Risk of adverse pregnancy complications similar between insulin detemir, other basal insulins

Among women with pre-existing diabetes, the risks of major congenital malformations and other severe adverse pregnancy complications associated with insulin detemir do not differ from those of other basal insulins, according to a study.

The study included 1,457 mothers with diabetes, among whom 727 received detemir and 730 received other basal insulins. The primary endpoint was the prevalence of newborns free from major congenital malformations or perinatal or neonatal death.

There was no significant between-group difference in the primary endpoint. Specifically, the prevalence of newborns free from major congenital malformations or perinatal or neonatal death was 97.0 percent with detemir vs 95.5 percent with other basal insulins (crude risk difference, 0.015, 95 percent confidence interval [CI], −0.01 to 0.04; adjusted risk difference, −0.003, 95 percent CI, −0.03 to 0.03).

With regard to one or more congenital malformations (major plus minor), the prevalence was 9.4 percent with detemir vs 12.6 percent with other basal insulins. There was no difference in the risk difference before (−0.032, 95 percent CI, −0.064 to 0.000) and after (−0.036, 95 percent CI, –0.081 to 0.009) adjustment for confounders.

Moreover, compared with other basal insulins, detemir was associated with lower maternal HbA1c during the first trimester (6.5 percent vs 6.7 percent; estimated mean difference −0.181, 95 percent CI, −0.300 to −0.062) and the second trimester (6.1 percent vs. 6.3 percent; risk difference, −0.139, 95 percent CI −0.232, −0.046) and a lower prevalence of major hypoglycaemia (6.0 percent vs 9.0 percent; risk difference, −0.030, 95 percent CI, −0.058 to −0.002]), pre-eclampsia (6.4 percent vs 10.0 percent; risk difference, −0.036, 95 percent CI, −0.064 to −0.007), and stillbirth (0.4 percent vs 1.8 percent; risk difference, −0.013, 95 percent CI, −0.024 to −0.002).

However, the significance of the differences disappeared after controlling for possible confounders.