July 25, 2016

expert reaction to study investigating use of a statin and birth outcomes in women with the autoimmune condition antiphospholipid syndrome

Publishing in the Journal of Clinical Investigation a group of researchers have reported that in a small group of 21 pregnant women with obstetric antiphospholipid syndrome (APS), the use of a specific statin was associated with improved pregnancy outcomes in terms of complications such as preeclampsia.

Dr Jennifer Hollowell, Senior epidemiologist (maternal health), National Perinatal Epidemiology Unit (NPEU), University of Oxford, said:

“This study is un-randomised and there is no evidence that adequate steps were taken to ensure that the groups were comparable.  The doctors treating the statin-treated women were explicitly trying to delay delivery until 37 weeks so may well have managed those women differently from those in the untreated control group, many of whom had elective early deliveries.

“This is an interesting exploratory study that suggests that further research into the use of statins in pregnant women with difficult to treat antiphospholipid syndrome (APS) may be merited. But the study is small and un-randomised so it is premature to suggest that the study has demonstrated that pravastatin reduces premature birth and improves babies’ survival in this group of women.”

Prof Peter Weissberg, Medical Director at the British Heart Foundation, said:

“The results of this study are very promising. Women with antiphospholipid syndrome can have very difficult pregnancies with dangers to both the mother and the child.

“This study shows that adding a statin to routine medication can have a rapidly beneficial impact on progress of the pregnancy and outcome for both mother and child. If the results of this small study are confirmed in a larger, randomised, placebo controlled trial then it will herald a cheap and effective way of combatting a devastating condition.”

Dr Jenny Myers, Clinician Scientist and Senior Lecturer in Maternal and Fetal Health, University of Manchester, said:

“The study demonstrates a very striking association with pravastatin treatment in women with antiphospholipid syndrome (APLS) who developed fetal growth restriction and pre-eclampsia. All parameters improved in those women treated with pravastatin.

“However, this was not a randomised controlled trial and the treatment was not concealed from the women or their care givers – this could considerably bias the results. In addition, the numbers are small and therefore the results need to be interpreted with caution, and it’s worth remembering all the women involved in this study had antiphospholipid syndrome, so we can’t say the results would apply more widely.

“The results of another study of statins for the treatment of pre-eclampsia is awaited and if this reports similar findings this will set the scene for larger randomised trials. Treatment with statins for placental insufficiency shows great promise but there is still concern regarding the long term effects of these drugs on the baby and therefore longer term follow up studies are also extremely important.”

‘Pravastatin improves pregnancy outcomes in obstetric antiphospholipid syndrome refractory to antithrombotic therapy’ by Eleftheria Lefkou et al.  published in the Journal of Clinical Investigation on Monday 25 July 2016. 

Declared interests

Prof. Peter Weissberg: “No interests to declare.”

No others received.