Generic placeholder image

Current Women`s Health Reviews

Editor-in-Chief

ISSN (Print): 1573-4048
ISSN (Online): 1875-6581

Systematic Review Article

Neonatal and Maternal Outcomes of Insulin Detemir versus Neutral Protamine Hagedorn for Diabetes Mellitus in Pregnancy

Author(s): Seif Bugazia, Mohamed Boshnaf, Mohammad Elbahnasawy, Mostafa Shehata, Fadel Alqatati, Khaled Mohamed Ragab, Ahmed Bostamy Elsnhory, Sarah Makram Elsayed, Mustafa Ali Fathy and Anas Zakarya Nourelden*

Volume 19, Issue 3, 2023

Published on: 15 September, 2022

Article ID: e210622206234 Pages: 10

DOI: 10.2174/1573404819666220621092340

Price: $65

Abstract

Background and Objective: Diabetes in pregnancy can lead to severe neonatal and maternal adverse events. Moreover, there is an increase in GDM prevalence. Therefore, we aimed to compare insulin detemir (IDet) with the neutral protamine Hagedorn (NPH) in diabetic pregnant women.

Methods: We searched four electronic databases until August 2021: PubMed, Scopus, Web of Science, and Cochrane. We included randomized controlled studies that compared IDet with NPH in diabetic pregnant women. We extracted both maternal and neonatal outcomes, and used RevMan software to conduct the analysis.

Results: Five studies were included. The analysis showed a significantly lower risk of hypoglycemic events during pregnancy in the IDet group than the NPH group [RR = 0.6, 95% CI [0.43, 0.84], p = 0.003], and a higher gestational age (GA) at delivery in the IDet group than the NPH group [MD = 0.28, 95% [0.02, 0.55], p = 0.03]. On the other hand, the analysis revealed non-significant differences between IDet and NPH in terms of birth weight, congenital anomalies, neonatal hypoglycemia, preterm delivery, and others.

Conclusion: Insulin detemir (IDet) was preferred over neutral protamine Hagedorn (NPH) in terms of showing lower rates of hypoglycemic events during pregnancy and a higher gestational age at delivery. Meanwhile, there were non-significant variations between them with respect to neonatal outcomes, such as weight at birth, congenital anomalies, or neonatal hypoglycemia.

Keywords: Insulin detemir, neutral protamine Hagedorn, diabetes, pregnancy, systematic review, meta-analysis.

Graphical Abstract
[1]
McIntyre, H.D. Discovery, knowledge, and action-diabetes in pregnancy across the translational spectrum: The 2016 norbert freinkel award lecture. Diabetes Care, 2018, 41(2), 227-232.
[http://dx.doi.org/10.2337/dci17-0056] [PMID: 29358466]
[2]
Wilmot, E.G.; Mansell, P. Diabetes and pregnancy. Clin. Med. , 2014, 14(6), 677-680.
[http://dx.doi.org/10.7861/clinmedicine.14-6-677] [PMID: 25468858]
[3]
Muche, A.A.; Olayemi, O.O.; Gete, Y.K. Effects of gestational diabetes mellitus on risk of adverse maternal outcomes: A prospective cohort study in Northwest Ethiopia. BMC Pregnancy Childbirth, 2020, 20(1), 73.
[http://dx.doi.org/10.1186/s12884-020-2759-8] [PMID: 32013909]
[4]
Sacks, D.A.; Black, M.H.; Li, X.; Montoro, M.N.; Lawrence, J.M. Adverse pregnancy outcomes using the international association of the diabetes and pregnancy study groups criteria. Obstet. Gynecol., 2015, 126(1), 67-73.
[http://dx.doi.org/10.1097/AOG.0000000000000865] [PMID: 26241258]
[5]
Sreelakshmi, P.R.; Nair, S.; Soman, B.; Alex, R.; Vijayakumar, K.; Kutty, V.R. Maternal and neonatal outcomes of gestational diabetes: A retrospective cohort study from Southern India. J. Family Med. Prim. Care, 2015, 4(3), 395-398.
[http://dx.doi.org/10.4103/2249-4863.161331] [PMID: 26288780]
[6]
Metcalfe, A.; Sabr, Y.; Hutcheon, J.A.; Donovan, L.; Lyons, J.; Burrows, J.; Joseph, K.S. Trends in obstetric intervention and pregnancy outcomes of canadian women with diabetes in pregnancy from 2004 to 2015. J. Endocr. Soc., 2017, 1(12), 1540-1549.
[http://dx.doi.org/10.1210/js.2017-00376] [PMID: 29308448]
[7]
Murphy, H.R.; Bell, R.; Cartwright, C.; Curnow, P.; Maresh, M.; Morgan, M.; Sylvester, C.; Young, B.; Lewis-Barned, N. Improved pregnancy outcomes in women with type 1 and type 2 diabetes but substantial clinic-to-clinic variations: A prospective nationwide study. Diabetologia, 2017, 60(9), 1668-1677.
[http://dx.doi.org/10.1007/s00125-017-4314-3] [PMID: 28597075]
[8]
Tinker, S.C.; Gilboa, S.M.; Moore, C.A.; Waller, D.K.; Simeone, R.M.; Kim, S.Y. Specific birth defects in pregnancies of women with diabetes: National Birth Defects Prevention Study, 1997-2011. Am. J. Obstet. Gynecol., 2020, 222(2), 176.e1-176.e11.
[9]
Evers, I.M.; de Valk, H.W.; Visser, G.H.A. Risk of complications of pregnancy in women with type 1 diabetes: Nationwide prospective study in the Netherlands. BMJ, 2004, 328(7445), 915.
[http://dx.doi.org/10.1136/bmj.38043.583160.EE] [PMID: 15066886]
[10]
Jensen, D.M.; Damm, P.; Moelsted-Pedersen, L.; Ovesen, P.; Westergaard, J.G.; Moeller, M.; Beck-Nielsen, H. Outcomes in type 1 diabetic pregnancies: A nationwide, population-based study. Diabetes Care, 2004, 27(12), 2819-2823.
[http://dx.doi.org/10.2337/diacare.27.12.2819] [PMID: 15562191]
[11]
Macintosh, M.C.M.; Fleming, K.M.; Bailey, J.A.; Doyle, P.; Modder, J.; Acolet, D.; Golightly, S.; Miller, A. Perinatal mortality and congenital anomalies in babies of women with type 1 or type 2 diabetes in England, Wales, and Northern Ireland: Population based study. BMJ, 2006, 333(7560), 177.
[http://dx.doi.org/10.1136/bmj.38856.692986.AE] [PMID: 16782722]
[12]
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(2), 176-185.
[http://dx.doi.org/10.1016/j.diabres.2013.11.003] [PMID: 24300020]
[13]
Hod, M.; Kapur, A.; Sacks, D.A.; Hadar, E.; Agarwal, M.; Di Renzo, G.C.; Roura, L.C.; McIntyre, H.D.; Morris, J.L.; Divakar, H. The International Federation of Gynecology and Obstetrics (FIGO) Initiative on gestational diabetes mellitus: A pragmatic guide for diagnosis, management, and care. Int. J. Gynaecol. Obstet., 2015, 131(Suppl. 3), S173-S211.
[http://dx.doi.org/10.1016/S0020-7292(15)30033-3]
[14]
Wang, H.; Li, N.; Chivese, T.; Werfalli, M.; Sun, H.; Yuen, L.; Hoegfeldt, C.A.; Elise Powe, C.; Immanuel, J.; Karuranga, S.; Divakar, H.; Levitt, N.A.; Li, C.; Simmons, D.; Yang, X. IDF Diabetes Atlas: Estimation of Global and Regional Gestational Diabetes Mellitus Prevalence for 2021 by International Association of Diabetes in Pregnancy Study Group’s Criteria. Diabetes Res. Clin. Pract., 2022, 183, 109050.
[http://dx.doi.org/10.1016/j.diabres.2021.109050] [PMID: 34883186]
[15]
Sleeman, A.; Odom, J.; Schellinger, M. Comparison of hypoglycemia and safety outcomes with long-acting insulins versus insulin NPH in pregestational and gestational diabetes. Ann. Pharmacother., 2020, 54(7), 669-675.
[http://dx.doi.org/10.1177/1060028019897897] [PMID: 31893932]
[16]
Association, A.D. Clinical practice recommendations: Gestational diabetes. Diabetes Care, 2004, 27(Suppl. 1), 88-90.
[17]
Ji, J.; He, Z.; Yang, Z.; Mi, Y.; Guo, N.; Zhao, H.; Gao, J.; Ma, Z.; Luo, X.; Han, Z. Comparing the efficacy and safety of insulin detemir versus neutral protamine hagedorn insulin in treatment of diabetes during pregnancy: A randomized, controlled study. BMJ Open Diabetes Res. Care, 2020, 8(1), e001155.
[http://dx.doi.org/10.1136/bmjdrc-2019-001155] [PMID: 32265255]
[18]
Toledano, Y.; Hadar, E.; Hod, M. Pharmacotherapy for hyperglycemia in pregnancy - The new insulins. Diabetes Res. Clin. Pract., 2018, 145, 59-66.
[http://dx.doi.org/10.1016/j.diabres.2018.04.035] [PMID: 29730391]
[19]
O’Neill, S.M.; Kenny, L.C.; Khashan, A.S.; West, H.M.; Smyth, R.M.D.; Kearney, P.M. Different insulin types and regimens for pregnant women with pre-existing diabetes. Cochrane Libr., 2017, 2017(2), CD011880.
[http://dx.doi.org/10.1002/14651858.CD011880.pub2] [PMID: 28156005]
[20]
Lambert, K.; Holt, R.I.G. The use of insulin analogues in pregnancy. Diabetes Obes. Metab., 2013, 15(10), 888-900.
[http://dx.doi.org/10.1111/dom.12098] [PMID: 23489521]
[21]
Fishel Bartal, M.; Ward, C.; Blackwell, S.C.; Ashby Cornthwaite, J.A.; Zhang, C. Refuerzo, JS Detemir vs neutral protamine Hagedorn insulin for diabetes mellitus in pregnancy: A comparative effectiveness, randomized controlled trial. Am. J. Obstet. Gynecol., 2021, 225(1), 87.e1-87.e10.
[http://dx.doi.org/10.1016/j.ajog.2021.04.223]
[22]
Herrera, K.M.; Rosenn, B.M.; Foroutan, J.; Bimson, B.E.; Al Ibraheemi, Z.; Moshier, E.L.; Brustman, L.E. Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes. Am. J. Obstet. Gynecol., 2015, 213(3), 426.e1-426.e7.
[http://dx.doi.org/10.1016/j.ajog.2015.06.010] [PMID: 26070699]
[23]
Higgins, J.P.; Green, S. Cochrane Handbook for Systematic Reviews of Interventions: Cochrane Book Series; Higgins, JP; Green, S. John Wiley and Sons Ltd, 2008.
[http://dx.doi.org/10.1002/9780470712184]
[24]
Moher, D.; Liberati, A.; Tetzlaff, J.; Altman, D.G.; Group, T.P. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. PLoS Med., 2009, 6(7), e1000097.
[http://dx.doi.org/10.1371/journal.pmed.1000097] [PMID: 19621072]
[25]
Higgins, J.P.T.; Altman, D.G. Gøtzsche, P.C.; Jüni, P.; Moher, D.; Oxman, A.D.; Savovic, J.; Schulz, K.F.; Weeks, L.; Sterne, J.A.C. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ, 2011, 343.
[http://dx.doi.org/10.1136/bmj.d5928] [PMID: 22008217]
[26]
Mathiesen, E.R.; Hod, M.; Ivanisevic, M.; Duran Garcia, S. Brøndsted, L.; Jovanovič L.; Damm, P.; McCance, D.R. Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes. Diabetes Care, 2012, 35(10), 2012-2017.
[http://dx.doi.org/10.2337/dc11-2264] [PMID: 22851598]
[27]
Hod, M.; Mathiesen, E.R. Jovanovič L.; McCance, D.R.; Ivanisevic, M.; Durán-Garcia, S. A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes. J. Matern. Fetal Neonatal Med., 2014, 27(1), 7-13.
[http://dx.doi.org/10.3109/14767058.2013.799650]
[28]
Fishel Bartal, M.; Ward, C.; Refuerzo, J.S.; Ashimi, S.S.; Joycelyn, C.A.; Chen, H.Y.; Chauhan, S.P.; Sibai, B.M. Basal insulin analogs versus neutral protamine hagedorn for type 2 diabetics. Am. J. Perinatol.,, 2020, 37(1), 030-036.
[http://dx.doi.org/10.1055/s-0039-1694733] [PMID: 31430822]
[29]
Saleem, F.; Sharma, A. NPH Insulin.StatPearls; StatPearls Publishing: Treasure Island, FL, 2022.
[30]
Lucidi, P.; Porcellati, F.; Marinelli Andreoli, A.; Carriero, I.; Candeloro, P.; Cioli, P.; Bolli, G.B.; Fanelli, C.G. Pharmacokinetics and pharmacodynamics of NPH insulin in type 1 diabetes: The importance of appropriate resuspension before subcutaneous injection. Diabetes Care, 2015, 38(12), 2204-2210.
[http://dx.doi.org/10.2337/dc15-0801] [PMID: 26358287]
[31]
Singh, A.; Gangopadhyay, K. Modern basal insulin analogs: An incomplete story. Indian J. Endocrinol. Metab., 2014, 18(6), 784-793.
[http://dx.doi.org/10.4103/2230-8210.140239] [PMID: 25364672]
[32]
Fournier, M.; Germe, M.; Theobald, K.; Scholz, G.H.; Lehmacher, W. Indirect comparison of lixisenatide versus neutral protamine Hagedorn insulin as add-on to metformin and sulphonylurea in patients with type 2 diabetes mellitus. GMS German Med. Sci., 2014, 12, Doc14.
[33]
Lepore, M.; Pampanelli, S.; Fanelli, C.; Porcellati, F.; Bartocci, L.; Di Vincenzo, A.; Cordoni, C.; Costa, E.; Brunetti, P.; Bolli, G.B. Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and ultralente human insulin and continuous subcutaneous infusion of insulin lispro. Diabetes, 2000, 49(12), 2142-2148.
[http://dx.doi.org/10.2337/diabetes.49.12.2142] [PMID: 11118018]
[34]
Kølendorf, K.; Ross, G.P.; Pavlic-Renar, I.; Perriello, G.; Philotheou, A.; Jendle, J.; Gall, M-A.; Heller, S.R. Insulin detemir lowers the risk of hypoglycaemia and provides more consistent plasma glucose levels compared with NPH insulin in Type 1 diabetes. Diabet. Med., 2006, 23(7), 729-735.
[http://dx.doi.org/10.1111/j.1464-5491.2006.01862.x] [PMID: 16842476]
[35]
ACOG Practice Bulletin No. ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet. Gynecol. 2018, 131(2), e49-e64.
[http://dx.doi.org/10.1097/AOG.0000000000002501] [PMID: 29370047]
[36]
American Diabetes Association 14. Management of diabetes in pregnancy: Standards of medical care in diabetes-2020. Diabetes Care, 2020, 43(Suppl. 1), S183-S192.
[http://dx.doi.org/10.2337/dc20-S014] [PMID: 31862757]
[37]
Hinkle, S.N.; Li, M.; Grewal, J.; Yisahak, S.F.; Grobman, W.A.; Newman, R.B.; Wing, D.A.; Grantz, K.L.; Zhang, C. Changes in diet and exercise in pregnant women after diagnosis with gestational diabetes: Findings from a longitudinal prospective cohort study. J. Acad. Nutr. Diet., 2021, 121(12), 2419-2428.e4.
[http://dx.doi.org/10.1016/j.jand.2021.04.014] [PMID: 34023277]
[38]
Martins, I.J. Insulin therapy and autoimmune disease with relevance to non alchoholic fatty liver disease. Nonalcoholic Fatty Liver Disease - An Update; Gad, E.H., Ed.; IntechOpen: London, 2018.
[39]
Mattagajasingh, I.; Kim, C.S.; Naqvi, A.; Yamamori, T.; Hoffman, T.A.; Jung, S.B.; DeRicco, J.; Kasuno, K.; Irani, K. SIRT1 promotes endothelium-dependent vascular relaxation by activating endothelial nitric oxide synthase. Proc. Natl. Acad. Sci. , 2007, 104(37), 14855-14860.
[http://dx.doi.org/10.1073/pnas.0704329104] [PMID: 17785417]
[40]
Balestrieri, M.L.; Rienzo, M.; Felice, F.; Rossiello, R.; Grimaldi, V.; Milone, L.; Casamassimi, A.; Servillo, L.; Farzati, B.; Giovane, A.; Napoli, C. High glucose downregulates endothelial progenitor cell number via SIRT1. Biochim. Biophys. Acta. Proteins Proteomics, 2008, 1784(6), 936-945.
[http://dx.doi.org/10.1016/j.bbapap.2008.03.004] [PMID: 18423418]
[41]
de Kreutzenberg, S.V.; Ceolotto, G.; Papparella, I.; Bortoluzzi, A.; Semplicini, A.; Man, C.D.; Cobelli, C.; Fadini, G.P.; Avogaro, A. Downregulation of the longevity-associated protein sirtuin 1 in insulin resistance and metabolic syndrome: Potential biochemical mechanisms. Diabetes, 2010, 59(4), 1006-1015.
[http://dx.doi.org/10.2337/db09-1187] [PMID: 20068143]
[42]
Gui, J.; Potthast, A.; Rohrbach, A.; Borns, K.; Das, A.M. von Versen-Höynck, F. Gestational diabetes induces alterations of sirtuins in fetal endothelial cells. Pediatr. Res., 2016, 79(5), 788-798.
[http://dx.doi.org/10.1038/pr.2015.269] [PMID: 26717002]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy