For the treatment of HRF associated with pulmonary hypertension

Clinical studies have demonstrated the efficacy of INOMAX for the treatment of hypoxic respiratory failure (HRF) associated with pulmonary hypertension (PH).

INOMAX is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

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INOMAX may help reduce median duration of oxygen therapy

INOMAX shortened median time on oxygen8,a

Time on oxygen therapy shown in a Kaplan-Meier analysis of retrospective data from the CINRGI Phase III study.8

  • Median oxygen time is defined as the day at which 50% of patients went off oxygen therapy. Patients who died or received extracorporeal membrane oxygenation (ECMO) were censored. Total length of hospital stay was not different between study groups. CINRGI was not sufficiently powered to show significance in this endpoint.8
  • INOMAX with ventilation was shown to shorten median time on oxygen therapy compared to ventilation alone (17 days vs 34 days)8

INOMAX may help reduce median time on mechanical ventilation

INOMAX shortened median time on mechanical ventilation9,a

bThe Golombek study was a retrospective pooled analysis of all subjects receiving 20 ppm inhaled nitric oxide (iNO) in the CINRGI, NINOS, and I-NO/PPHN Phase III trials, and included no censoring based on underlying diagnosis or baseline characteristics. The objective was to analyze the effects of iNO on measures of oxygenation, across a range of illness severity strata and on the duration of mechanical ventilation. For the purposes of this analysis, only those subjects who received 20 ppm of INOMAX, regardless of the underlying diagnosis, were compared with similar placebo-treated patients.9

Time on mechanical ventilation shown in a Kaplan-Meier analysis of retrospective pooled data from 3 controlled studies: NINOS, CINRGI, and I-NO/PPHN.a

  • Median ventilation time is defined as the day at which 50% of patients went off the ventilator. Patients who died or received ECMO were censored. Total length of hospital stay was not different between study groups. Individual studies were not sufficiently powered to show significance.9
  • The median time on mechanical ventilation was 11 days in the ventilation + INOMAX group vs 14 days in the ventilation-alone group9,b

Analysis: Impact of early INOMAX on disease progression

Konduri 2013: Post hoc analysis of the Konduri 2004 study

Early initiation decreased progression of HRF to OI of ≥3010,c

cPost hoc, subgroup analysis of prospectively collected data from the early INOMAX randomized controlled trial to identify factors associated with ECMO/death and the progression of HRF.
dThe control group was eligible to receive INOMAX if HRF progressed to an OI ≥25.10
48% relative reduction in disease progression

Analysis: Impact of early INOMAX on risk of ECMO/death

Konduri 2013: Post hoc analysis of the Konduri 2004 study

Early initiation significantly reduced risk of ECMO/death by OI at enrollment10,c

cPost hoc, subgroup analysis of prospectively collected data from the early iNO randomized, controlled trial to identify factors associated with ECMO/death and the progression of HRF.
“Statistical analysis of the data established that an OI of 20 was the best cut point for predicting ECMO or death.”60% relative reduction in ECMO/death

Analysis: Impact of early INOMAX on risk of ECMO/death

Konduri 2013: Post hoc analysis of the Konduri 2004 study

Early initiation reduced risk of ECMO/death by treatment assignment and OI at enrollment10,c

cPost hoc, subgroup analysis of prospectively collected data from the early INOMAX randomized, controlled trial to identify factors associated with ECMO/death and the progression of HRF.
dThe control group was eligible to receive INOMAX if HRF progressed to an OI ≥25.10

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