TABLE 3.
Short‐ and long‐term outcomes in PK parameters and variables from baseline to week 3, week 9, and year 2 in the RYGB group and diet group, respectively
| PK parameter | RYGB | Diet | Difference between groupsb | |||||
|---|---|---|---|---|---|---|---|---|
| Estimated mean difference (∆) [95% CI]a | ||||||||
| Week 0 – Week 3 | Week 0 – Week 9 | Week 0 – Year 2 | Week 0 – Week 3 | Week 0 – Week 9 | Week 0 – Year 2 | Week 9 | Year 2 | |
| Absolute bioavailability (%) | −2.0 [−7.7, 3.7] | −1.0 [−6.9, 4.9] | −10.0 *** [−16.1, −4.0] | −4.4 [−10.0, 1.1] | −2.1 [−7.8, 3.6] | −7.0* [−13.1, −0.97] | 4.3 [−0.99, 9.6] | 0.22 [−5.4, 5.8] |
| Clearance (L/h) | 1.6 [−3.9, 7.1] | 1.4 [−4.3, 7.1] | −0.66 [−6.5, 5.2] | −3.0 [−8.4, 2.4] | 1.7 [−3.8, 7.2] | −3.6 [−9.4, 2.3] | −4.2 [−9.0, 0.69] | −0.93 [−6.1, 4.2] |
| Oral clearance, CL/F (L/h) | 13 [−18, 45] | 19 [−14, 51] | 54 *** [21, 87] | 10 [−21, 40] | 13 [−18, 44] | 12 [−21, 45] | −41** [−71, −10] | −4.5 [−37, 28] |
| Volume of distribution (L) | 5.1 [−41, 30] | −58*** [−95, −21] | −77*** [−114, −39] | −29 [−64, 5.9] | −20 [−55, 15] | −41* [−79, −3.3] | −29 [−60, 3.2] | −26 [−60, 7.3] |
| Elimination half‐life, t½ (h) | −0.38 [−1.2, 0.49] | −1.8*** [−2.7, −0.88] | −2.2*** [−3.1, −1.3] | −0.75 [−1.6, 0.10] | −0.72 [−1.6, 0.14] | −1.0* [−1.9, −0.09] | −0.49 [−1.3, 0.30] | −0.65 [−1.5, 0.20] |
| Cmax, oral (µg/L) | −0.28 [−1.9, 1.3] | 3.2*** [1.6, 4.9] | −0.20 [−1.9, 1.5] | 0.70 [−0.89, 2.3] | 0.45 [−1.2, 2.1] | −0.33 [−2.1, 1.4] | 4.4*** [2.7, 6.0] | 1.7 [0.0, 3.5] |
| 4β‐hydroxycholesterol (ng/ml) | 0.69 [−1.1, 2.5] | −0.25 [−2.1, 1.6] | 5.3*** [3.4, 7.1] | −0.34 [−2.1, 1.4] | 1.2 [−0.59, 2.9] | 2.2* [0.26, 4.1] | −1.7 [−3.7, 0.28] | 2.8** [0.70, 4.9] |
Abbreviations: CI, confidence interval; CL/F, oral clearance; Cmax, maximum plasma concentration after oral midazolam; PK, pharmacokinetic; RYGB, Roux‐en‐Y gastric bypass.
Bold values show significant differences.
The p values are calculated from ∆ at week 3, week 9, and year 2 compared to baseline (week 0) within both groups and between groups at week 9 and year 2 (without adjustment for multiplicity). *p value <0.05; **p value ≤0.01; ***p value ≤0.001.
a
Linear mixed model was used to estimate mean difference in change (∆).
b
Difference between groups is calculated with RYGB as reference group.