Table 2.
Safety and tolerability of 4 RCTs of agomelatine for the treatment of generalized anxiety disorder
| Study | Drugs (mg/d) | Patient (n) | At least 1 AE | Increased LFT | Nausea | Somnolence | Headache | NPT | Dizziness | Dropout due to AE | SAE | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
| ||||||||||||
| Patient | Critical illness | |||||||||||
| Stein et al. 2008 [17] | PBO | 58 | 41 (70.7) | 0 | 1 (1.7) | - | 9 (15.5) | 10 (17.2) | 2 (3.4) | 0 | 0 | 0 |
| AGO (25−50) | 63 | 37 (58.7) | 2 (3.2) | 3 (4.8) | - | 9 (14.3) | 7 (11.1) | 5 (7.9) | 1 | 0 | 0 | |
| Stein et al. 2012 [18] | PBO | 114 | 31 (27.2) | 5 (4.4) | 0 (0) | 2 (1.8) | 3 (2.6) | 6 (5.3) | 3 (2.6) | 2 (1.8) | 0 | 0 |
| AGO (25−50) | 113 | 46 (40.7) | 13 (11.5) | 5 (4.4) | 3 (2.7) | 12 (10.6) | 6 (5.3) | 4 (3.5) | 0 | 0 | 0 | |
| Stein et al. 2014 [28] | PBO | 131 | 58 (44.3) | 0 | 1 (0.8) | 1 (0.8) | 14 (10.7) | 7 (5.3) | 4 (3.1) | 4 (3.1) | 4 (3.1) | 0 |
| AGO (25−50) | 139 | 66 (47.5) | 2 (1.4) | 5 (3.6) | 3 (2.2) | 10 (7.2) | 6 (4.3) | 3 (2.2) | 3 (2.2) | 1 (0.7) | 0 | |
| Stein et al. 2017 [29] | PBO | 140 | 36 (25.7) | 0 | 2 (1.4) | 1 (0.7) | 9 (6.4) | 1 (0.7) | 3 (2.1) | 2 (1.4) | 2 (1.4) | 0 |
| AGO (10−25) | 270 | 87 (32.2) | 2 (0.7) | 5 (1.9) | 6 (2.2) | 15 (5.6) | 8 (3.0) | 4 (1.5) | 4 (1.5) | 4 (1.5) | 0 | |
Values are presented as number (%).
RCT, randomized, double-blind, placebo-controlled trials; AE, adverse events; LFT, liver function test; NPT, nasopharyngitis; SAE, serious adverse events; PBO, placebo; AGO, agomelatine.