Table 3.

Association between a transition in albuminuria class (normo- to microalbuminuria transition or micro- to macroalbuminuria transition) during the first year of the ALTITUDE and subsequent renal (doubling serum creatinine, ESRD, or renal death) and cardiovascular (cardiovascular death, resuscitated sudden death, myocardial infarction, stroke, or unplanned hospitalization for heart failure) outcomes

Class TransitionsRenal OutcomeCardiovascular Outcome
HR (95% CI)Chi-SquaredP ValueHR (95% CI)Chi-SquaredP Value
Single visit
 Single urine sample1.92 (1.09 to 3.40) (1.15 to 1.83)9.810.002
 Two urine samples1.80 (1.01 to 3.20)3.980.051.30 (1.02 to 1.65)4.460.04
 Three urine samples1.82 (1.02 to 3.24) (1.06 to 1.72)6.000.01
Addition of confirmation visit2.47 (1.36 to 4.49)8.810.0031.42 (1.09 to 1.85)6.84<0.01
 Transition and 10% UACR increase1.94 (1.10 to 3.43) (1.14 to 1.82)9.450.002
 Transition and 30% UACR increase2.06 (1.17 to 3.64) (1.10 to 1.76)7.47<0.01
 Transition and 50% UACR increase2.22 (1.26 to 3.91)7.59<0.011.36 (1.07 to 1.72)6.390.01
 Transition and 100% UACR increase1.98 (1.11 to 3.51)5.420.021.30 (1.02 to 1.66)4.390.04
  • The definitions of albuminuria class transitions are similar as those that were used to assess the drug effect. The presented HRs are derived from a Cox proportional hazard models and adjusted for age, sex, albumin-to-creatinine ratio, eGFR, systolic and diastolic BPs, hemoglobin A1c, and cardiovascular disease history. The composite renal end point was defined as ESRD defined as the need for chronic dialysis or renal transplantation, renal death defined as the need for RRT with no dialysis or transplantation available or initiated, or doubling of serum creatinine from baseline sustained for at least 1 month. The composite cardiovascular end point was defined as death from cardiovascular causes or the first occurrence of cardiac arrest with resuscitation, nonfatal myocardial infarction, nonfatal stroke, or unplanned hospitalization for heart failure. All clinical end points were adjudicated by a central end point committee using standard definitions.