Exposure to candesartan during the first trimester of pregnancy in type 1 diabetes: experience from the placebo-controlled DIabetic REtinopathy Candesartan Trials. - Université de Bretagne Occidentale Accéder directement au contenu
Article Dans Une Revue Diabetologia Année : 2011

Exposure to candesartan during the first trimester of pregnancy in type 1 diabetes: experience from the placebo-controlled DIabetic REtinopathy Candesartan Trials.

Massimo Porta
  • Fonction : Auteur
  • PersonId : 951062
J. W. Hainer
  • Fonction : Auteur
S.-O. Jansson
  • Fonction : Auteur
A. Malm
  • Fonction : Auteur
R. Bilous
  • Fonction : Auteur
N. Chaturvedi
  • Fonction : Auteur
J. H. Fuller
  • Fonction : Auteur
R. Klein
  • Fonction : Auteur
T. Orchard
  • Fonction : Auteur
H.-H. Parving
  • Fonction : Auteur
A.-K. Sjølie
  • Fonction : Auteur

Résumé

AIMS/HYPOTHESIS: The teratogenic consequences of angiotensin-converting enzyme inhibitors angiotensin receptor blockers (ARBs) during the second and third trimesters of pregnancy are well described. However, the consequences of exposure during the first trimester are unclear, especially in diabetes. We report the experience from DIRECT (DIabetic REtinopathy and Candesartan Trials), three placebo-controlled studies designed to examine the effects of an ARB, candesartan, on diabetic retinopathy. METHODS: Over 4 years or longer, 178 normotensive women with type 1 diabetes (86 randomised to candesartan, 32 mg once daily, and 92 assigned to placebo) became pregnant (total of 208 pregnancies). RESULTS: More than half of patients were exposed to candesartan or placebo prior to or in early pregnancy, but all discontinued it at an estimated 8 weeks from the last menstrual period. Full-term pregnancies (51 vs 50), premature deliveries (21 vs 27), spontaneous miscarriages (12 vs 15), elective terminations (15 vs 14) and other outcomes (1 vs 2) were similar in the candesartan and placebo groups. There were two stillbirths and two 'sick babies' in the candesartan group, and one stillbirth, eight 'sick babies' and one cardiac malformation in the placebo group. CONCLUSIONS/INTERPRETATION: The risk for fetal consequences of ARBs in type 1 diabetes may not be high if exposure is clearly limited to the first trimester. Long-term studies in fertile women can be conducted with ARBs during pregnancy, provided investigators diligently stop their administration upon planning or detection of pregnancy. TRIAL REGISTRATION: ClinicalTrials.gov DIRECT-Prevent 1 NCT00252733; DIRECT-Protect 1 NCT00252720; DIRECT-Protect 2 NCT00252694. FUNDING: The study was funded jointly by AstraZeneca and Takeda.

Dates et versions

hal-00931358 , version 1 (15-01-2014)

Identifiants

Citer

Massimo Porta, J. W. Hainer, S.-O. Jansson, A. Malm, R. Bilous, et al.. Exposure to candesartan during the first trimester of pregnancy in type 1 diabetes: experience from the placebo-controlled DIabetic REtinopathy Candesartan Trials.. Diabetologia, 2011, 54 (6), pp.1298-303. ⟨10.1007/s00125-010-2040-1⟩. ⟨hal-00931358⟩
26 Consultations
0 Téléchargements

Altmetric

Partager

Gmail Facebook X LinkedIn More