madman
Super Moderator
Introduction: Hypogonadism affects 4-5 million males in the United States (US), and is associated with a number of important health problems, including obesity, metabolic syndrome, type 2 diabetes mellitus, and increased cardiovascular risk. Patients are typically treated using testosterone therapy (TTh), including long-acting testosterone undecanoate (TU) and short-acting injectables like testosterone cypionate (TC). Although the efficacy and safety of testosterone injections have been widely studied, the comparative advantages of long-acting TU, such as patient compliance and the subsequent potential health benefits, have not been examined in detail.
Objective: The purpose of this study was to compare patient characteristics, treatment patterns, and cardiometabolic outcomes for men using TU versus TC.
Methods: This retrospective cohort study utilized longitudinal US electronic health records (EHR) from the VeradigmTM database. Patients were adult (≥18 years) males treated with initial testosterone injections administered between January 1, 2014, and December 31, 2018. Eligible patients were identified in two cohorts based on the index treatment (TU: n=948; TC: n=121,852). Comparative analyses were performed between cohorts and sub-cohorts of TTh–naïve patients (TU: n=419; TC: n=86,219). Baseline characteristics, medical history, compliance, treatment patterns, blood pressure, and cardiometabolic events were assessed between cohorts.
Results: Baseline characteristics were similar between cohorts, except a higher percentage of patients in the TU cohort had established diagnoses of hypogonadism, ED, and obesity. In the 1-year post-index follow-up period, higher compliance was observed in the TU versus TC cohort during months 7-12 (82.0% versus 40.8%; P<0.001; Figure 1A). At 1-year, a significantly higher percentage of patients receiving TU maintained on index TTh versus those receiving TC (41.9% versus 8.2%, P<0.001; Figure 1B), and fewer patients in the TU cohort discontinued all forms of TTh compared with the TC cohort (33.8% versus 89.9%; P<0.001; Figure 1B). In the TTh-naïve population, numerically lower incident rates of cardiometabolic-related diagnoses were observed in patients receiving TU versus TC, including a significantly larger mean decrease from baseline in systolic blood pressure (mean change -2.3 ± 16.8 mmHg versus 0.0 ± 16.9 mmHg; P=0.024). At 1-year follow-up, a significantly lower rate of newly diagnosed hypertension was noted in men who started and remained on TU versus TC (28.6% versus 43.7%; P=0.027). Total testosterone level fluctuations were also significantly lower in the TU than TC cohort during the 1-year post-index period (mean maximum-minimum 126.9 ± 147.4 ng/dL versus 275.5 ± 319.2 ng/dL; P=0.03).
Conclusions: This retrospective study is the first comparative analysis between long- and short-acting injectable TTh using an EHR database. At 1-year follow-up, men who received TU demonstrated a 2-fold higher compliance, 5-fold improved maintenance on index TTh, nearly two-thirds lower discontinuation rate, and more stable testosterone levels compared to men who received TC. Increased compliance with the use of long-acting TU may result in improved health outcomes for men with testosterone deficiency.
Figure 1: Compliance and Treatment Patterns 1-year Post-index
Objective: The purpose of this study was to compare patient characteristics, treatment patterns, and cardiometabolic outcomes for men using TU versus TC.
Methods: This retrospective cohort study utilized longitudinal US electronic health records (EHR) from the VeradigmTM database. Patients were adult (≥18 years) males treated with initial testosterone injections administered between January 1, 2014, and December 31, 2018. Eligible patients were identified in two cohorts based on the index treatment (TU: n=948; TC: n=121,852). Comparative analyses were performed between cohorts and sub-cohorts of TTh–naïve patients (TU: n=419; TC: n=86,219). Baseline characteristics, medical history, compliance, treatment patterns, blood pressure, and cardiometabolic events were assessed between cohorts.
Results: Baseline characteristics were similar between cohorts, except a higher percentage of patients in the TU cohort had established diagnoses of hypogonadism, ED, and obesity. In the 1-year post-index follow-up period, higher compliance was observed in the TU versus TC cohort during months 7-12 (82.0% versus 40.8%; P<0.001; Figure 1A). At 1-year, a significantly higher percentage of patients receiving TU maintained on index TTh versus those receiving TC (41.9% versus 8.2%, P<0.001; Figure 1B), and fewer patients in the TU cohort discontinued all forms of TTh compared with the TC cohort (33.8% versus 89.9%; P<0.001; Figure 1B). In the TTh-naïve population, numerically lower incident rates of cardiometabolic-related diagnoses were observed in patients receiving TU versus TC, including a significantly larger mean decrease from baseline in systolic blood pressure (mean change -2.3 ± 16.8 mmHg versus 0.0 ± 16.9 mmHg; P=0.024). At 1-year follow-up, a significantly lower rate of newly diagnosed hypertension was noted in men who started and remained on TU versus TC (28.6% versus 43.7%; P=0.027). Total testosterone level fluctuations were also significantly lower in the TU than TC cohort during the 1-year post-index period (mean maximum-minimum 126.9 ± 147.4 ng/dL versus 275.5 ± 319.2 ng/dL; P=0.03).
Conclusions: This retrospective study is the first comparative analysis between long- and short-acting injectable TTh using an EHR database. At 1-year follow-up, men who received TU demonstrated a 2-fold higher compliance, 5-fold improved maintenance on index TTh, nearly two-thirds lower discontinuation rate, and more stable testosterone levels compared to men who received TC. Increased compliance with the use of long-acting TU may result in improved health outcomes for men with testosterone deficiency.
Figure 1: Compliance and Treatment Patterns 1-year Post-index
