Table 2.
Crude arrhythmia events
| Arrhythmia Type | Placebo (n=21) | Spironolactone Groups Combined (n=36) | Spironolactone 12.5 mg (n=11) | Spironolactone 25 mg (n=12) | Spironolactone 50 mg (n=13) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Pts w/Event n (%) | Events per 100 Pt-Days | Pts w/Event n (%) | Events per 100 Pt-Days | Pts w/Event n (%) | Events per 100 Pt-Days | Pts w/Event n (%) | Events per 100 Pt-Days | Pts w/Event n (%) | Events per 100 Pt-Days | ||
| Baseline | Monitoring done, n | 14 | 21 | 8 | 6 | 7 | |||||
| Atrial fibrillation/flutter | 2 (14.3) | 13.8 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | |
| Ventricular arrhythmia | 1 (7.1) | 0.9 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | |
| Conduction block | 3 (21.4) | 5.5 | 1 (4.8) | 0.6 | 0 (0.0) | 0 | 1 (16.7) | 2.1 | 0 (0.0) | 0 | |
| Bradycardia | 1 (7.1) | 0.9 | 1 (4.8) | 0.6 | 0 (0.0) | 0 | 0 (0.0) | 0 | 1 (14.3) | 1.9 | |
| Atrial/sinus/other nonventricular tachycardia | 4 (28.6) | 25.7 | 4 (19.0) | 7.5 | 2 (25.0) | 11.9 | 1 (16.7) | 8.5 | 1 (14.3) | 1.9 | |
| Bradycardia or conduction block | 4 (28.6) | 6.4 | 2 (9.5) | 1.3 | 0 (0.0) | 0 | 1 (16.7) | 2.1 | 1 (14.3) | 1.9 | |
| Any arrhythmia events | 9 (64.3) | 53.2 | 6 (28.6) | 10.1 | 2 (25.0) | 11.9 | 2 (33.3) | 12.8 | 2 (28.6) | 5.7 | |
| Week 6 | Monitoring done, n | 14 | 23 | 8 | 6 | 9 | |||||
| Atrial fibrillation/flutter | 2 (15.4) | 17.2 | 3 (13.0) | 5.2 | 0 (0.0) | 0 | 0 (0.0) | 0 | 3 (33.3) | 13.2 | |
| Ventricular arrhythmia | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | |
| Conduction block | 1 (7.7) | 1.0 | 5 (21.7) | 7.5 | 2 (25.0) | 3.2 | 1 (16.7) | 2.4 | 2 (22.2) | 14.7 | |
| Bradycardia | 1 (7.7) | 3.0 | 4 (17.4) | 6.4 | 2 (25.0) | 3.2 | 0 (0.0) | 0 | 2 (22.2) | 13.2 | |
| Atrial/sinus/other nonventricular tachycardia | 2 (15.4) | 4.0 | 5 (21.7) | 16.2 | 2 (25.0) | 20.6 | 1 (16.7) | 2.4 | 2 (22.2) | 20.6 | |
| Bradycardia or conduction block | 2 (15.4) | 4.0 | 7 (30.4) | 13.9 | 3 (37.5) | 6.3 | 1 (16.7) | 2.4 | 3 (33.3) | 27.9 | |
| Any arrhythmia events | 4 (30.8) | 29.3 | 11 (47.8) | 49.1 | 3 (37.5) | 33.3 | 2 (33.3) | 7.1 | 6 (66.7) | 89.7 | |
| End of study | Monitoring done, n | 21 | 32 | 9 | 11 | 12 | |||||
| Atrial fibrillation/flutter | 4 (19.0) | 7.1 | 4 (12.5) | 9.7 | 1 (11.1) | 2.9 | 1 (9.1) | 9.9 | 2 (16.7) | 15.4 | |
| Ventricular arrhythmia | 1 (4.8) | 1.3 | 1 (3.1) | 0.4 | 0 (0.0) | 0 | 0 (0.0) | 0 | 1 (8.3) | 1.3 | |
| Conduction block | 13 (61.9) | 38.7 | 20 (62.5) | 76.2 | 7 (77.8) | 69.1 | 6 (54.5) | 61.7 | 7 (58.3) | 97.4 | |
| Bradycardia | 0 (0.0) | 0 | 1 (3.1) | 6.2 | 0 (0.0) | 0 | 0 (0.0) | 0 | 1 (8.3) | 17.9 | |
| Atrial/sinus/other nonventricular tachycardia | 8 (38.1) | 14.2 | 11 (34.4) | 16.3 | 3 (33.3) | 7.4 | 4 (36.4) | 18.5 | 4 (33.3) | 21.8 | |
| Bradycardia or conduction block | 13 (61.9) | 38.7 | 20 (62.5) | 82.4 | 7 (77.8) | 69.1 | 6 (54.5) | 61.7 | 7 (58.3) | 115.4 | |
| Any arrhythmia events | 18 (85.7) | 100.0 | 25 (78.1) | 191.2 | 7 (77.8) | 148.5 | 9 (81.8) | 151.9 | 9 (75.0) | 269.2 | |
Sample sizes in the header represent numbers of patients with at least one monitoring done at baseline, week 6, or the end of study. Pts, participants.