Zohar Nachum1,2, Noah Zafran1,2, Raed Salim1,2, Noura Hissin1, Jamal Hasanein3, Yifat Gam Ze Letova1, Abeer Suleiman1, Enav Yefet4. 1. Department of Obstetrics and Gynecology, Emek Medical Center, Afula, Israel. 2. Rappaport Faculty of Medicine, Technion, Haifa, Israel. 3. Department of Neonatology, Emek Medical Center, Afula, Israel. 4. Department of Obstetrics and Gynecology, Emek Medical Center, Afula, Israel enavy1@gmail.com.
Abstract
OBJECTIVE: To compare the efficacy and safety of glyburide versus metformin and their combination for the treatment of gestational diabetes mellitus (GDM). RESEARCH DESIGN AND METHODS: 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 eitherglyburide 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. RESULTS:Glyburide was started in 53 patients andmetformin 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; P = 0.03). In the glyburide group, nine (17%) patients were eventually treated with insulin compared with two (4%) in the metformin group (P = 0.03). The combination of the drugs reduced the need for insulin from 33 (32%) to 11 (11%) patients (P = 0.0002). Mean daily blood glucose and other obstetrical and neonatal outcomes were comparable between groups, including macrosomia, neonatal hypoglycemia, and electrolyte imbalance. CONCLUSIONS: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.
RCT Entities:
OBJECTIVE: To compare the efficacy and safety of glyburide versus metformin and their combination for the treatment of gestational diabetes mellitus (GDM). RESEARCH DESIGN AND METHODS: 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. RESULTS: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; P = 0.03). In the glyburide group, nine (17%) patients were eventually treated with insulin compared with two (4%) in the metformin group (P = 0.03). The combination of the drugs reduced the need for insulin from 33 (32%) to 11 (11%) patients (P = 0.0002). Mean daily blood glucose and other obstetrical and neonatal outcomes were comparable between groups, including macrosomia, neonatal hypoglycemia, and electrolyte imbalance. CONCLUSIONS: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.
Authors: Linda A Barbour; Christina Scifres; Amy M Valent; Jacob E Friedman; Thomas A Buchanan; Donald Coustan; Kjersti Aagaard; Kent L Thornburg; Patrick M Catalano; Henry L Galan; William W Hay; Antonio E Frias; Kartik Shankar; Rebecca A Simmons; Robert G Moses; David A Sacks; Mary R Loeken Journal: Am J Obstet Gynecol Date: 2018-06-28 Impact factor: 8.661
Authors: Deborah J Wexler; Camille E Powe; Linda A Barbour; Thomas Buchanan; Donald R Coustan; Rosa Corcoy; Peter Damm; Fidelma Dunne; Denice S Feig; Assiamira Ferrara; Lorie M Harper; Mark B Landon; Sara J Meltzer; Boyd E Metzger; Hilary Roeder; Janet A Rowan; David A Sacks; David Simmons; Jason G Umans; Patrick M Catalano Journal: Obstet Gynecol Date: 2018-08 Impact factor: 7.661