Dataset Information

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

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.

SUBMITTER: Song R

PROVIDER: S-EPMC5542468 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Song Rongjing R Chen Ling L Chen Yue Y Si Xia X Liu Yi Y Liu Yue Y Irwin David M DM Feng Wanyu W

PloS one 20170803 8

<h4>Objective</h4>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.<h4>Methods</h4>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 includ ...[more]

PMID: 28771572

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Project description:ImportanceNearly 30% of individuals with gestational diabetes (GDM) do not achieve glycemic control with lifestyle modification alone and require medication treatment. Oral agents, such as glyburide, have several advantages over insulin for the treatment of GDM, including greater patient acceptance; however, the effectiveness of glyburide for the treatment of GDM remains controversial.ObjectiveTo compare the perinatal and neonatal outcomes associated with glyburide vs insulin using causal inference methods in a clinical setting with information on glycemic control.Design, setting, and participantsThe population-based cohort study included patients with GDM who required medication treatment from 2007 to 2017 in Kaiser Permanente Northern California. Machine learning and rigorous casual inference methods with time-varying exposures were used to evaluate associations of exposure to glyburide vs insulin with perinatal outcomes. Data analysis was conducted from March 2018 to July 2017.ExposuresTime-varying exposure to glyburide vs insulin during pregnancy.Main outcomes and measuresOutcomes evaluated separately included neonatal hypoglycemia, jaundice, shoulder dystocia, respiratory distress syndrome (RDS), neonatal intensive care unit (NICU) admission, size-for-gestational age, and cesarean delivery. Inverse probability weighting (IPW) estimation was used to separately compare perinatal outcomes between those initiating glyburide and insulin. This approach was combined with Super Learning for propensity score estimation to account for both baseline and time-dependent confounding in both per-protocol (primary) and intention-to-treat (secondary) analyses to evaluate sustained exposure to the same therapy.ResultsFrom 2007 to 2017, 11 321 patients with GDM (mean [SD] age, 32.9 [4.9] years) initiated glyburide or insulin during pregnancy. In multivariate models, the risk of neonatal respiratory distress was 2.03 (95% CI, 0.13-3.92) per 100 births lower and the risk of NICU admission was 3.32 (95% CI, 0.20-6.45) per 100 births lower after continuous exposure to glyburide compared with insulin. There were no statistically significant differences in glyburide vs insulin initiation in risk for neonatal hypoglycemia (0.85 [95% CI, -1.17 to 2.86] per 100 births), jaundice (0.02 [95% CI, -1.46 to 1.51] per 100 births), shoulder dystocia (-1.05 [95% CI, -2.71 to 0.62] per 100 births), or large-for-gestational age categories (-2.75 [95% CI, -6.31 to 0.80] per 100 births).Conclusions and relevanceUsing data from a clinical setting and contemporary causal inference methods, our findings do not provide evidence of a difference in the outcomes examined between patients with GDM initiating glyburide compared with those initiating insulin.

Project description:ObjectiveTo describe trends and identify factors associated with choice of pharmacotherapy for gestational diabetes (GDM) from 2000-2011 using a healthcare claims database.MethodsThis was a retrospective cohort study of a large nationwide population of commercially insured women with GDM and pharmacy claims for glyburide or insulin before delivery, 2000-2011. We excluded women younger than 15 years or older than 50 years, those with prior noninsulin-dependent diabetes mellitus, or those who had multiple gestations. We estimated trends over time in the use of glyburide compared with insulin and prevalence ratios and 95% confidence intervals (CIs) for the association between covariates of interest and treatment with glyburide compared with insulin.ResultsWe identified 10,778 women with GDM treated with glyburide (n=5,873) or insulin (n=4,905). From 2000 to 2011, glyburide use increased from 7.4% to 64.5%, becoming the more common treatment in 2007. Women less likely to be treated with glyburide were those with metabolic syndrome (prevalence ratio 0.71, 95% CI 0.50-0.99), hyperandrogenism (prevalence ratio 0.77, 95% CI 0.62-0.97), polycystic ovarian syndrome (prevalence ratio 0.88, 95% CI 0.78-0.99), hypothyroidism (prevalence ratio 0.89, 95% CI 0.83-0.96), or undergoing infertility treatment (prevalence ratio 0.93, 95% CI 0.86-1.02). The probability of receiving glyburide decreased by 5% for every 10-year increase in maternal age (prevalence ratio 0.95, 95% CI 0.91-0.99). Among women prescribed with glyburide, 7.8% switched or augmented to a different drug class compared with 1.1% of insulin initiators.ConclusionGlyburide has replaced insulin as the more common pharmacotherapy for GDM over the past decade among those privately insured. Given its rapid uptake and the potential implications of suboptimal glucose control on maternal and neonatal health, robust evaluation of glyburide's relative effectiveness is warranted to inform treatment decisions for women with gestational diabetes.Level of evidenceII.

Project description:ImportanceRandomized trials have not focused on neonatal complications of glyburide for women with gestational diabetes.ObjectiveTo compare oral glyburide vs subcutaneous insulin in prevention of perinatal complications in newborns of women with gestational diabetes.Design, settings, and participantsThe Insulin Daonil trial (INDAO), a multicenter noninferiority randomized trial conducted between May 2012 and November 2016 (end of participant follow-up) in 13 tertiary care university hospitals in France including 914 women with singleton pregnancies and gestational diabetes diagnosed between 24 and 34 weeks of gestation.InterventionsWomen who required pharmacologic treatment after 10 days of dietary intervention were randomly assigned to receive glyburide (n=460) or insulin (n=454). The starting dosage for glyburide was 2.5 mg orally once per day and could be increased if necessary 4 days later by 2.5 mg and thereafter by 5 mg every 4 days in 2 morning and evening doses, up to a maximum of 20 mg/d. The starting dosage for insulin was 4 IU to 20 IU given subcutaneously 1 to 4 times per day as necessary and increased according to self-measured blood glucose concentrations.Main outcomes and measuresThe primary outcome was a composite criterion including macrosomia, neonatal hypoglycemia, and hyperbilirubinemia. The noninferiority margin was set at 7% based on a 1-sided 97.5% confidence interval.ResultsAmong the 914 patients who were randomized (mean age, 32.8 [SD, 5.2] years), 98% completed the trial. In a per-protocol analysis, 367 and 442 women and their neonates were analyzed in the glyburide and insulin groups, respectively. The frequency of the primary outcome was 27.6% in the glyburide group and 23.4% in the insulin group, a difference of 4.2% (1-sided 97.5% CI, -∞ to 10.5%; P=.19).Conclusion and relevanceThis study of women with gestational diabetes failed to show that use of glyburide compared with subcutaneous insulin does not result in a greater frequency of perinatal complications. These findings do not justify the use of glyburide as a first-line treatment.Trial registrationclinicaltrials.gov Identifier: NCT01731431.

Project description:ObjectiveTo 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.DesignSystematic review and meta-analysis.Eligibility criteria for selecting studiesRandomized 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 sourcesMedline, CENTRAL, and Embase were searched up to 20 May 2014.Outcomes measuresWe considered 14 primary outcomes (6 maternal, 8 fetal) and 16 secondary (5 maternal, 11 fetal) outcomes.ResultsWe 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.ConclusionsAt 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.

Dataset Information

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

Objective

Methods

Results

Conclusion

Publications

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

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