Table 2.
Incidences of specific lower gastrointestinal AEs in patients treated with GLP‐1RAs, and comparisons of gastrointestinal AEs between patient subgroups
| Pooled analysis | DURATION‐6 | |||
|---|---|---|---|---|
| Exenatide once weekly (n = 617) | Exenatide twice daily (n = 606) | Exenatide once weekly (n = 461) | Liraglutide (n = 450) | |
| Subset of lower gastrointestinal AEs, n (%) | ||||
| Total | 98 (15.9) | 86 (14.2) | 50 (10.8) | 84 (18.7)‡ |
| Diarrhoea + constipation | 7 (1.1) | 4 (0.7) | 3 (0.7) | 3 (0.7) |
| Diarrhoea only | 62 (10.0) | 47 (7.8) | 28 (6.1) | 61 (13.6)* |
| Constipation only | 29 (4.7) | 35 (5.8) | 19 (4.1) | 20 (4.4) |
| Sex: women/men, n (%) 1 | ||||
| N (women/men) | 275/342 | 280/326 | 207/254 | 205/245 |
| Total | ||||
| Women | 106 (38.5)‡ | 157 (56.1)* | 66 (31.9)† | 99 (48.3)† |
| Men | 103 (30.1) | 118 (36.2) | 50 (19.7) | 87 (35.5) |
| Upper + lower | ||||
| Women | 34 (12.4) | 37 (13.2) | 16 (7.7) | 34 (16.6) |
| Men | 27 (7.9) | 27 (8.3) | 14 (5.5) | 28 (11.4) |
| Upper only | ||||
| Women | 46 (16.7) | 101 (36.1)* | 31 (15.0)‡ | 49 (23.9)‡ |
| Men | 44 (12.9) | 62 (19.0) | 19 (7.5) | 37 (15.1) |
| Lower only | ||||
| Women | 26 (9.5) | 19 (6.8) | 19 (9.2) | 16 (7.8) |
| Men | 32 (9.4) | 29 (8.9) | 17 (6.7) | 22 (9.0) |
| Race/ethnicity: Asian/Hispanic/white, n (%) 1 , 2 | ||||
| N (Asian/Hispanic/white) | 345/53/204 | 344/61/173 | 55/98/304 | 56/99/287 |
| Total | ||||
| Asian | 102 (29.6)* | 154 (44.8) | 21 (38.2)‡ | 33 (58.9)† |
| Hispanic | 9 (17.0)* | 22 (36.1) | 24 (24.5) | 36 (36.4) |
| White | 93 (45.6) | 88 (50.9) | 69 (22.7) | 113 (39.4) |
| Upper + lower | ||||
| Asian | 29 (8.4)‡ | 35 (10.2) | 8 (14.5)‡ | 12 (21.4) |
| Hispanic | 1 (1.9)† | 2 (3.3)‡ | 7 (7.1) | 14 (14.1) |
| White | 29 (14.2) | 24 (13.9) | 15 (4.9) | 34 (11.8) |
| Upper only | ||||
| Asian | 41 (11.9)† | 87 (25.3) | 7 (12.7) | 13 (23.2) |
| Hispanic | 4 (7.5)‡ | 16 (26.2) | 9 (9.2) | 15 (15.2) |
| White | 42 (20.6) | 54 (31.2) | 34 (11.2) | 58 (20.2) |
| Lower only | ||||
| Asian | 32 (9.3) | 32 (9.3) | 6 (10.9) | 8 (14.3) |
| Hispanic | 4 (7.5) | 4 (6.6) | 8 (8.2) | 7 (7.1) |
| White | 22 (10.8) | 10 (5.8) | 20 (6.6) | 21 (7.3) |
| Background metformin: use 3 /non‐use, n (%) 1 | ||||
| N (metformin/no metformin) | 506/111 | 484/122 | ||
| Total | ||||
| Metformin | 166 (32.8) | 225 (46.5) | ||
| No metformin | 43 (38.7) | 50 (41.0) | ||
| Upper + lower | ||||
| Metformin | 48 (9.5) | 55 (11.4) | ||
| No metformin | 13 (11.7) | 9 (7.4) | ||
| Upper only | ||||
| Metformin | 68 (13.4) | 135 (27.9) | ||
| No metformin | 22 (19.8) | 28 (23.0) | ||
| Lower only | ||||
| Metformin | 50 (9.9) | 35 (7.2) | ||
| No metformin | 8 (7.2) | 13 (10.7) | ||
*
P < .001.
†
P < .01.
‡
P < .05.
1
Statistical comparisons for subgroups are within each treatment group.
2
White subgroup used as reference for comparisons.
3
Metformin alone or in combination with other oral glucose‐lowering drugs or insulin.