Table 3.
Association of orthostatic hypotension as time-varying covariate detected during baseline or post-randomization follow-up with trial outcomes, N = 8,792
| Orthostatic Hypotension (Model 1) | Orthostatic Hypotension (Model 2) | |||||
|---|---|---|---|---|---|---|
| Total N of Events | HR (95% CI) | P | HR (95% CI) | P | ||
| Outcomes | ||||||
| Primary outcome | 649 | 1.16 (0.85, 1.57) | 0.36 | 1.06 (0.78, 1.44) | 0.72 | |
| Secondary outcomes | ||||||
| Myocardial infarction | 246 | 0.97 (0.57, 1.66) | 0.92 | 0.92 (0.54, 1.58) | 0.77 | |
| Acute coronary syndrome | 84 | 1.87 (0.91, 3.83) | 0.09 | 1.68 (0.81, 3.49) | 0.16 | |
| Stroke | 156 | 0.95 (0.47, 1.91) | 0.89 | 0.86 (0.43, 1.73) | 0.68 | |
| Heart failure | 187 | 1.09 (0.63, 1.88) | 0.76 | 0.96 (0.55, 1.68) | 0.89 | |
| Death from cardiovascular causes | 122 | 0.73 (0.32, 1.69) | 0.46 | 0.63 (0.27, 1.47) | 0.29 | |
| Death from any cause | 364 | 1.24 (0.84, 1.83) | 0.29 | 1.13 (0.76, 1.68) | 0.53 | |
| Primary outcome or death | 856 | 1.20 (0.92, 1.56) | 0.17 | 1.11 (0.85, 1.44) | 0.46 | |
| Serious Adverse Events | ||||||
| Hypotension | 220 | 1.99 (1.26, 3.14) | 0.003 | 1.77 (1.11, 2.82) | 0.02 | |
| Syncope | 247 | 1.49 (0.93, 2.39) | 0.10 | 1.38 (0.86, 2.23) | 0.18 | |
| Bradycardia | 176 | 2.10 (1.30, 3.39) | 0.002 | 1.94 (1.19, 3.15) | 0.008 | |
| Electrolyte abnormality | 298 | 1.08 (0.66, 1.75) | 0.76 | 0.99 (0.60, 1.62) | 0.97 | |
| Injurious Fall | 654 | 1.24 (0.91, 1.68) | 0.17 | 1.20 (0.88, 1.63) | 0.24 | |
| Acute kidney injury or acute renal failure | 317 | 1.35 (0.86, 2.13) | 0.20 | 1.14 (0.72, 1.81) | 0.58 | |
Model 1: Adjusted for age, sex, race
Model 2: Adjusted for age, sex, race and the following baseline characteristics: treatment assignment, systolic blood pressure, diastolic blood pressure, body mass index, high density lipoprotein cholesterol, total cholesterol, statin use, chronic kidney disease, estimated glomerular filtration rate, subclinical or clinical cardiovascular disease, smoking status, or number of hypertensive medications
Stratified by research site.
In SPRINT, a serious adverse event was defined as events that (1) were fatal or life-threatening, (2) resulted in clinically significant or persistent disability, (3) required or prolonged a hospitalization, or (4) were judged by the investigator to represent a clinically significant hazard or harm to the participant that might require intervention (medical or surgical) to prevent one of three previously mentioned events listed above.