Table 2.
Carotid Artery Intima-Media Thickness Progression Rates*
| Subject group | N† | Placebo | ISP | Differences in rates | p-value‡ |
|---|---|---|---|---|---|
| All Subjects | 325 (163/162) | 5.68 (4.30–7.06) | 4.77 (3.39–6.16) | −0.91(−2.86–1.05) | 0.36 |
| Age at randomization – yrs | |||||
| ≤55 | 82 (44/38) | 5.41 (2.70–8.11) | 2.92 (0.05–5.79) | −2.49 (−6.44–1.45) | 0.21 |
| 56–60 | 81 (40/41) | 5.76 (3.21–8.32) | 4.19 (1.64–6.74) | −1.57 (−5.18–2.04) | 0.39 |
| >60 | 162 (79/83) | 5.78 (3.74–7.82) | 5.89 (3.90–7.88) | 0.11 (−2.74–2.96) | 0.94 |
| Time-since-menopause – yrs | |||||
| <5 | 68 (35/33) | 6.79 (3.56–10.00) | 2.16 (−1.10–5.43) | −4.62 (−9.21– −0.04) | 0.05 |
| 5–10 | 89 (43/46) | 6.46 (4.10–8.83) | 5.36 (3.08–7.64) | −1.10 (−4.39–2.19) | 0.51 |
| >10 | 134 (65/69) | 5.24 (2.98–7.50) | 4.78 (2.58–6.98) | −0.46 (−3.62–2.70) | 0.77 |
| Ethnicity§ | |||||
| White (non-Hispanic) | 207 (110/97) | 5.89 (4.16–7.62) | 5.19 (3.35–7.03) | −0.70 (−3.22–1.83) | 0.59 |
| Black (non-Hispanic) | 22 (10/12) | 6.69 (1.25–12.13) | 6.27 (1.31–11.22) | −0.43 (−7.79–6.93) | 0.91 |
| Hispanic | 52 (21/31) | 3.42 (−0.29–7.12) | 4.63 (1.55–7.70) | 1.21 (−3.60–6.02) | 0.62 |
| Asian | 43 (22/21) | 6.37 (2.95–9.79) | 2.07 (−1.40–5.55) | −4.30 (−9.18–0.58) | 0.08 |
*
Mean (95% confidence interval) change rate in μm/year.
†
Total sample size (placebo treatment group sample size/isoflavone soy protein treatment group sample size).
‡
P-value for treatment group differences in carotid artery intima-media thickness rate analyzed by linear mixed effects models adjusting for carotid artery intima-media thickness randomization strata.
§
Ethnicity unknown for 1 participant and excluded from the model.
ISP = isoflavone soy protein treatment group.