APPENDIX TABLE 6.
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 † | |||||
FUNCTION TESTS | ||||||||||||
30 m walk, sec | Placebo | N=21 | 14.5 (2.8) | 9.5-21.2 | N=21 | -0.1 | N=21 | 0.2 | ||||
MK-677 | N=40 | 14.3 (2.9) | 9.0-20.5 | N=40 | -0.3 | N=40 | -0.2 | |||||
30 m walk, m/sec | Placebo | N=21 | 2.14 (0.40) | 1.42-3.17 | N=21 | 0.04 | N=21 | -0.01 | ||||
MK-677 | N=40 | 2.19 (0.47) | 1.46-3.32 | N=40 | 0.05 | N=40 | 0.06 | |||||
30 m walk/TASM, sec/kg ‡ | Placebo | N=21 | 0.89 (0.39) | 0.36-1.64 | N=21 | -0.01 | -0.04 - 0.03 | N=21 | 0.01 | -0.02 - 0.04 | ||
MK-677 | N=40 | 0.88 (0.33) | 0.32-1.42 | N=40 | -0.01 | -0.04 - 0.01 | >.99 | N=40 | -0.01 | -0.03 - 0.01 | 0.30 | |
6 min walk, m | Placebo | N=20 | 422 (58) | 267-534 | N=19 | 8 | N=20 | 5 | ||||
MK-677 | N=40 | 426 (58) | 334-567 | N=40 | 9 | N=40 | 11 | |||||
6 min walk, # laps | Placebo | N=20 | 4.7 (0.7) | 3.0-6.0 | N=19 | 0.1 | N=20 | 0.1 | ||||
MK-677 | N=40 | 4.8 (0.7) | 3.8-6.4 | N=40 | 0.1 | N=40 | 0.1 | |||||
6 min walk, # laps/TASM ‡ | Placebo | N=20 | 0.28 (0.08) | 0.15-0.41 | N=19 | 0.004 | -0.004-0.013 | N=20 | 0.002 | -0.005-0.009 | ||
MK-677 | N=40 | 0.28 (0.06) | 0.16-0.45 | N=40 | 0.005 | -0.001-0.011 | >.99 | N=40 | 0.006 | 0.001-0.011 | 0.44 | |
Sit-Stand x 5, sec | Placebo | N=17 | 11.0 (2.8) | 7.4-18.2 | N=17 | -0.6 | N=17 | -0.1 | ||||
MK-677 | N=30 | 11.2 (2.2) | 7.3-16.6 | N=30 | -0.6 | N=30 | -0.3 | |||||
Sit-Stand x 5/TASM, sec/kg ‡ | Placebo | N=17 | 0.70 (0.31) | 0.27-1.3 | N=17 | -0.04 | -0.10 - 0.02 | N=17 | 0.00 | -0.06 - 0.05 | ||
MK-677 | N=30 | 0.68 (0.23) | 0.26-1.04 | N=30 | -0.04 | -0.09 - 0.01 | >.99 | N=30 | -0.03 | -0.07 - 0.01 | 0.37 | |
FUNCTION TESTS | ||||||||||||
Stairs - DOWN, sec | Placebo | N=19 | 16.6 (3.7) | 12.5-27.5 | N=19 | 0.1 | N=19 | 0.4 | ||||
MK-677 | N=38 | 17.7 (4.8) | 10.7-32.2 | N=38 | -0.3 | N=38 | -0.3 | |||||
Stairs -DOWN/TASM, sec/kg ‡ | Placebo | N=19 | 1.0 (0.5) | 0.4-1.9 | N=19 | 0.01 | -0.05 - 0.07 | N=19 | 0.03 | -0.03 - 0.08 | ||
MK-677 | N=38 | 1.1 (0.5) | 0.4-2.0 | N=38 | -0.02 | -0.07 - 0.02 | 0.91 | N=38 | -0.03 | -0.06 - 0.01 | 0.180 | |
Stairs - UP, sec | Placebo | N=20 | 17.9 (4.1) | 12.7-29.6 | N=20 | 0.0 | N=20 | 0.2 | ||||
MK-677 | N=39 | 19.4 (4.9) | 10.8-31.9 | N=39 | 0.1 | N=39 | 0.3 | |||||
Stairs - UP/TASM, sec/kg ‡ | Placebo | N=20 | 1.09 (0.49) | 0.44-2.06 | N=20 | -0.01 | -0.06 - 0.05 | N=20 | 0.02 | -0.03 - 0.07 | ||
MK-677 | N=39 | 1.20 (0.51) | 0.36-2.09 | N=39 | 0.01 | -0.03 - 0.05 | >.99 | N=39 | 0.02 | -0.02 - 0.05 | 0.97 |
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.
Function variables were analyzed per kg TASM at baseline.
Empty cells = no statistical analyses were performed; raw data are reported in typical units for comparison
TASM = total appendicular skeletal muscle mass from DXA