Objective: To report the frequency of major malformations in lamotrigine-expo sed pregnancies from September 1, 1992,through March 31, 2004, in the Internatio nal Lamotrigine Pregnancy Registry.Methods: Health care pr...Objective: To report the frequency of major malformations in lamotrigine-expo sed pregnancies from September 1, 1992,through March 31, 2004, in the Internatio nal Lamotrigine Pregnancy Registry.Methods: Health care professionals throughout the world can voluntarily enroll lamotrigine-exposed pregnancies in this obser vational study. Only pregnancies with unknown outcomes at the time of enrollment were included in the analysis. The percentage of outcomes with major birth defe cts was calculated as the total number of outcomes with major birth defects divi ded by the sum of the number of outcomes with major birth defects +the number o f live births without defects. Results: Among 414 first-trimester exposures to lamotrigine monotherapy, 12 outcomes with major birth defects were reported (2.9 %, 95%CI 1.6%to 5.1%). Among the 88 first-trimester exposures to lamotrigin e polytherapy including valproate, 11 outcomes with major birth defects were rep orted(12.5%; 95%CI 6.7%to 21.7%). Among 182 first-trimester exposures to la motrigine polytherapy excluding valproate, 5 outcomes with major birth defects w ere reported (2.7%, 95%CI 1.0%to 6.6%). No distinctive pattern of major birt h defects was apparent among the offspring exposed to lamotrigine monotherapy or polytherapy. Conclusions: The risk of all major birth defects after first-trim ester exposure to lamotrigine monotherapy(2.9%) was similar to that in the gene ral population and in other registries enrolling women exposed to antiepileptic monotherapy (3.3%to 4.5%). However, the sample size was too small to detect an y but very large increases in specific birth defects.展开更多
文摘Objective: To report the frequency of major malformations in lamotrigine-expo sed pregnancies from September 1, 1992,through March 31, 2004, in the Internatio nal Lamotrigine Pregnancy Registry.Methods: Health care professionals throughout the world can voluntarily enroll lamotrigine-exposed pregnancies in this obser vational study. Only pregnancies with unknown outcomes at the time of enrollment were included in the analysis. The percentage of outcomes with major birth defe cts was calculated as the total number of outcomes with major birth defects divi ded by the sum of the number of outcomes with major birth defects +the number o f live births without defects. Results: Among 414 first-trimester exposures to lamotrigine monotherapy, 12 outcomes with major birth defects were reported (2.9 %, 95%CI 1.6%to 5.1%). Among the 88 first-trimester exposures to lamotrigin e polytherapy including valproate, 11 outcomes with major birth defects were rep orted(12.5%; 95%CI 6.7%to 21.7%). Among 182 first-trimester exposures to la motrigine polytherapy excluding valproate, 5 outcomes with major birth defects w ere reported (2.7%, 95%CI 1.0%to 6.6%). No distinctive pattern of major birt h defects was apparent among the offspring exposed to lamotrigine monotherapy or polytherapy. Conclusions: The risk of all major birth defects after first-trim ester exposure to lamotrigine monotherapy(2.9%) was similar to that in the gene ral population and in other registries enrolling women exposed to antiepileptic monotherapy (3.3%to 4.5%). However, the sample size was too small to detect an y but very large increases in specific birth defects.
