(069) Increased Risk of Major Adverse Cardiovascular Events in Testosterone Deficient Men and in Men Receiving Testosterone Replacement Therapy

Abstract

Abstract Introduction Testosterone deficiency (TD) has been shown to be associated with cardiovascular risk factors and an increased risk of cardiovascular events. Conversely, literature surrounding testosterone replacement therapy (TRT) and major adverse cardiovascular events (MACE) is conflicting. Currently, the Food and Drug Administration requires warnings regarding a possible increased cardiovascular risk for TRTs. Objective This study sought to investigate the association between TD and MACE. It also sought to investigate the association between TRT and MACE using a large population based database. The hypotheses were that TD men will have a higher risk of MACE, while men receiving TRT will also have a higher risk of MACE compared to controls. Methods A propensity-weighted, retrospective cohort study was conducted by accessing provincial health administrative databases. Eligibility criteria included men 18 years and older, with no prior TRT or MACE, who had at least 1 year of provincial health coverage from their index date between April 1st, 1995 to December 31st, 2018. TD was defined as men who had a serum testosterone level between 57-300 ng/dL. TRT was defined as having at least two testosterone prescriptions filled within one year (including capsules, gels, patches, and/or injections). MACE was defined as myocardial infarction, coronary revascularization procedures, ischemic stroke, or hospitalizations for heart failure. Controls were assigned a pseudo-index date at random based on the frequency distribution of index dates in the study group. Logistic regression model that included age, socioeconomic status, index year, diabetes, hypertension, dyslipidemia and renal disease was used to determine the propensity score. Stabilized inverse propensity treatment weighting was then applied to the propensity score. A cox proportional hazard model was used to examine our primary outcome of time to a MACE. Results Among 7918 men with TD and 442286 controls, men with TD were associated with a 87 % higher risk of a MACE (Hazard Ratio 1.76, 1.63 – 1.89) in unweighted and 21% higher risk (Hazard Ratio 1.27, 1.16 – 1.39) in weighted analyses. Among 6893 men receiving TRT and 415377 controls, men receiving TRT were associated with a 76% higher risk of a MACE (Hazard Ratio 1.76, 1.63 – 1.89) in unweighted and 26% higher risk (Hazard Ratio 1.27, 1.16 – 1.39) in weighted analyses. Conclusions This study demonstrates that both TD men and men receiving TRT had a higher risk of MACE as compared to controls. Whether TRT itself increases the odds of MACE requires further elucidation. Our study is limited by its retrospective nature and inability to capture for all confounders. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific.