TY - JOUR
T1 - Risk of major congenital malformations or perinatal or neonatal death with insulin detemir versus other basal insulins in pregnant women with preexisting diabetes
T2 - The real-world evolve study
AU - Mathiesen, Elisabeth R.
AU - Ali, Norsiah
AU - Alibegovic, Amra C.
AU - Anastasiou, Eleni
AU - Cypryk, Katarzyna
AU - De Valk, Harold
AU - Dores, Jorge
AU - Dunne, Fidelma
AU - Gall, Mari Anne
AU - Garcia, Santiago Duran
AU - Hanaire, Hèlène P.
AU - Husemoen, Lise Lotte N.
AU - Ivanišević, Marina
AU - Kempe, Hans Peter
AU - McCance, David R.
AU - Damm, Peter
N1 - Funding Information:
Acknowledgments. The authors thank all investigators, staff, and participants of this study. The authors also thank Rikke Baastrup Nordsborg and Usha Thamattoor for data analysis, Charlotte Højelse for study management, and Pranav Kelkar and Renuka Munik-rishnappa, all from Novo Nordisk, for the input into the manuscript. Medical writing and editorial assistance were provided by Jane Blackburn, Amy Hepple, and Helen Marshall of Ashfield MedComms, an Ashfield Health company, funded by Novo Nordisk A/S. A complete list of the investigators in the EVOLVE study can be found in the Supplementary Material. Funding. The EVOLVE study, including study design, data collection, analysis, and interpretation, was funded by Novo Nordisk A/S. Medical writing and editorial assistance were also sponsored by Novo Nordisk A/S. Duality of Interest. E.R.M. has received speakers fees from Novo Nordisk, Eli Lilly and Company, and Sanofi Aventis; has participated in steering committee tasks and guidance involving writing protocols for Novo Nordisk; is participating in several multinational clinical studies on the use of insulin in pregnant women with pre-existing diabetes, in collaboration with Novo Nordisk. K.C. has received speaker honoraria from or has participated in advisory boards for Novo Nordisk, Eli Lilly and Company, Sanofi, AstraZe-neca, Boehringer Ingelheim, and Servier. J.D. has received speaker honoraria from or has participated in advisory boards for Novo Nordisk, Eli Lilly and Company, Sanofi, Amgen, Abbott, Astra-Zeneca, Boehringer Ingelheim, Mundipharma, and Merck Sharp & Dohme. A.C.A., M.-A.G., and L.L.N.H. are employees of, and hold shares in, Novo Nordisk. S.D.G. is a consultant for Sanofi, Eli Lilly and Company, Novo Nordisk, Takeda Pharmaceutical Company, Merck Sharp & Dohme, Servier, and Theracos. H.P.H. has received lecturer and scientific advisor fees from Abbott, AstraZeneca, Eli Lilly and Company, Insu-let, LifeScan, and Novo Nordisk and research grants from Abbott, LifeScan, and Novo Nordisk. H.-P.K. has received speaker honoraria from, or has participated in advisory boards for, Novo Nordisk, Eli Lilly and Company, Sanofi, Astra-Zeneca, and Servier. D.R.M. has received speaker honoraria from, or has participated in advisory boards for, Novo Nordisk. P.D. is participating in clinical studies on the use of insulin analogs in pregnant women with preexisting diabetes and participates in an expert committee on this topic, in collaboration with Novo Nordisk, no personal honorarium is involved. No other potential conflicts of interest relevant to this article were reported. Author Contributions. E.R.M., N.A., A.C.A., E.A., K.C., H.d.V., J.D., F.D., M.-A.G., S.D.G., H.P.H., L.L.N.H., M.I., H.-P.K., D.R.M., and P.D. all interpreted results and provided input, critical review, and approval for the manuscript. All named authors meet the International Committee of Medical Journal Editors criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. E.R.M. is the guarantor of this work and, as such, had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Prior Presentation. This work was presented in poster form at the 80th Scientific Sessions of the American Diabetes Association, 12–16 June 2020, and in oral form at the 56th Annual Meeting of the European Association for the Study of Diabetes, 21–25 September 2020.
Publisher Copyright:
© 2021 by the American Diabetes Association.
PY - 2021/7/1
Y1 - 2021/7/1
N2 - OBJECTIVE To compare the risk of severe adverse pregnancy complications in women with preexisting diabetes. RESEARCH DESIGN AND METHODS Multinational, prospective cohort study to assess the prevalence of newborns free from major congenital malformations or perinatal or neonatal death (primary end point) following treatment with insulin detemir (detemir) versus other basal insulins. RESULTS Of 1,457 women included, 727 received detemir and 730 received other basal insulins. The prevalence of newborns free from major congenital malformations or perinatal or neonatal death was similar between detemir (97.0%) and other basal insulins (95.5%) (crude risk difference 0.015 [95% CI -0.01, 0.04]; adjusted risk difference -0.003 [95% CI -0.03, 0.03]). The crude prevalence of one or more congenital malformations (major plus minor) was 9.4% vs. 12.6%, with a similar risk difference before (-0.032 [95% CI -0.064, 0.000]) and after (-0.036 [95% CI -0.081, 0.009]) adjustment for confounders. Crude data showed lower maternal HbA1c during the first trimester (6.5% vs. 6.7% [48 vs. 50 mmol/mol]; estimated mean difference -0.181 [95% CI -0.300, -0.062]) and the second trimester (6.1% vs. 6.3%[43 vs. 45mmol/mol]; -0.139 [95% CI -0.232, -0.046]) and a lower prevalence of major hypoglycemia (6.0% vs. 9.0%; risk difference -0.030 [95% CI -0.058, -0.002]), preeclampsia (6.4% vs. 10.0%; -0.036 [95% CI -0.064, -0.007]), and stillbirth (0.4% vs. 1.8%; -0.013 [95% CI -0.024, -0.002]) with detemir compared with other basal insulins. However, differences were not significant postadjustment. CONCLUSIONS Insulin detemir was associated with a similar risk to other basal insulins of major congenital malformations, perinatal or neonatal death, hypoglycemia, preeclampsia, and stillbirth.
AB - OBJECTIVE To compare the risk of severe adverse pregnancy complications in women with preexisting diabetes. RESEARCH DESIGN AND METHODS Multinational, prospective cohort study to assess the prevalence of newborns free from major congenital malformations or perinatal or neonatal death (primary end point) following treatment with insulin detemir (detemir) versus other basal insulins. RESULTS Of 1,457 women included, 727 received detemir and 730 received other basal insulins. The prevalence of newborns free from major congenital malformations or perinatal or neonatal death was similar between detemir (97.0%) and other basal insulins (95.5%) (crude risk difference 0.015 [95% CI -0.01, 0.04]; adjusted risk difference -0.003 [95% CI -0.03, 0.03]). The crude prevalence of one or more congenital malformations (major plus minor) was 9.4% vs. 12.6%, with a similar risk difference before (-0.032 [95% CI -0.064, 0.000]) and after (-0.036 [95% CI -0.081, 0.009]) adjustment for confounders. Crude data showed lower maternal HbA1c during the first trimester (6.5% vs. 6.7% [48 vs. 50 mmol/mol]; estimated mean difference -0.181 [95% CI -0.300, -0.062]) and the second trimester (6.1% vs. 6.3%[43 vs. 45mmol/mol]; -0.139 [95% CI -0.232, -0.046]) and a lower prevalence of major hypoglycemia (6.0% vs. 9.0%; risk difference -0.030 [95% CI -0.058, -0.002]), preeclampsia (6.4% vs. 10.0%; -0.036 [95% CI -0.064, -0.007]), and stillbirth (0.4% vs. 1.8%; -0.013 [95% CI -0.024, -0.002]) with detemir compared with other basal insulins. However, differences were not significant postadjustment. CONCLUSIONS Insulin detemir was associated with a similar risk to other basal insulins of major congenital malformations, perinatal or neonatal death, hypoglycemia, preeclampsia, and stillbirth.
UR - https://www.scopus.com/pages/publications/85115075943
U2 - 10.2337/dc21-0472
DO - 10.2337/dc21-0472
M3 - Article
C2 - 34330786
AN - SCOPUS:85115075943
SN - 0149-5992
VL - 44
SP - 2069
EP - 2077
JO - Diabetes Care
JF - Diabetes Care
IS - 9
ER -