Pregnant women with hyperemesis gravidarum—the rare and
debilitating morning sickness that afflicted Kate
Middleton—notably benefit from the anti-seizure drug
gabapentin, according to a small pilot study conducted by Thomas
Guttuso Jr., MD.
“After two weeks of gabapentin therapy, the seven women in
the study experienced an average 80 percent reduction in their
nausea and a 94 percent reduction in their vomiting,” says
Guttuso, assistant professor of neurology.
Between 2008 and 2009, Guttuso ran an open-label pilot study to
evaluate the safety, tolerability and effectiveness of gabapentin
for hyperemesis gravidarum.
Women with the condition often retch every 15 to 30 minutes and
experience severe dehydration from persistent nausea and vomiting,
he explains.
Although the seven study participants had not seen any
improvement with other anti-emetic medications, they dramatically
improved with gabapentin.
“Within two hours of taking the first pill, most of the
patients were feeling much better, and several were able to start
eating and drinking again,” Guttuso says.
“It was really exciting to see how quickly the women
responded.”
On average, the participants needed to take gabapentin until
about halfway through their pregnancies, according to Guttuso’s
findings, published in Early Human Development.
In 2011 the Food and Drug Administration placed Guttuso’s
pilot study on clinical hold when congenital defects were found in
two of the study participants’ babies.
He was allowed to resume his research in 2012 after the FDA
reviewed data from pregnancy registries reporting that infants with
prenatal gabapentin exposure had about the same rate of congenital
defects as the general population.
Guttuso hopes to continue his research in a placebo-controlled
study with a larger pool of patients and enrolling sites at UB and
the University of Rochester. He plans to submit a grant proposal to
the National Institutes of Health.
“This is a study that really needs to be done because
currently there are no effective treatments,” he says.
Fifteen percent of women with the condition have abortions out
of desperation for relief, he notes.
“I think a lot of people don't appreciate just how sick
and disabled these women can be.”
Guttuso previously studied gabapentin in cancer patients
receiving chemotherapy.
He wanted to study the drug’s effect on hyperemesis
gravidarum when he observed marked improvements in
chemotherapy-induced nausea and vomiting in patients who had failed
treatment with conventional anti-emetics.
His interest in gabapentin was initially sparked when he
accidentally discovered that it appeared to successfully treat hot
flashes in postmenopausal women.
Comment(?)
