Table 5.
Change in Biomarkers from Baseline to Year 1
| CEE+MPA Trial | CEE Trial | ||||
|---|---|---|---|---|---|
| CEE+MPA | Placebo | CEE | Placebo | ||
| CHD/controls | 79/180 | 55/148 | 55/120 | 47/112 | |
| Median (Interquartile Range) | P value1 | ||||
| Inflammation | |||||
| C-reactive protein (ug/ml) | 1.1 (3.6) | −0.0 (1.5) | 2.2 (4.4) | 0.1 (2.3) | <0.001 |
| E-selectin (ng/ml) | −7.0 (9.0) | 0.0 (10.0) | −7.0 (12.0) | −1.0 (9.0) | <0.001 |
| Interleukin-6 (pg/ml) | 0.2 (1.5) | 0.1 (1.7) | 0.3 (1.6) | 0.1 (1.8) | 0.44 |
| MMP-9 (ng/ml) | 53.0 (154.0) | −3.00 (111.0) | 28.0 (154.0) | −11.5 (140.0) | <0.001 |
| Lipids | |||||
| HDL- cholesterol (mg/dl) | 4.0 (8.0) | 0.0 (9.0) | 7.0 (12.0) | 0.0 (6.0) | <0.001 |
| LDL-cholesterol (mg/dl) | −20.0 (30.0) | −1.0 (27.0) | −23.0 (32.0) | 1.0 (29.5) | <0.001 |
| Total cholesterol (mg/dl) | −16.0 (33.0) | −2.0 (33.0) | −12.5 (35.0) | 0.0 (33.0) | <0.001 |
| Triglycerides (mg/dl) | 14.0 (56.0) | 1.0 (49.0) | 17.5 (69.0) | 0.0 (50.0) | <0.001 |
| Thrombosis and other blood markers | |||||
| D-dimer (ug/ml) | 0.0 (0.3) | 0.0 (0.2) | 0.0 (0.3) | 0.0 (0.2) | 0.16 |
| Fibrinogen (mg/dl) | −26.5 (79.0) | −7.5 (68.0) | −10.0 (100.0) | −5.0 (80.0) | 0.02 |
| Factor VIII (%) | −2.0 (34.0) | 0.0 (30.0) | 1.0 (29.0) | 2.5 (34.0) | 0.27 |
| PAI-1 antigen (ng/ml) | −6.2 (25.4) | −0.6 (28.9) | −9.9 (34.0) | −0.6 (30.2) | <0.001 |
| Prothrombin F1.2 (nmol/L) | 0.1 (0.4) | 0.0 (0.4) | 0.1 (0.5) | 0.0 (0.4) | 0.13 |
| PAP (nmol/L) | 0.7 (2.0) | 0.1 (1.5) | 0.7 (1.9) | 0.2 (1.3) | <0.001 |
| TAFI (ug/ml) | −0.0 (0.7) | −0.1 (0.7) | 0.2 (0.7) | 0.0 (0.9) | 0.07 |
| von Willebrand factor (%) | 0.0 (33.0) | 3.0 (31.0) | 0.00 (33.0) | 0.0 (37.0) | 0.62 |
| Homocysteine (umol/L) | −0.4 (2.2) | −0.3 (2.4) | −0.4 (2.3) | 0.0 (2.7) | 0.01 |
| Glucose (mg/dl) | −3.0 (13.0) | −1.0 (12.0) | −3.0 (15.0) | 1.0 (16.0) | 0.002 |
| Insulin (UIU/ml) | −1.0 (3.3) | 0.1 (3.8) | −1.1 (4.8) | 0.8 (3.6) | <0.001 |
1
P-value from a paired t-test (per participant) of change in biomarker on hormone treatment compared to placebo, controlling for the same variables as in Table 3.