Tags

Type your tag names separated by a space and hit enter

Major congenital malformations after first-trimester exposure to ACE inhibitors.
N Engl J Med 2006; 354(23):2443-51NEJM

Abstract

BACKGROUND

Use of angiotensin-converting-enzyme (ACE) inhibitors during the second and third trimesters of pregnancy is contraindicated because of their association with an increased risk of fetopathy. In contrast, first-trimester use of ACE inhibitors has not been linked to adverse fetal outcomes. We conducted a study to assess the association between exposure to ACE inhibitors during the first trimester of pregnancy only and the risk of congenital malformations.

METHODS

We studied a cohort of 29,507 infants enrolled in Tennessee Medicaid and born between 1985 and 2000 for whom there was no evidence of maternal diabetes. We identified 209 infants with exposure to ACE inhibitors in the first trimester alone, 202 infants with exposure to other antihypertensive medications in the first trimester alone, and 29,096 infants with no exposure to antihypertensive drugs at any time during gestation. Major congenital malformations were identified from linked vital records and hospitalization claims during the first year of life and confirmed by review of medical records.

RESULTS

Infants with only first-trimester exposure to ACE inhibitors had an increased risk of major congenital malformations (risk ratio, 2.71; 95 percent confidence interval, 1.72 to 4.27) as compared with infants who had no exposure to antihypertensive medications. In contrast, fetal exposure to other antihypertensive medications during only the first trimester did not confer an increased risk (risk ratio, 0.66; 95 percent confidence interval, 0.25 to 1.75). Infants exposed to ACE inhibitors were at increased risk for malformations of the cardiovascular system (risk ratio, 3.72; 95 percent confidence interval, 1.89 to 7.30) and the central nervous system (risk ratio, 4.39; 95 percent confidence interval, 1.37 to 14.02).

CONCLUSIONS

Exposure to ACE inhibitors during the first trimester cannot be considered safe and should be avoided.

Authors+Show Affiliations

Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN 37232, USA. william.cooper@vanderbilt.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

16760444

Citation

Cooper, William O., et al. "Major Congenital Malformations After First-trimester Exposure to ACE Inhibitors." The New England Journal of Medicine, vol. 354, no. 23, 2006, pp. 2443-51.
Cooper WO, Hernandez-Diaz S, Arbogast PG, et al. Major congenital malformations after first-trimester exposure to ACE inhibitors. N Engl J Med. 2006;354(23):2443-51.
Cooper, W. O., Hernandez-Diaz, S., Arbogast, P. G., Dudley, J. A., Dyer, S., Gideon, P. S., ... Ray, W. A. (2006). Major congenital malformations after first-trimester exposure to ACE inhibitors. The New England Journal of Medicine, 354(23), pp. 2443-51.
Cooper WO, et al. Major Congenital Malformations After First-trimester Exposure to ACE Inhibitors. N Engl J Med. 2006 Jun 8;354(23):2443-51. PubMed PMID: 16760444.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Major congenital malformations after first-trimester exposure to ACE inhibitors. AU - Cooper,William O, AU - Hernandez-Diaz,Sonia, AU - Arbogast,Patrick G, AU - Dudley,Judith A, AU - Dyer,Shannon, AU - Gideon,Patricia S, AU - Hall,Kathi, AU - Ray,Wayne A, PY - 2006/6/9/pubmed PY - 2006/6/14/medline PY - 2006/6/9/entrez SP - 2443 EP - 51 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 354 IS - 23 N2 - BACKGROUND: Use of angiotensin-converting-enzyme (ACE) inhibitors during the second and third trimesters of pregnancy is contraindicated because of their association with an increased risk of fetopathy. In contrast, first-trimester use of ACE inhibitors has not been linked to adverse fetal outcomes. We conducted a study to assess the association between exposure to ACE inhibitors during the first trimester of pregnancy only and the risk of congenital malformations. METHODS: We studied a cohort of 29,507 infants enrolled in Tennessee Medicaid and born between 1985 and 2000 for whom there was no evidence of maternal diabetes. We identified 209 infants with exposure to ACE inhibitors in the first trimester alone, 202 infants with exposure to other antihypertensive medications in the first trimester alone, and 29,096 infants with no exposure to antihypertensive drugs at any time during gestation. Major congenital malformations were identified from linked vital records and hospitalization claims during the first year of life and confirmed by review of medical records. RESULTS: Infants with only first-trimester exposure to ACE inhibitors had an increased risk of major congenital malformations (risk ratio, 2.71; 95 percent confidence interval, 1.72 to 4.27) as compared with infants who had no exposure to antihypertensive medications. In contrast, fetal exposure to other antihypertensive medications during only the first trimester did not confer an increased risk (risk ratio, 0.66; 95 percent confidence interval, 0.25 to 1.75). Infants exposed to ACE inhibitors were at increased risk for malformations of the cardiovascular system (risk ratio, 3.72; 95 percent confidence interval, 1.89 to 7.30) and the central nervous system (risk ratio, 4.39; 95 percent confidence interval, 1.37 to 14.02). CONCLUSIONS: Exposure to ACE inhibitors during the first trimester cannot be considered safe and should be avoided. SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/16760444/Major_congenital_malformations_after_first_trimester_exposure_to_ACE_inhibitors_ L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa055202?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -