TOPLINE:
Buprenorphine combined with naloxone during pregnancy is associated with lower risks for neonatal abstinence syndrome and neonatal intensive care unit admission than buprenorphine alone. The study also found no significant differences in major congenital malformations between the two treatments.
METHODOLOGY:
- Researchers conducted a population-based cohort study using healthcare utilization data of people who were insured by Medicaid between 2000 and 2018.
- A total of 8695 pregnant individuals were included, with 3369 exposed to buprenorphine/naloxone and 5326 exposed to buprenorphine alone during the first trimester.
- Outcome measures included major congenital malformations, low birth weight, neonatal abstinence syndrome, neonatal intensive care unit admission, preterm birth, respiratory symptoms, small for gestational age, cesarean delivery, and maternal morbidity.
- The study excluded pregnancies with chromosomal anomalies, first-trimester exposure to known teratogens, or methadone use during baseline or the first trimester.
TAKEAWAY:
- According to the authors, buprenorphine/naloxone exposure during pregnancy was associated with a lower risk for neonatal abstinence syndrome (weighted risk ratio [RR], 0.77; 95% CI, 0.70-0.84) than buprenorphine alone.
- The researchers found a modestly lower risk for neonatal intensive care unit admission (weighted RR, 0.91; 95% CI, 0.85-0.98) and small risk for gestational age (weighted RR, 0.86; 95% CI, 0.75-0.98) in the buprenorphine/naloxone group.
- No significant differences were observed between the two groups in major congenital malformations, low birth weight, preterm birth, respiratory symptoms, or cesarean delivery.
IN PRACTICE:
“For the outcomes assessed, compared with buprenorphine alone, buprenorphine combined with naloxone during pregnancy appears to be a safe treatment option. This supports the view that both formulations are reasonable options for treatment of OUD in pregnancy, affirming flexibility in collaborative treatment decision-making,” the study authors wrote.
SOURCE:
The study was led by Loreen Straub, MD, MS, of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School in Boston. It was published online in JAMA.
LIMITATIONS:
Some potential confounders, such as alcohol use and cigarette smoking, may not have been recorded in claims data. The findings for many of the neonatal and maternal outcomes suggest that confounding by unmeasured factors is an unlikely explanation for the associations observed. Individuals identified as exposed based on filled prescriptions might not have used the medication. The study used outcome algorithms with relatively high positive predictive values to minimize outcome misclassification. The cohort was restricted to live births to enable linkage to infants and to assess neonatal outcomes.
DISCLOSURES:
Various authors reported receiving grants and personal fees from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute on Drug Abuse, Roche, Moderna, Takeda, and Janssen Global, among others.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.