Table 4.
Comparison of NAP226-90 steady-state plasma concentrations by patch size stratified by baseline renal impairment
| Patch size (cm2) | Group | n | Median (ng/mL) | Range (ng/mL) | Arithmetic mean (ng/mL) | Standard deviation (ng/mL) | Geometric mean (ng/mL) | Geometric mean 95 % CI | Ratio (%) of geometric means (renal impairment: control) |
|---|---|---|---|---|---|---|---|---|---|
| Renal impairment measured by CLCR | |||||||||
| 5 | Control | 8 | 2.0 | 1.0–4.7 | 2.2 | 1.2 | 1.9 | 1.4–2.8 | 112 |
| 5 | Renal impairment | 9 | 2.7 | 0.4–11.3 | 3.1 | 3.2 | 2.2 | 1.2–4.0 | |
| 10 | Control | 99 | 3.2 | 0.4–9.5 | 3.4 | 1.5 | 2.9 | 2.6–3.2 | 117 |
| 10 | Renal impairment | 72 | 3.6 | 0.4–14.9 | 4.3 | 3.0 | 3.4 | 2.9–4.0 | |
| 15 | Control | 6 | 5.4 | 3.0–17.9 | 8.3 | 6.2 | 6.7 | 3.7–11.9 | 76.6 |
| 15 | Renal impairment | 12 | 4.9 | 1.3–22.3 | 6.6 | 5.8 | 5.1 | 3.3–7.8 | |
| 20 | Control | 48 | 7.8 | 1.8–47.0 | 9.1 | 7.4 | 7.2 | 5.9–8.7 | 110 |
| 20 | Renal impairment | 49 | 8.1 | 1.9–19.5 | 9.0 | 4.3 | 7.9 | 6.8–9.2 | |
| Renal impairment measured by eGFR | |||||||||
| 5 | Control | 14 | 2.0 | 0.4–4.7 | 2.1 | 1.1 | 1.8 | 1.3–2.6 | 197 |
| 5 | Renal impairment | 3 | 2.8 | 1.5–11.3 | 5.2 | 5.3 | 3.6 | 1.1–11.7 | |
| 10 | Control | 134 | 3.2 | 0.6–14.9 | 3.6 | 2.4 | 3.1 | 2.8–3.4 | 108 |
| 10 | Renal impairment | 38 | 3.7 | 0.4–14.5 | 4.1 | 2.8 | 3.3 | 2.6–4.2 | |
| 15 | Control | 17 | 4.9 | 1.3–17.9 | 6.3 | 4.4 | 5.1 | 3.7–7.0 | |
| 15 | Renal impairment | 1 | 22.3 | 22.3 | 22.3 | ||||
| 20 | Control | 75 | 8.2 | 1.8–47.0 | 9.3 | 6.6 | 7.7 | 6.7–8.9 | 90.0 |
| 20 | Renal impairment | 22 | 6.9 | 2.4–19.5 | 7.9 | 4.1 | 7.0 | 5.6–8.7 | |
The control group includes patients with no renal impairment or with mild renal impairment, and the renal impairment group includes patients with moderate or severe renal impairment
CI confidence interval, CL CR creatinine clearance, eGFR estimated glomerular filtration rate