Table 5.
Changes in blood pressure at weeks 4 and 8 in the full analysis set
| FDC therapy group (n=61) | Olmesartan medoxomil group (n=36) | Rosuvastatin group (n=36) | Placebo group (n=29) | |
|---|---|---|---|---|
| Diastolic blood pressure | ||||
| Week 4 | ||||
| Mean (SD), mmHg | 84.8 (8.5) | 86.0 (7.9) | 90.9 (7.0) | 92.7 (8.6) |
| LS mean change from baseline (SE), mmHg | −7.4 (1.1) | −6.7 (1.4) | −1.6 (1.4) | 0.4 (1.5) |
| LS mean difference, mmHg (SE) (95% CI) | – | −0.7 (1.6) (−3.9 to 2.5) | −5.7 (1.6) (−9.0 to −2.5) | −7.7 (1.8) (−11.2 to 4.3) |
| P-value* vs FDC therapy | – | 0.6695 | 0.0006 | <0.0001 |
| Week 8 | ||||
| Mean (SD), mmHg | 82.1 (9.8) | 85.0 (8.3) | 93.0 (9.2) | 92.9 (8.7) |
| LS mean change from baseline (SE), mmHg | −10.4 (1.2) | −8.1 (1.5) | 0.1 (1.6) | 0.2 (1.7) |
| LS mean difference, mmHg (SE) (95% CI) | – | −2.3 (1.8) (−5.9 to 1.3) | −10.5 (1.8) (−14.1 to −6.9) | −10.5 (2.0) (−14.4 to −6.7) |
| P-value* vs FDC therapy | – | 0.2096 | <0.0001 | <0.0001 |
| Systolic blood pressure | ||||
| Week 4 | ||||
| Mean (SD), mmHg | 135.6 (14.8) | 133.9 (13.5) | 150.2 (17.1) | 151.5 (18.3) |
| LS mean change from baseline (SE), mmHg | −14.8 (2.1) | −16.5 (2.6) | 0.4 (2.6) | 0.2 (2.9) |
| LS mean difference, mmHg (SE) (95% CI) | – | 1.6 (3.1) (−4.5 to 7.8) | −15.3 (3.1) (−21.4 to −9.1) | −15.1 (3.3) (−21.7 to −8.5) |
| P-value* vs FDC therapy | – | 0.5996 | <0.0001 | <0.0001 |
| Week 8 | ||||
| Mean (SD), mmHg | 132.6 (17.9) | 133.4 (14.5) | 153.4 (19.1) | 154.2 (21.0) |
| LS mean change from baseline (SE), mmHg | −18.7 (2.3) | −17.9 (2.9) | 2.9 (2.9) | 1.75 (3.3) |
| LS mean difference, mmHg (SE) (95% CI) | – | −0.8 (3.5) (−7.8 to 6.1) | −21.6 (3.5) (−28.5 to −14.7) | −20.4 (3.8) (−27.9 to −13.0) |
| P-value* vs FDC therapy | – | 0.8147 | <0.0001 | <0.0001 |
Note:
*
Analysis of covariance.
Abbreviations: CI, confidence interval; FDC, fixed-dose combination; LS, least square; SD, standard deviation; SE, standard error.