Table 3.
Symptoms and adverse events
| Empagliflozin | Placebo | |||||
|---|---|---|---|---|---|---|
| Baseline | Day 4 | Day 30 | Baseline | Day 4 | Day 30 | |
| Symptoms | ||||||
| General wellbeing, VAS | 5 (3–7) | 6 (5–8) | 7 (6–8) | 5 (5–6) | 7 (5–8) | 6 (5–8) |
| Thirst, n (%) | 20 (47) | 18 (42) | 10 (23) | 18 (41) | 17 (39) | 9 (21) |
| Vertigo, n (%) | 11 (26) | 7 (16) | 8 (19) | 16 (36) | 10 (23) | 19 (43) |
| Headache, n (%) | 14 (33) | 9 (21) | 9 (21) | 11 (25) | 9 (21) | 8 (18) |
| Nausea, n (%) | 9 (21) | 4 (9) | 2 (5) | 12 (27) | 5 (11) | 7 (16) |
| AEs | ||||||
| All causes | 14 | 10 | ||||
| Serious AEs | 5 | 5 | ||||
| Withdrawal because of AE | 0 | 0 | ||||
| Potentially study related | 6 | 3 | ||||
| Serious AEs | 1 | 0 | ||||
| Withdrawal because of AE | 0 | 0 | ||||
| Specific AEs | ||||||
| Plasma-sodium overcorrection | 2 | 1 | ||||
| Potentially study related | 2 | 1 | ||||
| Neurologic complications | 0 | 0 | ||||
| Decreased renal function | 3 | 0 | ||||
| Potentially study related | 3 | |||||
| Persistent impairment | 0 | |||||
| Increased hepatic parameters | 0 | 1 | ||||
| Potentially study related | 0 | |||||
| Urinary tract infection | 3 | 1 | ||||
| Potentially study related | 0 | 0 | ||||
| Gastrointestinal disorders | 1 | 0 | ||||
| Potentially study related | 0 | |||||
| Orthostatic collapse | 0 | 2 | ||||
| Potentially study related | 2 | |||||
| Specific severe AEs | ||||||
| Decreased renal function leading to unblinding | 1 | 0 | ||||
| Potentially study related | 1 | |||||
| Persistent impairment | 0 | |||||
| Prolongation hospitalization | 1 | 4 | ||||
| Potentially study related | 0 | 0 | ||||
| Rehospitalization | 2 | 1 | ||||
| Potentially study related | 0 | 0 | ||||
| Death | 1 | 0 | ||||
| Potentially study related | 0 | |||||
Course of symptoms and adverse events (AEs) occurring during observation phase. VAS, visual analog scale; n, number of patients.