Table 2.
Serious adverse events by heart failure risk tertile and SPRINT treatment arm
| Characteristic | Low Risk (Range 0.6–5.4%) | Intermediate Risk (Range 5.4–9.0%) | High Risk (Range 9.0–50.3%) | |||
|---|---|---|---|---|---|---|
|
| ||||||
| Intensive N=1,149 | Standard N=1,154 | Intensive N=1,180 | Standard N=1,124 | Intensive N=1,134 | Standard N=1,170 | |
| Serious adverse events | 313 (27.2) | 263 (22.8) | 396 (33.6) | 386 (34.3) | 464 (40.9) | 453 (38.7) |
| Related serious adverse event | 29 (2.5) | 11 (1.0) | 40 (3.4) | 26 (2.3) | 69 (6.1) | 36 (3.1) |
| Hypotension | 16 (1.4) | 6 (0.5) | 18 (1.5) | 15 (1.3) | 36 (3.2) | 16 (1.4) |
| Syncope | 21 (1.8) | 9 (0.8) | 16 (1.4) | 17 (1.5) | 34 (3.0) | 20 (1.7) |
| Bradycardia | 8 (0.7) | 3 (0.3) | 15 (1.3) | 8 (0.7) | 21 (1.9) | 20 (1.7) |
| Electrolyte abnormality | 32 (2.8) | 17 (1.5) | 26 (2.2) | 29 (2.6) | 30 (2.6) | 25 (2.1) |
| Injurious fall | 12 (1.0) | 6 (0.5) | 20 (1.7) | 17 (1.5) | 21 (1.9) | 21 (1.8) |
| Acute kidney injury/acute renal failure | 25 (2.2) | 15 (1.3) | 32 (2.7) | 18 (1.6) | 55 (4.9) | 33 (2.8) |
| ER Visit or serious adverse event | ||||||
| Hypotension | 27 (2.3) | 10 (0.9) | 28 (2.4) | 20 (1.8) | 54 (4.8) | 23 (2.0) |
| Syncope | 33 (2.9) | 14 (1.2) | 26 (2.2) | 23 (2.0) | 46 (4.1) | 29 (2.5) |
| Bradycardia | 11 (1.0) | 4 (0.3) | 16 (1.4) | 11 (1.0) | 29 (2.6) | 21 (1.8) |
| Electrolyte abnormality | 41 (3.6) | 19 (1.6) | 34 (2.9) | 36 (3.2) | 42 (3.7) | 31 (2.6) |
| Injurious fall | 57 (5.0) | 35 (3.0) | 74 (6.3) | 64 (5.7) | 79 (7.0) | 84 (7.2) |
| Acute kidney injury or renal failure | 26 (2.3) | 15 (1.3) | 33 (2.8) | 19 (1.7) | 61 (5.4) | 33 (2.8) |