Table 3.
Primary efficacy endpoint.
| Timing | Group | N | NIHSS score, LSM (SE) | NIHSS changes from pre-treatment, LSM (SE) | Intergroup difference in NIHSS changes, LSM (95% CI) |
|---|---|---|---|---|---|
| Overall analysis | |||||
| 8-h | AM | 40 | 3.32 (0.17) | −0.03 (0.17) | 0.25 (−0.24−0.74) |
| Placebo | 20 | 3.07 (0.18) | −0.28 (0.18) | – | |
| 24-h | AM | 40 | 2.92 (0.24) | −0.43 (0.24) | 0.15 (−0.46−0.75) |
| Placebo | 20 | 2.77 (0.18) | −0.58 (0.18) | – | |
| 72-h | AM | 40 | 2.97 (0.36) | −0.38 (0.36) | 0.35 (−0.93−1.63) |
| Placebo | 20 | 2.62 (0.54) | −0.73 (0.54) | – | |
| 7-day | AM | 40 | 2.59 (0.34) | −0.76 (0.34) | 0.32 (−0.91−1.56) |
| Placebo | 20 | 2.27 (0.53) | −1.08 (0.53) | – | |
| Dose-finding analysis | |||||
| 8-h | C/P-AM | 20 | 3.41 (0.25) | 0.23 (0.25) | 0.52 (−0.12−1.16) |
| P-AM | 20 | 2.89 (0.21) | −0.28 (0.21) | – | |
| 24-h | C/P-AM | 20 | 3.06 (0.30) | −0.12 (0.30) | 0.62 (−0.29−1.53) |
| P-AM | 20 | 2.44 (0.34) | −0.73 (0.34) | – | |
| 72-h | C/P-AM | 20 | 2.96 (0.37) | −0.22 (0.37) | 0.32 (−1.09−1.72) |
| P-AM | 20 | 2.64 (0.61) | −0.53 (0.61) | – | |
| 7-day | C/P-AM | 20 | 2.76 (0.36) | −0.42 (0.36) | 0.67 (−0.64−1.98) |
| P-AM | 20 | 2.09 (0.55) | −1.08 (0.55) | – | |
Generalized estimating equations were applied, which included trial treatments, time points, and interaction of trial treatments with time points as fixed effects, with the pre-treatment NIHSS score included as a covariate.
AM, adrenomedullin; C/P-AM, continuous-pulsed adrenomedullin; LSM, least square mean; NIHSS, National Institutes of Health Stroke Scale; P-AM, pulsed adrenomedullin; SE, standard error.