Testosterone treatment is NOT associated with risk of adverse cardiovascular events – the RHYME study
Key Points
What is known
What this study adds
Comments
References:
1. Tong, S.F., et al., Effect of long-acting testosterone undecanoate treatment on quality of life in men with testosterone deficiency syndrome: a double blind randomized controlled trial. Asian J Androl, 2012. 14(4): p. 604-11.
2. Tan, W.S., et al., Efficacy and safety of long-acting intramuscular testosterone undecanoate in aging men: a randomised controlled study. BJU Int, 2013. 111(7): p. 1130-40.
3. Behre, H.M., et al., A randomized, double-blind, placebo-controlled trial of testosterone gel on body composition and health-related quality-of-life in men with hypogonadal to low-normal levels of serum testosterone and symptoms of androgen deficiency over 6 months with 12 months open-label follow-up. Aging Male, 2012. 15(4): p. 198-207.
4. Srinivas-Shankar, U., et al., Effects of testosterone on muscle strength, physical function, body composition, and quality of life in intermediate-frail and frail elderly men: a randomized, double-blind, placebo-controlled study. J Clin Endocrinol Metab, 2010. 95(2): p. 639-50.
5. Permpongkosol, S., N. Tantirangsee, and K. Ratana-olarn, Treatment of 161 men with symptomatic late onset hypogonadism with long-acting parenteral testosterone undecanoate: effects on body composition, lipids, and psychosexual complaints. J Sex Med, 2010. 7(11): p. 3765-74.
6. Dhindsa, S., et al., Insulin Resistance and Inflammation in Hypogonadotropic Hypogonadism and Their Reduction After Testosterone Replacement in Men With Type 2 Diabetes. Diabetes Care, 2016. 39(1): p. 82-91.
7. Traish, A.M., et al., Long-term testosterone therapy in hypogonadal men ameliorates elements of the metabolic syndrome: an observational, long-term registry study. Int J Clin Pract, 2014. 68(3): p. 314-29.
8. Yassin, A., et al., Effects of intermission and resumption of long-term testosterone replacement therapy on body weight and metabolic parameters in hypogonadal in middle-aged and elderly men. Clin Endocrinol (Oxf), 2016. 84(1): p. 107-14.
9. Marin, P., et al., The effects of testosterone treatment on body composition and metabolism in middle-aged obese men. Int J Obes Relat Metab Disord, 1992. 16(12): p. 991-7.
10. Finkelstein, J.S., et al., Gonadal steroids and body composition, strength, and sexual function in men. N Engl J Med, 2013. 369(11): p. 1011-22.
11. Vigen, R., et al., Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA, 2013. 310(17): p. 1829-36.
12. Finkle, W.D., et al., Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men. PLoS One, 2014. 9(1): p. e85805.
13. European Medicines Agency, No consistent evidence of an increased risk of heart problems with testosterone medicines, 2014. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Testosterone-containing_medicines/human_referral_prac_000037.jsp&mid=WC0b01ac05805c516f (accessed December 29th, 2015).
14. Maggi, M., et al., Testosterone treatment is not associated with increased risk of adverse cardiovascular events: results from the Registry of Hypogonadism in Men (RHYME). Int J Clin Pract, 2016. 70(10): p. 843-852.
15. Dohle, G.R., et al. 2016 EAU Guidelines on Male Hypogonadism, available at http://uroweb.org/wp-content/uploads/EAU-Guidelines-Male-Hypogonadism-2016.pdf (accessed July 26, 2016).
16. Dean, J.D., et al., The International Society for Sexual Medicine's Process of Care for the Assessment and Management of Testosterone Deficiency in Adult Men. J Sex Med, 2015. 12(8): p. 1660-86.
17. Dimopoulou, C., et al., EMAS position statement: Testosterone replacement therapy in the aging male. Maturitas, 2016. 84: p. 94-9.
18. Morales, A., et al., Diagnosis and management of testosterone deficiency syndrome in men: clinical practice guideline. Appendix available at: http://www.cmaj.ca/content/suppl/2015/10/26/cmaj.150033.DC1/15-0033-1-at.pdf (accessed Jan 10, 2016). CMAJ, 2015. 187(18): p. 1369-77.
19. Goodman, N., 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(9): p. 1066-73.
20. Snyder, P.J., et al., Effects of Testosterone Treatment in Older Men. N Engl J Med, 2016. 374(7): p. 611-24.
21. Sharma, R., et al., Normalization of testosterone level is associated with reduced incidence of myocardial infarction and mortality in men. Eur Heart J, 2015. 36(40): p. 2706-15.
22. Anderson, J.L., 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, 2016. 117(5): p. 794-9.
23. Wallis, C.J., et al., Survival and cardiovascular events in men treated with testosterone replacement therapy: an intention-to-treat observational cohort study. Lancet Diabetes Endocrinol, 2016.
24. Sharma, R., et al., Association Between Testosterone Replacement Therapy and the Incidence of DVT and Pulmonary Embolism: A Retrospective Cohort Study of the Veterans Administration Database. Chest, 2016. 150(3): p. 563-71.
25. Bhattacharya, R.K., et al., Testosterone replacement therapy among elderly males: the Testim Registry in the US (TRiUS). Clin Interv Aging, 2012. 7: p. 321-30.
26. Miner, M.M., et al., 12-month observation of testosterone replacement effectiveness in a general population of men. Postgrad Med, 2013. 125(2): p. 8-18.
27. Corona, G., E. Maseroli, and M. Maggi, Injectable testosterone undecanoate for the treatment of hypogonadism. Expert Opin Pharmacother, 2014: p. 1-24.
28. Corona, G., et al., Cardiovascular risk associated with testosterone-boosting medications: a systematic review and meta-analysis. Expert Opin Drug Saf, 2014. 13(10): p. 1327-51.
29. Rosen, R.C., et al., Registry of Hypogonadism in Men (RHYME): design of a multi-national longitudinal, observational registry of exogenous testosterone use in hypogonadal men. Aging Male, 2013. 16(1): p. 1-7.
30. Basaria, S., et al., Adverse events associated with testosterone administration. N Engl J Med, 2010. 363(2): p. 109-22.
31. Haider, A., et al., Hypogonadal obese men with and without diabetes mellitus type 2 lose weight and show improvement in cardiovascular risk factors when treated with testosterone: An observational study. Obes Res Clin Pract, 2014. 8(4): p. e339-49.
32. Yassin, A.A., et al., Effects of continuous long-term testosterone therapy (TTh) on anthropometric, endocrine and metabolic parameters for up to 10 years in 115 hypogonadal elderly men: real-life experience from an observational registry study. Andrologia, 2016: p. Jan 14. doi: 10.1111/and.12514. [Epub ahead of print].
33. Haider, A., et al., Men with testosterone deficiency and a history of cardiovascular diseases benefit from long-term testosterone therapy: observational, real-life data from a registry study. Vasc Health Risk Manag, 2016. 12: p. 251-61.
34. FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use 2015. Available at http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm (assessed December 8, 2016).