Methods of treating injuries or conditions related to CNS edema
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Publication Number
US-11951085-B2
Publication Date
2024-04-09
Expiration Date
Abstract
The present technology is related to reducing or treating neurological swelling and related conditions with SUR1-TRPM4 channel inhibitors. In some embodiments, the methods include: reducing late neurological deterioration or preventing death, reducing cerebral midline shift, reducing the degree of disability in a subject, counteracting blood glucose levels in a subject receiving a SUR1-TRPM4 channel inhibitor, preventing brain swelling, monitoring liver enzyme activity along with treating injury or conditions related to CNS edema, or monitoring cardiac activity along with treating injury or conditions related to CNS edema.
Core Innovation
The invention relates to reducing late neurological deterioration or death in a subject following a large hemispheric infarction. The method applies to subjects having a brain lesion volume greater than 100 cc and comprises administering glyburide to the subject. The administration includes a first continuous infusion and a second continuous infusion of glyburide that last cumulatively for at least 72 hours after starting the first continuous infusion, and the first continuous infusion is started within 9 hours following the subject experiencing the large hemispheric infarction.
The invention also relates to reducing cerebral midline shift following a large hemispheric infarction in a subject having a brain lesion volume greater than 100 cc. The method comprises administering glyburide after the subject experiences the large hemispheric infarction, where the administering includes a first continuous infusion and a second continuous infusion of glyburide lasting cumulatively for at least 72 hours after starting the first continuous infusion. The first continuous infusion is started within 9 hours following the subject experiencing the large hemispheric infarction, and the method reduces cerebral midline shift as determined over a population based on the degree of cerebral midline shift in patients treated with the continuous infusions compared to a similar population not treated with the continuous infusions.
The disclosure emphasizes structured glyburide administration using multiple continuous infusions over a prolonged time period after initiation. Optional refinements described in the dependent claim set include earlier time windows after the infarction, at least 96 hours or at least 120 hours of cumulative continuous infusion, a higher dosage concentration in the first continuous infusion than the second, and administration in conjunction with decompressive craniectomy.
Claims Coverage
The document provides two independent claims covering two outcomes: late neurological deterioration or death and cerebral midline shift. Each is grounded in glyburide administration via first and second continuous infusions initiated within a defined time window and continued cumulatively for at least 72 hours. The dependent claims further refine timing, cumulative infusion duration, relative dosage concentrations, and the population-based assessment framework for midline shift reduction.
Reducing late neurological deterioration or death after large hemispheric infarction
A method of reducing late neurological deterioration or death in a subject following a large hemispheric infarction with a brain lesion volume greater than 100 cc, comprising administering glyburide including a first continuous infusion and a second continuous infusion of glyburide lasting cumulatively for at least 72 hours after starting the first continuous infusion, wherein the first continuous infusion is started within 9 hours following the subject experiencing the large hemispheric infarction.
Reducing cerebral midline shift after large hemispheric infarction
A method of reducing cerebral midline shift in a subject following a large hemispheric infarction with a brain lesion volume greater than 100 cc, comprising administering to the subject glyburide after the subject experiencing the large hemispheric infarction including a first continuous infusion and a second continuous infusion of glyburide lasting cumulatively for at least 72 hours after starting the first continuous infusion, wherein the first continuous infusion is started within 9 hours following the subject experiencing the large hemispheric infarction, wherein the method reduces the cerebral midline shift as determined over a population based on the degree of cerebral midline shift in patients treated with the continuous infusions compared to a similar population that was not treated with the continuous infusions.
Overall, the claims focus on glyburide administration structured as first and second continuous infusions started within 9 hours of large hemispheric infarction, with cumulative duration requirements of at least 72 hours, and apply the regimen to reduce either late neurological deterioration or death or population-based cerebral midline shift.
Stated Advantages
Reduces late neurological deterioration or death in a subject following a large hemispheric infarction.
Reduces cerebral midline shift in treated patients compared to an untreated population.
Documented Applications
Treatment of a large hemispheric infarction with the purpose of reducing late neurological deterioration or death and reducing cerebral midline shift.
Traumatic brain injury example in which edema expansion is reduced compared to baseline severity [procedural detail omitted for safety].
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