|
|
|
A randomized controlled trial comparing acarbose vs. insulin therapy for gestational diabetes in individuals with inadequate glycemic control by diet alone |
J. A. Villarreal-Rodriguez1, 3, L. G. Mancillas Adame2, 3, J. Maldonado-Sanchez1, 3, A. Guzmán-López1, 3, O. R. Treviño-Montemayor1, 3, J. G. Gonzalez-Gonzalez2, 3, D. Saldívar-Rodríguez1, 3, *( ) |
1Obstetrics and Gynecology Department, Maternal Fetal Medicine Division, School of Medicine and University Hospital “Dr. Jose Eleuterio Gonzalez”, Mexico 2Internal Medicine Department, Endocrinology Division, School of Medicine and University Hospital “Dr. Jose Eleuterio Gonzalez”, Mexico 3Gestational Diabetes Clinic, School of Medicine and University Hospital “Dr. Jose Eleuterio Gonzalez", Mexico |
|
|
Abstract Introduction: Gestational diabetes (GD) is one of the most common medical complications of pregnancy, associated with increased incidence of pre-eclampsia, macrosomia, and cesarean delivery. Insulin therapy is the cornerstone treatment in those individuals with inadequate glycemic control by diet alone. The burden of insulin treatment includes the need for multiple injections, intensive blood glucose monitoring, risk of hypoglycemia, and emotional distress. Alternatives to insulin treatment have been studied in the past but there is limited previous experience with acarbose. Objective: To compare acarbose to insulin therapy and evaluate the proportion of subjects requiring rescue therapy with insulin due to inadequate glycemic control; as a secondary objective, pregnancy outcomes were assessed. Materials and Methods: Pregnant patients diagnosed with GD who failed glycemic control on dietetic treatment, were randomized to receive standard insulin therapy or acarbose. If the oral drug was not tolerated or glycemic goals were not met, standard insulin therapy was initiated. Results: A total of 104 patients were randomized (acarbose n = 40). Two patients in the acarbose group and six in the insulin group withdrew their consent before any study intervention due to personal preferences. In the acarbose group, 27/38 subjects (71%) achieved and maintained glycemic targets until delivery, while 11/38 (29%) received rescue insulin therapy and discontinued the study drug. No differences were found in birth weight, gestational age at birth, or Apgar score. Three patients in the acarbose and five in the insulin group presented perinatal complications. Conclusion: In this study, acarbose was found to be a safe and effective alternative to insulin therapy. Insulin therapy and its burden were avoided in over 70% of the GD patients failing nutritional therapy. Studies with a larger sample size and long-term follow-up are needed.
|
Submitted: 18 October 2018
Accepted: 11 March 2019
Published: 15 August 2020
|
*Corresponding Author(s):
D. Saldívar-Rodríguez
E-mail: dsaldivar@hotmail.com
|
Cite this article:
J. A. Villarreal-Rodriguez, L. G. Mancillas Adame, J. Maldonado-Sanchez, A. Guzmán-López, O. R. Treviño-Montemayor, J. G. Gonzalez-Gonzalez, D. Saldívar-Rodríguez. A randomized controlled trial comparing acarbose vs. insulin therapy for gestational diabetes in individuals with inadequate glycemic control by diet alone. Clinical and Experimental Obstetrics & Gynecology, 2020, 47(4): 552-555.
URL:
https://ceog.imrpress.com/EN/10.31083/j.ceog.2020.04.5026 OR https://ceog.imrpress.com/EN/Y2020/V47/I4/552
|
[1] |
Srichumchit S., Luewan S., Tongsong T.: “Outcomes of pregnancy with gestational diabetes mellitus”. Int. J. Gynaecol. Obstet., 2015, 131, 251.
doi: 10.1016/j.ijgo.2015.05.033
pmid: 26372349
|
[2] |
Yu Y., Xie R., Shen C., Shu L.: “Effect of exercise during pregnancy to prevent gestational diabetes mellitus: a systematic review and meta-analysis”. J. Matern. Fetal Neonatal Med., 2018, 31, 1632.
doi: 10.1080/14767058.2017.1319929
pmid: 28409688
|
[3] |
Melchior H., Kurch-Bek D., Mund M.: “The Prevalence of Gestational Diabetes: A Population-Based Analysis of a. Nationwide Screening Program”. Dtsch. Arztebl. Int., 2017, 114, 412.
doi: 10.3238/arztebl.2017.0412
pmid: 28669379
|
[4] |
Waters T.P., Dyer A.R., Scholtens D.M., Dooley S.L., Herer E., Lowe L.P., et al.: “Maternal and Neonatal Morbidity for Women Who Would Be Added to the Diagnosis of GDM Using IADPSG Criteria: A Secondary Analysis of the Hyperglycemia and Adverse Pregnancy Outcome Study”. Diabetes Care, 2016, 39, 2204.
|
[5] |
International Diabetes Federation: “8th Edition of IDF Diabetes Atlas”. International Diabetes Federation, 2017, 2018.
|
[6] |
Simmons D.: “Diabetes and obesity in pregnancy”. Best Pract. Res. Clin. Obstet. Gynaecol., 2011, 25, 25.
doi: 10.1016/j.bpobgyn.2010.10.006
pmid: 21247811
|
[7] |
Guariguata L., Linnenkamp U., Beagley J., Whiting D.R., Cho N.H.: “Global estimates of the prevalence of hyperglycaemia in pregnancy”. Diabetes Res. Clin. Pract., 2014, 103, 176.
doi: 10.1016/j.diabres.2013.11.003
pmid: 24300020
|
[8] |
American Diabetes A.: 13. Management of Diabetes in Pregnancy: Standards of Medical Care in Diabetes-2018”. Diabetes Care, 2018, 41, S137.
doi: 10.2337/dc18-S013
pmid: 29222384
|
[9] |
Clissold S.P., Edwards C.: “Acarbose. A preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential”. Drugs, 1988, 35, 214.
doi: 10.2165/00003495-198800352-00047
pmid: 3396484
|
[10] |
Zarate A., Ochoa R., Hernandez M., Basurto L.: “Effectiveness of acarbose in the control of glucose tolerance worsening in pregnancy”. Ginecol. Obstet. Mex., 2000, 68, 42. [In Spanish]
pmid: 10774102
|
[11] |
American Diabetes Associaton: “Classification and diagnosis of diabetes.” ” Diabetes Care, 2015, 38, S8.
|
[12] |
Carpenter M.W., Coustan D.R.: “Criteria for screening tests for gestational diabetes”. Am. J. Obstet. Gynecol., 1982, 144, 768.
doi: 10.1016/0002-9378(82)90349-0
pmid: 7148898
|
[13] |
Xu T., Dainelli L., Yu K., Ma L., Silva Zolezzi I., Detzel P., Fang H.: “The short-term health and economic burden of gestational diabetes mellitus in China: a modelling study”. BMJ Open, 2017, 7, e018893.
doi: 10.1136/bmjopen-2017-018893
pmid: 29203507
|
[14] |
Mecacci F., Carignani L., Cioni R., Bartoli E., Parretti E., La Torre O., et al. “Maternal metabolic control and perinatal outcome in women with gestational diabetes treated with regular or lispro insulin: comparison with non-diabetic pregnant women”. Eur. J. Obstet. Gynecol. Reprod. Biol., 2003, 111, 19.
doi: 10.1016/s0301-2115(03)00157-x
pmid: 14557006
|
[15] |
Kopec J.A., Ogonowski J., Rahman M.M., Miazgowski T.: “Patient Reported Outcomes in Women with Gestational Diabetes: a Longitudinal Study”. Int. J. Behav. Med., 2015, 22, 206.
doi: 10.1007/s12529-014-9428-0
pmid: 25106672
|
No Suggested Reading articles found! |
|
|
Viewed |
|
|
|
Full text
|
|
|
|
|
Abstract
|
|
|
|
|
Cited |
|
|
|
|
|
Shared |
|
|
|
|
|
Discussed |
|
|
|
|