Table 2.
Change From Baseline and Estimated Differences for Primary, Secondary, and Exploratory Outcomes in the Cardiovascular Trial
| Outcome | Treatment Group | Estimated Difference (95% CI)a | P Valueb | |
|---|---|---|---|---|
| Testosterone (n = 73) | Placebo (n = 65) | |||
| Primary | ||||
| Noncalcified plaque volume, mm3 | ||||
| Baseline, median (IQR) | 204 (60 to 420) | 317 (168 to 589) | ||
| Month 12, median (IQR) | 232 (103 to 473) | 325 (172 to 560) | ||
| Change from baseline value, unadjusted mean (95% CI) | 40 (23 to 56) | 4 (−14 to 22) | ||
| LS mean (95% CI)c | 54 (12 to 97) | 14 (−29 to 56) | 41 (14 to 67) | .003 |
| Secondary | ||||
| Total plaque volume, mm3 | ||||
| Baseline, median (IQR) | 272 (84 to 600) | 499 (246 to 925) | ||
| Month 12, median (IQR) | 318 (133 to 693) | 541 (248 to 950) | ||
| Change from baseline value, unadjusted mean (95% CI) | 57 (35 to 78) | 21 (0 to 42) | ||
| LS mean (95% CI)c | 75 (22 to 128) | 28 (−24 to 81) | 47 (13 to 80) | .006 |
| Coronary artery calcium score, Agatston unitsd | ||||
| Baseline, median (IQR) | 255 (43 to 963) | 494 (146 to 1892) | ||
| Month 12, median (IQR) | 244 (52 to 1013) | 503 (146 to 2108) | ||
| Change from baseline value, unadjusted mean (95% CI) | 53 (25 to 82) | 118 (73 to 164) | ||
| LS mean (95% CI)c | 64 (−19 to 146) | 91 (7 to 174) | −27 (−80 to 26) | .31 |
| Exploratory | ||||
| Low-attenuation plaque volume, mm3 | ||||
| Baseline, median (IQR) | 7.1 (1.5 to 32.4) | 15.3 (2.6 to 31.1) | ||
| Month 12, median (IQR) | 9.5 (2.1 to 24.2) | 11.0 (3.2 to 30.8) | ||
| Change from baseline value, unadjusted mean (95% CI) | 6 (0 to 12) | 2 (−2 to 6) | ||
| LS mean (95% CI)c | 8 (−4 to 20) | 3 (−9 to 14) | 5 (−2 to 13) | .14 |
| Fibrous-fatty plaque volume, mm3 | ||||
| Baseline, median (IQR) | 40.0 (11.5 to 72.6) | 43.7 (18.9 to 107) | ||
| Month 12, median (IQR) | 46.3 (14.0 to 100) | 54.5 (14.7 to 107) | ||
| Change from baseline value, unadjusted mean (95% CI) | 9 (1 to 17) | 1 (−6 to 9) | ||
| LS mean (95% CI)c | 12 (−7 to 30) | 2 (−17 to 21) | 10 (−2 to 21) | .11 |
| Fibrous plaque volume, mm3 | ||||
| Baseline, median (IQR) | 160 (51.5 to 305) | 254 (122 to 426) | ||
| Month 12, median (IQR) | 177 (64.1 to 320) | 253 (138 to 471) | ||
| Change from baseline value, unadjusted mean (95% CI) | 25 (14 to 35) | 1 (−13 to 15) | ||
| LS mean (95% CI)c | 31 (0 to 62) | 7 (−24 to 37) | 24 (5 to 43) | .01 |
| Dense calcium plaque volume, mm3 | ||||
| Baseline, median (IQR) | 69.5 (13.6 to 211) | 173 (35.2 to 351) | ||
| Month 12, median (IQR) | 74.8 (13.9 to 245) | 177 (47.2 to 323) | ||
| Change from baseline value, unadjusted mean (95% CI) | 17 (7 to 27) | 17 (6 to 28) | ||
| LS mean (95% CI)c | 17 (−8 to 42) | 11 (−14 to 36) | 5 (−11 to 21) | .51 |
Abbreviations: IQR, interquartile range; LS, least squares.
Mean difference in change from baseline for participants assigned to testosterone vs those assigned to placebo, with adjustment for balancing factors: baseline total testosterone level (≤200 or >200 ng/dL [to convert to nanomoles per liter, multiply by 0.0347]), age (≤75 or >75 years), trial site, participation in the main trials, use or nonuse of antidepressants, use or nonuse of phosphodiesterase type 5 inhibitors, and baseline value of the outcome variable.
Determined by a linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.
Adjusted treatment group mean of the change from baseline to month 12.
Higher values indicate more coronary artery calcium.