Naslov
Perinatal outcomes in pregnancy: a randomised trial comparing insulin detemir with NPH insulin in 310 subjects with type 1 diabetes

Autori
Hod, Moshe ; McCance, DR ; Ivanišević, Marina ; Garcia, Santiago ; Jovanovic, Lois ; Mathiesen, Elisabeth R ; Damm, Peter

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, znanstveni

Skup
47th EASD Annual Meeting

Mjesto i datum
Lisabon, Portugal, 12.09.2011. - 16.09.2011

Vrsta sudjelovanja
Predavanje

Vrsta recenzije
Nije recenziran

Ključne riječi
perinatal outcomes; Detemir; NPH; pregnancy; type 1 diabetes
(Perinatal Outcomes; Detemir; NPH; Pregnancy; Typerinatal outcomes; Detemir; NPH; pregnancy; type 1 diabetes pe 1 Diabetes)

Sažetak
Background and aims: The use of long-acting insulin analogues before and during pregnancy in type 1 diabetes is increasing, but their efficacy and safety remains uncertain. The aim of this prospective, randomised, controlled, parallel-group, open-label trial was to compare the efficacy and safety of insulin detemir (IDet) vs. NPH insulin (both with mealtime insulin aspart) in pregnant women with type 1 diabetes. Materials and methods: Pregnant women with type 1 diabetes (age ≥18 yrs, HbA1c ≤8% at pregnancy confirmation) were randomised to IDet (n=152) or NPH (n=158) either before (up to 12 months) pregnancy (n=148) or during pregnancy (8-12 weeks gestation) (n=162). Pregnancy outcomes included a composite endpoint comprising: live born infants with birth weight <10th or >90th percentile for gestational age (GA) and sex ; preterm delivery (<37 gestational weeks (GWs)) ; early fetal demise (<22 GWs) ; perinatal mortality ; neonatal mortality ; presence of major congenital malformations. Other endpoints included: live born infants ; neonatal hypoglycaemia (PG<1.7 mmol/l within 24 hours of delivery) ; and adverse events (AEs) in offspring. The data were analysed using logistic analysis with treatment and pregnancy status at randomisation as covariates. Results: There were 152 and 160 pregnancies in the IDet and NPH groups, respectively (2 women in the NPH group had a miscarriage and became pregnant again, without withdrawing). 25 pregnant women withdrew from the trial (10 in the IDet group vs. 15 in the NPH group) ; therefore pregnancy outcome is reported for 142 and 145 women, respectively. 89 (62.7%) of IDet vs. 96 (66.2%) of NPH-treated subjects experienced at least one endpoint in the composite outcome (odds ratio (OR) IDet/NPH: 0.86 [95% CI 0.53 ; 1.40], p=0.551). Maternal and neonatal outcomes for live born children were similar between the two groups (Table). 17 children (8 IDet/9 NPH) had congenital malformations. There were 2 perinatal deaths in the IDet group and 1 in the NPH group. 15 vs. 24 children in the IDet and NPH groups, respectively, experienced neonatal hypoglycaemia within 24 hours of delivery. There was no difference in the incidence of adverse events in the offspring between the two groups (37% IDet/35% NPH) or in the number of AEs/child (IDet 2.2/NPH 2.7). Conclusion: IDet is as well-tolerated as NPH with respect to perinatal morbidity and mortality when administered during pregnancy to subjects with type 1 diabetes.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti

POVEZANOST RADA