Table 2.

Baseline and end-of-treatment values of selected variables in the three treatment groups in 180 patients with type 2 diabetes mellitus and evidence of plasma volume expansion (hematocrit reduction ≥ 1.5 percentage points)

VariableSpironolactone Group (n=60)Amiloride Group (n=60)Control Group (n=60)
Weight (kg)
 Baseline65.5±11.367.0±11.662.2±09.2
 End of treatment68.0±11.470.1±11.565.1±10.2
 Absolute change (95% CI)2.5 (1.6–3.3)3.1(2.4 to −3.8)2.9 (2.1–3.6)
 P value for change from baseline0.0010.0010.001
Hemoglobin (g/dl)
 Baseline13.1±1.513.2±1.313.2±1.6
 End of treatment12.9±1.713.1±1.612.9±2.0
 Absolute change (95% CI)−0.2 ( −0.4 to 0.0)−0.1 (−0.2 to 0.1)−0.3 (−0.6 to 0.0)
 P value for change from baseline0.050.500.07
Hematocrit (%)
 Baseline39.4±3.839.8±3.539.8±4.3
 End of treatment38.7±4.539.8±4.738.5±5.3
 Absolute change (95% CI)a−0.7 (−0.1 to −1.4)0.0 (−0.8 to 0.8)−1.2 (−0.3 to −2.2)
 P value for change from baseline0.020.960.01
Serum albumin (g/dl)
 Baseline4.36±0.304.41±0.354.44±0.33
 End of treatment4.39±0.274.40±0.254.18±0.42
 Absolute change (95% CI)0.03 (−0.09 to 0.04)0.01 (−0.08 to 0.10)−0.27 (−0.53 to 0.0)
 P value for change from baseline0.410.800.049
Hemoglobin A1c (%)
 Baseline8.6±1.58.3±1.58.5±1.5
 End of treatment7.7±1.37.5±0.97.5±1.4
 Absolute change (95% CI)a−0.94 (−1.6 to −0.27)−0.81 (−1.4 to −0.21)−0.99 (−1.89 to 0.08)
 P value for change from baseline0.0080.010.03
Foot and ankle volume (ml)
 Baseline1185±189.01237.5±201.71149.7±163.7
 End of treatment1211.3±182.41274.3±181.11203.8±162.9
 Absolute change (95% CI)25.9 (8.3–41.3)36.8 (9.3–56.0)54.2 (35.5–72.8)
 P value for change from baseline0.310.110.001
  • a Change expressed as percentage points.