Kleintje66 schreef op 28 februari 2021 17:18:
Wat details uit het rapport:
Overall, 91 of 131 Aviptadil-treated participants survived to day 28 compared to 47 of 65 placebo-treated patients (70.6% vs 71.7%; P=NS). Among those treated with HFNC (n=127), the main outcome measure demonstrated a trend in favor of the drug treated group (Hazard Ratio 1.53; P=.08). Participants treated in tertiary care hospitals demonstrated a greater effect (HR 1.84; P=.058). A 10 day median difference in hospital length of stay was seen in all HFNC patients (P=.006) and a thirteen day difference was seen in those treated in tertiary care centers (P=.004), with both differences favoring treatment with aviptadil.
At 28 days, a smaller percentage of Aviptadil-treated vs. placebo-treated participants remained hospitalized for respiratory failure (37% vs 51%;P=.08). The study was insufficiently powered to detect differences in outcome among patients treated with non-invasive and mechanical ventilation and no differences were detected.
At 28 days, a Aviptadil patients treated with HFNC were 35% - 46% more likely to recover, return home, and survive to 28 days compared to placebo-treated patients, with a trend level of significance. Aviptadil patients additionally demonstrated a highly statistically significant and clinically dramatic ten day reduction in hospitalization time. Should similar findings be observed at 60 days, Emergency Use Authorization will be sought.
Aviptadil-treated participants were 35% (calculated as (1-(1/HR))) more likely to reach the prespecified composite endpoint than were participants treated with placebo (Hazard Ratio 1.53; P=.08). Participants treated in tertiary care hospitals demonstrated a 46% increased likelihood of reaching the composite endpoint (HR 1.84; P=.058).
10 day median difference in time to hospital length of stay was seen in all HFNC participants (P=.006) and a 13 day difference was seen in those treated in tertiary care centers (P=.004). Given the continued hospitalization of a greater proportion of placebo-treated than Aviptadil-treated patients at day 28, this difference may be more pronounced by day 60.
At day 28 (see Fig 1), 26 of 51 placebo participants compared to 28 of 76 drug-treated participants remain in the hospital, a trend that approaches significance (51% vs. 37%; Fisher Exact Test, P=.08).
Nog niet eerder zo'n ingewikkeld onderzoek gezien, groot verschil tussen behandel methoden (in aantallen en resultaat), verschil in ziekenhuizen ook door overbelaste IC's. Ook geen idee wat de FDA kan doen met het HFNC deel en de redelijk goede resultaten.
Wat de 60 dagen resultaten worden is ook onduidelijk maar ik verwacht verdere verbetering gezien de uitgangssituatie na 28 dagen. Voor EUA mbt HFNC moet het genoeg zijn maar de FDA kan ook weer een heel formeel standpunt innemen.