atorvastatin postpartum and reduction of cardiovascular risk

Conditions: Hypertensive Disorders of Pregnancy; Preeclampsia; Gestational Hypertension

Summary: the objective is to conduct a double-blinded randomized controlled trial of atorvastatin vs. placebo among postpartum individuals with hypertensive disorders of pregnancy, to improve cardiovascular risk score postpartum. for this, 76 individuals with hypertensive disorders of pregnancy (hdp) will be randomized to atorvastatin 10mg or placebo, which will be started in the postpartum period after cessation of breast feeding and continued for 3 months.

individuals will be followed for up to 1 year to address the following specific aims: specific aim 1: to determine if among individuals diagnosed with hypertensive disorders of pregnancy (hdp), the use of atorvastatin 10 mg daily initiated in the postpartum period following cessation of breastfeeding and continued for 3 months, lowers cardiovascular risk, as measured by the framingham risk score for cardiovascular disease (30 year risk, primary outcome) and cardiovascular risk prediction model (prevent, secondary outcome) compared with placebo; and if the benefit will persist for at least 3-6 months following discontinuation of atorvastatin treatment. specific aim 2: to determine if among individuals diagnosed with hdp the use of atorvastatin 10 mg daily initiated in the postpartum period following cessation of breastfeeding and continued for 3 months lowers the frequency of metabolic syndrome, improves lipid levels, and reduces inflammatory markers compared with placebo; and if this benefit will persist for at least 3-6 months following discontinuation of atorvastatin treatment.

Eligibility criteria:
inclusion criteria: 1. at least 24 hours after delivery 2. ≥ 20 years old with the ability to give informed consent 3. diagnosis of gestational hypertension, preeclampsia prior to delivery admission, or diagnosed with preeclampsia during delivery admission, as determined by clinical team using the american college of obstetricians and gynecologists (acog) criteria. 4. english speaking exclusion criteria: 1. individuals who were prescribed an 3-hydroxy-3 methyl-glutaryl coenzyme a (hmg-coa) reductase inhibitor prior to or during pregnancy, 2. known familial hypercholesterolemia or pre-existing hyperlipidemia, specifically low-density lipoprotein (ldl) \>190 prior to pregnancy or diagnosis of hyperlipidemia with prescription of hmg-coa reductase inhibitor prior to delivery, 3. plan to breastfeed for \>= 6 months, 4. plan for pregnancy conception in the next 6 months, 5. incarcerated individuals, 6. hypertensive diagnosis thought to be secondary to fetal condition, 7. contraindications to hmg-coa reductase inhibitor therapy or known hypersensitivity to atorvastatin or any component, 8. active liver disease (acute hepatitis, chronic active hepatitis, unexplained persistent transaminitis (at least twice upper limit of normal serum transaminases)), 9. history of rhabdomyolysis or myopathy, 10. human immunodeficiency virus (hiv) positivity, due to potential interactions between atorvastatin and hiv protease inhibitors, 11. history of solid organ transplant, due to potential interactions between atorvastatin and immunosuppressants 12. active cancer, or 13. current use of medications with potential drug interactions, namely cyclosporine, clarithromycin, itraconazole, hiv protease inhibitors, rifampin, and digoxin.

Keywords: hypertensive disorders of pregnancy atorvastatin treatment pregnancy preeclampsia