Pravastatin for early-onset pre-eclampsia: a randomised, blinded, placebo-controlled trial.

A Ahmed, D J Williams, V Cheed, L J Middleton, S Ahmad, K Wang, A T Vince, P Hewett, K Spencer, K S Khan, J P Daniels, StAmP trial Collaborative Group

BJOG : an international journal of obstetrics and gynaecology 2020 Mar

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Women with pre-eclampsia have elevated circulating levels of soluble fms-like tyrosine kinase-1 (sFlt-1). Statins can reduce sFlt-1 from cultured cells and improve pregnancy outcome in animals with a pre-eclampsia-like syndrome. We investigated the effect of pravastatin on plasma sFlt-1 levels during pre-eclampsia. Blinded (clinician and participant), proof of principle, placebo-controlled trial. Fifteen UK maternity units. We used a minimisation algorithm to assign 62 women with early-onset pre-eclampsia (24+0 -31+6 weeks of gestation) to receive pravastatin 40 mg daily (n = 30) or matched placebo (n = 32), from randomisation to childbirth. Difference in mean plasma sFlt-1 levels over the first 3 days following randomisation. The difference in the mean maternal plasma sFlt-1 levels over the first 3 days after randomisation between the pravastatin (n = 27) and placebo (n = 29) groups was 292 pg/ml (95% CI -1175 to 592; P = 0.5), and over days 1-14 was 48 pg/ml (95% CI -1009 to 913; P = 0.9). Women who received pravastatin had a similar length of pregnancy following randomisation compared with those who received placebo (hazard ratio 0.84; 95% CI 0.50-1.40; P = 0.6). The median time from randomisation to childbirth was 9 days (interquartile range [IQR] 5-14 days) for the pravastatin group and 7 days (IQR 4-11 days) for the placebo group. There were three perinatal deaths in the placebo-treated group and no deaths or serious adverse events attributable to pravastatin. We found no evidence that pravastatin lowered maternal plasma sFlt-1 levels once early-onset pre-eclampsia had developed. Pravastatin appears to have no adverse perinatal effects. Pravastatin does not improve maternal plasma sFlt-1 or placental growth factor levels following a diagnosis of early preterm pre-eclampsia #clinicaltrial finds. © 2019 Royal College of Obstetricians and Gynaecologists.

Citation

A Ahmed, D J Williams, V Cheed, L J Middleton, S Ahmad, K Wang, A T Vince, P Hewett, K Spencer, K S Khan, J P Daniels, StAmP trial Collaborative Group. Pravastatin for early-onset pre-eclampsia: a randomised, blinded, placebo-controlled trial. BJOG : an international journal of obstetrics and gynaecology. 2020 Mar;127(4):478-488