Pravastatin of no benefit in women at high pre-eclampsia risk

Use of pravastatin falls short of reducing the incidence of delivery with pre-eclampsia among high-risk women, according to a study.

In the study, a total of 1,120 women with singleton pregnancies at high risk of term pre-eclampsia were randomized to receive pravastatin at 20 mg/d or placebo. Treatment was given from 35 to 37 weeks of gestation until delivery or 41 weeks. There were 29 women who withdrew consent during the trial.

Pre-eclampsia occurred in 80 out of 548 (14.6 percent) women in the pravastatin group and in 74 out of 543 (13.6 percent) in the placebo group. On a mixed-effects Cox regression analysis that allowed for the effect of risk at the time of screening and participating centre, pravastatin treatment did not lead to a significant reduction in the incidence of delivery with pre-eclampsia compared with placebo (hazard ratio, 1.08, 95 percent confidence interval, 0.78–1.49; p=0.65).

There was no evidence of interaction between the effect of pravastatin, estimated risk of pre-eclampsia, pregnancy history, adherence, and aspirin treatment. Furthermore, pravastatin yielded effects similar to placebo in terms of the incidence of any secondary outcomes, such as gestational hypertension, stillbirth, abruption, delivery of small for gestational age neonates, neonatal death, or neonatal morbidity.

At 1 and 3 weeks following randomization, serum placental growth factor and soluble fms-like tyrosine kinase-1 concentrations were not significantly different between the pravastatin and placebo groups.

Meanwhile, adherence was satisfactory. Most participants (89 percent) had a reported intake of ≥80 percent of the required number of tablets. There were significant between-group differences in neither adverse neonatal outcomes nor other adverse events.