SILDI-SAFE found one hypotension event—not an efficacy verdict

In SILDI-SAFE's 122-infant safety population, protocol-defined hypotension occurred in 1/92 sildenafil recipients and 0/30 placebo recipients. Exposure was overwhelmingly enteral, efficacy analyses were exploratory, and three registry-reported deaths in sildenafil cohorts require explanation rather than causal spin.

THE HOT TAKE

SILDI-SAFE answers a narrow safety question: repeated, mostly enteral sildenafil did not produce a clear hypotension signal in this small trial. It does not show that sildenafil prevents pulmonary hypertension—or settle overall safety.

At 30 US NICUs, investigators randomized 125 infants born before 29 weeks who had protocol-defined severe BPD at 32+0 to 44+6 weeks PMA. Three received no study drug. The safety population comprised 92 sildenafil recipients and 30 placebo recipients across three sequential dose cohorts, allocated 3:1 within each cohort and followed for safety through 28 days after the last dose.