Association Between Testosterone Replacement Therapy and the Incidence of DVT and Pulmonary Embolism

Sharma, Rishi; Oni, Omobowale A.; Chen, Guoqing; Sharma, Mukut; Dawn, Buddhadeb; Sharma, Ram; Parashara, Deepak; Savin, Virginia J.; Barua, Rajat S.; Gupta, Kamal

doi:10.1016/j.chest.2016.05.007

Cited by 56 publications

(36 citation statements)

References 40 publications

(35 reference statements)

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“…TD is associated with increased incidence of metabolic syndrome, obesity, sexual dysfunction, impaired fertility, reduced motivation, increased fatigue, depressed mood, loss of bone and muscle mass, anemia, decreased energy and vigour, insulin resistance, diabetes, inflammation, dyslipidemia, sarcopenia and frailty, reduced quality of life (QoL) and increased mortality [1234567891011121314154041424344]. A substantial body of evidence indicates that coronary artery disease incidence and severity, carotid intima-media thickness, atherosclerosis is inversely correlated with serum T concentrations [45].…”

Section: Testosterone Deficiencymentioning

confidence: 99%

“…Thus, there is no credible evidence to indicate that T therapy increases the risk of CVD. On the contrary, T therapy may be protective [9101112131415]. …”

Section: Risks Of Testosterone Therapymentioning

confidence: 99%

“…The last 2 decades have witnessed a revolution in medical management of men with testosterone (T) deficiency (TD; also known as hypogonadism) [123456789101112131415]. TD has been recognized for more than 7 decades [161718] and T therapy has been used clinically, as early as 1940, both in men and women [161718].…”

Section: Introductionmentioning

confidence: 99%

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Testosterone therapy in men with testosterone deficiency: Are we beyond the point of no return?

Traish

2016

Investig Clin Urol

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Although testosterone therapy in men with testosterone deficiency was introduced in the early 1940s, utilization of this effective treatment approach in hypogonadal men is met with considerable skepticism and resistance. Indeed, for decades, the fear that testosterone may cause prostate cancer has hampered clinical progress in this field. Nevertheless, even after considerable knowledge was acquired that this fear is unsubstantiated, many in the medical community remain hesitant to utilize this therapeutic approach to treat men with hypogonadism. As the fears concerning prostate cancer have subsided, a new controversy regarding use of testosterone therapy and increase in cardiovascular disease was introduced. Although the new controversy was based on one ill-fated clinical trial, one meta-analysis with studies that utilized unapproved formulation in men with liver cirrhosis, and two retrospective studies with suspect or nonvalidated statistical methodologies and database contaminations, the flames of such controversy were fanned by the lay press and academics alike. In this review we discuss the adverse effect of testosterone deficiency and highlight the numerous proven benefits of testosterone therapy on men's health and debunk the myth that testosterone therapy increases cardiovascular risk. Ultimately, we believe that there is considerable scientific and clinical evidence to suggest that testosterone therapy is safe and effective with restoration of physiological levels in men with testosterone deficiency, irrespective of its etiology.

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Section: Testosterone Deficiencymentioning

confidence: 99%

“…Thus, there is no credible evidence to indicate that T therapy increases the risk of CVD. On the contrary, T therapy may be protective [9101112131415]. …”

Section: Risks Of Testosterone Therapymentioning

confidence: 99%

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Testosterone therapy in men with testosterone deficiency: Are we beyond the point of no return?

Traish

2016

Investig Clin Urol

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“…16 A cohort study and a case-control study did not show evidence of an association between testosterone use and an increased risk of venous thromboembolism. 17 18 None of the previous studies, however, investigated the timing and duration of testosterone use, which could have masked a risk of venous thromboembolism soon after the start of treatment, as seen with oral contraceptives. 19 In the absence of large randomised trials, we used a large UK database to investigate the association between testosterone use and the risk of venous thromboembolism in men, focusing particularly on the timing of exposure to testosterone and the presence of risk factors for venous thromboembolism.…”

Section: What This Study Addsmentioning

confidence: 99%

Testosterone treatment and risk of venous thromboembolism: population based case-control study

Martínez¹,

Suissa

Rietbrock³

et al. 2016

BMJ

132

114

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Objective To determine the risk of venous thromboembolism associated with use of testosterone treatment in men, focusing particularly on the timing of the risk.Design Population based case-control studySetting 370 general practices in UK primary care with linked hospital discharge diagnoses and in-hospital procedures and information on all cause mortality.Participants 19 215 patients with confirmed venous thromboembolism (comprising deep venous thrombosis and pulmonary embolism) and 909 530 age matched controls from source population including more than 2.22 million men between January 2001 and May 2013.Exposure of interest Three mutually exclusive testosterone exposure groups were identified: current treatment, recent (but not current) treatment, and no treatment in the previous two years. Current treatment was subdivided into duration of more or less than six months.Main outcome measure Rate ratios of venous thromboembolism in association with current testosterone treatment compared with no treatment were estimated using conditional logistic regression and adjusted for comorbidities and all matching factors.Results The adjusted rate ratio of venous thromboembolism was 1.25 (95% confidence interval 0.94 to 1.66) for current versus no testosterone treatment. In the first six months of testosterone treatment, the rate ratio of venous thromboembolism was 1.63 (1.12 to 2.37), corresponding to 10.0 (1.9 to 21.6) additional venous thromboembolisms above the base rate of 15.8 per 10 000 person years. The rate ratio after more than six months’ treatment was 1.00 (0.68 to 1.47), and after treatment cessation it was 0.68 (0.43 to 1.07). Increased rate ratios within the first six months of treatment were observed in all strata: the rate ratio was 1.52 (0.94 to 2.46) for patients with pathological hypogonadism and 1.88 (1.02 to 3.45) for those without it, and 1.41 (0.82 to 2.41) for those with a known risk factor for venous thromboembolism and 1.91 (1.13 to 3.23) for those without one.Conclusions Starting testosterone treatment was associated with an increased risk of venous thromboembolism, which peaked within six months and declined thereafter.

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“…There were only four thrombotic events, all occurring after ≥2 years of follow-up, with no difference between TT-treated men and untreated hypogonadal men for myocardial infarction (MI), trensient ischemic atttack (TIA)/ cerebrovascular accident (CVA), or PE 58. Sharma et al 59 retrospectively studied 10,854 veterans not receiving TRT and 60,553 receiving TRT. Sharma et al 59 did not detect a significant association between TRT and risk of DVT/PE in adult men with low serum T, who were at low to moderate baseline risk of DVT/PE.…”

Section: Discussionmentioning

confidence: 99%

Thromboembolism Peaking 3 Months after Starting Testosterone Therapy: Testosterone–Thrombophilia Interactions

Glueck

Goldenberg

Wang

2018

Journal of Investigative Medicine

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We assessed time of thrombotic events (venous thromboembolism (VTE)) after starting testosterone therapy (TT) in 21 men who sustained 23 VTE. The density of thrombotic events was greatest at 3 months after starting TT, with a rapid decline in events by 10 months. The 21 cases with VTE on TT differed from 110 patient controls with unprovoked VTE, not taking TT (VTE-no TT) for Factor V Leiden heterozygosity (FVL) (33 per cent vs 13 per cent, P=0.037), for high lipoprotein (a) (Lp(a)) (55 per cent vs 17 per cent, P=0.012), and for the lupus anticoagulant (33 per cent vs 4 per cent, P=0.003). These differences between cases and VTE-no TT controls were independent of age and gender. TT can interact with underlying thrombophilia-hypofibrinolysis promoting VTE. We suggest that TT should not be started in subjects with known thrombophilia. Coagulation screening, particularly for the FVL , Lp(a), and the lupus anticoagulant should be considered before starting TT, to identify men at high VTE risk who have an adverse risk/benefit ratio for TT.

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Association Between Testosterone Replacement Therapy and the Incidence of DVT and Pulmonary Embolism

Cited by 56 publications

References 40 publications

Testosterone therapy in men with testosterone deficiency: Are we beyond the point of no return?

Testosterone therapy in men with testosterone deficiency: Are we beyond the point of no return?

Testosterone treatment and risk of venous thromboembolism: population based case-control study

Thromboembolism Peaking 3 Months after Starting Testosterone Therapy: Testosterone–Thrombophilia Interactions

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