APPENDIX TABLE 7.
EFFECTS OF TREATMENT ON CHOLESTEROL, CORTISOL, TESTOSTERONE AND PSA
| 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 † | |||||
| CHOLESTEROL | ||||||||||||
| Total Cholesterol, mmol/L | Placebo | N=21 | 4.65 (0.79) | 3.01-5.76 | N=21 | 0.05 | -0.19 - 0.28 | N=21 | 0.19 | -0.01 - 0.40 | ||
| MK-677 | N=43 | 4.93 (0.84) | 3.22-6.91 | N=43 | 0.09 | -0.08 - 0.25 | >.99 | N=43 | -0.01 | -0.16 - 0.13 | 0.087 | |
| Total Cholesterol, mg/dL | Placebo | N=21 | 179.5 (30.5) | 116-222 | N=21 | 1.9 | -7.3 - 10.8 | N=21 | 7.3 | -0.4 - 15.4 | ||
| MK-677 | N=43 | 190.3 (32.4) | 124-267 | N=43 | 3.5 | -3.1 - 9.7 | >.99 | N=43 | -0.4 | -6.2 - 5.0 | 0.087 | |
| LDL Cholesterol, mmol/L | Placebo | N=21 | 2.91 (0.71) | 1.45-4.11 | N=21 | -0.04 | -0.25 - 0.17 | N=21 | 0.12 | -0.07 - 0.30 | ||
| MK-677 | N=43 | 3.16 (0.71) | 1.82-4.84 | N=43 | -0.04 | -0.19 - 0.11 | >.99 | N=43 | -0.14 | -0.27 - -0.01 | 0.026 | |
| LDL Cholesterol, mg/dL | Placebo | N=21 | 112.4 (27.4) | 56-159 | N=21 | -1.5 | -9.7 - 6.6 | N=21 | 4.6 | -2.7 - 11.6 | ||
| MK-677 | N=43 | 122.0 (27.4) | 70-187 | N=43 | -1.5 | -7.3 - 4.2 | >.99 | N=43 | -5.4 | -10.4 - -0.4 | 0.026 | |
| HDL Cholesterol, mmol/L | Placebo | N=21 | 1.30 (0.39) | 0.69-2.12 | N=21 | -0.06 | -0.15 - 0.04 | N=21 | 0.05 | -0.03 - 0.13 | ||
| MK-677 | N=43 | 1.38 (0.43) | 0.62-2.51 | N=43 | 0.09 | 0.02 - 0.16 | 0.014 | N=43 | 0.07 | 0.02 - 0.13 | 0.73 | |
| HDL Cholesterol, mg/dL | Placebo | N=21 | 50.2 (15.1) | 27-82 | N=21 | -2.3 | -5.8 - 1.5 | N=21 | 1.9 | -1.2 - 5.0 | ||
| MK-677 | N=43 | 53.3 (16.6) | 24-97 | N=43 | 3.5 | 0.8 - 6.2 | 0.014 | N=43 | 2.7 | 0.8 - 5.0 | 0.73 | |
| CORTISOL, TESTOSTERONE AND PSA | ||||||||||||
| Cortisol, nmol/L | Placebo | 367 (77) | 251-519 | N=22 | -18 | -55 - 19 | N=22 | -2 | -36 - 30 | |||
| MK-677 | N=42 | 353 (74) | 218-530 | N=42 | 28 | 0 - 54 | 0.071 | N=42 | 47 | 28 - 71 | 0.020 | |
| Cortisol, μg/dL | Placebo | 13.3 (2.8) | 9.1-18.8 | N=22 | -0.7 | -2.0 - 0.7 | N=22 | -0.1 | -1.3 - 1.1 | |||
| MK-677 | N=42 | 12.8 (2.7) | 7.9-19.2 | N=42 | 1.0 | 0.0 - 1.9 | 0.071 | N=42 | 1.7 | 1.0 - 2.6 | 0.020 | |
| Total Testosterone, nmol/L | Placebo | N=7 | 16.6 (4.3) | 12.3-22.7 | N=7 | 1.1 | -1.8 - 4.1 | N=7 | -0.5 | -3.0 - 2.1 | ||
| MK-677 | N=16 | 18.7 (5.2) | 12.1-29.8 | N=16 | -0.6 | -2.6 - 1.3 | 0.50 | N=16 | -0.6 | -2.3 - 1.1 | <.99 | |
| Total Testosterone, ng/dL | Placebo | N=7 | 479 (123) | 354-655 | N=7 | 33 | -51 - 118 | N=7 | -13 | -86 - 61 | ||
| MK-677 | N=16 | 538 (149) | 350-858 | N=16 | -18 | -74 - 37 | 0.50 | N=16 | -16 | -65 - 32 | <.99 | |
| PSA, μg/L | Placebo | N=7 | 1.8 (1.6) | 0.6-4.9 | N=7 | 0.2 | -0.4 - 0.8 | N=7 | 0.1 | -0.4 - 0.5 | ||
| MK-677 | N=16 | 2 (1.6) | 0.4-5.1 | N=16 | -0.4 | -0.8 - 0.0 | 0.073 | N=16 | -0.3 | -0.6 - 0.1 | 0.30 | |
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.
Total testosterone normal range for men >50 y is 6.3 - 26.8 nmol/L (181 - 772 ng/dL)
PSA normal range for men 66-70 y is <4.5 μg/L; for >70 y it is <6.5 μg/L
Abbreviations: LDL = low-density lipoprotein; HDL = high-density lipoprotein; PSA = prostate-specific antigen