Risk of Major Congenital Malformations or Perinatal or Neonatal Death With Insulin Detemir Versus Other Basal Insulins in Pregnant Women With Preexisting Diabetes: The Real-World EVOLVE Study

<p>OBJECTIVE: To compare the risk of severe adverse pregnancy complications in women with pre-existing diabetes.</p> <p>RESEARCH DESIGN AND METHODS: Multinational, prospective cohort study to assess the prevalence of newborns free from major congenital malformations, perinatal or neonatal death (primary endpoint) following treatment with insulin detemir (detemir) vs other basal insulins.</p> <p>RESULTS: Of 1,457 women included, 727 received detemir and 730 received other basal insulins. The prevalence of newborns free from major congenital malformations, 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 ≥1 congenital malformation (major + 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 HbA_1c 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 45 mmol/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]), pre-eclampsia (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 to other basal insulins. However, differences were not significant post-adjustment.</p> <p>CONCLUSION: Insulin detemir was associated with a similar risk to other basal insulins of major congenital malformations, perinatal or neonatal death, hypoglycemia, pre-eclampsia and stillbirth. </p>