Dr. DiLorenzo, M.D., Chief of Gastroenterology at Nationwide Children's Hospital, tells DOTmed News that the other treatment options, including medications, have been much less effective than the gastric pacemaker.

He says drugs currently used to treat gastroparesis in children and adults are: metoclopramide, which has a minimal effect on the stomach and a high risk of side effects; erythromycin, an antibiotic that has been found to stimulate gastric contractions but may cause diarrhea, nausea-- and there's a risk of developing antibiotic-resistant infections when erythromycin is used for prolonged periods of time; and domperidone, which is not FDA approved, but is widely available everywhere else in the world and can be used in the U.S. on a compassionate basis.


"None of these options are really that effective. Hence, the need for better treatment with the gastric pacemaker, "Dr. DiLorenzo says.

When asked if the gastric pacemaker will undergo clinical trials for children, Dr. DiLorenzo told DOTmed, "It is always difficult to do clinical trials in pediatrics, especially in this case, due to the severity of symptoms, the invasiveness of the pacemaker and the relative rarity of this condition in children. Given these factors, I doubt that traditional placebo controlled pediatric research studies will be developed."

However, he says, it will be possible for children to receive the pacemaker in hospitals "that are comfortable with its placement and use, since the device has been approved for use in adults.

"Most institutions would probably require that their local human protection committee be aware of its use, and would grant its approval for compassionate use in children," Dr. DiLorenzo says.

Source: Nationwide Children's Hospital



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