Table 2.
Incidence rates (per 100 person-years [N of event per follow-up year]) for intensive and standard treatment groups, hazard ratios, and 95% confidence intervals for the effect of the intensive versus standard systolic BP intervention on serious adverse events in the Systolic Blood Pressure Intervention Trial participants with CKD by tertile of baseline diastolic BP
Adverse Event Type | Lowest tertile <69 mm Hg | Middle tertile =69–79 mm Hg | Highest tertile ≥80 mm Hg |
Any serious adverse event a | |||
Incidence rate | |||
Intensive | 24.3 (223/919) | 21.6 (218/1010) | 15.0 (187/1246) |
Standard | 26.4 (233/883) | 18.5 (206/1111) | 18.1 (202/1118) |
HR (95% CI) intensive versus standard | 0.93 (0.78 to 1.12) | 1.11 (0.92 to 1.35) | 0.84 (0.69 to 1.03) |
Hypotension | |||
Incidence rate | |||
Intensive | 1.0 (13/1263) | 1.3 (18/1338) | 1.1 (17/1525) |
Standard | 0.9 (11/1238) | 0.8 (12/1423) | 0.8 (11/1424) |
HR (95% CI) intensive versus standard | 1.14 (0.51 to 2.55) | 1.55 (0.75 to 3.23) | 1.37 (0.64 to 3.00) |
Syncope | |||
Incidence rate | |||
Intensive | 1.3 (16/1264) | 1.1 (15/1349) | 0.7 (10/1538) |
Standard | 0.9 (11/1244) | 0.8 (12/1426) | 0.5 (7/1431) |
HR (95% CI) intensive versus standard | 1.38 (0.64 to 3.00) | 1.28 (0.60 to 2.74) | 1.25 (0.46 to 3.37) |
Electrolyte abnormality | |||
Incidence rate | |||
Intensive | 1.8 (22/1245) | 2.0 (27/1324) | 0.9 (14/1532) |
Standard | 1.4 (17/1228) | 0.8 (12/1425) | 1.1 (16/1408) |
HR (95% CI) intensive versus standard | 1.37 (0.73 to 2.60) | 2.33 (1.18 to 4.61) | 0.73 (0.36 to 1.51) |
AKI or acute kidney failure | |||
Incidence rate | |||
Intensive | 3.7 (45/1220) | 3.1 (41/1302) | 1.8 (27/1515) |
Standard | 2.4 (29/1227) | 1.6 (23/1418) | 1.9 (27/1394) |
HR (95% CI) intensive versus standard | 1.53 (0.95 to 2.44) | 1.81 (1.08 to 3.01) | 1.00 (0.58 to 1.72) |
HR, hazard ratio; 95% CI, 95% confidence interval.
Models adjusted for age, sex, race, cardiovascular disease, Framingham 10-year cardiovascular disease risk score ≥15%, smoking history, and baseline eGFR. Likelihood ratio tests comparing HRs for the systolic BP intervention among baseline diastolic BP tertiles were nonsignificant.