Table 2.
Adjusted* incidence rates (per 10,000 person-years) of trial outcomes or serious adverse events, overall and by baseline orthostatic hypotension status
| Overall | No baseline OH | Baseline OH | ||||||
|---|---|---|---|---|---|---|---|---|
| Event/No Event | IR (95% CI) | Event/No Event | IR (95% CI) | Event/No Event | IR (95% CI) | |||
| Outcomes | ||||||||
| Primary outcome | 649/8089 | 5.7 (5.2,6.1) | 588/7515 | 5.6 (5.2,6.1) | 61/574 | 5.8 (5.4,6.2) | ||
| Secondary outcomes | ||||||||
| Myocardial infarction | 246/8495 | 2.2 (2.0,2.5) | 225/7881 | 2.2 (2.0,2.5) | 21/614 | 2.3 (2.1,2.6) | ||
| Acute coronary syndrome | 84/8659 | 0.8 (0.7,1.0) | 72/8036 | 0.9 (0.7,1.0) | 12/623 | 0.8 (0.6,1.0) | ||
| Stroke | 156/8590 | 1.6 (1.3,1.8) | 141/7970 | 1.6 (1.3,1.8) | 15/620 | 1.7 (1.5,1.9) | ||
| Heart failure | 187/8555 | 1.5 (1.2,1.8) | 172/7935 | 1.5 (1.2,1.8) | 15/620 | 1.7 (1.4,1.9) | ||
| Death from cardiovascular causes | 122/8624 | 0.8 (0.7,1.0) | 111/8000 | 0.8 (0.7,1.0) | 11/624 | 0.9 (0.7,1.1) | ||
| Death from any cause | 364/8381 | 2.6 (2.3,2.9) | 322/7788 | 2.6 (2.3,2.8) | 42/593 | 2.8 (2.5,3.0) | ||
| Primary outcome or death | 856/7880 | 5.5 (5.2,5.9) | 774/7327 | 5.5 (5.1,5.9) | 82/553 | 5.6 (5.3,6.0) | ||
| Serious Adverse Events | ||||||||
| Hypotension | 220/8562 | 2.4 (2.1,2.7) | 201/7945 | 2.4 (2.1,2.7) | 19/617 | 2.4 (2.1,2.7) | ||
| Syncope | 247/8539 | 2.3 (2.1,2.6) | 227/7923 | 2.3 (2.1,2.6) | 20/616 | 2.5 (2.2,2.8) | ||
| Bradycardia | 176/8610 | 1.7 (1.4,2.0) | 154/7997 | 1.7 (1.4,2.0) | 22/613 | 1.9 (1.6,2.2) | ||
| Electrolyte abnormality | 298/8488 | 2.8 (2.5,3.1) | 269/7881 | 2.8 (2.5,3.1) | 29/607 | 3.0 (2.7,3.3) | ||
| Injurious Fall | 654/8122 | 5.5 (5.0,6.0) | 590/7551 | 5.4 (5.0,5.9) | 64/571 | 6.4 (5.9,6.8) | ||
| Acute kidney injury or acute renal failure | 317/8465 | 2.7 (2.4,3.0) | 294/7853 | 2.7 (2.4,3.0) | 23/612 | 2.7 (2.5,3.0) | ||
Abbreviations: CI, confidence interval; IR, incidence rate; OH, orthostatic hypotension
*
Adjusted for blood pressure assignment, age, sex, and race
Note: Total number varies by outcome or serious adverse event depending on whether orthostatic hypotension assessments were missing before the outcome or serious adverse event occurred.