Objective: To assess the safety of the use of insulin lispro during pregnancy on the basis of published literature and to report on any related efficacy findings.
Methods: The National Center for Biotechnology Information Entrez Database PubMed (http://www.ncbi. nlm.nih.gov/pubmed/) was used to search for citations from MEDLINE in the November 2009 time frame that contained safety data and efficacy results on the use of insulin lispro during pregnancy.
Results: From the MEDLINE search, we identified a total of 27 publications (with 1,265 pregnancies) with relevant information, which were included in this report. No statistically significant differences in the rates of occurrence of congenital anomalies or spontaneous abortions associated with the use of insulin lispro during pregnancy, in comparison with the use of human insulin, were reported. Moreover, in comparison with human insulin, insulin lispro was reported to result in improved glycemic control, as demonstrated by lower postprandial glucose concentrations and hemoglobin A1c levels.
Conclusion: The current review of the published literature indicates that insulin lispro is a safe alternative to human insulin with similar perinatal outcomes and potentially improved glycemic control in the management of diabetes during pregnancy.