Table 4.
Overall summary of serum Ca, serum P, and Ca × P values at selected visitsa
| Time Period | Ca (mg/dl) |
P (mg/dl) |
Ca×P (mg2/dl2) |
|||
|---|---|---|---|---|---|---|
| Original Cinacalcet | Original Placebo | Original Cinacalcet | Original Placebo | Original Cinacalcet | Original Placebo | |
| Baseline (lead-in study) | ||||||
| Mean (SE) | 9.83 (0.04) | 9.88 (0.05) | 6.23 (0.09) | 6.11 (0.09) | 61.01 (0.90) | 60.27 (0.94) |
| Median (Q1, Q3) | 9.80 | 9.83 | 6.00 | 6.12 | 58.99 | 60.18 |
| (9.27, 10.27) | (9.24, 10.49) | (5.10, 7.27) | (5.00, 7.03) | (48.78, 71.46) | (50.72, 69.91) | |
| [n] | [334] | [255] | [334] | [255] | [333] | [255] |
| Week 34 (end of titration)b | ||||||
| Mean (SE) | 9.17 (0.05) | 9.24 (0.07) | 5.72 (0.11) | 5.61 (0.11) | 52.44 (1.03) | 51.73 (1.08) |
| Median (Q1, Q3) | 9.20 | 9.20 | 5.60 | 5.50 | 51.66 | 49.00 |
| (8.50, 9.80) | (8.45, 9.95) | (4.45, 6.90) | (4.40, 6.70) | (39.72, 62.64) | (39.33, 62.89) | |
| [n] | [318] | [243] | [312] | [240] | [312] | [240] |
| Week 58 (end of maintenance)c | ||||||
| Mean (SE) | 9.26 (0.06) | 9.06 (0.07) | 5.70 (0.11) | 5.58 (0.13) | 52.70 (1.00) | 50.37 (1.19) |
| Median (Q1, Q3) | 9.20 | 9.10 | 5.50 | 5.50 | 52.14 | 49.50 |
| (8.70, 9.80) | (8.43, 9.70) | (4.40, 6.70) | (4.20, 6.60) | (40.04, 63.19) | (38.54, 58.00) | |
| [n] | [273] | [192] | [269] | [189] | [269] | [189] |
| End follow-up phase (week 180) | ||||||
| Mean (SE) | 9.43 (0.32) | 9.58 (0.28) | 5.99 (0.42) | 5.21 (0.76) | 56.02 (4.06) | 52.72 (8.01) |
| Median (Q1, Q3) | 9.75 | 9.65 | 5.90 | 4.20 | 54.02 | 44.25 |
| (8.90, 10.20) | (8.95, 10.20) | (5.80, 6.90) | (3.50, 7.20) | (49.56, 61.95) | (37.03, 69.60) | |
| [n] | [10] | [8] | [9] | [9] | [9] | [8] |
a
Some scheduled visits were shifted up to a maximum of 2 wk to align with the closest week indicated in the table.
b
Week 34 corresponds to end-of-dose-titration phase for subjects whose lead-in study duration was 26 wk.
c
Week 58 corresponds to end of maintenance phase for subjects whose lead-in study duration was 26 wk.