Table 5 Treatment comparison of 24 h urinary cortisol excretion at end of treatment (nmol/24 h) (Urinary Cortisol population)
Placebo | FF/VI 100/25 μg OD | FF/VI 200/25 μg OD | FF 100 μg OD | FF 200 μg OD | ||
|---|---|---|---|---|---|---|
Overall | N | 258 | 153 | 140 | 301 | 270 |
n† | 258 | 153 | 140 | 301 | 270 | |
LS geometric mean | 64.29 | 56.01 | 56.90 | 61.43 | 54.10 | |
LS ratio to baseline | 1.03 | 0.9 | 0.91 | 0.99 | 0.87 | |
Ratio to placebo (95 % CI) | — | — | — | 0.96 (0.85–1.08) | 0.84 (0.71–0.99)* | |
Ratio to FF 100 μg (95 % CI) | — | 0.91 (0.78–1.06) | — | — | — | |
Ratio to FF 200 μg (95 % CI) | — | — | 1.05 (0.88–1.26) | — | — | |
Japan + Korea | N | 14 | 12 | 10 | 21 | 14 |
n† | 14 | 12 | 10 | 21 | 14 | |
LS geometric mean | 71.40 | 68.27 | 47.52 | 66.13 | 49.20 | |
LS ratio to baseline | 1.15 | 1.10 | 0.76 | 1.06 | 0.79 | |
Ratio to placebo (95 % CI) | – | – | – | 0.93 (0.56–1.52) | 0.69 (0.40–1.20) | |
Ratio to FF 100 μg (95 % CI) | – | 1.03 (0.61–1.74) | – | – | – | |
Ratio to FF 200 μg (95 % CI) | – | – | 0.97 (0.53–1.78) | – | – | |
Not-Japan + Korea | N | 244 | 141 | 130 | 280 | 256 |
n† | 244 | 141 | 130 | 280 | 256 | |
LS geometric mean | 63.73 | 55.11 | 58.00 | 61.09 | 54.34 | |
LS ratio to baseline | 1.02 | 0.89 | 0.93 | 0.98 | 0.87 | |
Ratio to placebo (95 % CI) | – | – | – | 0.96 (0.84–1.09) | 0.85 (0.72–1.01) | |
Ratio to FF 100 μg (95 % CI) | – | 0.90 (0.77–1.06) | – | – | – | |
Ratio to FF 200 μg (95 % CI) | – | – | 1.07 (0.89–1.28) | – | – |