy AR, Tamblyn RM, Fitchett D, McLeod PJ, Hanley JA. Coding accuracy of hospital discharge data for elderly survivors of myocardial infarction. Can J Cardiol 1999; 15(11): 1277-1282.
25. Austin PC, Daly PA, Tu JV. A multicenter study of the coding accuracy of hospital discharge administrative data for patients admitted to cardiac care units in Ontario. Am Heart J 2002; 144(2): 290-296.
26. Kiyota Y, Schneeweiss S, Glynn RJ, Cannuscio CC, Avorn J, Solomon DH. Accuracy of Medicare claims-based diagnosis of acute myocardial infarction: estimating positive predictive value on the basis of review of hospital records. Am Heart J 2004; 148(1): 99-104.
27. Choma NN, Griffin MR, Huang RL, et al. An algorithm to identify incident myocardial infarction using Medicaid data. Pharmacoepidemiol Drug Saf 2009; 18(11): 1064-1071.
28. Tirschwell DL, Longstreth WT. Validating administrative data in stroke research. Stroke 2002; 33(10): 2465-2470.
29. Roumie CL, Mitchel E, Gideon PS, Varas-Lorenzo C, Castellsague J, Griffin MR. Validation of ICD-9 codes with a high positive predictive value for incident stroke resulting in hospitalization using Medicaid health data. Pharmacoepidemiol Drug Saf 2008; 17(1): 20-26.
30. Kokotaila RA, Hill MD. Coding of stroke and stroke risk factors using International Classification of Diseases, revision 9 and 10. Stroke 2005; 36(8): 1776-1781.
31. Hill ME, Rosenwaike I. The Social Security Administration's Death Master File: the completeness of death reporting at older ages. Soc Secur Bull 2001/2002; 64(1): 45-51. Available at: http://www.socialsecurity.gov/policy/docs/ssb/v64n1/v64n1p45.pdf [26 June 2012].
32. Varas-Lorenzo C, Castellsague J, Stang MR, Tomas L, Aguado J, Perez-Gutthann S. Positive predictive value of ICD-9 codes 410 and 411 in the identification of cases of acute coronary syndromes in the Saskatchewan Hospital Automated Database. Pharmacoepidemiol Drug Saf 2008; 17: 842-852.
33. Epstein AJ, Polsky D, Yang F, Yang L, Groeneveld PW. Coronary revascularization trends in the United States, 2001-2008. JAMA 2011; 305: 1769-1776.
34. Schulz R, Beach SR, Ives DG, Martire LM, Ariyo AA, Kop WJ. Association between depression and mortality in older adults. The Cardiovascular Health Study. Arch Intern Med 2000; 160: 1761-1768.
35. Wulsin LR, Evans JC, Vasan RS, Murabito JM, Kelly-Hayes M, Benjamin EJ. Depressive symptoms, coronary heart disease, and overall mortality in the Framingham Heart Study. Psychosom Med 2005; 67: 697-702.
36. Rea TD, Heckbert SR, Kaplan RC, Smith NL, Lemaitre RN, Psaty BM. Smoking status and risk for recurrent coronary events after myocardial infarction. Ann Intern Med 2002; 137: 494-500.
37. Teo KK, Ounpuu S, Hawken S, et al. Tobacco use and risk of myocardial infarction in 52 countries in the INTERHEART study: a case-control study. Lancet 2006; 368: 647-658.
38. Product labeling fro Zyban (bupropion) tablets. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020711s036lbl.pdf [30 May 2013].
39. Harrison-Woolrych M, Ashton J. Utilization of the smoking cessation medicine varenicline: an intensive post-marketing study in New Zealand. Pharmacoepidemiol Drug Saf 2010; 19: 949-953.