In a recent study, long-term neurodevelopmental outcomes were improved in children of parents receiving pravastatin compared to placebo.
According to a recent study published in the American Journal of Obstetrics & Gynecology, pravastatin use improves motor and cognitive functions in children and is not associated with safety risks.
Preeclampsia affects 3% to 8% of pregnant women and causes over 70,000 maternal deaths and over 500,000 preterm births per year worldwide. Long-term adverse cognitive, neurodevelopmental, and motor outcomes in offspring are also associated with preeclampsia. Preventing preeclampsia may reduce the prevalence of these outcomes.
Data has indicated pravastatin, a hydrophilic hydroxymethylglutaryl-coenzyme A reductase inhibitor, may be used for preeclampsia prevention. It has also been associated with improved perinatal outcomes in patients with antiphospholipid syndrome during pregnancy.
Use of pravastatin during pregnancy is supported by safety data. However, it is unclear how long-term child neurodevelopment is affected by the drug. To determine how child long-term health, growth, and neurodevelopment are impacted by antenatal pravastatin treatment in high-risk pregnant patients, investigators conducted an ancillary follow-up cohort study.
Participants included children of individuals who participated in the Obstetric-Fetal Pharmacology Research Centers Network trial, which compared outcomes of pravastatin vs placebo. Mothers in the trial had singleton, nonanomalous pregnancies and a history of preeclampsia.
Patients in the first trial were randomized into a 10-mg pravastatin group or placebo group, while those in the second trial were randomized into a 20-mg pravastatin group or placebo group. Children of these patients aged over 2 years who consented were included in the ancillary study.
Participating families attended a follow-up visit with their child at the original clinic center of participation. Families unable to visit the center were visited by research staff at their home. Otherwise, a virtual interview or consultation of the child’s medical records was conducted.
Study staff collected participating children’s medical history and measured their weight, height, and motor function. Cognitive, motor, and language scores were evaluated using the Bayley Scales of Infant and Toddler Development III or Differential Ability Scales-Second Edition depending on child age.
Outcomes included child height, weight, body mass index (BMI) percentiles, rates of extreme BMI percentiles, vision or hearing impairments, and general medical complications. Motor outcomes were evaluated on the Gross Motor Function Classification System and Manual Abilities Classification System.
Developmental and cognitive outcomes included cognitive, motor, and language scores. For children assessed with the Bayley Scales of Infant and Toddler Development III, the mean score was 100, with scores under 85 categorized as below the mean.
In the pravastatin group, a gestational age at birth of 37.5±1.4 weeks was reported, compared to the placebo group with a gestational age of 36.5±2.5. The median follow-up time of 4.7 years did not differ between the 2 groups.
In the placebo group, 6.7% were underweight and 26.7% obese, compared to 0% and 14.3% respectively in the pravastatin group. Hearing impairments were not reported, and other medical or behavioral complications did not differ between groups.
No limitations in gross motor function were observed in the pravastatin group, while difficulty walking and reduced manual abilities were reported in 13.3% and 26.7% of the placebo group, respectively.
A higher mean General Conceptual Ability (GCA) score was also observed in the pravastatin group compared to the placebo group, along with a lower rate of GCA scores below 85. However, these differences were not statistically significant.
These results indicated improved long-term neurodevelopmental outcomes among children of parents who used pravastatin during pregnancy. Investigators concluded this study supported further use of pravastatin in clinical trials.
Costantine MM, Clifton RG, Boekhoudt TM, Longo M, Saade GR. Long-term neurodevelopmental follow-up of children exposed to pravastatin in utero. American Journal of Obstetrics & Gynecology. 2023;229(2):53.E1-53.E12. doi:10.1016/j.ajog.2023.02.016
This article was initially published by our sister publication, Contemporary OB/GYN®.