Is insulin lispro safe in pregnant women: Does it cause any adverse outcomes on infants or mothers?
OBJECTIVE
To determine the rate of major congenital anomalies and complications retrospectively in offspring of women with diabetes mellitus treated insulin lispro.


METHODS
Twenty-seven patients had used insulin lispro (ILYS) and 59 patients had used regular human insulin (RHI) during the pregnancy period were evaluated. We also evaluated and analyzed the results of 53 of the 86 women who had gestational diabetes mellitus only. They were not using insulin aspart or insulin glarjine. We evaluated the birth weight, congenital anamolies, mode of delivery, abortus and stillbirth rates.


RESULTS
Mean HbA1c level was 6.27+2.23 for ILYS group and 7.07+2.09 for RHI group (p: 0.067). The duration of diabetes, gestational age, mode of delivery, type of diabetes, number of liveborn, stillbirth and miscarriages were not stastically different between all groups (p>0.05). Nine (15.25%) of 59 infants treated with RHI had congenital anomalies and one stillborn. The infants in ILYS-receiving group had no congenital anomalies but one pregnant (3.70%) had a stillborn. The difference in incidence of congenital anomalies between those using ILYS and RHI was not statistically significant (p: 0.157). There was also no difference in respect to congenital anomalies of gestational diabetic groups which used either ILYS or RHI.


CONCLUSIONS
Major congenital anomalies for offspring of mothers treated with ILYS are similar with RHI group. Although HbA1c levels were lower in ILYS group, all outcomes are similar with RHI. So ILYS is an alternative choice in treatment of pregnant women with DM.
Aydin
Yusuf
Y
Ankara Numune Education and Research Hospital, Department of Endocrinology and Metabolism, 06610 Ankara, Turkey. dryusufaydin@yahoo.com
Berker
Dilek
D
Direktör
Nafiye
N
Ustün
Ihsan
I
Tütüncü
Yasemin Ateş
YA
Işik
Serhat
S
Delibaşi
Tuncay
T
Guler
Serdar
S
D000022:Abortion, Spontaneous / Q000453:epidemiology; D000328:Adult; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D002585:Cesarean Section / Q000706:statistics & numerical data; D000013:Congenital Abnormalities / Q000453:epidemiology*; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy; D016640:Diabetes, Gestational / Q000188:drug therapy; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use; D007223:Infant; D007328:Insulin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D061268:Insulin Lispro; D011247:Pregnancy; D011254:Pregnancy in Diabetics / Q000188:drug therapy*; D012189:Retrospective Studies; D012449:Safety
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D061268:Insulin Lispro