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Thread: Metformin Alone or With Insulin May Be Safe in Gestational Diabetes

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    Default Metformin Alone or With Insulin May Be Safe in Gestational Diabetes

    Insulin May Be Safe in Gestational Diabetes

    May 7, 2008 In pregnant women with gestational diabetes, metformin alone or metformin supplemented with insulin did not increase perinatal complications vs insulin alone, according to the results of a study reported in the May 8 issue of the New England Journal of Medicine.

    "Metformin is a logical treatment for women with gestational diabetes mellitus, but randomized trials to assess the efficacy and safety of its use for this condition are lacking," write Janet A. Rowan, MB, ChB, from Auckland City Hospital in Auckland, New Zealand, and colleagues from the Metformin in Gestational Diabetes Trial Investigators.

    In this trial, 751 women with gestational diabetes mellitus at 20 to 33 weeks of gestation were randomized to receive open treatment with metformin plus supplemental insulin if needed or insulin alone. The main endpoints were a composite outcome of neonatal hypoglycemia, respiratory distress, need for phototherapy, birth trauma, 5-minute Apgar score of less than 7, or prematurity.

    The trial was designed to rule out a 33% increase (from 30% - 40%) in this composite endpoint in infants of women treated with metformin vs those treated with insulin. Secondary endpoints were neonatal anthropometric measurements, maternal glycemic control, maternal hypertensive complications, postpartum glucose tolerance, and tolerability and acceptability of treatment.

    Of 363 women randomized to receive metformin, 92.6% continued to receive metformin until delivery, and 46.3% received supplemental insulin. The primary composite endpoint occurred in 32.0% of the group randomized to receive metformin and 32.2% of those randomized to receive insulin (relative risk [RR], 1.00; 95% confidence interval [CI], 0.90 - 1.10).

    Compared with women in the insulin group, more women in the metformin group stated that they would choose to receive their assigned treatment again (76.6% vs 27.2%; P < .001). Other secondary endpoints were similar in both groups, and there were no serious adverse events associated with metformin use.

    "In women with gestational diabetes mellitus, metformin (alone or with supplemental insulin) is not associated with increased perinatal complications as compared with insulin," the study authors write. "The women preferred metformin to insulin treatment."

    Limitations of this study include open-label design; lack of blinding; use of a superiority design to determine whether insulin was superior to metformin, with acceptance rather than proof of the null hypothesis (that there is no difference between treatments); use of a composite outcome that included outcomes of differing clinical significance; and lack of follow-up data for offspring.

    "Further follow-up data are needed to establish long-term safety," the study authors conclude.

    In an accompanying editorial, Jeffrey L. Ecker, MD, and Michael F. Greene, MD, from Harvard Medical School and Massachusetts General Hospital in Boston, note that maternal outcomes such as cesarean delivery were not reported but that birth weights were similar in the 2 groups.

    "The main question now is whether metformin is better or worse than glyburide, an acceptable alternative pill," Drs. Ecker and Greene write. "Identifying women at risk for diabetes offers the possibility of intervention to reduce risk, yet frequently these women do not receive recommended follow-up and surveillance. . . . Recognizing the continuum of risk between hyperglycemia in pregnancy and associated outcomes, we should recommit ourselves to sharing this information so that it can meaningfully affect a woman's health long after she has completed childbearing."

    The Auckland Medical Research Foundation, the National Women's Evelyn Bond Charitable Trust, the Health Research Council of New Zealand, and the National Health and Medical Research Council of Australia supported this study. One of the study authors has received speaking fees from sanofi-aventis. The other study authors have disclosed no relevant financial relationships.

    Drs. Ecker and Greene have disclosed no relevant financial relationships.

    N Engl J Med. 2008;358:2003-2015, 2061-2063.

    Clinical Context
    In gestational diabetes, lifestyle interventions, with treatment with additional insulin for persistent maternal hyperglycemia, have been shown to improve perinatal outcomes. However, use of insulin is also associated with hypoglycemia and weight gain, suggesting that the use of safe and effective oral hypoglycemic agents may offer advantages vs insulin.

    Oral metformin may be a feasible option for the treatment of gestational diabetes because it improves insulin sensitivity, probably by activating adenosine monophosphate kinase, and is not associated with weight gain or hypoglycemia. However, metformin crosses the placenta and could directly affect fetal physiology, and its use in pregnancy remains controversial.

    Study Highlights

    The Metformin in Gestational Diabetes Trial was designed to rule out a 33% increase (from 30% - 40%) in a composite endpoint of perinatal complications in infants of women treated with metformin vs insulin.
    The hypotheses of this study were that perinatal outcomes would be similar for both treatments, women would find metformin to be a more acceptable treatment than insulin, and metformin would improve markers of insulin sensitivity in both the mother and infant.

    This trial was conducted at 10 New Zealand and Australian urban obstetric hospitals.
    Between October 2002 and November 2006, a total of 751 women with gestational diabetes at 20 to 33 weeks of gestation were randomized to receive open treatment with metformin plus supplemental insulin if needed or insulin.
    Baseline characteristics of the 2 groups were similar.
    The median daily dose of metformin was 2500 mg (interquartile range, 1750 - 2500 mg).
    Of 363 women randomized to receive metformin, 92.6% continued to receive metformin until delivery, and 46.3% received supplemental insulin.
    The primary composite endpoints (neonatal hypoglycemia, respiratory distress, need for phototherapy, birth trauma, 5-minute Apgar score < 7, or prematurity) occurred in 32.0% of the group randomized to receive metformin and 32.2% of those randomized to receive insulin (RR, 1.00; 95% CI, 0.90 - 1.10).
    Severe hypoglycemia (blood glucose levels < 1.6 mmol/L [28.8 mg/dL]) occurred significantly less often in infants of women taking metformin.
    The metformin group did not have a reduction in the insulin concentration in umbilical cord serum, but this finding should be interpreted with caution because results were available for less than half of the participants.
    Frequency of preterm birth was greater in the metformin vs the insulin group, but the difference was associated with a higher frequency of spontaneous (rather than iatrogenic) preterm births that could have occurred by chance or by an unrecognized effect of metformin on the labor process.
    The increased rate of preterm birth was not associated with higher rates of other complications, most likely because the difference between groups in mean gestational age at delivery was not clinically significant.
    Compared with women in the insulin group, more women in the metformin group stated that they would again choose to receive their assigned treatment (76.6% vs 27.2%; P < .001).
    More women in the metformin vs the insulin group said that taking medication was the easiest part of treatment (59.0% vs 35.3%; P < .001).
    Fewer women in the metformin vs the insulin group said that taking medication was the hardest part of treatment (10.5% vs 27.2%; P < .001).
    Other secondary endpoints (neonatal anthropometric measurements, maternal glycemic control, maternal hypertensive complications, postpartum glucose tolerance) were similar in both groups.
    Women receiving combined treatment required less insulin and gained less weight than those taking insulin alone.
    There were no serious adverse events associated with metformin use.
    Based on these findings, the investigators concluded that in women with gestational diabetes, metformin (alone or with supplemental insulin) is not associated with increased perinatal complications vs insulin and that the women preferred metformin to insulin treatment.
    Limitations of this study include open-label design, lack of blinding, use of a superiority design to determine whether insulin was superior to metformin, use of a composite outcome that included outcomes of differing clinical significance, and lack of follow-up data for offspring.

    Pearls for Practice

    In the Metformin in Gestational Diabetes Trial, metformin (alone or with supplemental insulin) was not associated with increased perinatal complications vs insulin. The primary composite endpoints occurred in 32.0% of the group randomized to receive metformin and 32.2% of those randomized to receive insulin.

    In this trial, the women preferred metformin to insulin treatment. Compared with women in the insulin group, more women in the metformin group stated that they would choose to receive their assigned treatment again. There were no serious adverse events associated with metformin use.

  2. #2
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    Isn't AntiDiabetic drugs like metformin contraindicated in pregnancy, among them only Glyburide has some safety margin! Its given in my book that Except Insulin all are contraindicated in pregnancy!

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