Table 4.
Association between ursodeoxycholic acid (UDCA) treatment and metachronous adenoma, stratified bv sex and BMI
| BMI*, kg/m2 | Men |
Women |
||||
|---|---|---|---|---|---|---|
| 18 – <25 (n = 160) |
25 – <30 (n = 373) |
≥ 30 (n = 256) |
18 – <25 (n = 144) |
25 – <30 (n = 129) |
≥ 30 (n = 101) |
|
|
|
|
|||||
| Any adenoma | ||||||
| UDCA, n (%) | 28/82 (34) | 87/194 (45) | 64/137 (47) | 23/66 (35) | 25/68 (37) | 19/46 (41) |
| Placebo, n (%) | 33/78 (42) | 87/179 (49) | 56/119 (47) | 29/78 (37) | 25/61 (41) | 20/55 (36) |
| OR (95% CI) | 0.71 (0.37 – 1.34) | 0.86 (0.57 – 1.29) Pinteraction† = 0.773 (0.721) |
0.99 (0.60 – 1.61) | 0.90 (0.46 – 1.79) | 0.84 (0.41 – 1.70) Pinteraction = 0.261 (0.763) |
1.23 (0.55 – 2.75) |
| Advanced lesion‡ | ||||||
| UDCA, n (%) | 7/81 (9) | 34/193 (18) | 21/135 (16) | 10/66 (15) | 15/67 (22) | 11/46 (24) |
| Placebo, n (%) | 9/78 (12) | 41/177 (23) | 31/119 (26) | 17/78 (22) | 7/60 (12) | 3/55 (5) |
| OR (95% CI) | 0.73 (0.26 – 2.05) | 0.71 (0.43 – 1.18) Pinteraction = 0.408 (0.733) |
0.52 (0.28 – 0.97) | 0.64 (0.27 – 1.52) | 2.18 (0.82 – 5.79) Pinteraction = 0.013 (0.014) |
5.45 (1.42 – 20.9) |
| Proximal location§ | ||||||
| UDCA, n (%) | 17/81 (21) | 69/192 (36) | 44/137 (32) | 16/66 (24) | 18/68 (26) | 15/46 (33) |
| Placebo, n (%) | 16/78 (21) | 65/178 (37) | 48/119 (40) | 18/78 (23) | 20/61 (33) | 16/55 (29) |
| OR (95% CI) | 1.03 (0.48 – 2.22) | 0.98 (0.64 – 1.49) Pinteraction = 0.270 (0.562) |
0.70 (0.42 – 1.17) | 1.07 (0.49 – 2.31) | 0.74 (0.35 – 1.58) Pinteraction = 0.285 (0.684) |
1.18 (0.51 – 2.75) |
| Multiple adenomas∥ | ||||||
| UDCA, n (%) | 7/82 (9) | 19/194 (10) | 14/137 (10) | 1/66 (2) | 4/68 (6) | 2/46 (4) |
| Placebo, n (%) | 6/78 (8) | 18/179 (10) | 15/119 (13) | 5/78 (6) | 6/61 (10) | 3/55 (5) |
| OR (95% CI) | 1.12 (0.36 – 3.49) | 0.97 (0.49 – 1.92) Pinteraction = 0.749 (0.865) |
0.79 (0.36 – 1.71) | 0.22 (0.03 – 1.97) | 0.57 (0.15 – 2.13) Pinteraction = 0.509 (0.644) |
0.79 (0.13 – 4.93) |
Abbreviations: UDCA, ursodeoxycholic acid; BMI, body mass index; OR, odds ratio; CI, confidence interval
*
Missing data on BMI for 15 men and 11 women; there are 0 men and 3 women (2 placebo, 1 UDCA) with BMI < 18.5
†
P for treatment-by-BMI interaction calculated using likelihood ratio tests with continuous (and categorical) BMI
‡
Advanced: adenocarcinoma, high-grade dysplasia, villous or tubulovillous histology, or large (≥ 1 cm); missing advanced lesion data for 6 men and 2 women
§
Proximal: any proximal adenoma; missing proximal location data for 4 men and 0 women
∥
Multiple: three or more adenomas