Patterns of Outpatient Antihypertensive Medication Use During Pregnancy in a Medicaid Population
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02115. . Hypertension
(Impact Factor: 6.48).
09/2012; 60(4):913-20. DOI: 10.1161/HYPERTENSIONAHA.112.197095
Hypertensive disorders occur in approximately 6% to 8% of all pregnancies and are a significant source of maternal and fetal morbidity. Little is known about the range of agents routinely used in practice. We used Medicaid claims from 2000 to 2007 to identify completed pregnancies. We included women who were Medicaid beneficiaries from at least 3 months prior to last menstrual period to 1 month postdelivery, and were successfully linked to infant records. Maternal exposure to antihypertensive medications was derived from Medicaid pharmacy claim files, and duration of exposure was assigned based on the days' supply dispensed. We identified 1 106 757 Medicaid patients in our cohort, of whom 48 453 (4.4%) were exposed to antihypertensive medications during pregnancy. The prevalence of antihypertensive use increased from 3.5% to 4.9% during the study period. Antihypertensive medication users were older than nonusers, more likely to be white or black, and more likely to have comorbid diabetes mellitus and renal disease. Overall, 1.9% of pregnant women were exposed during the first trimester, 1.7% during the second trimester, and 3.2% during the third trimester. The range of antihypertensive medications to which patients were exposed was highly heterogeneous and frequently included agents other than methyldopa or labetalol. Angiotensin-converting enzyme inhibitor exposure, which is contraindicated in late pregnancy, occurred in 928 (4.9%) antihypertensive medication users in the second trimester and 383 (1.1%) in the third trimester. Antihypertensive use during pregnancy is relatively common and increasing. The wide range of agents used during pregnancy includes medications considered contraindicated during pregnancy.
Available from: Jolien W Roos-Hesselink
- "Equally, maternal treatment has the potential to exert a negative effect on the fetus, meaning that adequate and appropriate treatment is vital. Consequently, with the greater use of cardiac medication , it is crucial to have accurate information on the fetal effects of cardiac medication so that the advantages of treating the mother can be weighted against the possible negative effects on the baby. Most of the experience is on the treatment of hypertension and pre-eclampsia "
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Data on pharmacological management during pregnancy are scarce. The aim of this study was to describe the type and frequency of cardiac medication used in pregnancy in patients with cardiovascular disease and to assess the relationship between medication use and fetal outcome.
Methods and results
Between 2007 and 2011 sixty hospitals in 28 countries enrolled 1321 pregnant women. All patients had structural heart disease (congenital 66%, valvular 25% or cardiomyopathy 7% or ischemic 2%). Medication was used by 424 patients (32%) at some time during pregnancy: 22% used beta-blockers, 8% antiplatelet agents, 7% diuretics, 2.8% ACE inhibitors and 0.5% statins. Compared to those who did not take medication, patients taking medication were older, more likely to be parous, have valvular heart disease and were less often in sinus rhythm. The odds ratio of fetal adverse events in users versus non-users of medication was 2.6 (95% CI 2.0–3.4) and after adjustment for cardiac and obstetric parameter was 2.0 (95% CI 1.4–2.7). Babies of patients treated with beta-blockers had a significantly lower adjusted birth weight (3140 versus 3240 g, p = 0.002). The highest rate of fetal malformation was found in patients taking ACE inhibitors (8%).
One third of pregnant women with heart disease used cardiac medication during their pregnancy, which was associated with an increased rate of adverse fetal events. Birth weight was significantly lower in children of patients taking beta-blockers. A randomized trial is needed to distinguish the effects of the medication from the effects of the underlying maternal cardiac condition.
Available from: Donald R Mattison
- "The safety of beta-blockers (including labetalol) in pregnancy has not been well established, as some studies have reported an association between pregnancy exposure to beta-blockers and low birth weight infants   . The literature on the actual use of antihypertensive drugs in routine obstetric practice is sparse    . The objective of the present study was to assess trends and patterns of beta-blockers and methyldopa in pregnancy in general obstetric practice, using a population-based health care database in the Canadian province of Saskatchewan. "
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ABSTRACT: To describe trends in and patterns of antihypertensive drug use in a general obstetric population.
Historical cohort study. A total of 18,117 women who gave birth in a Saskatchewan hospital between January 1, 1980 and December 31, 2005 with a diagnosis of hypertensive disorders in pregnancy were identified and included in the analysis.
The rate of treatment with antihypertensive drugs for pregnant women with chronic hypertension rose from 19.94% in 1980-1984 to 37.63% in 2000-2005. There were similar increases in antihypertensive drug use from 1.51% to 14.47% for gestational hypertension/non-severe preeclampsia, and from 1.56% to 20.86% for severe preeclampsia/eclampsia. Methyldopa was the most frequently used drug, followed by beta-blockers, with other antihypertensive drugs accounting for about 18.43% of total uses. The use of both methyldopa and labetalol has increased in recent years while the use of other antihypertensive drugs has decreased. Other antihypertensive drugs were more commonly prescribed in earlier gestation, while methyldopa and labetalol were generally prescribed in later gestation.
The use of antihypertensive drugs in pregnancy is relatively common and is increasing, with the liberal use of methyldopa and (especially) labetalol contributing appreciably to this increase.
Available from: Mohammad Yakoob
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ABSTRACT: β-blockers are commonly used during the first trimester of pregnancy. Data about risks of congenital anomalies in offspring have not been summarized. We performed a meta-analysis to determine teratogenicity of β-blockers in early pregnancy. A systematic literature search was performed using PubMed, EMBASE, Cochrane Clinical Trials, and hand search. Meta-analyses were performed using random-effects models based on odds ratios (ORs). Prespecified subgroup analyses were performed to explore heterogeneity. Randomized controlled trials or observational studies examining risks of congenital malformations associated with first trimester β-blocker exposure compared with no exposure were included. Thirteen population-based case-control or cohort studies were identified. Based on meta-analyses, first-trimester oral β-blocker use showed no increased odds of all or major congenital anomalies (OR=1.00; 95% confidence interval, 0.91-1.10; 5 studies). However, in analyses examining organ-specific malformations, increased odds of cardiovascular defects (OR=2.01; 95% confidence interval, 1.18-3.42; 4 studies), cleft lip/palate (OR=3.11; 95% confidence interval, 1.79-5.43; 2 studies), and neural tube defects (OR=3.56; 95% confidence interval, 1.19-10.67; 2 studies) were observed. The effects on severe hypospadias were nonsignificant (1 study). Causality is difficult to interpret given the small number of heterogeneous studies and possibility of biases. Given the frequency of this exposure in pregnancy, further research is needed.
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