Glibenclamida no tratamento do diabete melito gestacional em estudo comparado à insulina Translated title: Glibenclamide in the treatment for gestational diabetes mellitus in a compared study to insulin

Abstract

OBJETIVOS: Estudar a glibenclamida no tratamento do diabete melito gestacional (DMG) e sua repercussão no peso e na glicemia do recém-nascido (RN), em comparação com a insulina. MÉTODOS: Ensaio clínico randomizado e aberto, realizado entre 1º de outubro de 2003 e 8 de março de 2005. Foram sujeitas 72 gestantes com DMG que necessitaram de terapêutica complementar, sendo randomizadas em dois grupos: insulina e glibenclamida. RESULTADOS: As características gerais nos grupos não apresentaram diferença estatística, com exceção dos resultados do TTOG 75 g, que apresentaram valores maiores no grupo da glibenclamida (p= 0,02). As glicemias médias maternas não apresentaram diferença. Seis (18,75%) gestantes atingiram a dose máxima de glibenclamida sem o controle glicêmico. O peso dos RNs foi maior no grupo tratado com glibenclamida (p= 0,01), com diferença na incidência de macrossômico (p= 0,01). A hipoglicemia neonatal estava mais presente (p= 0,01) nos RNs do grupo da glibenclamida, porém com apenas um caso de hipoglicemia persistente. CONCLUSÃO: A glibenclamida pode ser a droga de escolha para tratamento do DMG na maioria das pacientes.

Translated abstract

OBJECTIVES: To study glibenclamide as a treatment for gestational diabetes mellitus (GDM) and its impact on newborn birth weight and neonatal glycemia as compared to insulin. METHODS: A randomized and open-label clinical trial, conducted from October 1st, 2003 to March 8, 2005. Seventy-two pregnant women with gestational diabetes mellitus requiring drug therapy were randomized and allocated into two groups - insulin and glibenclamide. RESULTS: The general characteristics in both groups were similar, except for the results of the 75 g OGTT, which were higher in the glibenclamide group (p= 0.02). Maternal fasting and postprandial glucose levels presented no difference. Six (18.75%) pregnant women received the maximum dose of glibenclamide with no glycemic control. The birth weight was higher in the group treated with glibenclamide (p= 0.01), and the incidence of macrosomic newborns statistically different (p= 0.01). Neonatal hypoglycemia was more frequent (p= 0.01) in newborns of glibenclamide group, with one single case of persistent hypoglycemia. CONCLUSION: Glibenclamide can be the first line drug for glycemic control in most GDM patients. The birth weight and incidence of hypoglycemia were higher in the glibenclamide group, but with one single case of persistent hypoglycemia that required intravenous infusion of glucose.