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"There are currently very few medical treatments for HI, and those treatments are of limited effectiveness while also associated with significant side effects," Dr. Diva De León-Crutchlow said in a news release from Children's Hospital of Philadelphia. She's chief of endocrinology and diabetes and director of the hospital's Congenital Hyperinsulinism Center.
De León-Crutchlow and colleagues developed a treatment called exendin-(9-39). They say it could prevent hypoglycemia in patients with HI and may eliminate the need for the removal of the pancreas, a current standard treatment for severe diffuse HI.
In a new study, the team tested the drug's effectiveness during fasting and after a meal in 16 children, aged 10 months to 15 years. All had persistent hypoglycemia due to HI.
After fasting for about 12 hours, the patients received six-hour infusions of three different doses (low, middle or high) of the drug or a saline solution. Over another two days, a subset of eight patients received either the high dose of exendin-(9-39) or a saline solution during a mixed meal tolerance test and an oral protein tolerance test.
Fasting hypoglycemia fell by 76% in patients who received the middle dose and by 84% in those who received the high dose of the drug. Also, administering exendin-(9-39) during the protein challenge resulted in an 82% decrease in hypoglycemia, the findings showed.
The middle-dose group also had a 20% increase in fasting glucose, while the high-dose group had a 28% increase in glucose after a meal and a 30% increase in glucose after a protein challenge, according to the study. The results were published April 13 in the journal Diabetes Care.
"This study is further evidence supporting the use of exendin-(9-39), which has been granted breakthrough therapy designation for the treatment of HI, and we look forward to moving this therapy into a phase 3 trial," said De León-Crutchlow, the study's senior author.
SOURCE: Children's Hospital of Philadelphia, news release, April 13, 2022
By Robert Preidt HealthDay Reporter
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