Poster Presentation Australian Diabetes Society and the Australian Diabetes Educators Association Annual Scientific Meeting 2014

Pregnancy outcomes after unintentional exposure to vildagliptin (#277)

Päivi M. Paldánius 1 , Calvin McNeill 2 , Changan Chu 2 , Wolfgang Kothny 1
  1. Novartis Pharma AG, Basel, Switzerland
  2. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA

The issue of pregnancy complicated by type 2 diabetes mellitus (T2DM) has become increasingly important as women increasingly develop T2DM at a younger age. T2DM increases the risk of adverse maternal and fetal outcomes, including preterm delivery, abortions, congenital abnormalities and neonatal mortality. Data on outcomes in women exposed to newer oral anti-diabetic drugs (OADs), including vildagliptin, are limited. Here, we report outcomes of 37 pregnancies in women exposed unintentionally to vildagliptin (± metformin).

The Novartis Safety Database was searched to identify all known records (cut-off date: 30 April 2014) of exposure to vildagliptin during pregnancy. The database includes clinical study and post-marketing surveillance reports, as well as spontaneous reports.

37 pregnancies in 36 women with T2DM were identified: 14 from clinical trials, 18 spontaneous reports and 5 post-marketing reports. Demographic data were limited. Mean age was 34 years (range 19-44), and 27.7% of women had a previous history of abortion. Limited information was available on cumulative vildagliptin dose or trimester(s) of exposure. 27 out of 37 pregnancies (73.0%) resulted in a live birth, and more than half of the pregnancies (n=21, 56.8%) had an unremarkable outcome (normal infants born without complications). Three (8.1%) pregnancies resulted in normal newborns with complications (one case of gestational hypertension, haemorrhage during pregnancy and placenta previa) and three (8.1%) resulted in preterm delivery. Five caesarean sections were reported (all live births): two preterm and three term pregnancies. There were nine (24.3%) spontaneous or missed abortions, but their relationship to vildagliptin was unclear. Additionally, one case of therapeutic abortion was reported. No congenital abnormalities or neonatal deaths were reported.

Although numbers are low, this analysis provides preliminary information on pregnancy outcomes in T2DM after exposure to vildagliptin. No prospective studies of vildagliptin have been performed in pregnant women with T2DM. As with most OADs, vildagliptin is not recommended for use during pregnancy.