Table 3:
Changes in Biochemical Data with Clinical Trial Therapy
| Baseline Lonafarnib Monotherapy Mean ± SD (n) | Lonafarnib Monotherapy 1 year Mean ±SD (n) | Lonafarnib Monotherapy 2 years Mean ±SD (n) | Baseline Triple Trial Mean ± SD (n) | Triple Therapy with calcium supplement (1 year) Mean ±SD (n) | Triple Therapy only (2–4 years) Mean ±SD (n) | |
|---|---|---|---|---|---|---|
| Calcium (mg/dL) | 9.98±0.32 (25) | 10.2312.13 (25) | 9.89±0.47 (25) | 10.05±0.46 (37) | 9.69±0.47 (35) | 9.67±0.44 (32) |
| Change from prior column (a P value) | - | 0.25±2.12 (0.55) (24) | −0.34±2.11 (0.40) (25) | - | −0.35±0.43 (<0.001) (35) | −0.04±0.57 (0.67) (32) |
| Phosphorus (mg/dL) | 4.97±0.56 (25) | 4.96±0.63 (25) | 4.4811.13 (25) | 4.78±0.65 (37) | 4.23±0.71 (35) | 4.35±0.63 (32) |
| Change from prior column (a P value) | - | −0.01±0.61 (0.94) (24) | −0.49±1.23 (0.06) (25) | - | −0.52±0.77 (<0.001) (35) | 0.21±0.61 (0.14) (32) |
| Ca × Pi. | 49.68±6.29 (25) | 51.02±13.99 (25) | 44.16±11.13 (25) | 48.05±7.19 (37) | 40.86±6.36 (35) | 42.09±6.91 (32) |
| Change from prior column (a P value) | - | 1.32±14.33 (0.64) (24) | −6.86±17.54 (0.06) (25) | - | −6.91±8.26 (<0.001) (35) | 1.99±6.74 (0.22) (32) |
| PTH (pg/mL) | 12.22±6.18 (25) | 29.57±17.83 (24) | 22.09±15.82 (25) | 19.54±14.66 (36) | 35.69±28.06 (35) | 33.45±21.29 (30) |
| Change from prior column (a P value) | - | 18.39±16.73 (<0.001) (23) | −8.03±23.76 (0.14) (24) | - | 16.88±23.91 (<0.001) (34) | −0.31±31.41 (0.77) (30) |
| Magnesium (mg/dL) | 2.30±0.17 (25) | 2.20±0.20 (25) | 2.10±0.19 (25) | 2.12±0.17 (37) | 2.03±0.14 (35) | 2.04±0.19 (32) |
| Change from prior column (a P value) | - | −0.11±0.15 (<0.001) (24) | −0.09±0.16 (0.002) (25) | −0.09±0.13 (<0.001) (35) | 0.01±0.15 (0.79) (32) | |
| Alkaline phosphatas e (IU/L) | 143.5±46.9 (25) | 154.1 ±46.1 (25) | 153.0±41.9 (25) | 156.2±54.7 (37) | 122.6±35.6 (35) | 127.4±38.1 (32) |
| Change from prior column (a P value) | - | 14.0±21.8 (0.002) (24) | −1.1±21.6 (0.94) (25) | - | −33.7±50.2 (<0.001) (35) | 2.0±31.6 (0.66) (32) |
| TRP (%) | 94.57±2.70 (25) | ND | 91.16±9.98 (22) | 91.36±8.41 (34) | 92.30±8.31 (35) | 91.17±8.76 (28) |
| Change from prior column (a P value) | - | - | −3.43±9.62 (0.07) (22) | 1.24±12.44 (0.75) (33) | −1.11±10.03 (0.62) (28) | |
| Urinary Ca/Cr | 0.38±0.22 (26) | 0.48±0.31 (25) | 0.48±0.40 (25) | 0.45±0.37 (37) | 0.56±0.44 (35) | 0.61±0.39 (27) |
| Change from prior column (a P value) | - | 0.11±0.31 (0.05) (25) | 0.02±0.46 (0.92) (25) | - | 0.10±0.57 (0.25) (35) | 0.06±0.50 (0.39) (27) |
a
P-values based on GEE model adjusting for baseline, age and sex; number of patients included in changes from prior column include only patients with data at both examinations. ND= not determined