Effects of the oral testosterone undecanoate Kyzatrex™ on ambulatory blood pressure in hypogonadal men

Abstract

Testosterone replacement therapies have been shown to increase blood pressure (BP) in hypogonadal men. We studied the effects of a new formulation of testosterone undecanoate (Kyzatrex™) on ambulatory blood pressure (ABP) and heart rate, in 155 men with hypogonadism (mean age, 50.5 years, 76.8% white, 36.1% on antihypertensive therapy). The ABP, heart rate and clinical assessments were obtained at baseline and following 120 and 180 days of therapy. Mean changes from baseline in 24‐h ambulatory systolic BP of 1.7 mmHg (95% CI, 0.3, 3.1) at day 120 and 1.8 mmHg (95% CI, 0.3, 3.2) at day 180 were observed post‐treatment. For those men on antihypertensive drug therapy, increases in mean 24‐h systolic BP were greater than those not taking antihypertensive drugs (3.4 vs 0.7 mmHg at day 120 and 3.1 vs 1.0 mmHg at day 180, respectively). Changes from baseline in 24‐h diastolic BP and heart rate at day 120 were smaller (<1 mmHg and <1 beat/min, respectively). There were no relationships observed between testosterone concentration or hemoglobin levels with ABP. Multivariable analyses showed that baseline ambulatory BP and antihypertensive therapy were significantly correlated with BP changes. These data demonstrate small increases in ambulatory BP following 120 days on this oral testosterone undecanoate with no further changes at 180 days. Changes in ambulatory BP were minimal in patients not taking antihypertensive therapy.

A new oral testosterone (TLANDO) treatment regimen without dose titration requirement for male hypogonadism

“… 17 Another ambulatory BP study of a developmental oral TU drug with dose titrations reported that the oral TU increased mean ambulatory systolic/diastolic BPs as 1.7 mmHg/0.6 mmHg and 1.8 mmHg/0.6 mmHg for 120 days and 180 days, respectively, in 155 hypogonadal subjects. 20 The mean increases in systolic BP in patients receiving antihypertensive medication were slightly higher (3.4 mmHg) compared to those without anti‐hypertensive therapy (0.7 mmHg). Note that, 3.2% of the oral TU patients were started on new antihypertensive agents during the 180‐day study.…”

“…Oral administration of TU has been shown to increase ambulatory blood pressures in previous literature 17,20,21 . The review report of Swerdloff et al.…”

“…Oral administration of TU has been shown to increase ambulatory blood pressures in previous literature. 17 , 20 , 21 The review report of Swerdloff et al. on a recently approved oral TU product with dose titrations showed the oral TU increased mean ambulatory systolic/diastolic blood pressures (BPs) as 4.9 mmHg/2.8 mmHg for 3–4 months in 166 hypogonadal subjects.…”

“…Note that, 3.2% of the oral TU patients were started on new antihypertensive agents during the 180‐day study. 20 A recent ambulatory BP study of the current study drug (TLANDO) was performed for four months in 138 hypogonadal subjects. 21 Note that, 48% of the subjects had a medical history of hypertension or were receiving an anti‐hypertensive medication during therapy.…”

Clinical and pharmacological basis of the use of testosterone drugs for hormonal replacement therapy for hypogonadism in men

“…В результате у участников исследования с артериальной гипертензией в анамнезе, получавших антигипертензивную терапию, и у пациентов с сахарным диабетом 2 типа наблюдалось большее увеличение как артериального давления, так и частоты сердечных сокращений в амбулаторных условиях на фоне приема тестостерона ундеканоата в дозе от 100 мг один раз в день до 400 мг два раза в день, чем у тех, у кого не было этих 2 сопутствующих заболеваний. У мужчин с гипогонадизмом, которые не получали антигипертензивные препараты, наблюдались незначительные изменения артериального давления и частоты сердечных сокращений [41].…”