Association between exogenous testosterone and cardiovascular events: an overview of systematic reviews

Lancet Diabetes and Endocrinology,The - Tập 4 - Trang 943-956 - 2016
Oluwadamilola Onasanya1,2, Geetha Iyer1,2, Eleanor Lucas1,2, Dora Lin1,2, Sonal Singh1,2,3, G Caleb Alexander1,2,3
1Center for Drug Safety and Effectiveness, Johns Hopkins University, Baltimore, MD, USA
2Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
3Division of General Internal Medicine, Department of Medicine, Johns Hopkins Medicine, Baltimore, MD, USA

Tài liệu tham khảo

Baillargeon, 2015, Screening and monitoring in men prescribed testosterone therapy in the US, 2001–2010, Public Health Rep, 130, 143, 10.1177/003335491513000207 Baillargeon, 2013, Trends in androgen prescribing in the United States, 2001 to 2011, JAMA Intern Med, 173, 1465, 10.1001/jamainternmed.2013.6895 Basaria, 2010, Adverse events associated with testosterone administration, N Engl J Med, 363, 109, 10.1056/NEJMoa1000485 Vigen, 2013, Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels, JAMA, 310, 1829, 10.1001/jama.2013.280386 Finkle, 2014, Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men, PLoS One, 9, e85805, 10.1371/journal.pone.0085805 Shores, 2012, Testosterone treatment and mortality in men with low testosterone levels, J Clin Endocrinol Metab, 97, 2050, 10.1210/jc.2011-2591 Baillargeon, 2014, Risk of myocardial infarction in older men receiving testosterone therapy, Ann Pharmacother, 48, 1138, 10.1177/1060028014539918 Menke, 2010, Sex steroid hormone concentrations and risk of death in US men, Am J Epidemiol, 171, 583, 10.1093/aje/kwp415 Khaw, 2007, Endogenous testosterone and mortality due to all causes, cardiovascular disease, and cancer in men: European prospective investigation into cancer in Norfolk (EPIC-Norfolk) prospective population study, Circulation, 116, 2694, 10.1161/CIRCULATIONAHA.107.719005 Laughlin, 2008, Low serum testosterone and mortality in older men, J Clin Endocrinol Metab, 93, 68, 10.1210/jc.2007-1792 Calof, 2005, Adverse events associated with testosterone replacement in middle-aged and older men: a meta-analysis of randomized, placebo-controlled trials, J Gerontol A Biol Sci Med Sci, 60, 1451, 10.1093/gerona/60.11.1451 Haddad, 2007, Testosterone and cardiovascular risk in men: a systematic review and meta-analysis of randomized placebo-controlled trials, Mayo Clin Proc, 82, 29, 10.1016/S0025-6196(11)60964-6 Fernandez-Balsells, 2010, Adverse effects of testosterone therapy in adult men: a systematic review and meta-analysis, J Clin Endocrinol Metab, 95, 2560, 10.1210/jc.2009-2575 Xu, 2013, Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials, BMC Med, 11, 108, 10.1186/1741-7015-11-108 Borst, 2014, Cardiovascular risks and elevation of serum DHT vary by route of testosterone administration: a systematic review and meta-analysis, BMC Med, 12, 211, 10.1186/s12916-014-0211-5 Corona, 2014, Cardiovascular risk associated with testosterone-boosting medications: a systematic review and meta-analysis, Expert Opin Drug Saf, 13, 1327, 10.1517/14740338.2014.950653 Albert, 2016, Testosterone therapy, association with age, initiation and mode of therapy with cardiovascular events: a systematic review, Clin Endocrinol, 85, 436, 10.1111/cen.13084 Becker, 2008, Overviews of reviews, 22.1.1 Smith, 2011, Methodology in conducting a systematic review of systematic reviews of healthcare interventions, BMC Med Res Methodol, 11, 1, 10.1186/1471-2288-11-15 Shea, 2007, Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews, BMC Med Res Methodol, 7, 1, 10.1186/1471-2288-7-10 Shea, 2009, AMSTAR is a reliable and valid measurement tool to assess the methodological quality of systematic reviews, J Clin Epidemiol, 62, 1013, 10.1016/j.jclinepi.2008.10.009 Shea, 2007, External validation of a measurement tool to assess systematic reviews (AMSTAR), PLoS One, 2, e1350, 10.1371/journal.pone.0001350 Suebnukarn, 2010, A systematic evaluation of the quality of meta-analyses in endodontics, J Endod, 36, 602, 10.1016/j.joen.2009.12.019 Seo, 2012, Quality assessment of systematic reviews or meta-analyses of nursing interventions conducted by Korean reviewers, BMC Med Res Methodol, 12, 129, 10.1186/1471-2288-12-129 Bradburn, 2007, Much ado about nothing: a comparison of the performance of meta-analytical methods with rare events, Stat Med, 26, 53, 10.1002/sim.2528 Stoto, 2015, Drug safety meta-analysis: promises and pitfalls, Drug Saf, 38, 233, 10.1007/s40264-015-0268-x Higgins JPT, Deeks JJ, Altman DG. Special topics in statistics. In: Higgins JPT, Green S, eds. Cochrane handbook for systematic reviews of interventions, version 5.1.0 (updated March, 2011). The Cochrane Collaboration, 2011: 16.9.5. Rosner, 2010, Hypothesis testing: categorical data—estimation of sample size and power for comparing two binomial proportions, 381 1986, Testosterone treatment of men with alcoholic cirrhosis: a double blind study, Hepatology, 6, 807, 10.1002/hep.1840060502 Marin, 1992, The effects of testosterone treatment on body composition and metabolism in middle-aged obese men, Int J Obes Relat Metab Disord, 16, 991 Tenover, 1992, Effects of testosterone supplementatio in the aging male, J Clin Endocrinol Metab, 75, 1092 Morley, 1993, Effects of testosterone replacement therapy in old hypogonadal males: a preliminary study, J Am Geriatr Soc, 41, 149, 10.1111/j.1532-5415.1993.tb02049.x Drinka, 1995, Polycythemia as a complication of testosterone replacement therapy in nursing home men with low testosterone levels, J Am Geriatr Soc, 43, 899, 10.1111/j.1532-5415.1995.tb05534.x Hall, 1996, A randomized trial of testosterone therapy in males with rheumatoid arthritis, Br J Rheumatol, 35, 568, 10.1093/rheumatology/35.6.568 Reid, 1996, Testosterone therapy in glucocorticoid-treated men, Arch Intern Med, 156, 1173, 10.1001/archinte.1996.00440100065008 Sih, 1997, Testosterone replacement in older hypogonadal men: a 12-month randomized controlled trial, J Clin Endocrinol Metab, 82, 1661, 10.1210/jcem.82.6.3988 English, 2000, Low-dose transdermal testosterone therapy improves angina threshold in men with chronic stable angina: a randomized, double-blind, placebo-controlled study, Circulation, 102, 1906, 10.1161/01.CIR.102.16.1906 Snyder, 2001, Effect of transdermal testosterone treatment on serum lipid and apolipoprotein levels in men more than 65 years of age, Am J Med, 111, 255, 10.1016/S0002-9343(01)00813-0 Simon, 2001, Androgen therapy improves insulin sensitivity and decreases leptin level in healthy adult men with low plasma total testosterone: a 3-month randomized placebo-controlled trial, Diabetes Care, 24, 2149, 10.2337/diacare.24.12.2149 Seidman, 2001, Testosterone replacement therapy for hypogonadal men with major depressive disorder: a randomized, placebo-controlled clinical trial, J Clin Psychiatry, 62, 406, 10.4088/JCP.v62n0602 Münzer, 2001, Effects of GH and/or sex steroid administration on abdominal subcutaneous and visceral fat in healthy aged women and men, J Clin Endocrinol Metab, 86, 3604, 10.1210/jc.86.8.3604 Kenny, 2002, Effects of transdermal testosterone on lipids and vascular reactivity in older men with low bioavailable testosterone levels, J Gerontol A Biol Sci Med Sci, 57, M460, 10.1093/gerona/57.7.M460 Amory, 2002, Preoperative supraphysiological testosterone in older men undergoing knee replacement surgery, J Am Geriatr Soc, 50, 1698, 10.1046/j.1532-5415.2002.50462.x Ferrando, 2003, Differential anabolic effects of testosterone and amino acid feeding in older men, J Clin Endocrinol Metab, 88, 358, 10.1210/jc.2002-021041 Boyanov, 2003, Testosterone supplementation in men with type 2 diabetes, visceral obesity and partial androgen deficiency, Aging Male, 6, 1, 10.1080/tam.6.1.1.7 Wittert, 2003, Oral testosterone supplementation increases muscle and decreases fat mass in healthy elderly males with low-normal gonadal status, J Gerontol A Biol Sci Med Sci, 58, 618, 10.1093/gerona/58.7.M618 Steidle, 2003, AA2500 testosterone gel normalizes androgen levels in aging males with improvements in body composition and sexual function, J Clin Endocrinol Metab, 88, 2673, 10.1210/jc.2002-021058 Crawford, 2003, Randomized placebo-controlled trial of androgen effects on muscle and bone in men requiring long-term systemic glucocorticoid treatment, J Clin Endocrinol Metab, 88, 3167, 10.1210/jc.2002-021827 Amory, 2004, Exogenous testosterone or testosterone with finasteride increases bone mineral density in older men with low serum testosterone, J Clin Endocrinol Metab, 89, 503, 10.1210/jc.2003-031110 Kenny, 2004, Effects of testosterone on behavior, depression, and cognitive function in older men with mild cognitive loss, J Gerontol A Biol Sci Med Sci, 59, 75, 10.1093/gerona/59.1.M75 Svartberg, 2004, Testosterone treatment improves body composition and sexual function in men with COPD, in a 6-month randomized controlled trial, Respir Med, 98, 906, 10.1016/j.rmed.2004.02.015 Brockenbrough, 2006, Transdermal androgen therapy to augment EPO in the treatment of anemia of chronic renal disease, Am J Kidney Dis, 47, 251, 10.1053/j.ajkd.2005.10.022 Malkin, 2006, Testosterone therapy in men with moderate severity heart failure: a double-blind randomized placebo controlled trial, Eur Heart J, 27, 57, 10.1093/eurheartj/ehi443 Merza, 2006, Double-blind placebo-controlled study of testosterone patch therapy on bone turnover in men with borderline hypogonadism, Int J Androl, 29, 381, 10.1111/j.1365-2605.2005.00612.x Nair, 2006, DHEA in elderly women and DHEA or testosterone in elderly men, N Engl J Med, 355, 1647, 10.1056/NEJMoa054629 Emmelot-Vonk, 2008, Effect of testosterone supplementation on functional mobility, cognition and other parameters in older men: a randomized controlled trial, JAMA, 299, 39, 10.1001/jama.2007.51 Svartberg, 2008, Testosterone treatment in elderly men with subnormal testosterone levels improves body composition and BMD in the hip, Int J Impotence Res, 20, 378, 10.1038/ijir.2008.19 Caminiti, 2009, Effect of long-acting testosterone treatment on functional exercise capacity, skeletal muscle performance, insulin resistance, and baroreflex sensitivity in elderly patients with chronic heart failure a double-blind, placebo-controlled, randomized study, J Am Coll Cardiol, 54, 919, 10.1016/j.jacc.2009.04.078 Chapman, 2009, Effect of testosterone and a nutritional supplement, alone and in combination, on hospital admissions in undernourished older men and women, Am J Clin Nutr, 89, 880, 10.3945/ajcn.2008.26538 Legros, 2009, Oral testosterone replacement in symptomatic late-onset hypogonadism: effects on rating scales and general safety in a randomized, placebo-controlled study, Eur J Endocrinol, 160, 821, 10.1530/EJE-08-0634 Mathur, 2009, Long-term benefits of testosterone replacement therapy on angina threshold and atheroma in men, Eur J Endocrinol, 161, 443, 10.1530/EJE-09-0092 Shores, 2009, A randomized, double-blind, placebo-controlled study of testosterone treatment in hypogonadal older men with subthreshold depression (dysthymia or minor depression), J Clin Psychiatry, 70, 1009, 10.4088/JCP.08m04478 Aversa, 2010, Effects of testosterone undecanoate on cardiovascular risk factors and atherosclerosis in middle-aged men with late-onset hypogonadism and metabolic syndrome: results from a 24-month, randomized, double-blind, placebo-controlled study, J Sex Med, 7, 3495, 10.1111/j.1743-6109.2010.01931.x Cornoldi, 2010, Effects of chronic testosterone administration on myocardial ischemia, lipid metabolism and insulin resistance in elderly male diabetic patients with coronary artery disease, Int J Cardiol, 142, 50, 10.1016/j.ijcard.2008.12.107 Srinivas-Shankar, 2010, 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, 95, 639, 10.1210/jc.2009-1251 Kalinchenko, 2010, Effects of testosterone supplementation on markers of the metabolic syndrome and inflammation in hypogonadal men with the metabolic syndrome: the double-blinded placebo-controlled Moscow study, Clin Endocrinol, 73, 602, 10.1111/j.1365-2265.2010.03845.x Kenny, 2010, Effects of transdermal testosterone on bone and muscle in older men with low bioavailable testosterone levels, low bone mass, and physical frailty, J Am Geriatr Soc, 58, 1134, 10.1111/j.1532-5415.2010.02865.x Jones, 2011, Testosterone replacement in hypogonadal men with type 2 diabetes and/or metabolic syndrome (the TIMES2 study), Diabetes Care, 34, 828, 10.2337/dc10-1233 Ho, 2012, A randomized, double-blind, placebocontrolled trial on the effect of longacting testosterone treatment as assessed by the Aging Male Symptoms scale, BJU Int, 110, 260, 10.1111/j.1464-410X.2011.10755.x Kaufman, 2011, Efficacy and safety study of 1·62% testosterone gel for the treatment of hypogonadal men, J Sex Med, 8, 2079, 10.1111/j.1743-6109.2011.02265.x Sheffield-Moore, 2011, A randomized pilot study of monthly cycled testosterone replacement or continuous testosterone replacement versus placebo in older men, J Clin Endocrinol Metab, 96, E1831, 10.1210/jc.2011-1262 Hoyos, 2012, Body compositional and cardiometabolic effects of testosterone therapy in obese men with severe obstructive sleep apnoea: a randomised placebo-controlled trial, Eur J Endocrinol, 167, 531, 10.1530/EJE-12-0525 Spitzer, 2012, Effect of testosterone replacement on response to sildenafil citrate in men with erectile dysfunction: a parallel, randomized trial, Ann Intern Med, 157, 681, 10.7326/0003-4819-157-10-201211200-00004 Glintborg, 2013, Strength training and testosterone treatment have opposing effects on migration inhibitor factor levels in ageing men, Mediators Inflamm, 2013, 539156, 10.1155/2013/539156 Hildreth, 2013, Effects of testosterone and progressive resistance exercise in healthy, highly functioning older men with low-normal testosterone levels, J Clin Endocrinol Metab, 98, 1891, 10.1210/jc.2012-3695 Hackett, 2013, Testosterone replacement therapy with long-acting testosterone undecanoate improves sexual function and quality-of-life parameters vs placebo in a population of men with type 2 diabetes, J Sex Med, 10, 1612, 10.1111/jsm.12146 Tan, 2013, Efficacy and safety of long-acting intramuscular testosterone undecanoate in aging men: a randomised controlled study, BJU Int, 111, 1130, 10.1111/bju.12037 Borst, 2014, Musculoskeletal and prostate effects of combined testosterone and finasteride administration in older hypogonadal men: a randomized, controlled trial, Am J Physiol Endocrinol Metab, 306, E433, 10.1152/ajpendo.00592.2013 Gianatti, 2014, Effect of testosterone treatment on constitutional and sexual symptoms in men with type 2 diabetes in a randomized, placebo-controlled clinical trial, J Clin Endocrinol Metab, 99, 3821, 10.1210/jc.2014-1872 Basaria, 2015, Effects of testosterone administration for 3 years on subclinical atherosclerosis progression in older men with low or low-normal testosterone levels: a randomized clinical trial, JAMA, 314, 570, 10.1001/jama.2015.8881 Snyder, 2016, Effects of testosterone treatment in older men, N Engl J Med, 374, 611, 10.1056/NEJMoa1506119 Rauch, 2015, Opportunities and challenges of clinical trials in cardiology using composite primary endpoints, World J Cardiol, 7, 1, 10.4330/wjc.v7.i1.1 Ferreira-Gonzalez, 2007, Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials, BMJ, 334, 786, 10.1136/bmj.39136.682083.AE Montori, 2005, Validity of composite end points in clinical trials, BMJ, 330, 594, 10.1136/bmj.330.7491.594 Herring, 2013, Testosterone and the cardiovascular system: a comprehensive review of the basic science literature, J Am Heart Assoc, 2, e000271, 10.1161/JAHA.113.000271 Gotzsche, 2007, Data extraction errors in meta-analyses that use standardized mean differences, JAMA, 298, 430 DerSimonian, 2007, Random-effects model for meta-analysis of clinical trials: an update, Contemp Clin Trials, 28, 105, 10.1016/j.cct.2006.04.004 DerSimonian, 1986, Meta-analysis in clinical trials, Control Clin Trials, 7, 177, 10.1016/0197-2456(86)90046-2 Shuster, 2010, Empirical vs natural weighting in random effects meta-analysis, Stat Med, 29, 1259, 10.1002/sim.3607 McAuley, 2000, Does the inclusion of grey literature influence estimates of intervention effectiveness reported in meta-analyses?, Lancet, 356, 1228, 10.1016/S0140-6736(00)02786-0 Moreno, 2009, Assessment of regression-based methods to adjust for publication bias through a comprehensive simulation study, BMC Med Res Methodol, 9, 2, 10.1186/1471-2288-9-2 Ahmed, 2012, Assessment of publication bias, selection bias, and unavailable data in meta-analyses using individual participant data: a database survey, BMJ, 344, d7762, 10.1136/bmj.d7762 Muraleedharan, 2013, Testosterone deficiency is associated with increased risk of mortality and testosterone replacement improves survival in men with type 2 diabetes, Eur J Endocrinol, 169, 725, 10.1530/EJE-13-0321 Wallis, 2016, Survival and cardiovascular events in men treated with testosterone replacement therapy: an intention-to-treat observational cohort study, Lancet Diabetes Endocrinol, 4, 498, 10.1016/S2213-8587(16)00112-1 Sharma, 2015, Normalization of testosterone level is associated with reduced incidence of myocardial infarction and mortality in men, Eur Heart J, 36, 2706, 10.1093/eurheartj/ehv346 Anderson, 2016, 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, 117, 794, 10.1016/j.amjcard.2015.11.063 Smith, 2003, ‘Mendelian randomization’: can genetic epidemiology contribute to understanding environmental determinants of disease?, Int J Epidemiol, 32, 1, 10.1093/ije/dyg070 Smith, 2014, Mendelian randomization: genetic anchors for causal inference in epidemiological studies, Hum Mol Genet, 23, R89, 10.1093/hmg/ddu328 Riley, 2010, Meta-analysis of individual participant data: rationale, conduct, and reporting, BMJ, 340, c221, 10.1136/bmj.c221 Lago, 2007, Congestive heart failure and cardiovascular death in patients with prediabetes and type 2 diabetes given thiazolidinediones: a meta-analysis of randomised clinical trials, Lancet, 370, 1129, 10.1016/S0140-6736(07)61514-1 Graham, 2005, Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study, Lancet, 365, 475, 10.1016/S0140-6736(05)70270-1 McGettigan, 2006, Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of the observational studies of selective and nonselective inhibitors of cyclooxygenase 2, JAMA, 296, 1633, 10.1001/jama.296.13.jrv60011 Stone, 2009, Risk of suicidality in clinical trials of antidepressants in adults: analysis of proprietary data submitted to US Food and Drug Administration, BMJ, 339, b2880, 10.1136/bmj.b2880