Models | Effect | Number with event (n = 89)^{†} | Patient-years^{‡} | Rate per 1,000 patient-years | Cox proportional hazard model^{*} | GLMM^{§} | ||
---|---|---|---|---|---|---|---|---|
Hazard ratio (95% CI) | Pair-wise P value | % Decrease per year (95% CI) | Pair-wise P value | |||||
M vs. N | M vs. N | |||||||
Current albuminuria model | Normal (N) | 30 | 28,123 | 1.1 | 1 | <0.0001 | 1.2% (1.2–1.3) | <0.0001 |
A vs. M | A vs. M | |||||||
Albuminuria category defined from the AER value at the time of estimated GFR assessment | Microalbuminuria (M) | 18 | 4,041 | 4.4 | 3.3 (1.8–6.1) | <0.0001 | 1.8% (1.6–1.9) | <0.0001 |
A vs. N | A vs. N | |||||||
Macroalbuminuria (A) | 41 | 837 | 46.7 | 15.3 (8.9–26.3) | <0.0001 | 5.7% (4.5–6.8) | <0.0001 | |
M vs. N | M vs. N | |||||||
History of albuminuria model | Normal (N) | 21 | 21,069 | 1.0 | 1 | 0.281 | 1.2% (1.2–1.3) | 0.0007 |
A vs. M | A vs. M | |||||||
Albuminuria category defined from the highest AER value observed before or at the time of estimated GFR assessment | Microalbuminuria (M) | 14 | 10,492 | 1.3 | 0.7 (0.4–1.4) | <0.0001 | 1.4% (1.3–1.4) | <0.0001 |
A vs. N | A vs. N | |||||||
Macroalbuminuria (A) | 54 | 1,440 | 36.1 | 8.6 (5.0–14.7) | <0.0001 | 5.1% (4.0–6.2) | <0.0001 |
Crude risk of developing sustained estimated GFR <60 ml/min/1.73 m^{2} (or ESRD) and the relative risk (hazard ratio) estimated from the Cox proportional hazards model are shown. Mean of the rate of decline (% decrease per year) in estimated GFR was obtained from the general linear mixed model.
↵*Cox proportional hazard model of the time from DCCT randomization to the initial sustained eGFR <60 ml/min/1.73 m^{2} through EDIC year 14, after adjustment for mean arterial pressure and ACE inhibitor use versus not at each visit as time-dependent covariates. For those with a missing covariate value at a visit, the prior observed value was carried forward. Mean arterial pressure was computed as (2/3 diastolic blood pressure + 1/3 systolic blood pressure). ACE inhibitor use was proscribed during DCCT (1983–1993).
↵†The 89 patients with events are subjects with sustained eGFR <60 ml/min/1.73 m^{2}.
↵‡For each patient, patient-years is calculated as the elapsed whole years from randomization into the DCCT to either the visit at which a sustained eGFR <60 ml/min/1.73 m^{2} was first observed or the last visit at which the eGFR was measured if a patient had no event during the time.
↵§Percent decrease in eGFR per year while in each category of albuminuria obtained from the generalized linear mixed model of log-transformed levels of eGFR as a function of time, with heterogeneous random intercept, random slope over time, and residual errors among the time-dependent AER categories, after adjustment for time-dependent use of ACE inhibitor and time-dependent mean blood pressure at each DCCT-EDIC visit. For subjects with a missing covariate (AER, ACE inhibitor use, or mean blood pressure) at a visit, the prior observed value was carried forward. For subjects reaching ESRD, an eGFR value of 15 ml/min/1.73 m^{2} was assigned thereafter for annual visits.