Table 2.
Preferred term | Double-blind cross-over | Open-label follow-up | ||
Levosimendan 1 mg (N=59) |
Levosimendan 1 mg two times a day (N=59) |
Placebo (N=58) |
Levosimendan 1–2 mg (N=50) |
|
Participants (%) | ||||
Headache | 10 (16.9)* | 17 (28.8)† | 2 (3.4) | 5 (10.0) |
Fall | 9 (15.3) | 9 (15.3) | 5 (8.6) | 14 (28.0) |
Heart rate increased‡ | 3 (5.1)§ | 11 (18.6)¶ | 1 (1.7) | 1 (2.0) |
Nasopharyngitis | 4 (6.8) | 4 (6.8) | 3 (5.2) | 4 (8.0) |
Cough | 6 (10.2) | – | 1 (1.7) | 3 (6.0) |
Contusion | 2 (3.4) | 4 (5.1) | 1 (1.7) | – |
Nausea | 4 (6.8) | 1 (1.7) | 1 (1.7) | 3 (6.0) |
Diarrhoea | 1 (1.7) | 3 (5.1) | 1 (1.7) | 3 (6.0) |
Constipation | 2 (3.4) | 2 (3.4) | 3 (5.2) | 1 (2.0) |
Oxygen saturation decreased** | 3 (5.1) | 4 (6.8) | – | 1 (2.0) |
*P=0.030.
†p=0.002.
‡Preferred terms ‘heart rate increased’, ‘tachycardia’ and ‘sinus tachycardia’ combined.
§P=0.337.
¶P=0.018.
**Decreased oxygen saturation was reported in a total of two patients from two centres.