2023-10-25 03:09:32
A study showed that metformin, a first-line treatment for diabetes, is not effective in treating gestational diabetes. Since the availability of metformin for gestational diabetes varies from country to country, it is expected to be used as a reference in reflecting the approval requirements.
The clinical results of early metformin use for gestational diabetes conducted by Professor Fidelma Dunn and others at Galway School of Nursing and Health Sciences, Ireland, were published in the international journal JAMA on the 3rd (doi:10.1001/jama.2023.19869).
Gestational diabetes is a condition in which a person who did not have diabetes develops diabetes following the 20th week of pregnancy. Unlike general diabetes, it is caused by physiological changes such as hormonal changes. Blood sugar levels usually return to normal following birth.
Research results have shown that metformin, a representative first-line treatment for diabetes, is not effective in treating gestational diabetes.
Metformin is a representative first-line diabetes treatment drug that prevents the production of glucose in the liver, reduces glucose absorption in the intestines, and improves sensitivity to insulin.
It is a widely used diabetes drug because it does not cause weight gain and has a low incidence of hypoglycemia, but studies have mixed conclusions regarding its effectiveness in gestational diabetes.
Researchers designed a placebo-controlled, double-blind clinical trial at two medical institutions in Ireland to determine whether administering metformin early in pregnancy to women with gestational diabetes improved blood sugar control and reduced insulin use.
Participants were 510 people diagnosed with gestational diabetes according to the World Health Organization (WHO) 2013 criteria, enrolled from June 2017 to September 2022, and followed up until 12 weeks postpartum.
Researchers randomly assigned participants 1:1 to receive placebo or metformin (maximum dose 2500 mg) to their usual treatment, with changes in blood sugar as the primary endpoint and whether or not they started insulin at 32 or 38 weeks of pregnancy or fasting as secondary endpoints. Blood sugar levels of 5.1 mmol/L or higher were compared.
As a result of the analysis, the primary composite outcome occurred in 150 cases (56.8%) in the metformin group and 167 cases (63.7%) in the placebo group, with no significant difference between groups (relative risk 0.89).
Among the six items set as secondary evaluation indicators, the metformin group showed favorable results in the initiation of insulin medication, self-reported blood sugar control rate, and pregnancy weight gain, but the rest did not.
Although the results of secondary evaluation indicators were different for each group, the metformin group was found to be at a disadvantage in terms of birth weight and the proportion of small newborns with a weight of less than 4 kg.
“Initial treatment with metformin was not superior to placebo for the composite primary outcome,” the researchers concluded. “Prespecified secondary endpoints had mixed results and require further investigation in larger clinical trials.”
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