Article Figures & Data
Figures
Figure 1. Incidence of ESRD (left) and first hospitalizations for heart failure (right) in 1513 patients with type 2 diabetes and overt nephropathy according to treatment and tertiles of basal serum creatinine concentration.
, placebo; , losartan.Figure 2. Kaplan-Meier curves of the percentage of patients with type 2 diabetes and overt nephropathy with ESRD according to treatment and tertiles of basal serum creatinine concentration.
Figure 3. Median changes from baseline in the level of proteinuria throughout the whole study period in 1513 patients with type 2 diabetes and overt nephropathy according to treatment and tertiles of basal serum creatinine concentration.
Figure 4. Kaplan-Meier curves of the percentage of patients with type 2 diabetes and overt nephropathy with a first hospitalization for heart failure according to treatment and tertiles of basal serum creatinine concentration.
Figure 5. Cumulative ESRD days throughout the whole study period in 1513 patients with type 2 diabetes and overt nephropathy according to treatment and tertiles of basal serum creatinine concentration.
Tables
Table 1. Stratification of renal patients according to their NKF stage
Stage GFR (ml/min per 1.73 m2) No. of Patients I ≥90 0 II 60–89 95 III 30–59 1030 IV 15–29 387 V <15 1 Table 2. Baseline characteristics of 1513 patients with type 2 diabetes and overt nephropathy according to tertile of baseline serum creatinine concentration and randomization to losartan or placebo treatment
Lowest Tertile (Range, 0.9–1.6 mg/dl; Mean ± SD, 1.4 ± 0.1 mg/dl) Middle Tertile (Range, 1.6–2.0 mg/dl; Mean ± SD, 1.8 ± 0.1 mg/dl) Highest Tertile (Range, 2.1–3.6 mg/dl; Mean ± SD, 2.4 ± 0.3 mg/dl) Losartan Placebo Losartan Placebo Losartan Placebo Patients (n) 239 255 264 244 248 263 Asian/black/white/hispanic/other (%) 12/19/52/16/1 12/17/48/22/1 17/15/46/20/2 21/13/51/14/1 18/16/45/20/1 20/11/49/17/2 Clinical parameters Age (yr) 59.6 ± 7.4 60.2 ± 7.5 60.7 ± 7.2 60.3 ± 7.6 59.6 ± 7.4 60.5 ± 7.4 male gender (%) 53 58 65 73 67 64 body mass index (kg/m2) 30.9 ± 6.6 29.8 ± 6.2 30.0 ± 5.9 29.3 ± 5.9 29.0 ± 6.4 29.2 ± 6.4 systolic BP (mmHg) 149 ± 18 149 ± 19 152 ± 19 153 ± 20 154 ± 19 157 ± 20 diastolic BP (mmHg) 82 ± 10 83 ± 10 83 ± 10 82 ± 11 82 ± 11 83 ± 10 mean BP (mmHg) 104 ± 11 105 ± 11 106 ± 11 106 ± 13 106 ± 11 108 ± 11 oral antidiabetic drugs/insulin (%/%) 55/62 55/58 48/59 53/55 42/64 42/64 smoking (%) 20 20 20 15 18 15 Laboratory parameters HbA1C (%) 8.7 ± 1.7 8.7 ± 1.7 8.6 ± 1.6 8.4 ± 1.6 8.3 ± 1.6 8.2 ± 1.4 total cholesterol (mg/dl) 228 ± 54 227 ± 54 227 ± 57 229 ± 52 227 ± 55 230 ± 60 HDL cholesterol (mg/dl) 47 ± 17 47 ± 14 45 ± 15 44 ± 15 43 ± 14 44 ± 14 triglycerides (mg/dl) 239 ± 195 222 ± 208 207 ± 174 241 ± 235 194 ± 168 213 ± 150 potassium (mEq/L) 4.5 ± 0.5 4.6 ± 0.5 4.6 ± 0.4 4.6 ± 0.5 4.7 ± 0.5 4.7 ± 0.5 uric acid (mg/dl) 6.2 ± 1.6 6.1 ± 1.5 6.8 ± 1.7 6.9 ± 1.6 7.0 ± 1.7 7.1 ± 1.7 creatinine clearance (ml/min per 1.73 m2) mean ± SD 50.7 ± 6.0 50.8 ± 5.7 39.1 ± 2.7 39.1 ± 2.8 28.9 ± 3.4 28.8 ± 3.3 range 43.1–76.7 44.5–76.7 34.5–43.1 34.5–43.1 19.2–33.7 21.6–33.7 median albumin/creatinine ratio (g/mg) 947 882 1045 1178 1737 1800 Table 3. Incidence of ESRD and hospitalization for CHF in 1513 patients with type 2 diabetes and overt nephropathy according to NKF stages and randomization to losartan or placebo treatmenta
NKF Stage GFR (ml/min per 1.73 m2) No. of Patients ESRD on Losartan (%) ESRD on Placebo (%) Risk Reduction (%; 95% CI) P (Losartan versus Placebo) CHF on Losartan (%) CHF on Placebo (%) Risk Reduction (%; 95% CI) P (Losartan versus Placebo) Stage I (GFR ≥90 ml/min per 1.73 m2) and stage V (GFR <15 ml/min per 1.73 m2) were not considered because they included only 0 and 1 patient, respectively. CHF, congestive heart failure; CI, confidence interval. II 60–89 95 1 (2.7) 6 (10.3) 82 (−64 to 98) 0.13 5 (13.5) 5 (8.6) −42 (−400 to 60) 0.58 III 30–59 1030 64 (12.1) 87 (17.3) 33 (8 to 52) 0.02 55 (10.4) 71 (14.1) 29 (−1 to 50) 0.06 IV 15–29 387 81 (43.6) 101 (50.3) 23 (−4 to 43) 0.08 29 (15.6) 50 (24.9) 41 (6 to 63) 0.03 Table 4. Adverse events leading to patient withdrawal in 1513 patients with type 2 diabetes and overt nephropathy according to tertile of baseline serum creatinine and randomization to losartan or placebo treatmenta
Event Lowest Tertile Middle Tertile Highest Tertile Losartan Placebo Losartan Placebo Losartan Placebo a ARF, acute renal failure. b Cardiac arrest. c Brain death. d P < 0.01 versus Losartan. Death 0 0 2b 0 1c 0 Cardiovascular events 10 13 12 12 10 12 myocardial infarction 5 4 1 5 6 7 stroke 3 5 7 5 1 1 angina/coronary disease 2 4 4 2 3 4 Heart failure/left ventricular dysfunction 9 11 10 20 6 23d Increasing serum creatinine/ARF 1 2 3 5 9 6 Chronic renal insufficiency/failure 4 1 3 8 11 10 ESRD 1 0 2 4 8 13 Hyperkalemia 2 1 5 3 3 2 Angioedema 0 0 0 1 1 0 Hypertension/uncontrolled BP 3 0 3 3 1 1 Uncontrolled diabetes 0 2 0 1 0 0 Cancer 1 3 2 0 1 0 Other 6 13 14 14 19 20 Table 5. Basal and mean follow-up serum potassium levels in 1513 patients with type 2 diabetes and overt nephropathy according to tertile of baseline serum creatinine and randomization to losartan or placebo treatment
Serum Potassium (mEq/L) Lowest Tertile Middle Tertile Highest Tertile Losartan Placebo Losartan Placebo Losartan Placebo a P < 0.001 versus basal. b P < 0.001 versus Losartan. Basal 4.5 ± 0.5 4.6 ± 0.5 4.6 ± 0.5 4.6 ± 0.5 4.7 ± 0.5 4.7 ± 0.5 Follow-up 4.8 ± 0.2a 4.6 ± 0.1b 4.9 ± 0.1a 4.7 ± 0.1b 4.9 ± 0.1a 4.7 ± 0.1b Table 6. Days of ESRD saved by losartan therapy according to duration of follow-up and different tertiles of baseline serum creatinine concentration
Follow-up (Days) Tertiles Lowest Middle Highest 180 0.0 0.0 0.4 360 0.6 0.1 0.7 540 2.1 0.3 0.6 720 5.2 3.6 7.0 900 10.1 7.5 17.3 1080 15.8 15.7 29.3 1260 22.0 30.2 44.9 1440 29.0 47.9 59.2
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