LOS ANGELES -- Oral acarbose may be as effective as insulin therapy for glycemic control in patients with gestational diabetes if they adhere to dietary recommendations, a preliminary study of 110 patients suggests.
A larger multicenter trial is underway to corroborate the efficacy and safety of acarbose (Precose) as an alternative to insulin in these patients. Results of that trial will be needed before acarbose can be recommended for widespread use in patients with gestational diabetes, Dr. Margarita de Veciana said at the annual meeting of the American College of Obstetricians and Gynecologists.
All participants in the current study received diabetes education and dietary counseling. The women were asked to eat 1,8002,000 calories/day in three meals and three snacks; 40%-45% of their calories came from carbohydrates.
Diet alone does not achieve euglycemia in 10%-20% of women with gestational diabetes. AGOG recommends insulin therapy when dietary changes are insufficient.
The women in the study had failed to reach glycemic control using diet alone and were randomized to further therapy with acarbose or insulin, said Dr. de Veciana, director of the diabetes in pregnancy program and perinatal research at Eastern Virginia Medical School, Noffolk.
The 56 patients in the acarbose group started out taking 25 mg of the agent three times per day with the first bite of each meal. The dose was increased as needed to a maximum of 100 mg t.i.d.
In the insulin group the initial total daily insulin dosage was 0.8 U/kg in the second trimester and 0.9 U/kg in the third trimester. At term, the mean total daily dosage was 120 mg/day in the acarbose group and 43 U/day in the insulin group.
Both groups improved their glucose levels with treatment. There were no significant differences between groups m maternal demographics, duration of therapy, glucose levels, birth weight, gestational age, or C-section rate, she said.
Three women (5%) in the acarbose group switched to insulin therapy one due to gastrointestinal side effects from acarbose and two because they did not achieve euglycemia on the maximum acarbose dose.
Acarbose was approved in 1995 for the management of type 2 diabetes. Its nonsystemic mode of action occurs primarily in the GI tract, blocking the enzymes that digest starches and limiting the rise in a patient's postprandial blood sugar.
"Strict dietary control is essential to successful treatment with acarbose," emphasized Dr. de Veciana, who disclaimed any financial interest in the agent.
Acarbose is classified by the Food and Drug Administration in pregnancy risk category B, meaning there is no evidence that it poses a risk to human fetuses.
COPYRIGHT 2002 International Medical News Group
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