Wednesday, December 23, 2015

Is Pravastatin the magic Bullet to quench Preeclampsia!


Preeclampsia complicates approximately 3-5% of pregnancies and remains one of the major causes of maternal and neonatal morbidity. In fact it is linked to one in 20 stillbirths.

The human placenta is central to the development of preeclampsia. The incidence of preeclampsia increases as pregnancy proceeds from singleton to twin, triplets and quadruplets as the mass of placenta increases.

It shares pathogenic similarities with adult cardiovascular disease as well as many risk factors. According to American Heart Association Preeclampsia doubles the risk for stroke and quadruples the risk for high blood pressure later in life.

Worldwide attempts to prevent preeclampsia using various supplements or other class of drugs have met with limited success, so a policy regarding there use could not be adopted.

In contrast the reduction of Cardiovascular Morbidity and Mortality using 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase inhibitors, or statins, is widely accepted.

Pravastatin and other statins have shown to reverse various pathophysiologic pathways associated with preeclampsia, such as angiogenic imbalance, endothelial injury, inflammation, and oxidative stress.
Therefore, According to a forthcoming article is the ACOG Journal, Eunice Kennedy Shriver National Institute of Child Health and Human Development Obstetric--Fetal Pharmacology Research Units Network undertook a pilot trial to collect maternal--fetal safety data and to evaluate pravastatin pharmacokinetics when used as a prophylactic daily treatment in high-risk pregnant women.

So, we now have encouraging data from 3 small  pilot clinical trials across the globe.

A small observational pilot study by Dr. Fiona C. Brownfoot carried out at the University of Melbourne in Heidelberg, Victoria, Australia, showed promising results in stabilizing the disease process, resolving the symptoms.

The second trial is known as StAmP trial. StAmP stands for ‘Statins to Ameliorate early-onset Pre-eclampsia’ initiated by Vascular Research team at Aston Medical School, Birmingham, U.K. It is the world’s first randomized controlled clinical trial on the use of statins in pregnancy, and has the potential to completely transform the way we treat preeclampsia. The trial has recruited 64 patients and the final results are awaited.

Professor Asif Ahmed of Aston University, who led the UK trial, said: ‘Although we don’t know the full results, I believe there were no ill effects among the 64 women involved. What we have discovered here is a way of putting the brakes on pre-eclampsia.’

Meanwhile, the results of the small pilot RCT by Eunice Kennedy Shriver National Institute of Child Health and Human Development Obstetric--Fetal Pharmacology Research Units have shown promising results.

It is a pilot, multicenter, double-blind, placebo-controlled, randomized trial of women with singleton, non-anomalous pregnancies at high risk for preeclampsia

The 10 women in this study received 10 mg of oral Pravastatin daily, started between 12-16 weeks, while the 10 controls received placebos.

Primary outcomes were maternal-fetal safety and pharmacokinetic parameters of pravastatin during pregnancy.

Secondary outcomes included rates of preeclampsia and preterm delivery, gestational age at delivery, birth weight, and maternal and cord blood lipid profile.

Four subjects in the placebo group developed preeclampsia compared to none in the pravastatin group.

This study provides preliminary safety and pharmacokinetic data regarding the use of pravastatin for preventing preeclampsia in high-risk pregnant women. Although the data are preliminary, no identifiable safety risks were associated with pravastatin use in this cohort.

 This favorable risk-benefit analysis justifies using pravastatin in a larger clinical trial with dose escalation.


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