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Table 3 Effect of LCI699 on plasma and urinary sodium and potassium (human study, multiple-dose phase)

From: Aldosterone synthase inhibition: cardiorenal protection in animal disease models and translation of hormonal effects to human subjects

  LCI699 0.5 mg LCI699 1 mg LCI699 3 mg Eplerenone Placebo
  n Mean n Mean n Mean n Mean n Mean
Plasma sodium, mEq/L
Baseline 12 139.3 12 140.1 12 140.6 10 139.9 11 139.6
Δ Day2a 12 +0.23 12 −0.59 12 −0.73* 10 −0.64 11 +0.26
Δ Day7b 12 −1.71 12 −0.11 12 −2.87 10 +0.31 11 +0.41
Δ Day14c 12 +0.41 12 −0.01 12 −0.45 10 −0.07 11 +0.35
Plasma potassium, mEq/L
Baseline 12 4.19 12 4.03 12 4.13 10 3.97 11 4.14
Δ Day2a 12 +0.20 12 +0.08 12 +0.40 10 +0.08 11 0.00
Δ Day7b 12 +0.25 12 +0.12* 12 +0.28 10 −0.02 11 −0.05
Δ Day14c 12 +0.05 12 −0.06 12 +0.22* 10 −0.09 11 −0.06
Urinary sodium, mEq/24 h
Baseline 12 52.3 9 109.3 11 60.7 9 66.5 11 70.1
Δ Day 1a 12 +45.2 9 +76.3 11 +64.0 9 +53.8‡ 11 +5.6
Δ Day 7b 12 +3.6 9 +44.0 11 +22.2 9 +16.2 11 +16.7
Δ Day 14c 12 −25.5 12 −3.6 12 −17.2 10 −24.0 9 −12.2
Urinary potassium, mEq/24 h
Baseline 12 38.7 9 42.5 11 49.1 9 46.4 11 44.8
Δ Day 1a 12 +9.2 9 +9.7 11 +2.9 9 +5.2 11 +8.6
Δ Day 7b 12 +12.8 9 +17.4* 11 +12.2 9 +6.4 11 +1.6
Δ Day 14c 12 +20.2 12 +4.2 12 +37.6* 10 +3.7 9 +17.5
  1. aΔ values are comparisons of Day 1/Day 2–baseline (Day −1); bΔ values are comparisons of Day 7– baseline (Day −1); cΔ values are comparisons of Day 14– Day 7. Mean changes (last observation carried forward) were derived from an analysis of covariance model with baseline value as a covariate. Based on urinary electrolyte values obtained from placebo subjects on Day 7 and Day 14 respectively, the actual diet was ~95 ± 63 mEq Na+/46 ± 12 mEq K+ for the first week and ~86 ± 42 mEq Na+/69 ± 25 mEq K+ for the second week.
  2. *P < 0.05, P < 0.01, P < 0.001 vs placebo.