Table 2.
Pharmacokinetic parameters of enalapril and enalaprilat in pediatric patients with heart failure due to DCM and CHD.
| Patient Group | Enalapril | Enalaprilat | Enalapril | Enalaprilat | Enalapril | Enalaprilat | ||
|---|---|---|---|---|---|---|---|---|
| n | AUCtau, ss, norm (ng/mL·h/mg·kg) |
Cmax, ss, norm (ng/mL/mg·kg) |
tmax or tmax, ss (h) |
|||||
| Total (All) | 89 | 637.5 | 1166.4 | 231.6 | 138.5 | 1.98 | 5.95 | |
| (0–3144.8) | (0–5451.9) | (0–760.8) | (0–719.5) | (0–5.95) | (0–12.2) | |||
| 1 day to <1 year (Ia) | 65 | 721.9 | 1111.7 | 219.4 | 128.8 | 2 | 6 | |
| (0–3144.8) | (0–5451.9) | (0–603.5) | (0–719.5) | (0–5.95) | (0–12.2) | |||
| 1 year to <6 years (Ib) | 18 | 580.2 | 1272.2 | 279.2 | 139.7 | 1.03 | 4 | |
| (313.0–1338.2) | (0–4468.2) | (78.9–279.2) | (0–516.3) | (1–4.08) | (0–12.02) | |||
| 6 years to <12 years (Ic) | 6 | 514.6 | 1618.7 | 240.95 | 187.8 | 1 | 3.92 | |
| (373.1–597.8) | (872.6–1968.6) | (155.5–273.2) | (103.3–268) | (1–2) | (2–4) | |||
| p, Ia vs. Ib | 0.849 | 0.4039 | 0.1038 | 0.3613 | 0.011 # | 0.003 # | ||
| p, Ia vs. Ic | 0.0809 | 0.0333 | 0.1851 | 0.1721 | 0.022 | <0.0001 # | ||
| p, Ib vs. Ic | 0.1476 | 0.3257 | 0.4547 | 0.5413 | 0.8683 | 0.5149 | ||
| Dilated Cardiomyopathy | 26 | 455.4 | 1194.4 | 148.0 | 129.2 | 1.51 | 4.56 | |
| (235.5–1338.2) | (0–4468.2) | (44–760.8) | (0–516.3) | (0.93–4.17) | (0–12.0) | |||
| 1 months to <1 year (IIa) | 9 | 387.7 | 929.5 | 97.1 | 109.6 | 2.03 | 6 | |
| (235.5–626.1) | (390.7–1569) | (44–219.4) | (66.8–187.7) | (0.93–4.17) | (4.03–6.08) | |||
| 1 year to <6 years (IIb) | 11 | 470.7 | 1285.4 | 225.3 | 148.8 | 1.03 | 4 | |
| (313–1338.2) | (0–4468.2) | (78.9–760.8) | (0–516.3) | (1–4.08) | (0–12.0) | |||
| 6 years to <12 years (IIc) | 6 | 514.6 | 1618.7 | 240.95 | 187.8 | 1 | 3.92 | |
| (373.1–597.8) | (872.6–1968.6) | (155.5–273.2) | (103.3–268) | (1–2) | (2–4) | |||
| p, IIa vs. IIb | 0.1005 | 0.0212 | 0.0039 # | 0.0213 | 0.0646 | 0.128 | ||
| p, IIa vs. IIc | 0.1018 | 0.0062 # | 0.0005 # | 0.015 # | 0.0229 | 0.0003 # | ||
| p, IIb vs. IIc | 0.7078 | 0.7708 | 0.8555 | 0.8426 | 0.6496 | 0.6443 | ||
| Congenital Heart Disease | 63 | 778.2 | 1166.1 | 260.3 | 142.2 | 1.98 | 6.0 | |
| (0–3144.8) | (0–5451.9) | (0–603.5) | (0–719.5) | (0–5.95) | (0–12.2) | |||
| 1 day to <1 year (IIIa) | 56 | 783.7 | 1156.6 | 257.1 | 142.7 | 2 | 6 | |
| (0–3144.8) | (0–5451.9) | (0–603.5) | (0–719.5) | (0–5.95) | (0–12.2) | |||
| 1 year to <6 years (IIIb) | 7 | 778.2 | 1258.9 | 471.9 | 130.5 | 1.03 | 4 | |
| (448.8–1334.8) | (166.5–2706.9) | (105.1–564) | (81.8–289.3) | (1–2.1) | (2.07–6) | |||
| p, IIIa vs. IIIb | 0.5217 | 0.8282 | 0.1021 | 0.9591 | 0.0026 # | 0.0006 # | ||
Data reported as median (range), statistical testing was performed by t-test were used to compare means and their variance, p-values are reported; DCM = Dilated Cardiomyopathy; CHD = Congenital Heart Disease, AUC = Area under the curve; Cmax = maximal serum concentrations; tmax = time of maximal serum concentrations; ss = steady state, norm = normalized. # significant based on p adjusted according to Bonferoni.