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) |
*First event did not lead to discontinuation. †SOC: general disorders and administration site conditions (death, sudden death, sudden cardiac death). FAE, fatal adverse event, MACE, major adverse cardiovascular event, MI, myocardial infarction, SAE, serious adverse event, SOC, system organ class; UPLIFT®, Understanding Potential Long-term Impacts on Function with Tiotropium.