Table 2.
Summary of stratified findings for primary endpoint analysis in the per-protocol population
| PSG | Placebo/Placebo (N = 7) |
Fl 10 mg/Ond 24 mg (N = 10) |
||||
|---|---|---|---|---|---|---|
| Baseline | Day 14 | Day 28 | Baseline | Day 14 | Day 28 | |
| REM AHI | 55.2 | 58.6 | 62.4 | 45.5 | 27.3P = 0.018 | 36.8 |
| NREM AHI | 53.8 | 55.4 | 55.2 | 33.8 | 23.4 | 20.5 |
| Supine AHI | 84.4 | 64.9 | 92.6 | 48.4 | 40.9 | 33.4 |
| Non-Supine AHI | 50.3 | 56.4 | 53.6 | 22.7 | 16.1P = 0.044 | 14.8 |
| AHI 1st Half | 63.5 | 59.8 | 61.7 | 37.9 | 29.7 | 23.3 |
| AHI 2nd Half | 45.5 | 52.5 | 52.8 | 36.5 | 20.4P = 0.004 | 25.0P = 0.035 |
| Apnea Index | 24.4 | 27.5 | 25.2 | 13.8 | 7.1 | 8.0 |
| Hypopnea Index | 29.8 | 28.7 | 31.8 | 23.2 | 17.8 | 16.2 |
| Arousal Index | 43.6 | 46.3 | 40.7 | 24.2 | 18.9 | 21.4 |
Fl, Fluoxetine; Ond, Ondansetron; PSG, polysomnogram; AHI, apnea hyponea index;
1s and 2nd half of the entire night of PSG recording. The polysomnographic parameters with statistically significant change at days 14 and 28 of treatment compared to baseline are indicated within the table with numerical P values specified.