Table 4.
Nausea incidence by sex, age group, and body mass index
| CIC | OIC | IBS-C | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo | Lubiprostone 24 mcg BID | P value* | Placebo | Lubiprostone 24 mcg BID | P value* | Placebo | Lubiprostone 8 mcg BID | P value* | |
| Randomized controlled trials | |||||||||
| Patients with nausea, n | 15 | 70 | 42 | 89 | 28 | 91 | |||
| Sex, n (%) | |||||||||
| Male | 0 | 2 (2.9) | 0.007 | 14 (33.3) | 31 (34.8) | 0.639 | 2 (7.1) | 5 (5.5) | 0.250 |
| Female | 15 (100) | 68 (97.1) | 28 (66.7) | 58 (65.2) | 26 (92.9) | 86 (94.5) | |||
| Age group, n (%) | |||||||||
| <65 years | 14 (93.3) | 68 (97.1) | 0.028 | 37 (88.1) | 84 (94.4) | 0.821 | 26 (92.9) | 82 (90.1) | 0.292 |
| ≥65 years | 1 (6.7) | 2 (2.9) | 5 (11.9) | 5 (5.6) | 2 (7.1) | 9 (9.9) | |||
| BMI | |||||||||
| <25 | 10 (66.7) | 37 (52.9) | 0.117 | 10 (23.8) | 23 (25.8) | 0.501 | 13 (46.4) | 51 (56.0) | 0.014 |
| ≥25 | 6 (33.3) | 33 (47.1) | 32 (76.2) | 66 (74.2) | 15 (53.6) | 40 (44.0) | |||
| Patients with severe nausea, n | 0 | 5 | 7 | 7 | 1 | 5 | |||
| Sex, n (%) | |||||||||
| Male | 0 | 0 | 1.000 | 4 (57.1) | 0 | 0.050 | 0 | 1 (20.0) | 0.377 |
| Female | 0 | 5 (100) | 3 (42.9) | 7 (100) | 1 (100) | 5 (80.0) | |||
| Age group, n (%) | |||||||||
| <65 years | 0 | 5 (100) | 1.0000 | 6 (85.7) | 6 (85.7) | 0.390 | 1 (100) | 5 (100) | 1.0000 |
| ≥65 years | 0 | 0 | 1 (14.3) | 1 (14.3) | 0 | 0 | |||
| BMI | |||||||||
| <25 | 0 | 4 (80.0) | 0.1760 | 1 (14.3) | 2 (28.6) | 0.665 | 0 | 5 (100) | 0.0160 |
| ≥25 | 0 | 1 (20.0) | 6 (85.7) | 5 (71.4) | 1 (100) | 0 | |||
| CIC | OIC | IBS-C | |
|---|---|---|---|
| Lubiprostone 24 mcg BID | Lubiprostone 24 mcg BID | Lubiprostone 8 mcg BID | |
| All trials | |||
| Patients with nausea, n | 346 | 124 | 115 |
| Sex, n (%) | |||
| Male | 12 (3.5) | 44 (35.5) | 6 (5.12) |
| Female | 334 (96.5) | 80 (64.5) | 109 (94.8) |
| Age group, n (%) | |||
| <65 years | 311 (89.9) | 117 (94.4) | 102 (88.7) |
| ≥65 years | 35 (10.1) | 7 (5.6) | 13 (11.3) |
| BMI | |||
| <25 | 177 (51.2) | 33 (26.6) | 65 (56.5) |
| ≥25 | 169 (48.8) | 91 (73.4) | 50 (43.5) |
| Patients with severe nausea, n | 39 | 9 | 9 |
| Sex, n (%) | |||
| Male | 1 (2.6) | 2 (22.2) | 1 (11.1) |
| Female | 38 (97.4) | 7 (77.8) | 8 (88.9) |
| Age group, n (%) | |||
| <65 years | 34 (87.2) | 8 (88.9) | 8 (88.9) |
| ≥65 years | 5 (12.8) | 1 (11.1) | 1 (11.1) |
| BMI, n (%) | |||
| <25 | 23 (59.0) | 2 (22.2) | 7 (77.8) |
| ≥25 | 16 (41.0) | 7 (77.8) | 2 (22.2) |
BID twice daily, BMI body mass index, CIC chronic idiopathic constipation, IBS-C irritable bowel syndrome with constipation, OIC opioid-induced constipation
* P values for comparison of the differences of the incidence rate between the subgroups in patients treated with lubiprostone using the Fisher’s exact test