Impact of A New Oral Testosterone Undecanoate on Blood Pressure and Cardiovascular Risk Introduction: Chronic use of testosterone replacement therapy (TRT) might effect cardiovascular (CV) risk. Clinical trials for recen

Impact of A New Oral Testosterone Undecanoate on Blood Pressure

and Cardiovascular Risk

Introduction: Chronic use of testosterone replacement

therapy (TRT) might effect cardiovascular (CV) risk. Clinical trials for recently approved TRTs have shown impacts on blood pressure

(BP) that led to an increase anti-hypertensive dose or new starts: e.g., Xyosted (10% of patients in a 1-year study) and Jatenzo

(7.2% in a 4-month study). Here we present the effect of oral testosterone undecanoate (TLANDO, a novel prodrug of bioidentical

testosterone) on BP and CV risk including Framingham Risk Score (FRS), and dipping patterns.

Objective: To assess the impact of TLADO treatment on

BP and CV risk in hypogonadal men.

Methods: Assessment of

BP was conducted in a 16-week, multicenter, open-label, single arm ambulatory blood pressure monitoring (ABPM) study in hypogonadal

men (N=138). A fixed dose of 225 mg TLANDO was given BID orally for 16 weeks. 24-hr mean changes from baseline (CBL) of BP were

measured and analyzed. Subgroup analysis of systolic blood pressure (SBP) CBL was performed in subjects categorized as low, moderate,

or high CV FRS risk at baseline (BL). Dipping [ ] was also

measured. Dipping was categorized as reverse dipper (<0%), non-dipper (0-10%), dipper (10-20%), and extreme dipper ( 20%).

Results: Demographics were 53.8 10.2 yrs , BMI

33.1 5.8 kg/m2, 79% white ethinicity. Co-morbidities were obesity (30%), type 2 diabetes (24%) and hypertension

(48%). 126 subjects completed the study and 118 subjects had valid 24-hr evaluable ABPM data at both baseline and EOS. Overall,

T was well tolerated with no death, no drug related SAEs, and no major adverse cardiovascular events (MACE). 1.4% of subjects either

had an increase in anti-hypertensive medication dose or started a new medication with T treatment. 24-hr mean (95% CI) SBP CBL

was 3.8 2.1 mmHg. 25 subjects had SBP>140 mmHg at BL and their 24-hr mean SBP CBL was -3.4 mmHg. Among them, 8 (32%)

subjects were normalized post-treatment. Based on FRS categories at BL, 40 (33.9%), 74 (62.7%), and 4 (3.4%) subjects were at low,

moderate and high risk, respectively. 24-hr mean SBP CBL for low, moderate, and high-risk subjects was 2.6, 4.8, and -1.8 mmHg,

respectively. Post TLANDO treatment, shifts from less dippers at BL to greater dippers at EOS were slightly higher (or comparable

with the opposite shifts) implying lower all-cause mortality.

Conclusions: Marginal increases in BP, the dipping shifts,

and the FRS with TLANDO treatment does not appear to have a meaningful impact on CV risk.

Authors: Muhammad B Shahid, Kongnara Papangkorn, Nachiappan

Chidambaram, Kilyoung Kim, Anthony DelConte, Mohit Khera, Martin Miner, Jed Kaminetsky, Irwin Goldstein, Linda Vignozzi, and Mahesh