Methods of reducing the risk of mortality associated with a medical treatment
Inventors
Potenziano, Jim • Stauffer, Joe
Assignees
Mallinckrodt Hospital Products IP Unlimited Co • Mallinckrodt Pharma IP Trading DAC • Therakos Inc • Mallinckrodt Critical Care Finance Inc
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Publication Number
US-11992620-B2
Publication Date
2024-05-28
Expiration Date
Abstract
Disclosed are methods of treatment that permit a reduction of risk of mortality in infants who are candidates for treatment with inhaled nitric oxide, by identifying a subset of such infants who are at an increased risk of mortality upon treatment with inhaled nitric oxide; also disclosed are related systems for use in administering inhaled nitric oxide and methods of distributing a pharmaceutical product.
Core Innovation
The invention relates to a method of treating a plurality of neonates of the same gestational age who are candidates for treatment with inhaled nitric oxide. The method identifies neonates of less than 27 weeks postmenstrual age and uses race and gender to define a subset for which inhaled nitric oxide is not initially used.
White, male neonates of less than 27 weeks postmenstrual age are excluded from inhaled nitric oxide treatment until they reach 27 weeks postmenstrual age solely because they are white, male neonates of less than 27 weeks postmenstrual age. The method administers inhaled nitric oxide to each neonate of the plurality who is less than 27 weeks postmenstrual age and is not a white, male neonate.
For each white, male neonate of less than 27 weeks postmenstrual age, the method administers a treatment that includes one or more of ventilatory support, intravenous fluids, surfactant, and bicarbonate therapy, and does not initially include inhaled nitric oxide. After the white, male neonates reach 27 weeks postmenstrual age, the method begins administration of inhaled nitric oxide to them.
The disclosed rationale is based on background reporting that, in the BPD-301 randomized double-blind placebo-controlled trial, there is an unexpected increased mortality in a subgroup defined by race and gender. The document also describes system or distribution aspects for inhaled nitric oxide administration equipment, including warnings or contraindications, and product distribution to providers, together with mortality tables stratified by race and gender.
Claims Coverage
The document includes one independent claim. It covers a selective inhaled nitric oxide treatment method for preterm neonates based on race and gender, using timing of inhaled nitric oxide initiation relative to 27 weeks postmenstrual age, and initial use of alternative treatments for a defined high-risk subset.
Selective withholding of inhaled nitric oxide for white, male neonates under 27 weeks postmenstrual age
Excluding white, male neonates of less than 27 weeks postmenstrual age from inhaled nitric oxide treatment until they reach 27 weeks postmenstrual age, where the exclusion is solely because the neonate is a white, male neonate of less than 27 weeks postmenstrual age.
Initial inhaled nitric oxide administration to non-white, non-male and postponing only the excluded subgroup
Administering inhaled nitric oxide to each neonate of the plurality who is less than 27 weeks postmenstrual age and is not a white, male neonate, while applying withholding to each white, male neonate of less than 27 weeks postmenstrual age until 27 weeks postmenstrual age.
Alternative initial therapy for excluded white, male neonates using ventilatory support and adjunct treatments
For each white, male neonate of less than 27 weeks postmenstrual age, administering a treatment that includes one or more of ventilatory support, intravenous fluids, surfactant, and bicarbonate therapy and does not initially include inhaled nitric oxide.
Overall claim coverage centers on excluding only white, male neonates under 27 weeks postmenstrual age from initially receiving inhaled nitric oxide, using an alternative initial treatment regimen, and beginning inhaled nitric oxide administration when they reach 27 weeks postmenstrual age.
Stated Advantages
Reduced risk of mortality associated with inhaled nitric oxide in preterm neonates by identifying a high-risk subset.
Prevents the unexpected increased mortality observed in the BPD-301 trial subgroup (white, male neonates under 27 weeks postmenstrual age) by excluding that subgroup from initial inhaled nitric oxide treatment.
Documented Applications
Treatment selection for a plurality of preterm neonates who are candidates for treatment with inhaled nitric oxide, using race and gender to determine withholding or postponing for white, male neonates under 27 weeks postmenstrual age and alternative initial therapy.
Clinical trial safety and outcome evaluation supporting the selection logic, including mortality tables stratified by race and gender from the BPD-301 randomized double-blind placebo-controlled trial.
Inhaled nitric oxide system or product distribution context, including warnings or contraindications for inhaled nitric oxide administration equipment and pharmaceutical product distribution to providers.
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