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      Comparison of glyburide and insulin in the management of gestational diabetes: A meta-analysis

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          Abstract

          Objective

          The aim of this meta-analysis was to determine the efficacy and safety of glyburide as a treatment for gestational diabetes mellitus (GDM) compared to insulin.

          Methods

          A meta-analysis was conducted to compare the management of gestational diabetes with glyburide and insulin. Studies fulfilling all of the following inclusion criteria were included in this meta-analysis: subjects were women with gestational diabetes requiring drug treatment; the comparison treatment included glyburide vs insulin; one or more outcomes (maternal or neonatal) should be provided in the individual study; the study design should be a randomized control trial. Exclusion criteria: non-RCT studies; non-human data. PubMed, Embase and CENTRAL databases were searched from inception until 10 October 2016.

          Results

          Ten randomized control trials involving 1194 participants met the inclusion criteria and were included. 13 primary outcomes (6 maternal, 7 neonatal) and 26 secondary outcomes (9 maternal, 17 neonatal) were detected and analyzed in this study. Glyburide significantly increased the risk of any neonatal hypoglycemia [risk ratio (RR), 1.89; 95% confidence interval (95%CI), 1.26 to 2.82; p = 0.002]. Sensitivity analysis confirmed robustness of this result [RR, 2.29; 95%CI, 1.49 to 3.54; p = 0.0002]. No differences were observed between the two groups with respect to birth weights [mean difference (MD), 79; 95%CI, -64 to 221.99; p = 0.28] and the risk of macrosomia [RR, 1.69; 95%CI, 0.57 to 5.08; p = 0.35].

          Conclusion

          For women with gestational diabetes, no differences in maternal short term outcomes were observed in those treated with glyburide or insulin. However, the incidence of neonatal hypoglycemia was higher in the glyburide group compared to the insulin group.

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          Most cited references 42

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          Metformin versus insulin for the treatment of gestational diabetes.

          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. We randomly assigned 751 women with gestational diabetes mellitus at 20 to 33 weeks of gestation to open treatment with metformin (with supplemental insulin if required) or insulin. The primary outcome was a composite of neonatal hypoglycemia, respiratory distress, need for phototherapy, birth trauma, 5-minute Apgar score less than 7, or prematurity. The trial was designed to rule out a 33% increase (from 30% to 40%) in this composite outcome in infants of women treated with metformin as compared with those treated with insulin. Secondary outcomes included neonatal anthropometric measurements, maternal glycemic control, maternal hypertensive complications, postpartum glucose tolerance, and acceptability of treatment. Of the 363 women assigned to metformin, 92.6% continued to receive metformin until delivery and 46.3% received supplemental insulin. The rate of the primary composite outcome was 32.0% in the group assigned to metformin and 32.2% in the insulin group (relative risk, 0.99 [corrected]; 95% confidence interval, 0.80 [corrected] to 1.23 [corrected]). More women in the metformin group than in the insulin group stated that they would choose to receive their assigned treatment again (76.6% vs. 27.2%, P<0.001). The rates of other secondary outcomes did not differ significantly between the groups. There were no serious adverse events associated with the use of metformin. In women with gestational diabetes mellitus, metformin (alone or with supplemental insulin) is not associated with increased perinatal complications as compared with insulin. The women preferred metformin to insulin treatment. (Australian New Zealand Clinical Trials Registry number, 12605000311651.). Copyright 2008 Massachusetts Medical Society.
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            A comparison of glyburide and insulin in women with gestational diabetes mellitus.

            Women with gestational diabetes mellitus are rarely treated with a sulfonylurea drug, because of concern about teratogenicity and neonatal hypoglycemia. There is little information about the efficacy of these drugs in this group of women. We studied 404 women with singleton pregnancies and gestational diabetes that required treatment. The women were randomly assigned between 11 and 33 weeks of gestation to receive glyburide or insulin according to an intensified treatment protocol. The primary end point was achievement of the desired level of glycemic control. Secondary end points included maternal and neonatal complications. The mean (+/-SD) pretreatment blood glucose concentration as measured at home for one week was 114+/-19 mg per deciliter (6.4+/-1.1 mmol per liter) in the glyburide group and 116+/-22 mg per deciliter (6.5+/-1.2 mmol per liter) in the insulin group (P=0.33). The mean concentrations during treatment were 105+/-16 mg per deciliter (5.9+/-0.9 mmol per liter) in the glyburide group and 105+/-18 mg per deciliter (5.9+/-1.0 mmol per liter) in the insulin group (P=0.99). Eight women in the glyburide group (4 percent) required insulin therapy. There were no significant differences between the glyburide and insulin groups in the percentage of infants who were large for gestational age (12 percent and 13 percent, respectively); who had macrosomia, defined as a birth weight of 4000 g or more (7 percent and 4 percent); who had lung complications (8 percent and 6 percent); who had hypoglycemia (9 percent and 6 percent); who were admitted to a neonatal intensive care unit (6 percent and 7 percent); or who had fetal anomalies (2 percent and 2 percent). The cord-serum insulin concentrations were similar in the two groups, and glyburide was not detected in the cord serum of any infant in the glyburide group. In women with gestational diabetes, glyburide is a clinically effective alternative to insulin therapy.
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              Glibenclamide, metformin, and insulin for the treatment of gestational diabetes: a systematic review and meta-analysis

              Objective To summarize short term outcomes in randomized controlled trials comparing glibenclamide or metformin versus insulin or versus each other in women with gestational diabetes requiring drug treatment. Design Systematic review and meta-analysis. Eligibility criteria for selecting studies Randomized controlled trials that fulfilled all the following: (1) published as full text; (2) addressed women with gestational diabetes requiring drug treatment; (3) compared glibenclamide v insulin, metformin v insulin, or metformin v glibenclamide; and (4) provided information on maternal or fetal outcomes. Data sources Medline, CENTRAL, and Embase were searched up to 20 May 2014. Outcomes measures We considered 14 primary outcomes (6 maternal, 8 fetal) and 16 secondary (5 maternal, 11 fetal) outcomes. Results We analyzed 15 articles, including 2509 subjects. Significant differences for primary outcomes in glibenclamide v insulin were obtained in birth weight (mean difference 109 g (95% confidence interval 35.9 to 181)), macrosomia (risk ratio 2.62 (1.35 to 5.08)), and neonatal hypoglycaemia (risk ratio 2.04 (1.30 to 3.20)). In metformin v insulin, significance was reached for maternal weight gain (mean difference −1.14 kg (−2.22 to −0.06)), gestational age at delivery (mean difference −0.16 weeks (−0.30 to −0.02)), and preterm birth (risk ratio 1.50 (1.04 to 2.16)), with a trend for neonatal hypoglycaemia (risk ratio 0.78 (0.60 to 1.01)). In metformin v glibenclamide, significance was reached for maternal weight gain (mean difference −2.06 kg (−3.98 to −0.14)), birth weight (mean difference −209 g (−314 to −104)), macrosomia (risk ratio 0.33 (0.13 to 0.81)), and large for gestational age newborn (risk ratio 0.44 (0.21 to 0.92)). Four secondary outcomes were better for metformin in metformin v insulin, and one was worse for metformin in metformin v glibenclamide. Treatment failure was higher with metformin than with glibenclamide. Conclusions At short term, in women with gestational diabetes requiring drug treatment, glibenclamide is clearly inferior to both insulin and metformin, while metformin (plus insulin when required) performs slightly better than insulin. According to these results, glibenclamide should not be used for the treatment of women with gestational diabetes if insulin or metformin is available. Systematic review registration NCT01998113
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: Project administrationRole: SoftwareRole: SupervisionRole: ValidationRole: Writing – original draft
                Role: InvestigationRole: MethodologyRole: ResourcesRole: Software
                Role: Formal analysisRole: MethodologyRole: SoftwareRole: Validation
                Role: Data curationRole: InvestigationRole: Resources
                Role: InvestigationRole: MethodologyRole: Software
                Role: MethodologyRole: Software
                Role: ConceptualizationRole: Project administrationRole: SupervisionRole: VisualizationRole: Writing – review & editing
                Role: ConceptualizationRole: Formal analysisRole: Funding acquisitionRole: Project administrationRole: VisualizationRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                3 August 2017
                2017
                : 12
                : 8
                Affiliations
                [1 ] Department of Pharmacy, Peking University People’s Hospital, Beijing, China
                [2 ] Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China
                [3 ] Department of Pharmacology, Peking University, Health Science Center, Beijing, China
                [4 ] Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Canada
                Shanghai Jiaotong University School of Medicine Xinhua Hospital, CHINA
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Article
                PONE-D-16-45163
                10.1371/journal.pone.0182488
                5542468
                28771572
                © 2017 Song et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                Page count
                Figures: 5, Tables: 6, Pages: 18
                Product
                Funding
                The authors received no specific funding for this work.
                Categories
                Research Article
                Medicine and Health Sciences
                Endocrinology
                Diabetic Endocrinology
                Insulin
                Biology and Life Sciences
                Biochemistry
                Hormones
                Insulin
                Medicine and Health Sciences
                Metabolic Disorders
                Hypoglycemia
                Research and Analysis Methods
                Mathematical and Statistical Techniques
                Statistical Methods
                Meta-Analysis
                Physical Sciences
                Mathematics
                Statistics (Mathematics)
                Statistical Methods
                Meta-Analysis
                Biology and Life Sciences
                Developmental Biology
                Neonates
                Medicine and Health Sciences
                Endocrinology
                Endocrine Disorders
                Diabetes Mellitus
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                Metabolic Disorders
                Diabetes Mellitus
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                Endocrinology
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                Diabetes Mellitus
                Gestational Diabetes
                Medicine and Health Sciences
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                Medicine and Health Sciences
                Women's Health
                Maternal Health
                Pregnancy
                Medicine and Health Sciences
                Women's Health
                Obstetrics and Gynecology
                Pregnancy
                Medicine and health sciences
                Diagnostic medicine
                Diabetes diagnosis and management
                HbA1c
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                All relevant data are within the paper and its Supporting information files.

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