Effects of a Novel Oral Testosterone Undecanoate on Ambulatory Blood Pressure in Hypogonadal Men

2021 ◽  
pp. 107424842110273
Author(s):  
William B. White ◽  
Adrian Dobs ◽  
Culley Carson ◽  
Anthony DelConte ◽  
Mohit Khera ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Ambulatory Blood Pressure ◽  
Clinical Relevance ◽  
Testosterone Replacement ◽  
Male Hypogonadism ◽  
Increase Blood Pressure ◽  
Testosterone Therapy ◽  
Testosterone Undecanoate ◽  
Chronic Use

Background: Testosterone replacement therapies may increase blood pressure (BP) with chronic use but the mechanism is not clear. TLANDO™ is a new oral testosterone undecanoate (TU) under development for the treatment of male hypogonadism. Methods: We studied the effects of the TU at 225 mg twice daily on ambulatory BP (ABP) and heart rate, in 138 men with hypogonadism (mean age, 54 years, 79% white, 48% with hypertension). Ambulatory BP and heart rate and hematologic assessments were obtained at baseline and following 4-months of therapy. Results: Changes from baseline in ambulatory 24-hour, awake, and sleep systolic BP (SBP) of 3.8 ( P < 0.001), 5.2 ( P < 0.001), and 4.3 mmHg ( P = 0.004) were observed post-treatment, respectively. Lesser changes in the diastolic BP (DBP) were observed (1.2 ( P = 0.009), 1.7 ( P = 0.004), and 1.7 mmHg ( P = 0.011) for 24-hour, awake, and sleep, respectively). Hematocrit and hemoglobin were increased by 3.2% and 0.9 g/dL ( P < 0.001), respectively. In those men in the top quartile of changes in hematocrit (range of 6% to 14%), the largest increases in ambulatory SBP (mean, 8.3 mmHg) were observed, whereas the changes in ambulatory SBP in the lower 3 quartiles were smaller (mean, 1.9, 3.3, and 2.1 mmHg in 1st, 2nd and 3 rd quartiles, respectively). Conclusion: These data demonstrate that small increases in ABP occurred following 4 months of the oral TU. For those men whose hematocrit rose by >6%, BP increases were of greater clinical relevance. Hence, hematocrit may aid in predicting the development of BP increases on testosterone therapy. ClinicalTrials.gov identifier: NCT 03868059.

scholarly journals SAT-038 Ambulatory Blood Pressure Increases in Hypogonadal Men Who Develop Increases in Hematocrit on Oral Testosterone Undecanoate

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Adrian Sandra Dobs ◽  
William B White ◽  
Culley Carson ◽  
Anthony DelConte ◽  
Mohit Khera ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Ambulatory Blood Pressure ◽  
Lower Boundary ◽  
Clinical Parameter ◽  
Male Hypogonadism ◽  
Testosterone Undecanoate ◽  
History Of ◽  
Subgroup Versus ◽  
Chronic Use

Abstract There is concern that testosterone replacement therapies might increase blood pressure (BP) with chronic use. Testosterone undecanoate is a novel oral testosterone therapy under development for the treatment of male hypogonadism. We studied the effects of testosterone undecanoate (225 mg twice daily) on ambulatory blood pressure (ABP) and heart rate, in 138 men with hypogonadism (mean age, 54 years, 79% white, 48% with a history of hypertension). Ambulatory BP and heart rate and hematologic parameters were obtained at baseline and following 4 months of daily therapy. Changes from baseline in ambulatory 24-hour, awake, and sleep systolic BP of 3.8 (p=0.06), 5.2 (p=0.01), and 4.3 mmHg (p=0.07) were observed post-treatment, respectively. Smaller changes in the diastolic BP were observed (1.2 (p=0.13), 1.7 (p=0.04), and 1.7 mmHg (p=0.11) for 24-hour, awake, and sleep, respectively). Changes in the 24-hour, awake and sleep heart rates were 1.9 (p=0.07), 2.6 (p=0.02), and 0.4 (p=0.68) beats/minute respectively. There were no significant differences in changes from baseline in the 24-hour ambulatory BP for the 57 subjects who had a medical history of hypertension versus the 61 subjects who did not have hypertension: 4.5/1.5 mmHg in the hypertension subgroup versus 3.2/0.9 mmHg in the non-hypertensive subgroup (p = 0.53/0.46 between groups). Hematocrit and hemoglobin increased by 3.2% and 0.9 g/dl in all subjects after 4 months of therapy. In those men in the top quartile of changes in hematocrit (corresponding to upper / lower boundary increases of 6 and 14% with 9.3% achieving levels &gt; 52%), the largest increases in ambulatory systolic BP (8.3 mmHg) were observed, whereas the changes in ambulatory systolic BP in the lower 3 quartiles were substantially smaller (1.6, 3.2, and 2.7 mmHg in quartiles 1, 2 and 3 of hematocrit change, respectively). In conclusion, these data demonstrate increases in ambulatory BP occurred following 4 months of oral testosterone undecanoate, particularly in those men whose hematocrit rose by &gt; 6% or whose resultant hematocrit was 52% or higher. Hence, hematocrit maybe a useful clinical parameter that could effectively predict the risk of developing increases in BP on oral testosterone undecanoate.

scholarly journals Association of Ambulatory Blood Pressure and Heart Rate With Advanced White Matter Lesions in Ischemic Stroke Patients

2013 ◽  
Vol 27 (2) ◽  
pp. 177-183 ◽  
Author(s):  
Hyuk Sung Kwon ◽  
Young-Hyo Lim ◽  
Hyun Young Kim ◽  
Hee-Tae Kim ◽  
Hyung-Min Kwon ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Ischemic Stroke ◽  
White Matter ◽  
Ambulatory Blood Pressure ◽  
White Matter Lesions ◽  
Stroke Patients

Ambulatory Blood Pressure Recordings in Children and Adolescents

PEDIATRICS ◽  
1994 ◽  
Vol 94 (2) ◽  
pp. 180-184
Author(s):  
Gregory A. Harshfield ◽  
Bruce S. Alpert ◽  
Derrick A. Pulliam ◽  
Grant W. Somes ◽  
Dawn K. Wilson
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Systolic Blood Pressure ◽  
Ambulatory Blood Pressure ◽  
Reference Data ◽  
Blood Pressure Monitoring ◽  
Age Groups ◽  
Specific Reference ◽  
Pressure Monitoring ◽  
Black And White

Objective. To provide reference data for ambulatory blood pressure monitoring (ABPM) and to determine the influence of age, sex, and race on these values. Methods. ABPM was performed on 300 healthy, normotensive boys and girls between the ages of 10 and 18 years, including 160 boys and 140 girls, of whom 149 were white and 151 were black. Mean systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR) while awake and during sleep were calculated for black and white boys and girls aged 10 to 12 years, 13 to 15 years, and 16 to 18 years. Results. Boys compared with girls 10 to 12 years of age had higher mean (±SD) SBP (115 ± 9 vs 112 ± 9 mm Hg; P &lt; .01) and DBP (67 ± 7 vs 65 ± 5 mm Hg; P &lt; .01) while awake. Boys compared to girls 13 to 15 years of age had higher SBP while awake (116 ± 11 vs 112 ± 8 mm Hg; P &lt; .01). Boys compared with girls 16 to 18 years of age had higher SBP while awake (125 ± 12 vs 111 ± 9 mm Hg; P &lt; .01) and during sleep (116 ± 11 vs 106 ± 9 mm Hg). Comparisons within sex showed similar changes with age for boys and girls. Blacks compared with whites 13 to 15 years of age had higher SBP during sleep (109 ± 11 vs 105 ± 10 mm Hg; P &lt; .01), and blacks compared with whites 16 to 18 years of age had higher DBP during sleep (66 ± 7 vs 58 ± 6 mm Hg; P &lt; .01). Comparisons across age groups within race showed that blacks 16 to 18 years of age had higher SBP during sleep than blacks 10 to 12 years of age (109 ± 11 vs 104 ± 10 mm Hg), and higher DBP during sleep (66 ± 7 mm Hg; P &lt; .01) than blacks 10 to 12 years of age (61 ± 7 mm Hg; P &lt; .01) and 13 to 15 years of age (61 ± 8; P &lt; .01 mm Hg). The changes with age were not significant for white subjects. Conclusion. These results provide age-specific reference data for ABPM in youths. These values differ by sex (boys more than girls) and race (Blacks more than Whites).

Sign in / Sign up

Export Citation Format

Share Document