Table 2.
Association between ursodeoxycholic acid (UDCA) and metachronous adenoma, stratified by sex (n = 1192)
| Men (n = 804) |
Women (n = 388) |
P interaction * | |
|---|---|---|---|
|
|
|
|
|
| Any adenoma | |||
| UDCA, n (%) | 182/423 (43) | 69/190 (36) | |
| Placebo, n (%) | 179/381 (47) | 75/198 (38) | |
| OR (95% CI) | 0.85 (0.65 – 1.13) | 0.94 (0.62 – 1.41) | 0.714 |
| High-grade dysplasia† | |||
| UDCA, n (%) | 19/415 (5) | 14/188 (7) | |
| Placebo, n (%) | 38/377 (10) | 12/197 (6) | |
| OR (95% CI) | 0.43 (0.24 – 0.76) | 1.24 (0.56 – 2.76) | 0.033 |
| Large (≥ 1 cm) | |||
| UDCA, n (%) | 34/423 (8) | 20/190 (11) | |
| Placebo, n (%) | 48/381 (13) | 12/197 (6) | |
| OR (95% CI) | 0.61 (0.38 – 0.96) | 1.82 (0.87 – 3.84) | 0.013 |
| Villous/tubulovillous histology | |||
| UDCA, n (%) | 32/423 (8) | 18/190 (9) | |
| Placebo, n (%) | 34/381 (9) | 11/198 (6) | |
| OR (95% CI) | 0.84 (0.50 – 1.38) | 1.78 (0.82 – 3.87) | 0.107 |
| Advanced lesion‡ | |||
| UDCA, n (%) | 62/418 (15) | 37/189 (20) | |
| Placebo, n (%) | 83//379 (22) | 27/197 (14) | |
| OR (95% CI) | 0.62 (0.43 – 0.89) | 1.53 (0.89 – 2.64) | 0.006 |
| Proximal location§ | |||
| UDCA, n (%) | 133/420 (32) | 50/190 (26) | |
| Placebo, n (%) | 132/380 (35) | 54/198 (27) | |
| OR (95% CI) | 0.87 (0.65 – 1.17) | 0.95 (0.61 – 1.49) | 0.744 |
| Multiple adenomas∥ | |||
| UDCA, n (%) | 41/423 (10) | 7/190 (4) | |
| Placebo, n (%) | 40/381 (11) | 14/198 (7) | |
| OR (95% CI) | 0.91 (0.58 – 1.45) | 0.50 (0.20 – 1.27) | 0.250 |
Abbreviations: UDCA, ursodeoxycholic acid; OR, odds ratio; CI, confidence interval
*
P for treatment-by-sex interaction calculated using likelihood ratio tests
†
Missing dysplasia data for 12 men and 3 women
‡
Advanced: adenocarcinoma, high-grade dysplasia, villous or tubulovillous histology, or large (≥ 1 cm); missing advanced lesion data for 7 men and 2 women
§
Proximal: any proximal adenoma; missing proximal location data for 4 men and 0 women
∥
Multiple: three or more adenomas