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. 2019 Aug 6;8(15):e012093.
doi: 10.1161/JAHA.119.012093. Epub 2019 Jul 26.

Safety of Amlodipine in Early Pregnancy

Asako Mito  1   2 , Atsuko Murashima  1   2 , Yoshinao Wada  3 , Mai Miyasato-Isoda  4 , Chizuko A Kamiya  5 , Masako Waguri  3 , Jun Yoshimatsu  5 , Naho Yakuwa  1 , Omi Watanabe  1 , Tomo Suzuki  1   6 , Naoko Arata  1   2 , Masashi Mikami  7 , Shinya Ito  8
Affiliations

Safety of Amlodipine in Early Pregnancy

Asako Mito et al. J Am Heart Assoc. .

Abstract

Background Amlodipine is used for the treatment of hypertension, but reports on its use in early pregnancy are limited. Methods and Results In the present study, we recruited 231 women with chronic hypertension, including those who received amlodipine or other antihypertensives during early pregnancy, and investigated frequencies of morphologic abnormalities in their 231 offspring. Specifically, we evaluated 48 neonates exposed to amlodipine in the first trimester (amlodipine group, Group A), 54 neonates exposed to antihypertensives other than amlodipine (other antihypertensive group, Group O), and 129 neonates not exposed to antihypertensives (no-antihypertensive group, Group N). The number of morphologic abnormalities of offspring in each group were 2 in Group A (4.2%; 95% CI, 0.51-14.25); 3 in Group O (5.6%; 95% CI, 1.16-15.39) and 6 in Group N (4.7%; 95% CI, 1.73-9.85). The odds ratio of the primary outcome comparing Group A and Group O was 0.74 (95% CI: 0.118-4.621) and Group A and Group N was 0.89 (95% CI: 0.174-4.575). Conclusions The odds of birth defects in Group A in the first trimester were not significantly different from those with or without other antihypertensives.

Keywords: amlodipine; chronic hypertension; first trimester; pregnancy.

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Figures

Figure 1
Figure 1
Flow chart representing the recruiting process of study subjects. There were 25 485 live births delivered in this period. Among them, there were 1624 singletons with “Hypertension” documented in their mothers’ electronic medical records or “Chronic hypertension” in the delivery records. After excluding those who did not meet criteria of chronic hypertension, a total of 231 neonates were included in the final analyses.
Figure 2
Figure 2
Unmeasured confounder‐birth defects odds ratio. The 95% CI was estimated by the range of 2.5 and 97.5 percentile points of exp (log [odds ratio]+error), which was calculated by Monte Carlo simulations. The error term was randomly sampled from the Normal distribution with mean 0 and the SD, which was substituted by the SE of unadjusted log odds ratio.
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