The use of glyburide in women with gestational diabetes is not linked to lower frequency of perinatal complications as compared to subcutaneous insulin, concluded a study published in the journal JAMA. Hence, the use of glyburide as a first-line treatment for gestational diabetes is not justified.
This was drawn on basis of the study conducted by Marie-Victoire Sénat, MD, PhD, Department of Obstetrics and Gynecology, Hôpital Bicêtre, Le Kremlin Bicêtre, France, and colleagues, to compare oral glyburide vs subcutaneous insulin in the prevention of perinatal complications in newborns of women with gestational diabetes.
Gestational diabetes is a condition characterized by high blood sugar levels during pregnancy in an earlier non-diabetic woman. It predisposes the person to type 2 diabetes development later in life. It is a major public health concern, and its rate is increasing worldwide. Fetal and maternal morbidity can be reduced by its adequate treatment.
Insulin is the American Diabetes Association–recommended first-line therapy and the only pharmacologic treatment approved by the U.S. Food and Drug Administration (FDA). However, insulin is costly and inconvenient owing to its requirement of careful management of subcutaneous injections. Glyburide is a potential alternative treatment and, as an oral drug is more convenient to patients.
The researchers performed a noninferiority test to determine the potency of glyburide in the prevention of perinatal complications as compared to subcutaneous insulin. The study which was designed to demonstrate noninferiority, “failed to show that use of glyburide compared with subcutaneous insulin does not result in a greater frequency of perinatal complications.
For this study, the researchers performed Insulin Daonil trial (INDAO), a multicenter noninferiority randomized trial conducted between May 2012 and November 2016 in 13 tertiary care university hospitals in France including 914 women with singleton pregnancies and gestational diabetes diagnosed between 24 and 34 weeks of gestation.
The scientists found that among the 914 patients who were randomized, 98% completed the trial. In a per-protocol analysis, 367 and 442 women and their neonates were analyzed in the glyburide and insulin groups, respectively. The frequency of the primary outcome was 27.6% in the glyburide group and 23.4% in the insulin group, a difference of 4.2%.
On this basis, the researchers concluded that “This study of women with gestational diabetes failed to show that use of glyburide compared with subcutaneous insulin does not result in a greater frequency of perinatal complications.” In other words, glyburide is not noninferior to insulin. So, the use of glyburide as the first-line treatment for gestational diabetes is not justified.
For further information click on the link: 10.1001/jama.2018.4072