Oral anti-diabetic agents for women with pre-existing diabetes mellitus/impaired glucose tolerance or previous gestational diabetes mellitus

 

Abstract

Background

While most guidelines recommend the use of insulin in women whose pregnancies are affected by pre-existing diabetes, oral agents have obvious benefits for patient acceptability and adherence. It is necessary, however, to assess the effects of these anti-diabetic agents on maternal and infant health outcomes. Additionally, women with previous gestational diabetes mellitus are increasingly found to be predisposed to impaired glucose tolerance and, despite the potential need for intervention for these women, there has been little evidence about the use of oral anti-diabetic agents by these women pre-conceptionally or during a subsequent pregnancy.

Objectives

To investigate the effect of oral anti-diabetic agents in women with pre-existing diabetes mellitus, impaired glucose tolerance or previous gestational diabetes planning a pregnancy or pregnant women with diabetes mellitus on maternal and infant health.

The use of oral antidiabetic agents for management of gestational diabetes in a current pregnancy is evaluated in a separate Cochrane review.

Search strategy

We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (March 2010).

Selection criteria

We included randomised and quasi-randomised trials.

Data collection and analysis

Two review authors independently assessed trial eligibility for inclusion.

Main results

We identified 13 trials published as 25 papers using the Cochrane Pregnancy and Childbirth group literature search, and an additional ongoing trial. We have not included any trials in the review. One trial is awaiting assessment and we have excluded twelve trials because they evaluated treatment of women with gestational diabetes or women with polycystic ovary syndrome, were not randomised controlled trials or data were not available.

Authors' conclusions

Little randomised evidence is available evaluating the use of oral anti-diabetic agents in women with diabetes mellitus, impaired glucose tolerance, previous gestational diabetes mellitus planning a pregnancy or pregnant women with pre-existing diabetes mellitus. Large trials comparing any combination of oral anti-diabetic agent, insulin and dietary and lifestyle advice in these women, reporting on maternal and infant health outcomes, glycaemic control, women's views on the intervention and long-term health outcomes for mother and child, are required to guide clinical practice.

 

Plain language summary

Oral anti-diabetic agents for women with pre-existing diabetes mellitus, impaired glucose tolerance or previous gestational diabetes mellitus

Pregnant women with type 1 or type 2 diabetes are at a greater risk of adverse outcomes in pregnancy, such as miscarriage or large babies and preterm birth. Being pregnant can trigger diabetes in women with impaired glucose tolerance or can accelerate the development of diabetic complications in women who are already diabetic. Women who have gestational diabetes are at risk of developing diabetes later in life. This means that management is important for women with diabetes and also for women with impaired glucose tolerance or previously diagnosed gestational diabetes.

It is usually recommended that women with diabetes have good control of their blood sugar levels before they become pregnant, and guidelines suggest insulin be used where additional control is required. Women with type 1 diabetes are likely to have used insulin for some time. Women with type 2 diabetes may have good control of their diabetes with diet and lifestyle changes alone, or with the use of an oral anti-diabetic agent. Women with diabetes using an oral anti-diabetic agent are usually advised to change to insulin before pregnancy for better blood sugar control and because there is little known about the effects of oral anti-diabetic agents in early pregnancy. Oral agents are, however, more convenient and acceptable than insulin injections and do not require the intensive education that is needed with insulin injections.

This review sought to investigate the effect of oral anti-diabetic agents in women with pre-existing diabetes mellitus, impaired glucose tolerance, or previous gestational diabetes, or women with diabetes mellitus planning a pregnancy on maternal and infant health.

We were not able to include any of the studies identified by the Cochrane literature search in the review. One trial has not been published in full yet and is awaiting assessment. An additional trial is ongoing. Further research is required comparing the effects of the oral anti-diabetic agents with insulin and dietary and lifestyle advice in these women, in order to determine effects on the health of the mother and her baby, the level of blood sugar control achieved, women's views on the treatment, and long-term outcomes for the woman and child.

 

Resumen

Antecedentes

Agentes antidiabéticos orales para mujeres con diabetes mellitus/intolerancia a la glucosa preexistente o diabetes mellitus en el embarazo anterior

Aunque la mayoría de las guías recomiendan el uso de insulina en las mujeres cuyos embarazos son afectados por una diabetes preexistente, los agentes orales tienen beneficios obvios para la aceptabilidad y el cumplimiento de las pacientes. Sin embargo, es necesario evaluar los efectos de estos agentes antidiabéticos sobre los resultados de salud maternos e infantiles. Además, las mujeres con diabetes mellitus en el embarazo anterior cada vez están más predispuestas a la intolerancia a la glucosa y, a pesar de la posible necesidad de intervención para estas mujeres, existen escasas pruebas acerca del uso por parte de ellas de los agentes antidiabéticos orales de forma preconcepcional o durante un embarazo posterior.

Objetivos

Investigar el efecto sobre la salud materna e infantil de los agentes antidiabéticos orales en mujeres con diabetes mellitus preexistente, intolerancia a la glucosa o diabetes en el embarazo anterior que planifican un embarazo o en las mujeres embarazadas con diabetes mellitus.

El uso de los agentes antidiabéticos orales para el tratamiento de la diabetes gestacional en un embarazo actual se evalúa en otra revisión Cochrane.

Estrategia de búsqueda

Se hicieron búsquedas en el Registro de Ensayos del Grupo Cochrane de Embarazo y Parto (Cochrane Pregnancy and Childbirth Group) (marzo 2010).

Criterios de selección

Se incluyeron ensayos aleatorios y cuasialeatorios.

Obtención y análisis de los datos

Dos autores de la revisión evaluaron de forma independiente la elegibilidad de los ensayos para su inclusión.

Resultados principales

Mediante la búsqueda bibliográfica del Grupo Cochrane de Embarazo y Parto (Cochrane Pregnancy and Childbirth Group) se identificaron 13 ensayos publicados como 25 artículos, así como un ensayo en curso adicional. No se ha incluido ningún ensayo en la revisión. Un ensayo está en espera de evaluación y se excluyeron 12 ensayos porque evaluaron el tratamiento de las mujeres con diabetes gestacional o de mujeres con síndrome de ovario poliquístico, no fueron ensayos controlados aleatorios o los datos no estaban disponibles.

Conclusiones de los autores

Se dispone de pocas pruebas aleatorias que evalúen el uso de agentes antidiabéticos orales en mujeres con diabetes mellitus, intolerancia a la glucosa, diabetes mellitus en el embarazo anterior que planifican un embarazo o en mujeres embarazadas con diabetes mellitus preexistente. Para guiar la práctica clínica, se requieren ensayos grandes que comparen cualquier combinación de agentes antidiabéticos orales, insulina y asesoramiento dietético y del estilo de vida en estas mujeres, informen sobre los resultados de salud maternos e infantiles, el control glucémico, los criterios de las mujeres sobre la intervención y los resultados de salud a largo plazo para la madre y el niño.

Traducción

Traducción realizada por el Centro Cochrane Iberoamericano