Department of Obstetrics and Gynecology, Emek Medical Center, Afula, Israel.
Rappaport Faculty of Medicine, Technion, Haifa, Israel.
Diabetes Care. 2017 Mar;40(3):332-337. doi: 10.2337/dc16-2307. Epub 2017 Jan 11.
To compare the efficacy and safety of glyburide versus metformin and their combination for the treatment of gestational diabetes mellitus (GDM).
In this prospective randomized controlled study, we randomly assigned patients with GDM at 13-33 weeks gestation and whose blood glucose was poorly controlled by diet to receive either glyburide or metformin. If optimal glycemic control was not achieved, the other drug was added. If adverse effects occurred, the drug was replaced. If both failed, insulin was given. The primary outcomes were the rate of treatment failure and glycemic control after the first-line medication according to mean daily glucose charts.
Glyburide was started in 53 patients and metformin in 51. In the glyburide group, the drug failed in 18 (34%) patients due to adverse effects (hypoglycemia) in 6 (11%) and lack of glycemic control in 12 (23%). In the metformin group, the drug failed in 15 (29%) patients, due to adverse effects (gastrointestinal) in 1 (2%) and lack of glycemic control in 14 (28%). Treatment success after second-line therapy was higher in the metformin group than in the glyburide group (13 of 15 [87%] vs. 9 of 18 [50%], respectively; = 0.03). In the glyburide group, nine (17%) patients were eventually treated with insulin compared with two (4%) in the metformin group ( = 0.03). The combination of the drugs reduced the need for insulin from 33 (32%) to 11 (11%) patients ( = 0.0002). Mean daily blood glucose and other obstetrical and neonatal outcomes were comparable between groups, including macrosomia, neonatal hypoglycemia, and electrolyte imbalance.
Glyburide and metformin are comparable oral treatments for GDM regarding glucose control and adverse effects. Their combination demonstrates a high efficacy rate with a significantly reduced need for insulin, with a possible advantage for metformin over glyburide as first-line therapy.
比较格列本脲、二甲双胍及其联合用药治疗妊娠期糖尿病（GDM）的疗效和安全性。
本前瞻性随机对照研究纳入了 13-33 孕周、饮食控制血糖不佳的 GDM 患者，随机接受格列本脲或二甲双胍治疗。如果血糖控制仍不理想，则加用另一种药物。如果出现不良反应，则更换药物。如果上述方法均失败，则给予胰岛素治疗。主要结局为根据平均日血糖图评估一线药物治疗后的治疗失败率和血糖控制情况。
53 例患者起始应用格列本脲，51 例患者起始应用二甲双胍。在格列本脲组，因不良反应（低血糖）而停药 6 例（11%）、血糖控制不佳而停药 12 例（23%），共 18 例（34%）治疗失败。在二甲双胍组，因不良反应（胃肠道不适）停药 1 例（2%）、血糖控制不佳而停药 14 例（28%），共 15 例（29%）治疗失败。二线治疗后，二甲双胍组的治疗成功率高于格列本脲组（分别为 13 例[87%]和 9 例[50%]， = 0.03）。格列本脲组最终有 9 例（17%）患者需要使用胰岛素，而二甲双胍组仅有 2 例（4%），差异有统计学意义（ = 0.03）。两药联合可使需要使用胰岛素的患者从 33 例（32%）降至 11 例（11%）（ = 0.0002）。两组间平均日血糖及其他产科和新生儿结局相似，包括巨大儿、新生儿低血糖和电解质失衡。
格列本脲和二甲双胍治疗 GDM 的疗效和不良反应相当。两药联合应用可显著提高疗效，降低胰岛素使用率，且二甲双胍作为一线治疗可能优于格列本脲。
