APPENDIX TABLE 5.
EFFECTS OF TREATMENT ON MUSCLE STRENGTH
| BASELINE | 6 MONTHS | 12 MONTHS | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean (SD) | minimum-maximum | Mean Change * | 95% CI | P Value MK-677 vs. Placebo † | Mean Change * | 95% CI | P Value MK-677 vs. Placebo † | |||||
| MUSCLE STRENGTH | ||||||||||||
| KNEE | ||||||||||||
| Extension | Placebo | N=20 | 518 (225) | 149-1044 | N=20 | -10 | N=20 | -3 | ||||
| MK-677 | N=41 | 501 (173) | 193-1014 | N=39 | -14 | N=41 | -8 | |||||
| Extension/Leg Lean, N.m/kg ‡ | Placebo | N=20 | 72.1 (20.1) | 26.9-113.9 | N=20 | -0.8 | -5.1 - 3.6 | N=20 | -0.4 | -4.2 - 3.4 | ||
| MK-677 | N=41 | 72.6 (14.4) | 35.8-96.6 | N=39 | -2.1 | -5.2 - 1.0 | >.99 | N=41 | -1.3 | -3.9 - 1.4 | 0.73 | |
| Flexion | Placebo | N=20 | 336 (149) | 142-702 | N=20 | 9 | N=20 | 7 | ||||
| MK-677 | N=41 | 341 (120) | 166-624 | N=39 | 6 | N=41 | 15 | |||||
| Flexion/Leg Lean, N.m/kg ‡ | Placebo | N=20 | 51.1 (13.0) | 25.6-76.6 | N=20 | 1.9 | -1.0 - 4.8 | N=20 | 0.8 | -1.7 - 3.4 | ||
| MK-677 | N=41 | 49.3 (9.9) | 30.8-71.8 | N=39 | 0.8 | -1.3 - 2.9 | 0.91 | N=41 | 2.1 | 0.4 - 3.9 | 0.46 | |
| SHOULDER | ||||||||||||
| Extension | Placebo | N=20 | 389 (162) | 163-705 | N=20 | -3 | N=20 | 6 | ||||
| MK-677 | N=40 | 375 (134) | 210-746 | N=38 | 14 | N=40 | 20 | |||||
| Extension/Arm Lean, N.m/kg ‡ | Placebo | N=20 | 171.5 (36.0) | 98.9-232 | N=20 | -2.1 | -13.7-9.6 | N=20 | 0.9 | -9.3 - 11.0 | ||
| MK-677 | N=40 | 170.8 (41.6) | 87.1-306.1 | N=38 | 5.3 | -2.8 - 14.0 | 0.42 | N=40 | 6.4 | -0.8 - 13.6 | 0.36 | |
| Flexion | Placebo | N=20 | 203 (114) | 95-454 | N=20 | -12 | N=20 | -13 | ||||
| MK-677 | N=40 | 194 (75) | 81-427 | N=38 | -3 | N=40 | 0 | |||||
| Flexion/Arm Lean, N.m/kg ‡ | Placebo | N=20 | 86 (20.8) | 45.5-127.4 | N=20 | -5.1 | -10.1 to -0.1 | N=20 | -5.7 | -10.1 to -1.4 | ||
| MK-677 | N=40 | 87.4 (20.9) | 46.8-145.8 | N=38 | -1.0 | -4.7 - 2.6 | 0.24 | N=40 | -1.0 | -4.1 - 2.1 | 0.073 | |
Baseline data presented are the arithmetic mean (SD) and the minimum and maximum values; N for each test is indicated.
*
Mean change (arithmetic difference) from baseline with 95% confidence limits at 6 months and at 12 months
†
P values are for the pivotal comparisons between the two groups at 6 months and at 12 months.
‡
Strength variables were analyzed per kg leg lean (for knee) and arm lean (for shoulder) at baseline.
Muscle strength was determined using an isokinetic dynamometer; Cybex II.
Empty cells = no statistical analyses were performed; raw data are reported in typical units for comparison
Leg Lean and Arm Lean = sum of appendicular skeletal muscle mass of legs and of arms (from DXA)