Table 3.
Event Rates for Primary and Secondary Outcomes, According to Study Phase and Proteinuria Status at Baseline.*
| Variable | Intensive Control | Standard Control | Hazard Ratio (95% CI) |
P Value | ||
|---|---|---|---|---|---|---|
| no./total no. |
rate per 100 person-yr |
no./total no. |
rate per 100 person-yr |
|||
| All patients | ||||||
| Doubling of serum creatinine level, ESRD, or death | ||||||
| Trial phase | 159/540 | 7.0 | 169/554 | 7.3 | 0.88 (0.71–1.09) | 0.24 |
| Cohort phase | 123/377 | 7.9 | 116/382 | 7.7 | 0.95 (0.74–1.23) | 0.70 |
| Both phases | 282/540 | 7.3 | 285/554 | 7.5 | 0.91 (0.77–1.08) | 0.27 |
| Doubling of serum creatinine level or ESRD | ||||||
| Trial phase | 121/540 | 5.3 | 125/554 | 5.4 | 0.91 (0.71–1.18) | 0.49 |
| Cohort phase | 92/377 | 5.9 | 84/382 | 5.5 | 0.99 (0.73–1.33) | 0.95 |
| Both phases | 213/540 | 5.5 | 209/554 | 5.5 | 0.95 (0.78–1.15) | 0.59 |
| ESRD or death | ||||||
| Trial phase | 124/540 | 5.3 | 140/554 | 5.9 | 0.84 (0.66–1.07) | 0.16 |
| Cohort phase | 114/412 | 6.4 | 116/411 | 6.9 | 0.86 (0.67–1.12) | 0.27 |
| Both phases | 238/540 | 5.8 | 256/554 | 6.3 | 0.85 (0.71–1.02) | 0.08 |
| Patients with baseline urinary protein-to-creatinine ratio ≤0.22 | ||||||
| Doubling of serum creatinine level, ESRD, or death | ||||||
| Trial phase | 64/357 | 4.0 | 61/376 | 3.6 | 1.14 (0.80–1.63) | 0.46 |
| Cohort phase | 81/290 | 6.5 | 74/312 | 5.6 | 1.21 (0.88–1.66) | 0.24 |
| Both phases | 145/357 | 5.1 | 135/376 | 4.5 | 1.18 (0.93–1.50) | 0.16 |
| Doubling of serum creatinine level or ESRD | ||||||
| Trial phase | 42/357 | 2.6 | 34/376 | 2.0 | 1.44 (0.91–2.26) | 0.12 |
| Cohort phase | 56/290 | 4.5 | 49/312 | 3.7 | 1.36 (0.92–2.00) | 0.12 |
| Both phases | 98/357 | 3.4 | 83/376 | 2.7 | 1.39 (1.04–1.87) | 0.03 |
| ESRD or death | ||||||
| Trial phase | 47/357 | 2.9 | 50/376 | 2.9 | 0.98 (0.66–1.47) | 0.94 |
| Cohort phase | 72/307 | 5.2 | 62/323 | 4.3 | 1.22 (0.87–1.72) | 0.25 |
| Both phases | 119/357 | 3.9 | 112/376 | 3.6 | 1.12 (0.87–1.45) | 0.39 |
| Patients with baseline urinary protein-to-creatinine ratio >0.22 | ||||||
| Doubling of serum creatinine level, ESRD, or death | ||||||
| Trial phase | 94/181 | 13.9 | 108/176 | 18.3 | 0.74 (0.56–0.99) | 0.04 |
| Cohort phase | 42/86 | 13.7 | 41/68 | 21.1 | 0.66 (0.43–1.03) | 0.07 |
| Both phases | 136/181 | 13.8 | 149/176 | 19.0 | 0.73 (0.58–0.93) | 0.01 |
| Doubling of serum creatinine level or ESRD | ||||||
| Trial phase | 78/181 | 11.5 | 91/176 | 15.4 | 0.76 (0.55–1.04) | 0.08 |
| Cohort phase | 36/86 | 11.8 | 35/68 | 18.0 | 0.68 (0.43–1.09) | 0.11 |
| Both phases | 114/181 | 11.6 | 126/176 | 16.1 | 0.76 (0.58–0.99) | 0.04 |
| ESRD or death | ||||||
| Trial phase | 76/181 | 10.6 | 90/176 | 14.3 | 0.76 (0.56–1.04) | 0.09 |
| Cohort phase | 42/104 | 11.0 | 53/86 | 20.3 | 0.55 (0.37–0.84) | 0.005 |
| Both phases | 118/181 | 10.8 | 143/176 | 16.1 | 0.67 (0.52–0.87) | 0.002 |
*
Hazard ratios and P values are for the comparison between the intensive-control group and the standard-control group. Hazard ratios have been adjusted for five prespecified baseline factors (log-transformed urinary protein excretion, age, sex, presence or absence of a history of heart disease, and baseline mean arterial pressure), along with a linear interaction term between the log-transformed baseline urinary protein-to-creatinine ratio and follow-up time. ESRD denotes end-stage renal disease.