Risk of Opioid Overdose Associated with Concurrent Use of Hydrocodone and CYP3A4-inhibiting Calcium Channel Blockers: A Population-based Cohort Study.

Non-dihydropyridine calcium channel blockers (CCBs), including diltiazem and verapamil, inhibit cytochrome P450 3A4 (CYP3A4), an enzyme involved in the metabolism of hydrocodone, the most commonly used opioid in the United States (US). This study evaluated whether concomitant use of hydrocodone with CYP3A4-inhibiting CCBs increases the risk of opioid overdose compared to use of hydrocodone with amlodipine, a CCB that does not inhibit CYP3A4. Using three US databases (2000-2021), two cohorts were identified: (1) hydrocodone initiation while on CCB; and (2) CCB initiation while on hydrocodone.

Leveraging Health Insurance Claims Data to Complement the Centers for Disease Control and Prevention Surveillance System for Birth Defects.

Background: Birth defect surveillance can help identify temporo-spatial clusters and teratogenic signals to inform subsequent investigations or interventions. In the United States, state surveillance systems exist but collect limited information, prompting a complementary use of health insurance claims data to describe national birth defect prevalence trends and investigate signals.

Methods: The Merative MarketScan Commercial Claims and Encounters (MarketScan) database was used to identify liveborn infants from 2016 to 2022, with linkage to maternal health care records during pregnancy.

Buprenorphine and Methadone Discontinuation During Pregnancy and the Postpartum Period: A Nationwide Cohort Study.

Objective: Treatment of pregnant patients with opioid use disorder with methadone or buprenorphine is crucial for maternal and neonatal safety. While several clinical trials have demonstrated higher treatment discontinuation rates for buprenorphine compared with methadone outside of pregnancy, evidence during pregnancy and the postpartum period is limited. The authors compared treatment discontinuation between buprenorphine and methadone during pregnancy and over follow-up through 1 year postpartum.

Analgesic opioids in pregnancy and placental malperfusion-related disorders: a population-based cohort study.

Background: Analgesic opioid use in pregnancy could increase the risk of disorders related to placental malperfusion, but this relationship is incompletely characterized. We aimed to study the causal association between analgesic opioids in pregnancy and placental abruption, pre-eclampsia, preterm birth, and fetal growth restriction (FGR).

Methods: We conducted a population-based cohort study of pregnancies resulting in birth at ≥20 weeks of gestation between July 2013 and December 2019 in New South Wales, Australia.

Comparative Effectiveness and Safety of Labetalol Versus Nifedipine for Treatment of Chronic Hypertension During Pregnancy.

Background: Clinical guidelines recommend treatment of chronic hypertension during pregnancy, with either labetalol or nifedipine as the first-line medication.

Objectives: This study aimed to compare the effectiveness and safety of labetalol and nifedipine for the treatment of chronic hypertension during pregnancy.

Methods: We used a target trial emulation approach to compare new users of labetalol with new users of nifedipine.

Preconception, prenatal and early childhood exposure to green space and risk of neurodevelopmental delays: a national cohort study among Medicaid enrollees.

Background: Exposure to green space is associated with children's mental health, but its impact on neurodevelopment has been underexplored, especially in socioeconomically disadvantaged populations. This study examined the link between exposure to green space before, during, and after pregnancy and neurodevelopmental delays in children enrolled in Medicaid.

Methods: This cohort study of 1,841,915 mother-child pairs used data from the Medicaid Analytic Extract (MAX) from 2001 to 2014, with up to 14 years of follow-up.

Synthesizing Cohort Study Results to Promote Knowledge Transfer of Safety Data Regarding Gestational Antidepressant Exposure and Offspring Congenital Anomalies: A Test of Concept.

Background: Health practitioners tend to overestimate potential risks to pregnancy from antidepressant (AD) exposure. Through a literature review focused on major congenital anomalies (MCA) and cardiac anomalies (CA) in association with gestational AD exposure, we evaluated the strength of the available evidence and explored ways to facilitate communication of the evidence to providers and patients.

Methods: In PubMed, we searched English language publications, from January 2013 to March 2024, using search terms for ADs and MCA to identify cohort studies that took steps to minimize confounding and misclassification bias.

Antihypertensive treatment adherence during pregnancy by race and ethnicity.

Background: Recent evidence from the Chronic Hypertension and Pregnancy trial demonstrates that treatment of even mild chronic hypertension during pregnancy reduces the risk of severe adverse maternal, fetal, and neonatal outcomes. Black patients are disproportionately affected by hypertension-related morbidity during pregnancy. Outside of pregnancy, substantial racial and ethnic differences in antihypertensive medication adherence have been reported.

Modern Evidence Generation on Medication Effectiveness and Safety During Pregnancy: Study Design Considerations.

Non-randomized studies will remain the mainstay for evidence on medications' effects in pregnancy since the number of pregnant participants in randomized clinical trials is insufficient to evaluate uncommon but serious pregnancy outcomes. There has been a growing interest in conceptualizing causal inference based on observational data as an attempt to emulate a hypothetical randomized trial: the target trial. This approach can help identify design flaws and ensuing biases and can point toward potential solutions.

Global Trends in Analgesic Opioid Use in Pregnancy: A Retrospective Cohort Study.

Background: Pain is common during pregnancy, yet there are few contemporary studies of opioid use in pregnancy. This study aimed to describe prescription analgesic opioid use during pregnancy across four regions: Oceania (New South Wales, Australia, and New Zealand), North America (Ontario, Canada, and United States), Northern Europe (Denmark, Finland, Iceland, Norway, Sweden, and United Kingdom), and East Asia (Hong Kong, South Korea, and Taiwan).

Methods: A common protocol was applied to population-based data to measure analgesic opioid dispensing or prescriptions during pregnancy before birth in 2000 to 2020.

Accounting for Twins and Other Multiple Births in Perinatal Studies of Live Births Conducted Using Healthcare Administration Data.

The analysis of perinatal studies is complicated by twins and other multiple births even when multiples are not the exposure, outcome, or a confounder of interest. In analyses of infant outcomes restricted to live births, common approaches to handling multiples include restriction to singletons, counting outcomes at the pregnancy level (i.e.

Lithium Use During Pregnancy in 14 Countries.

Importance: In pregnancy, the benefits of lithium treatment for relapse prevention in psychiatric conditions must be weighed against potential teratogenic effects. Currently, there is a paucity of information on how and when lithium is used by pregnant women.

Objective: To examine lithium use in the perinatal period.

Development and validation of an algorithm to predict stillbirth gestational age in Medicaid billing records.

With Medicaid covering half of US pregnancies, Medicaid Analytic eXtract (MAX) provides a valuable data source to enrich understanding about stillbirth etiologies. We developed and validated a claims-based algorithm to predict gestational age (GA) at stillbirth. We linked the stillbirths identified in MAX 1999-2013 to Florida fetal death records (FDRs) to obtain clinical estimates of GA (n = 825).

Temporal variation in the effectiveness of biologics in asthma: Effect modification by changing patient characteristics.

Background: The underlying population of patients selected for each respiratory monoclonal antibody might change as other biologics are approved.

Objective: To evaluate effect modification by calendar time of the effectiveness of each respiratory biologics in asthma.

Methods: The Effectiveness of Respiratory biologics in Asthma (ERA) is a retrospective cohort of severe asthma patients from the Mass General Brigham clinics between January 2013 and September 2023.

Comparative Safety of In Utero Exposure to Buprenorphine Combined With Naloxone vs Buprenorphine Alone.

Importance: Buprenorphine combined with naloxone is commonly used to treat opioid use disorders outside of pregnancy. In pregnancy, buprenorphine alone is generally recommended because of limited perinatal safety data on the combination product.

Objective: To compare perinatal outcomes following prenatal exposure to buprenorphine with naloxone vs buprenorphine alone.

Hierarchical clustering analysis to inform classification of congenital malformations for surveillance of medication safety in pregnancy.

There is growing interest in the secondary use of health care data to evaluate medication safety in pregnancy. Tree-based scan statistics (TBSS) offer an innovative approach to help identify potential safety signals; they use hierarchically organized outcomes, generally based on existing clinical coding systems that group outcomes by organ system. When assessing teratogenicity, such groupings often lack a sound embryologic basis, given the etiologic heterogeneity of congenital malformations.