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    Home > Active Ingredient News > Blood System > JAMA: The effect of intravenous poloxamer 188 on the duration of painful vascular occlusion in patients with sickle cell anemia

    JAMA: The effect of intravenous poloxamer 188 on the duration of painful vascular occlusion in patients with sickle cell anemia

    • Last Update: 2021-05-08
    • Source: Internet
    • Author: User
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    Sickle cell anemia (SCD) is an autosomal dominant hemoglobinopathy characterized by a vascular occlusive crisis and acute pain.
    At present, the
    FDA has approved three drugs to prevent the onset of vascular occlusion, namely hydroxyurea, L-glutamine and crizanlizumab-tmca.
    However, there is currently no effective treatment for patients who have had painful vascular occlusion.
    Poloxamer 188 (poloxamer 188) is a common pharmaceutical excipient.
    In previous clinical studies, poloxamer 188 treatment can shorten the duration of the onset of painful vascular occlusion in SCD patients, especially for
    children and previously received Hydroxyurea is effective in treating patients.

    Vascular FDA Prevents Children

    Recently, researchers have re-evaluated the efficacy of Poloxamer 188 in the treatment of SCD vascular occlusion.

    Recently, researchers have re-evaluated the efficacy of Poloxamer 188 in the treatment of SCD vascular occlusion.
    Recently, researchers have re-evaluated the efficacy of Poloxamer 188 in the treatment of SCD vascular occlusion.

    The Phase III clinical study was carried out in 66 hospitals in 12 countries.
    It was a randomized, double-blind, placebo-controlled, multi-center, international trial, including 388 SCD patients (hemoglobin SS, SC, S-β0 thalassemia, or S-β+ thalassemia), age range 4-65 years old, with acute moderate to severe pain requiring hospitalization.
    Patients were randomized to receive intravenous poloxamer 188 with an initial dose of 100 mg/kg for 1 hour, followed by continuous infusion for 12-48 hours, with a dose of 30 mg/kg/h (n=194) or placebo (n=194) ).
    The primary endpoint of the study was the time from randomization to the last opioid injection, in hours.

    The average age of the patients was 15.
    2 years, 176 women (45.
    4%), 384 (99.
    0%) patients obtained the main outcome data, 357 (92.
    0%) patients completed 15-day follow-up, and 368 (94.
    8%) patients completed 30-day follow-up .
    The study found that there was no significant difference between the groups in the time to the last opioid injection (81.
    8 hours in the poloxamer 188 group and 77.
    8 hours in the placebo group; the difference was 4.
    0 hours, OR=1.
    2)
    .
    In a subgroup analysis of participants younger than 16 years old, there was a difference in the time between the group and the last opioid injection (88.
    7 hours in the poloxamer 188 group and 71.
    9 hours in the placebo group; the difference was 16.
    8 hours, OR =1.
    4).
    The more common adverse event in the poloxamer 188 group was hyperbilirubinemia (12.
    7% vs 5.
    2%), while the more common adverse event in the placebo group was hypoxia (12.
    0% vs 5.
    3%).

    The study found that there was no significant difference in the time from the group to the last opioid injection (81.
    8 hours for the poloxamer 188 group and 77.
    8 hours for the placebo group; the difference was 4.
    0 hours, OR=1.
    2).
    The
    study found that the group There was no significant difference in the time between the groupings and the last opioid injection (81.
    8 hours in the poloxamer 188 group and 77.
    8 hours in the placebo group; the difference was 4.
    0 hours, OR=1.
    2)

    Studies have found that for adults and children with sickle cell anemia, intravenous poloxamer 188 cannot shorten the duration of painful vascular occlusion .

    For adults and children with sickle cell anemia, intravenous poloxamer 188 cannot shorten the duration of painful vascular occlusion .
    For adults and children with sickle cell anemia, intravenous poloxamer 188 does not shorten the duration of painful vascular occlusion episodes

    Original source

    Original source

    James F.
    Casella et al.
    com/journals/jama/article-abstract/2778807" target="_blank" rel="noopener">Effect of Poloxamer 188 vs Placebo on Painful Vaso-Occlusive Episodes in Children and Adults With Sickle Cell Disease A Randomized Clinical Trial.
    JAMA .
    April 20, 2021.

    com/journals/jama/article-abstract/2778807" target="_blank" rel="noopener">Effect of Poloxamer 188 vs Placebo on Painful Vaso-Occlusive Episodes in Children and Adults With Sickle Cell Disease A Randomized Clinical Trial.
    JAMA

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