Survival and cardiovascular events in men treated with testosterone replacement therapy: An intention-to-treat observational cohort study

The Lancet Diabetes and Endocrinology

Volumn 4, Issue 6, 2016, Pages 498-506

  Wallis, Christopher J D ^a   Lo, Kirk ^a   Lee, Yuna ^b   Krakowsky, Yonah ^a   Garbens, Alaina ^a   Satkunasivam, Raj ^a   Herschorn, Sender ^a   Kodama, Ronald T ^a   Cheung, Patrick ^c   Narod, Steven A ^a   Nam, Robert K ^a  

^a UNIVERSITY OF TORONTO   (Canada)

^b ST MICHAEL'S HOSPITAL   (Canada)

^c SUNNYBROOK RESEARCH INSTITUTE   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

TESTOSTERONE; ANDROGEN;

AGED; ANDROGEN DEFICIENCY; ANDROGEN THERAPY; ARTICLE; CANADA; CARDIOVASCULAR DISEASE; COHORT ANALYSIS; COMORBIDITY; CONTROLLED STUDY; DIABETES MELLITUS; HIGH RISK PATIENT; HUMAN; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; MORTALITY; OBSERVATIONAL STUDY; PRIORITY JOURNAL; PROSTATE CANCER; RESIDENTIAL AREA; RETROSPECTIVE STUDY; RISK REDUCTION; SURVIVAL RATE; TREATMENT DURATION; CASE CONTROL STUDY; CHEMICALLY INDUCED; HORMONE SUBSTITUTION; ONTARIO; PROSTATE TUMOR; VERY ELDERLY;

AGED; AGED, 80 AND OVER; ANDROGENS; CARDIOVASCULAR DISEASES; CASE-CONTROL STUDIES; COHORT STUDIES; HORMONE REPLACEMENT THERAPY; HUMANS; MALE; ONTARIO; PROSTATIC NEOPLASMS; TESTOSTERONE;

EID: 84968912241     PISSN: 22138587     EISSN: 22138595     Source Type: Journal    
DOI: 10.1016/S2213-8587(16)00112-1     Document Type: Article

References (35)

1. Traish AM Adverse health effects of testosterone deficiency (TD) in men. Steroids 2014, 88:106-116.
2. Bhasin S, Cunningham GR, Hayes FJ, et al. Testosterone therapy in adult men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metabol 2006, 91:1995-2010.
3. Ohlsson C, Barrett-Connor E, Bhasin S, et al. High serum testosterone is associated with reduced risk of cardiovascular events in elderly men. The MrOS (Osteoporotic Fractures in Men) study in Sweden. J Am Coll Cardiol 2011, 58:1674-1681.
4. Vigen R, O'Donnell CI, Baron AE, et al. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA 2013, 310:1829-1836.
5. Finkle WD, Greenland S, Ridgeway GK, et al. Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men. PLoS One 2014, 9:e85805.
6. Xu L, Freeman G, Cowling BJ, Schooling CM Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials. BMC Med 2013, 11:108.
7. Baillargeon J, Urban RJ, Kuo YF, et al. Risk of myocardial infarction in older men receiving testosterone therapy. Ann Pharmacother 2014, 48:1138-1144.
8. Sharma R, Oni OA, Gupta K, et al. Normalization of testosterone level is associated with reduced incidence of myocardial infarction and mortality in men. Eur Heart J 2015, 36:2706-2715.
9. Shores MM, Smith NL, Forsberg CW, Anawalt BD, Matsumoto AM Testosterone treatment and mortality in men with low testosterone levels. J Clin Endocrinol Metabol 2012, 97:2050-2058.
10. Muraleedharan V, Marsh H, Kapoor D, Channer KS, Jones TH Testosterone deficiency is associated with increased risk of mortality and testosterone replacement improves survival in men with type 2 diabetes. Eur J Endocrinol 2013, 169:725-733.
11. Anderson JL, May HT, Lappe DL, et al. Impact of testosterone replacement therapy on myocardial infarction, stroke, and death in men with low testosterone concentrations in an integrated health care system. Am J Cardiol 2015, 117:794-799.
12. Moeny D, Staffa J Joint meeting for bone, reproductive and urologic drugs advisory committee (BRUDAC) and the drug safety and risk management advisory committee (DSARM AC): the potential for adverse cardiovascular outcomes associated with use of TRT Sept 17, 2014, US Food and Drug Administration.
13. Corona GG, Rastrelli G, Maseroli E, Sforza A, Maggi M Testosterone replacement therapy and cardiovascular risk: a review. World J Mens Health 2015, 33:130-142.
14. Goodman N, Guay A, Dandona P, et al. American Association of Clinical Endocrinologists and American College of Endocrinology position statement on the association of testosterone and cardiovascular risk. Endocr Pract 2015, 21:1066-1073.
15. Dean JD, Carnegie C, Rodzvilla J, Smith T Long-term effects of testim(r) 1% testosterone gel in hypogonadal men. Rev Urol 2005, 7:87-94.
16. Menopausal hormone use and ovarian cancer risk: individual participant meta-analysis of 52 epidemiological studies. Lancet 2015, 385:1835-1842. Collaborative Group On Epidemiological Studies Of Ovarian Cancer.
17. Etminan M, Skeldon SC, Goldenberg SL, Carleton B, Brophy JM Testosterone therapy and risk of myocardial infarction: a pharmacoepidemiologic study. Pharmacotherapy 2015, 35:72-78.
18. Levy AR, O'Brien BJ, Sellors C, Grootendorst P, Willison D Coding accuracy of administrative drug claims in the Ontario Drug Benefit database. Can J Clin Pharmacol 2003, 10:67-71.
19. Juurlink DN, Preyra C, Croxford R, et al. Canadian Institute for Health Information Discharge Abstract Database: a validation study 2006, Institute for Clinical Evaluation Sciences, Toronto.
20. Williams JI, Young W A summary of studies on the quality of health care administrative databases in Canada. Patterns of health care in Ontario, Canada: the Ices Practice Atlas 1996, 339-345. Canadian Medical Association, Ottawa. V. Goel, J. Williams, G. Anderson (Eds.).
21. Tu JV, Naylor CD, Austin P Temporal changes in the outcomes of acute myocardial infarction in Ontario, 1992-1996. CMAJ 1999, 161:1257-1261.
22. Hux JE, Ivis F, Flintoft V, Bica A Diabetes in Ontario: determination of prevalence and incidence using a validated administrative data algorithm. Diabetes Care 2002, 25:512-516.
23. Robles SC, Marrett LD, Clarke EA, Risch HA An application of capture-recapture methods to the estimation of completeness of cancer registration. J Clin Epidemiol 1988, 41:495-501.
24. Iron K, Zagorski BM, Sykora K, Manuel DG Living and dying in Ontario: an opportunity for improved health information 2008, ICES, Toronto.
25. Mittmann N, Isogai PK, Saskin R, et al. Population-based home care services in breast cancer: utilization and costs. Curr Oncol 2012, 19:e383-e391.
26. The Johns Hopkins ACG Case-Mix System Reference Manual Version 7.0 2005, Health Services Research & Development Center, Johns Hopkins University Bloomberg School of Public Health, Baltimore.
27. Piszczek J, Mamdani M, Antoniou T, Juurlink DN, Gomes T The impact of drug reimbursement policy on rates of testosterone replacement therapy among older men. PLoS One 2014, 9:e98003.
28. Austin PC Using the standardized difference to compare the prevalence of a binary variable between two groups in observational research. Commun Stat Simul Comput 2009, 38:1228-1234.
29. Shintani AK, Girard TD, Eden SK, Arbogast PG, Moons KG, Ely EW Immortal time bias in critical care research: application of time-varying Cox regression for observational cohort studies. Crit Care Med 2009, 37:2939-2945.
30. Daniel S, Koren G, Lunenfeld E, Levy A Immortal time bias in drug safety cohort studies: spontaneous abortion following nonsteroidal antiinflammatory drug exposure. Am J Obstet Gynecol 2015, 212:307.e1-307.e6.
31. Stricker BH, Stijnen T Analysis of individual drug use as a time-varying determinant of exposure in prospective population-based cohort studies. Eur J Epidemiol 2010, 25:245-251.
32. Morgentaler A, Traish A, Kacker R Deaths and cardiovascular events in men receiving testosterone. JAMA 2014, 311:961-962.
33. Basaria S, Coviello AD, Travison TG, et al. Adverse events associated with testosterone administration. N Engl J Med 2010, 363:109-122.
34. Cui Y, Zong H, Yan H, Zhang Y The effect of testosterone replacement therapy on prostate cancer: a systematic review and meta-analysis. Prostate Cancer Prostatic Dis 2014, 17:132-143.
35. Hernan MA, Alonso A, Logan R, et al. Observational studies analyzed like randomized experiments: an application to postmenopausal hormone therapy and coronary heart disease. Epidemiology 2008, 19:766-779.