Testosterone replacement therapy among elderly males: the Testim Registry in the US (TRiUS)

Figures & data

Table 1 Baseline demographic and clinical characteristics of patients ≥ 65 vs <65 years old

	Baseline, mean ± SD		P value
	Patients ≥65	Patients <65
Patients enrolled, n	133	712
Age, years (range)	71.7 ± 5.1 (65–84)	48.5 ± 9.4 (20–64)	<0.001
Total testosterone, ng/dL (nmol/L)	265.0 ± 108.9 (9.2 ± 3.8)	290.4 ± 158.3 (10.1 ± 5.5)	0.1
Free testosterone, pg/mL (pmol/L)	46.0 ± 38.0 (159.6 ± 131.9)	40.0 ± 65.4 (138.8 ± 226.9)	0.5
BMI, kg/m^2	30.0 ± 5.4	31.7 ± 7.1	0.008
PSA, ng/mL (μg/L)	1.82 ± 1.65 (1.82 ± 1.65)	0.95 ± 0.86 (0.95 ± 0.86)	<0.001
Medical history/current medication use (%)
Smoking (current or former)	38%	31%	0.2
Metabolic syndrome (calculated using ATP III definition and baseline data)	39%	36%	0.6
Hypertension	25%	19%	0.1
Dyslipidemia	16%	21%	0.2
Coronary artery disease	20%	17%	0.5
Diabetes mellitus	19%	11%	0.02
Depression	5%	9%	0.2
Sleep disorders (including apnea)	3%	5%	0.5
Prior TRT	23%	24%	0.9
Current opioid use	7%	11%	0.1
Current ED (PDE5 inhibitor use)	29%	18%	0.002
Current antidepressant use	0	0	–

Abbreviations: ATP, Adult Treatment Panel; BMI, body mass index; ED, erectile dysfunction; PDE5, phosphodiesterase type 5; PSA, prostate-specific antigen; TRT, testosterone replacement therapy.

Table 2 Baseline total and free testosterone with TRT use prior to enrollment compared with no prior TRT use in patients ≥ 65 vs <65 years old

	Mean ± SD, n
	Patients ≥65		Patients <65
	Prior TRT	No prior TRT	Prior TRT	No prior TRT
Serum TT, ng/dL (nmol/L)	326.1 ± 160.8 (11.3 ± 5.6) n = 10	259.0 ± 101.6 (9.0 ± 3.5) n = 102	355.5 ± 207.1 (12.3 ± 7.2) n = 85	279.9 ± 146.5 (9.7 ± 5.1) n = 526
FT, pg/mL (pmol/L)	34.3 ± 28.2 (119.0 ± 97.9) n = 7	47.3 ± 38.9 (164.1 ± 135.0) n = 61	61.4 ± 67.6 (213.1 ± 234.6) n = 61	36.0 ± 64.4 (124.9 ± 223.5) n = 332

Abbreviations: FT, free testosterone; SD, standard deviation; TRT, testosterone replacement therapy; TT, total testosterone.

Table 3 Baseline first-order Spearman ρ partial correlations for the entire study group

	Spearman ρ, P value
	TT	FT	PSA	SHBG
n	708	450	454	127
Weight	−0.19, P < 0.001	−0.04, P = 0.4	−0.05, P = 0.3	−0.07, P = 0.4
BMI	−0.21, P < 0.001	−0.07, P = 0.2	−0.06, P = 0.2	−0.09, P = 0.3
Waist circumference	−0.16, P < 0.001	−0.07, P = 0.1	−0.04, P = 0.5	−0.01, P = 0.9
Hip circumference	−0.14, P < 0.001	−0.07, P = 0.1	−0.04, P = 0.4	−0.02, P = 0.8
SBP	−0.07, P = 0.06	0.04, P = 0.4	−0.01, P = 0.8	0.11, P = 0.2
DBP	−0.16, P < 0.001	−0.14, P = 0.004	−0.02, P = 0.7	0.11, P = 0.2

Abbreviations: BMI, body mass index; DBP, diastolic blood pressure; FT, free testosterone; PSA, prostate-specific antigen; SBP, systolic blood pressure; SHBG, sex hormone–binding globulin; TT, total testosterone.

Table 4 Change from baseline to 12-month follow-up in testosterone and PSA in patients ≥ 65 vs <65 years old

	Mean ± SD, n, P value for change from baseline
	Patients ≥ 65		Patients < 65
	Month 12 measurement	Change from baseline	Month 12 measurement	Change from baseline
Serum TT, ng/dL (nmol/L)	524.0 ± 393.7 (18.2 ± 13.7) n = 24	229.7 ± 454.1 (8.0 ± 15.8) n = 23, ^aP = 0.02	491.1 ± 201.8 (17.0 ± 7.0) n = 126, ^bP = 0.5	232.9 ± 230.2 (8.1 ± 8.0) n = 114, ^aP < 0.001
FT, pg/mL (pmol/L)	95.2 ± 163.4 (330.3 ± 567.0) n = 16	15.4 ± 72.8 (53.4 ± 252.6) n = 12, ^aP = 0.5	65.5 ± 61.8 (227.3 ± 214.4) n = 94, ^bP = 0.2	27.7 ± 88.8 (96.1 ± 308.1) n = 70, ^aP = 0.01
PSA, ng/mL (μg/L)	2.18 ± 2.18 (2.18 ± 2.18) n = 20	0.33 ± 1.57 (0.33 ± 1.57) n = 20, ^aP = 0.4	1.14 ± 0.84 (1.14 ± 0.84) n = 69, ^bP = 0.1	0.17 ± 0.58 (0.17 ± 0.58) n = 69, ^aP = 0.01

Notes:

a Compared with baseline;

b compared with patients ≥65 years old.

Abbreviations: FT, free testosterone; PSA, prostate-specific antigen; TT, total testosterone.

Table 5 Spearman ρ partial correlations of the change in parameters from baseline to 12-month follow-up in the entire study group

	Spearman ρ, P value
	TT	FT	PSA
n	126	75	84
Weight	−0.15, P = 0.1	−0.01, P = 0.9	−0.09, P = 0.4
BMI	−0.15, P = 0.1	−0.01, P = 0.9	−0.10, P = 0.4
Waist circumference	−0.23, P = 0.01	−0.10, P = 0.4	−0.05, P = 0.6
Hip circumference	−0.15, P = 0.1	−0.06, P = 0.6	−0.07, P = 0.5
SBP	−0.03, P = 0.7	0.004, P = 0.9	−0.02, P = 0.8
DBP	0.01, P = 0.9	0.11, P = 0.3	−0.10, P = 0.4

Abbreviations: BMI, body mass index; DBP, diastolic blood pressure; FT, free testosterone; PSA, prostate-specific antigen; SBP, systolic blood pressure; TT, total testosterone.