Table 2.
Lipid, body weight, and BP responses to treatment at Week 14
| Parameter | Placebo | MK-0941 dose (mg t.i.d. a.c.) |
|||
|---|---|---|---|---|---|
| 10 | 20 | 30 | 40 | ||
| n | 111 to 114 | 112 to 118 | 113 to 117 | 113 to 117 | 113 to 118 |
| Total cholesterol | |||||
| % Change from baseline | 4.3 (1.2 to 7.4) | 4.7 (1.5 to 7.9) | 6.2 (3.1 to 9.4) | 5.1 (1.9 to 8.3) | 7.4 (4.2 to 10.5) |
| Change from placebo | — | 0.4 (−4.0 to 4.7) | 1.9 (−2.4 to 6.2) | 0.8 (−3.5 to 5.1) | 3.0 (−1.3 to 7.4) |
| LDL cholesterol | |||||
| % Change from baseline | 7.8 (3.2 to 12.4) | 2.6 (−2.2 to 7.5) | 5.6 (0.8 to 10.3) | 5.5 (0.7 to 10.2) | 5.5 (0.7 to 10.3) |
| Change from placebo | — | −5.2 (−11.7 to 1.4) | −2.2 (−8.7 to 4.3) | −2.3 (−8.8 to 4.2) | −2.3 (−8.9 to 4.3) |
| HDL cholesterol | |||||
| % Change from baseline | −0.2 (−2.9 to 2.5) | 2.3 (−0.5 to 5.1) | −0.1 (−2.8 to 2.6) | −0.9 (−3.7 to 1.8) | 1.9 (−0.9 to 4.6) |
| Change from placebo | — | 2.5 (−1.3 to 6.3) | 0.1 (−3.7 to 3.8) | −0.7 (−4.5 to 3.1) | 2.1 (−1.7 to 5.9) |
| Non-HDL cholesterol | |||||
| % Change from baseline | 6.3 (2.2 to 10.4) | 6.1 (1.9 to 10.4) | 9.3 (5.2 to 13.4) | 8.2 (4.0 to 12.4) | 9.8 (5.6 to 14.0) |
| Change from placebo | — | −0.2 (−5.9 to 5.6) | 3.0 (−2.6 to 8.7) | 1.9 (−3.8 to 7.6) | 3.5 (−2.2 to 9.3) |
| Triglycerides | |||||
| % Change from baseline† | 8.0 (−1.6 to 17.5) | 15.3 (6.0 to 24.6) | 27.6 (15.5 to 39.7) | 12.1 (3.4 to 20.8) | 18.2 (8.8 to 27.5) |
| Change from placebo† | — | 7.8 (−3.4 to 18.7) | 19.3 (7.2 to 31.2)* | 6.1 (−4.7 to 16.8) | 12.7 (1.9 to 24.3)** |
| Body weight (kg) | |||||
| Change from baseline | −0.2 (−0.7 to 0.3) | 0.0 (−0.5 to 0.6) | 0.3 (−0.2 to 0.8) | 0.4 (−0.1 to 0.9) | 0.6 (0.1 to 1.1) |
| Change from placebo | — | 0.2 (−0.5 to 0.9) | 0.5 (−0.2 to 1.2) | 0.6 (−0.1 to 1.3) | 0.8 (0.0 to 1.5)** |
| SBP (mmHg) | |||||
| Change from baseline | −1.3 (−3.7 to 1.2) | 1.7 (−0.8 to 4.2) | −1.2 (−3.6 to 1.2) | 0.8 (−1.7 to 3.3) | 2.5 (−0.1 to 5.0) |
| Change from placebo | — | 3.0 (−0.4 to 6.4) | 0.1 (−3.2 to 3.4) | 2.0 (−1.3 to 5.4) | 3.7 (0.3 to 7.2)** |
| DBP (mmHg) | |||||
| Change from baseline | −0.5 (−2.0 to 1.0) | 0.4 (−1.1 to 2.0) | −1.0 (−2.5 to 0.5) | 0.5 (−1.0 to 2.0) | 0.8 (−0.8 to 2.3) |
| Change from placebo | — | 1.0 (−1.1 to 3.0) | −0.5 (−2.5 to 0.5) | 1.0 (−1.0 to 3.1) | 1.3 (−0.8 to 3.4) |
Change from baseline or change from placebo data are expressed as LS mean change or LS mean percent change (95% CI) with LDA unless otherwise indicated.
†Data are median percent change (95% CI) using ANCOVA with last observation carried forward analysis; n per group ranged from 82 to 96 for triglycerides.
*P ≤ 0.001 for the between-group difference relative to placebo.
**P ≤ 0.05 for the between-group difference relative to placebo.