Table 1.
Outcomes during the Intervention Period (through August 20, 2015).*
| Outcome | Intensive Treatment | Standard Treatment | Hazard Ratio (95% Cl) | P Value † | ||
|---|---|---|---|---|---|---|
| no. of participants | % per year | no. of participants | % per year | |||
| All participants | (N = 4678) | (N = 4683) | ||||
| Primary outcome‡ | 264 | 1.77 | 354 | 2.40 | 0.73 (0.63–0.86) | <0.001 |
| Primary outcome without nonfatal heart failure | 222 | 1.48 | 293 | 1.97 | 0.75 (0.63–0.89) | 0.001 |
| Secondary outcomes‡ | ||||||
| Myocardial infarction | 102 | 0.68 | 140 | 0.93 | 0.72 (0.56–0.93) | 0.01 |
| Acute coronary syndrome | 42 | 0.28 | 41 | 0.27 | 1.02 (0.66–1.57) | 0.93 |
| Stroke | 69 | 0.45 | 78 | 0.52 | 0.89 (0.64–1.23) | 0.48 |
| Heart failure | 68 | 0.45 | 105 | 0.70 | 0.63 (0.46–0.86) | 0.003 |
| Nonfatal heart failure | 66 | 0.43 | 101 | 0.67 | 0.64 (0.47–0.87) | 0.004 |
| Death from cardiovascular causes | 41 | 0.27 | 71 | 0.47 | 0.58 (0.39–0.84) | 0.004 |
| Death from any cause | 163 | 1.06 | 215 | 1.41 | 0.75 (0.61–0.92) | 0.006 |
| Primary outcome or death from any cause | 370 | 2.47 | 474 | 3.20 | 0.77 (0.67–0.88) | <0.001 |
| Participants with CKD at baseline | (N = 1330) | (N = 1316) | ||||
| Composite renal outcome§ | 17 | 0.39 | 16 | 0.37 | 1.03 (0.52–2.06) | 0.93 |
| >50% Reduction in eGFR¶ | 12 | 0.28 | 12 | 0.28 | 0.98 (0.43–2.22) | 0.97 |
| Long-term dialysis | 7 | 0.16 | 10 | 0.23 | 0.66 (0.24–1.72) | 0.39 |
| Kidney transplantation | 0 | 0 | — | — | ||
| Incident albuminuria║ | 64 | 3.93 | 85 | 5.61 | 0.71 (0.50–1.00) | 0.05 |
| Participants without CKD at baseline | (N = 3332) | (N = 3345) | ||||
| ≥30% Reduction in eGFR¶ | 148 | 1.39 | 41 | 0.38 | 3.67 (2.62–5.26) | <0.001 |
| Long-term dialysis | 0 | 0 | - | - | ||
| Kidney transplantation | 0 | 0 | — | — | ||
| Incident albuminuria║ | 142 | 2.54 | 184 | 3.25 | 0.77 (0.62–0.96) | 0.02 |
Additional events not previously reported1 are included. Cl denotes confidence interval, CKD chronic kidney disease, and eGFR estimated glomerular filtration rate.
P values for between-group differences are shown; inferences drawn from these tests may not be reproducible, since none of the P values or 95% confidence intervals were adjusted for multiplicity.
The primary outcome was the first occurrence of myocardial infarction, acute coronary syndrome not resulting in infarction, stroke, acute decompensated heart failure, or death from cardiovascular causes. Components of the primary outcome are shown with fatal and nonfatal cases included, except where noted for nonfatal heart failure.
The composite renal outcome for participants with CKD at baseline was the first occurrence of a reduction in eGFR of 50% or more, long-term dialysis, or kidney transplantation.
Reductions in eGFR were confirmed by a second laboratory test at least 90 days later.
Incident albuminuria was defined by a doubling of the ratio of urinary albumin (in milligrams) to creatinine (in grams) from less than 10 at baseline to greater than 10 during follow-up. The numbers of participants represent those without albuminuria at baseline.