Table 3.
Pancreatin | Placebo | |||
---|---|---|---|---|
Baseline (n = 32) | End of double-blind phase (n = 31)* | Baseline (n = 26) | End of double-blind phase (n = 25)* | |
CFA, % | ||||
Full analysis sample | 56.9 ± 17.6 | 76.6 ± 17.2 | 49.5 ± 23.5 | 46.3 ± 31.1 |
Subjects with positive CFA values | 56.9 ± 17.6 | 76.6 ± 17.2 | 55.4 ± 19.1§ | 55.5 ± 18.3¶ |
By malignancy status | ||||
Malignancy† | 54.8 ± 18.9 | 69.4 ± 23.7 | 62.7 ± 12.4 | 46.3 ± 32.4 |
No malignancy (chronic pancreatitis) ‡ | 57.8 ± 17.5 | 79.5 ± 13.3 | 46.4 ± 24.6 | 46.3 ± 31.7 |
CNA, % | 55.3 ± 22.2 | 73.0 ± 16.6 | 49.6 ± 26.9 | 39.7 ± 39.0 |
Stool fat, g/day | 44.5 ± 22.4 | 21.6 ± 12.4 | 49.3 ± 30.1 | 55.8 ± 37.3 |
Stool nitrogen, g/day | 6.7 ± 3.5 | 3.8 ± 2.1 | 6.7 ± 3.6 | 8.4 ± 5.3 |
Fat intake, g/day | 104.3 ± 31.5 | 98.9 ± 31.3** | 97.4 ± 33.4 | 102.5 ± 25.7†† |
Nitrogen intake, g/day | 15.7 ± 7.0 | 15.0 ± 5.9** | 13.6 ± 3.3 | 14.3 ± 3.2†† |
Stool weight, g/day | 451 ± 210 | 282 ± 145 | 487 ± 257 | 514 ± 268 |
Number of stools per day | 2.5 ± 1.5 | 1.6 ± 1.2** | 2.3 ± 1.7 | 2.8 ± 1.5 |
CFA, coefficient of fat absorption; CNA, coefficient of nitrogen absorption; s.d., standard deviation.
There were no stool analysis data at the end of the double-blind period for one subject in the pancreatin group and one subject in the placebo group.
Number of patients was nine in pancreatin group and five in the placebo group.
Number of patients was 23 in the pancreatin group and 21 in the placebo group.
n = 22;
n = 21;
n = 32;
n = 26;