TABLE 1.
Demographic characteristics of the cohort of pregnant and control nonpregnant women with epilepsy taking levetiracetam (LEV).
| Cohort variable | Total | Nonpregnant | Pregnant | First trimester | Second trimester | Third trimester | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| Mean ± SD | Mean ± SD | Mean ± SD | p‐value | Mean ± SD | p‐value | Mean ± SD | p‐value | Mean ± SD | p‐value | |
| Patients, no. | 231 | 200 | 31 | 14 | 12 | 5 | ||||
| Age, years | 27.92 ± 6.18 | 27.99 ± 6.42 | 27.52 ± 4.43 | 0.695 | 26.07 ± 2.95 | 0.27 | 29.33 ± 5.11 | 0.476 | 27.2 ± 5.45 | 0.787 |
| Weight, kg | 55.48 ± 8.97 | 55.25 ± 9.11 | 56.95 ± 8.04 | 0.329 | 54.84 ± 8.49 | 0.872 | 57.33 ± 7.22 | 0.438 | 61.9 ± 7.8 | 0.107 |
| Height, cm | 160.1 ± 5.25 | 160 ± 5.26 | 161 ± 5.19 | 0.359 | 160.8 ± 5.51 | 0.635 | 161.6 ± 5.82 | 0.317 | 160 ± 3.08 | 0.999 |
| All (morning samples and samples after intaking of LEV) saliva and plasma samples collected in pairs | ||||||||||
| Sample pairs, no. | 407 | 338 | 69 | 30 | 25 | 14 | ||||
| LEV daily dose, mg | 1227.8 ± 501 | 1232 ± 498.6 | 1206.5 ± 516 | 0.7 | 1075 ± 342.1 | 0.026 | 1290 ± 623.7 | 0.583 | 1339.3 ± 585 | 0.434 |
| LEV plasma concentration, μg/mL | 10.86 ± 8.45 | 11.67 ± 8.72 | 6.86 ± 5.47 | <0.001 | 7.46 ± 5.66 | 0.001 | 6.87 ± 6.12 | 0.007 | 5.55 ± 3.62 | <0.001 |
| LEV saliva concentration, μg/mL | 10.69 ± 9.67 | 11.46 ± 10.1 | 6.97 ± 5.89 | <0.001 | 7.13 ± 5.22 | <0.001 | 7.2 ± 7.18 | 0.04 | 6.21 ± 4.99 | 0.054 |
| Ratio saliva: plasma | 0.99 ± 0.39 | 0.98 ± 0.4 | 1.02 ± 0.35 | 0.472 | 0.98 ± 0.36 | 0.979 | 1 ± 0.34 | 0.787 | 1.12 ± 0.36 | 0.199 |
| DNCp of LEV, ng/mL/mg | 9.15 ± 6.59 | 9.74 ± 6.57 | 6.23 ± 5.91 | <0.001 | 7.12 ± 5.44 | 0.034 | 6.09 ± 7.46 | 0.008 | 4.56 ± 2.97 | <0.001 |
| DNCs of LEV, ng/mL/mg | 8.96 ± 7.27 | 9.53 ± 7.39 | 6.18 ± 5.98 | <0.001 | 6.65 ± 4.61 | 0.037 | 6.2 ± 7.93 | 0.031 | 5.14 ± 4.65 | 0.028 |
| Only morning (trough steady‐state) saliva and plasma samples collected in pairs | ||||||||||
| Sample pairs, No | 318 | 258 | 60 | 25 | 22 | 13 | ||||
| Seizure frequency in the last months prior to sampling | 1.68 ± 3.68 | 1.54 ± 2.74 | 2.18 ± 5.89 | 0.278 | 2.29 ± 6.49 | 0.608 | 2.52 ± 6.54 | 0.502 | 1.11 ± 1.69 | 0.644 |
| Seizure frequency in the 3 months prior to sampling | 4.51 ± 9.61 | 4.33 ± 8.19 | 5.34 ± 14.62 | 0.516 | 4.58 ± 10.51 | 0.903 | 7.2 ± 20.02 | 0.532 | 2.5 ± 3.46 | 0.529 |
| LEV daily dose, mg | 1219.6 ± 503 | 1216 ± 494.7 | 1233 ± 540.5 | 0.814 | 1070 ± 364.6 | 0.151 | 1341 ± 638.8 | 0.27 | 1365 ± 600.5 | 0.295 |
| LEV plasma concentration, μg/mL | 7.85 ± 5.07 | 8.43 ± 5.18 | 5.36 ± 3.63 | <0.001 | 5.48 ± 3.11 | 0.006 | 5.21 ± 4.23 | 0.005 | 5.4 ± 3.72 | 0.039 |
| LEV saliva concentration, μg/mL | 7.69 ± 5.83 | 8.18 ± 5.98 | 5.59 ± 4.63 | 0.002 | 5.59 ± 3.99 | 0.035 | 5.33 ± 5.17 | 0.021 | 6.01 ± 5.13 | 0.2 |
| Ratio saliva: plasma | 0.99 ± 0.41 | 0.98 ± 0.41 | 1.02 ± 0.37 | 0.441 | 1 ± 0.39 | 0.749 | 0.99 ± 0.35 | 0.909 | 1.12 ± 0.37 | 0.238 |
| DNCp of LEV, ng/mL/mg | 6.72 ± 4.16 | 7.24 ± 4.26 | 4.51 ± 2.83 | <0.001 | 5.3 ± 3.05 | 0.027 | 3.71 ± 2.32 | <0.001 | 4.34 ± 2.96 | 0.016 |
| DNCs of LEV, ng/mL/mg | 6.61 ± 4.94 | 7.08 ± 5.12 | 4.56 ± 3.45 | <0.001 | 5.25 ± 3.42 | 0.081 | 3.61 ± 2.43 | 0.002 | 4.86 ± 4.71 | 0.126 |
Abbreviations: DNCp, dose‐normalized concentration in plasma; DNCs, dose‐normalized concentration in saliva; LEV, levetiracetam; SD, standard deviation.