Table 2. Incidence of nausea and vomiting during the 2-year trial period.
|
Liraglutide |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment: |
Placebo |
1.2 mg |
1.8 mg |
2.4 mg |
3.0 mg |
Orlistat |
||||||
| N (%) |
E |
N (%) |
E |
N (%) |
E |
N (%) |
E |
N (%) |
E |
N (%) |
E |
|
| Year 1 | n=98 | n=95 | n=90 | n=93 | n=93 | n=95 | ||||||
| Nausea | 7 (7.1%) | 8 | 23 (24%) | 27 | 29 (32%) | 33 | 35 (38%) | 48 | 45 (48%) | 68 | 7 (7.4%) | 7 |
| N (%) episodes starting in weeks 1–4 | 3/8 (38%) | 24/27 (89%) | 25/33 (76%) | 32/48 (67%) | 42/68 (62%) | 2/7 (29%) | ||||||
| N (%) episodes starting in weeks 5–8 | 1/8 (13%) | 1/27 (3.7%) | 1/33 (3.0%) | 7/48 (15%) | 7/68 (10%) | 1/7 (14%) | ||||||
| N (%) individuals with only 1 episode | 6/7 (86%) | 19/23 (83%) | 26/29 (90%) | 24/35 (69%) | 36/45 (80%) | 7/7 (100%) | ||||||
| N (%) individuals with⩾3 episodes | 0/7 (0%) | 0/23 (0%) | 1/29 (3.4%) | 2/35 (5.7%) | 5/45 (11%) | 0/7 (0%) | ||||||
| Vomiting | 2 (2.0%) | 2 | 5 (5.3%) | 6 | 9 (10%) | 18 | 14 (15%) | 17 | 12 (13%) | 16 | 2 (2.1%) | 4 |
| N (%) episodes starting in weeks 1–4 | 1/2 (50%) | 5/6 (83%) | 7/18 (39%) | 11/17 (65%) | 7/16 (44%) | 0/4 (0%) | ||||||
| N (%) episodes starting in weeks 1–6 | ½ (50%) | 5/6 (83%) | 9/18 (50%) | 12/17 (71%) | 11/16 (67%) | 0/4 (0%) | ||||||
| N (%) episodes starting in weeks 5–8 | 0/2 (0%) | 0/6 (0%) | 3/18 (17%) | 3/17 (18%) | 4/16 (25% | 1/4 (25%) | ||||||
| N (%) individuals with only 1 episode | 2/2 (100%) | 4/5 (80%) | 3/9 (33%) | 11/14 (79%) | 9/12 (75%) | 1/2 (50%) | ||||||
| Serious episodes | ||||||||||||
| Nausea | − | − | − | − | − | − | ||||||
| Vomiting | − | − | − | 1 (1.1%) | 1 | 1 (1.1%) | 1 | − | ||||
| Episodes leading to withdrawal | ||||||||||||
| Nausea | − | 2 (2.1%) | 2 | 2 (2.2%) | 2 | 3 (3.2%) | 3 | 2 (2.2%) | 2 | − | ||
| Vomiting | − | − | – | 2 (2.2%) | 2 | 3 (3.2%) | 3 | − | ||||
| Treatment: |
Liraglutide 2.4 mg then 3.0 mga |
Orlistat |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year 2 | n=67 | n=68 | n=59 | n=65 | n=72 | n=67 | ||||||
| Nausea | 26 (39%) | 32 | 18 (26%) | 20 | 7 (12%) | 7 | 10 (15%) | 13 | 6 (8.3%) | 7 | 1 (1.5%) | 1 |
| Vomiting | 4 (6.0%) | 5 | 8 (12%) | 9 | 5 (8.5%) | 6 | 2 (3.1%) | 3 | 1 (1.4%) | 1 | 1 (1.5%) | 2 |
| Serious episodes | ||||||||||||
| Nausea | − | − | − | − | − | − | ||||||
| Vomiting | − | − | − | − | − | − | ||||||
| Episodes leading to withdrawal | ||||||||||||
| Nausea | − | − | 1 (1.7%) | 1 | − | − | − | |||||
| Vomiting | − | 1 (1.5%) | 1 | 1 (1.7%) | 2 | − | − | − | ||||
Abbreviations: E, number of adverse events; N (%), number and proportion of participants with an adverse event.
a
All on liraglutide/placebo switched to liraglutide 2.4 mg at week 52, then between 70–96 weeks to 3.0 mg.