2023-12-13 12:02:50
Similar to placebo in terms of perinatal death, premature birth, hyperbilirubinemia, etc.
Connected to the clinical department at the University of Galway, Ireland… “Is my position narrowing?”
[이미지=pixabay] ⓒKorean Medical Association Newspaper
A clinical study was published showing that prescribing metformin for type 2 or gestational diabetes during pregnancy did not reduce complex neonatal side effects such as premature birth and perinatal death. The test results were published in JAMA on the 12th.
This study is also connected to the conclusion that there was ‘no significant difference’ in a placebo-controlled study of metformin in patients with gestational diabetes previously announced by a research team at the University of Galway, Ireland, putting the status of metformin in gestational diabetes into a question mark.
MOMPOD, a randomized clinical trial announced this time, targeted pregnant women receiving insulin treatment for type 2 diabetes or gestational diabetes.
They were divided into a group that added metformin and a placebo group, and neonatal side effects such as perinatal death, premature birth, birth that was too big or too small for the period, and hyperbilirubinemia occurred at similar rates.
The rate was 71% in the metformin group and 74% in the placebo group (OR 0．86, 95% CI 0．63-1．19). However, the metformin group had a lower incidence of macrosomia compared to gestational age.
Dr. Kim Boggess of the University of North Carolina at Chapel Hill said, “The difference in birth weight was about 180 g,” and concluded, “However, this weight loss did not lead to a decrease in the number of surgical deliveries.”
A research team at the University of Galway, Ireland, also recently announced the results of a study with a similar design. The research team published the results of a randomized placebo-controlled study on patients with gestational diabetes in JAMA last October.
The researchers concluded, “There was no significant difference from the placebo group in the primary endpoints, such as initiation of insulin treatment or increase in fasting blood sugar level.”
794 people participated in the MOMPOD clinical trial. Adults aged 18 to 45 who had a singleton pregnancy at 10 to 22 weeks of gestation and 6 days of gestation were included. All had existing type 2 diabetes requiring insulin or had been diagnosed with diabetes by the 23rd week of pregnancy.
Most had pre-existing type 2 diabetes (78%), and the rest were diagnosed early in pregnancy (21%). The allocation was 1:1 in a random manner, and 1000 mg of insulin and metformin or insulin and placebo were administered.
Hemoglobin A1c in the third trimester of pregnancy was 5.97% for metformin and 6.22% for placebo. This difference was borderline (geometric mean ratio 0.96, 95% CI 0.93-1.00) and was measured in only 39% of trial participants.
Preterm birth, neonatal hypoglycemia, and macrosomia were common in both groups. Among side effects, nausea and vomiting were similar in both groups. However, more cases of diarrhea were reported in the metformin group (28 vs 12%, P<0.01).
Dr. Dennis Feig of the University of Toronto said, “This clinical study means that the benefits of metformin use in patients with type 2 diabetes during pregnancy, other than glycemic control and reduction of large infants, may be reduced in some groups.”
Current guidelines recommend insulin for patients with existing type 2 diabetes. Metformin is considered suitable as first-line drug therapy only for patients who cannot use or refuse to use insulin. In particular, the American Diabetes Association advises that caution is needed for pregnant women at risk of high blood pressure, preeclampsia, or intrauterine growth retardation.
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