Table 1 SAEs (on-treatment), FAEs (on-treatment/vital status follow-up) and MACE (on-treatment + 30 days) in patients with cardiac events during UPLIFT ®
Patients with event, n (%) | ||||||
|---|---|---|---|---|---|---|
First event | Cardiac arrhythmia * | MI * | Cardiac failure * | |||
Treatment arm/ | Placebo | Tiotropium | Placebo | Tiotropium | Placebo | Tiotropium |
Subsequent event | (n = 181) | HandiHaler ® | (n = 68) | HandiHaler ® | (n = 186) | HandiHaler ® |
18 μg (n = 193) | 18 μg (n = 63) | 18 μg (n = 155) | ||||
SAEs (total) | 109 (60.2) | 104 (53.9) | 38 (55.9) | 43 (68.3) | 113 (60.8) | 91 (58.7) |
Cardiac | 37 (20.4) | 44 (22.8) | 19 (27.9) | 18 (28.6) | 44 (23.7) | 44 (28.4) |
Vital status FAE (total) | 38 (21.0) | 34 (17.6) | 11 (16.2) | 8 (12.7) | 41 (22.0) | 34 (21.9) |
Cardiac | 12 (6.6) | 8 (4.1) | 3 (4.4) | 3 (4.8) | 15 (8.1) | 9 (5.8) |
General disorders† | 6 (3.3) | 6 (3.1) | 1 (1.5) | 1 (1.6) | 6 (3.2) | 3 (1.9) |
On-treatment FAE (total) | 36 (19.9) | 28 (14.5) | 11 (16.2) | 6 (9.5) | 31 (16.7) | 30 (19.4) |
Cardiac | 13 (7.2) | 9 (4.7) | 3 (4.4) | 3 (4.8) | 11 (5.9) | 9 (5.8) |
General disorders† | 4 (2.2) | 3 (1.6) | 1 (1.5) | 0 (0.0) | 3 (1.6) | 2 (1.3) |
Fatal MACE | 15 (8.3) | 10 (5.2) | 5 (7.4) | 3 (4.8) | 13 (7.0) | 11 (7.1) |
Fatal MACE (including death unknown) | 18 (9.9) | 13 (6.7) | 5 (7.4) | 3 (4.8) | 16 (8.6) | 11 (7.1) |
MACE | 25 (13.8) | 15 (7.8) | 11 (16.2) | 6 (9.5) | 23 (12.4) | 16 (10.3) |