Long-Term Effects of Testosterone Undecanoate Therapy on Blood Pressure, Pulse Pressure and Heart Rate in Hypogonadal Men:  Real-Life Data from a Registry Study

Program: Abstracts - Orals, Poster Previews, and Posters
Session: SUN 176-202-Male Reproductive Endocrinology and Male Reproductive Tract (posters)
Bench to Bedside
Sunday, April 3, 2016: 1:15 PM-3:15 PM
Exhibit/Poster Hall (BCEC)

Poster Board SUN 196
Farid Saad*1, Ahmad Haider2, Karim Sultan Haider2, Gheorghe Doros3 and Abdulmaged M Traish4
1Bayer Pharma AG, Berlin, Germany, 2Private Urology Practice, Bremerhaven, Germany, 3Boston University School of Public Health, Boston, MA, 4Boston Univ Sch of Med, Boston, MA
Objective:

A registry was established to assess long-term effectiveness and safety of TU in a urological setting in comparison to an untreated hypogonadal control group.

Material and Methods:

Observational, prospective, cumulative registry study in 656 men (age: 60.72 ± 7.15 years) with total testosterone (T) levels below 12.1 nmol/L and symptoms of hypogonadism. 360 men received parenteral TU 1000 mg/12 weeks following an initial 6-week interval for up to 10 years. 296 men had opted against TTh and served as controls. Median follow-up in both groups was 7 years. Measurements were taken at least twice a year, and 8-year data were analysed. Mean changes over time between the two groups were compared by means of a mixed effects model for repeated measures with a random effect for intercept and fixed effects for time, group and their interaction. Changes were adjusted for age, weight, waist circumference, blood pressure, and lipids. To account for baseline differences between the two groups.

Results:

Systolic blood pressure (mmHg) decreased from 151.28 ± 16.97 to 129.98 ± 6.59 (p<0.0001) in the T group and increased from 139.46 ± 15.00 to 140.34 ± 13.29 (p=0.0004) in the controls. The model-adjusted estimated difference between groups at 8 years was -28.90 (p<0.0001).

Diastolic blood pressure (mmHg) decreased from 90.59 ± 11.57 to 74.36 ± 4.57 (p<0.0001) in the T group and increased from 79.55 ± 9.19 to 81.09 ± 8.42 (p=0.0022) in the controls. The difference between groups at 8 years was -18.94 (p<0.0001).

Pulse pressure decreased from 60.69 ± 7.69 to 55.62 ± 4.88 (p<0.0001) in the T group and remained stable from 59.91 ± 10.16 to 59.25 ± 6.91 (NS) in the controls. The difference between groups at 8 years was -9.77 (p<0.0001).

Heart rate (bpm) decreased from 77.53 ± 3.67 to 72.44 ± 2.09 (p<0.0001) in the T group and increased from 76.16 ± 4.97 to 77.64 ± 4.04 (p=0.0063) in the controls. The difference between groups at 8 years was -6.25 (p<0.0001).

There were two deaths in the T group and 21 deaths in the control group. No patient dropped out.

Conclusions:

Long-term TTh with TU in an unselected cohort of hypogonadal men resulted in improvements in the blood pressure, pulse pressure and heart rate, whereas there was a worsening except for pulse pressure in untreated controls. Long-term TU was well tolerated and excellent adherence suggested a high level of patient satisfaction.

Disclosure: FS: Employee, Bayer Schering Pharma. AH: Investigator, Bayer Schering Pharma. GD: Coinvestigator, Bayer Schering Pharma. Nothing to Disclose: KSH, AMT

*Please take note of The Endocrine Society's News Embargo Policy at https://www.endocrine.org/news-room/endo-annual-meeting/pr-resources-for-endo

Sources of Research Support: Data entry and statistical analyses were partially funded by Bayer Pharma, Berlin, Germany.