preeclampsia prevention: review of …/media/images/swedish/cme1/syllabuspdf… · u.s. preventive...
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Alicia Parsons, MD, MPH
Swedish Family Medicine Advanced Obstetrics Fellow
PREECLAMPSIA PREVENTION: REVIEW OF GUIDELINES & NEW AREAS OF RESEARCH
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Why prevent preeclampsia?
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Objectives1. Understand current guidelines for preeclampsia prevention.
2. Review studies on the efficacy of low dose aspirin use for preeclampsia prevention.
3. Discuss new areas of research in preeclampsia prevention.
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Framework for PresentationAmerican College of Obstetricians and Gynecologists (ACOG)
2013 Hypertension in Pregnancy Task Force Report
U.S. Preventive Services Task Force (USPSTF)
2014 Recommendation Statement on Low-dose Aspirin in Preeclampsia Prevention
Norton, Mary. What Is New in the Prevention of Preeclampsia?: Best Articles From the Past Year. Obstetrics & Gynecology 2016;128:651-2.
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Preeclampsia DefinitionACOG 2013 Guidelines:
• New onset BP>/=140/90 on 2 reads 4hr apart after 20wk GA
and
• Proteinuria
• >/= 300 mg on 24hr urine or
• P/C ratio >/= 0.3mg/dL
• Dipstick 1+ if other methods NOT available
or
• Severe Features with or without Proteinuria (other than severe range BP)
ACOG 2013
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Preeclampsia with Severe Features• BP>/=160/110 on 2 reads (4 hours apart on bed rest or spaced
minutes apart if antihypertensive initiated before)
• Platelets <100,000
• LFTs 2x normal
• Severe RUQ or epigastric pain persistent and not explained by other Dx
• Cr >1.1 or doubling of baseline Cr without other renal disease
• Pulmonary edema
• New headache or visual changes
ACOG 2013
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2013 Preeclampsia Definition Update• Proteinuria not required
• Massive proteinuria not a severe feature
• IUGR not criteria
• No more “mild” or “severe” preeclampsia
ACOG 2013
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Preeclampsia Background• Placental dysfunction
• Maternal endothelial dysfunction
• Inflammation
• Prostacyclin-thromboxane imbalance -> vasoconstriction and platelet aggregation
ACOG 2013Duley et al. 2007
Redman and Sargent 2005
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Schramm and Clowse 2014
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Schramm and Clowse 2014
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ACOG 2013 Guidelines
• 60-80mg aspirin daily starting in first trimester for
• Women with Hx of preeclampsia <34wk
or
• Preeclampsia in greater than one prior pregnancy
• No acute risk seen with aspirin
• Long-term fetal effects not known
ACOG 2013
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ACOG 2013 Guidelines
• Calcium supplement in calcium deficient patients
• Deficiency <600mg/day at baseline
• Benefit not seen in developed countries
ACOG 2013
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ACOG 2013 GuidelinesUnknown/Insufficient Evidence:
• Vitamin D
• Fish oil
• Garlic
• Moderate exercise
ACOG 2013
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ACOG: What doesn’t help• Vit C or E
• Protein and calorie restriction in obese women
• Salt restriction
• Diuretics
• Bed rest/physical activity restriction
ACOG 2013
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USPSTF Recommendations• Aspirin 81mg starting at 12-16wk for women at high risk for
preeclampsia
• One high risk criteria – start aspirin
• Two moderate risk criteria – consider aspirin
• Grade B evidence
USPSTF 2014
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USPSTF Recommendations Risk Criteria
USPSTF 2014
High Moderate Low
-Hx preeclampsia-Multifetal gestation-CHTN-Type 1 or 2 DM-Kidney disease-Autoimmune disease
-Nulliparity-BMI>30-FHx preeclampsia (1st degree)-Sociodemographic (African American, low socioeconomic status)-AMA-Personal Hx factor (incl. low birthweight or SGA, previous adverse pregnancy outcome, >10 yr since last pregnancy)
-Previousuncomplicated term delivery
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Aspirin• Anti-inflammatory
• Blocks thromboxane synthesis
ACOG 2013
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Efficacy of Low Dose Aspirin• Mixed conclusions in past
• Small initial studies show aspirin effective
• 3 larger RCT did not show significant benefit
• No major adverse outcomes
ACOG 2013
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Efficacy of Low Dose AspirinCochrane meta-analysis 2007 (updated 2010)
• Anti-platelet agents to prevent preeclampsia
• 37,560 women
• 59 trials (51 studied aspirin alone)
• 17% risk reduction preeclampsia (RR 0.83, 95% CI 0.77-0.89)
ACOG 2013Duley et al. 2007
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Cochrane Meta-analysis 2007
• NNT with antiplatelet agent to prevent preeclampsia
• 72 women (52, 119)
• 19 high risk women (13, 34)
• 119 moderate risk women (73, 333)
ACOG 2013Duley et al. 2007
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Cochrane Meta-analysis 2007 • 8% risk reduction preterm birth (RR 0.92, 95% CI 0.88-0.97)
• 14% risk reduction fetal/newborn/infant death (RR 0.86, 95% CI 0.76-0.98)
• 10% risk reduction small for gestational age births (RR 0.9, 95% CI 0.83-0.98)
• Safe
• No significant increased risk abruption, maternal death, C/S, fetal intraventricular hemorrhage or neonatal bleeding
Duley et al. 2007
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Cochrane Meta-analysis 2007
• Small trials mostly positive
• Publication bias?
• Exact GA to start aspirin
• Noted higher efficacy with higher doses aspirin – need a study to compare doses
Limitations: Key areas of future study:
Duley et al. 2007
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A closer look at aspirin…• What gestational age to start aspirin?
• Which guidelines to use to determine preeclampsia risk?
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What gestational age to start aspirin? Roberg et al. 2016
• Meta-analysis of RCTs looking at benefits of aspirin in pregnancy
• 6 studies, 3 sent data
• Had to have at least 350 people
• 11949 participants total; 3293 recruited before 17 wk
• 60mg aspirin dose, started before or after 17wk gestation
• Outcomes: preeclampsia, preeclampsia with SF, SGA
Roberg et al. 2016
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What gestational age to start aspirin?
No difference between starting aspirin before or after 17wk GA
• RR preeclampsia before 17 wk 0.93 (CI 0.75-1.15)
• RR preeclampsia at or after 17wk 0.93 (CI 0.7-1.23)
• Difference between groups p=0.99, not significant
Future study implications:
• Need a large RCT to study further
• Need to study a dose larger than 60mg
Roberg et al. 2016
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Which guidelines to use? Werner et al. 2015
• Attempted to create a decision model based on cost
• Compared 4 protocols of preeclampsia aspirin prevention:
• No aspirin
• ACOG guidelines
• USPSTF guidelines
• Universal aspirin
• Included cost of aspirin, preeclampsia, preterm birth and adverse outcome of aspirin
• Aspirin started at first prenatal visit and continued until delivery
Werner et al. 2015
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Which guidelines to use?
Approach Rate of Preeclampsia
% getting Aspirin $ saved compared to no Aspirin *
No Aspirin 4.18% 0%
ACOG 4.17% 0.35% $12 million
USPSTF 3.83% 23.5% $377 million
Universal Aspirin 3.81% 100% $365 million
Werner et al. 2015
*Assumes 4 million births per year.
USPSTF guidelines: Similar cost savings to universal aspirin use, ¼ women treated.
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Which guidelines to use? • USPSTF criteria or universal aspirin prophylaxis – both pragmatic
and cost effective
• Recommended USPSTF criteria
• Similar cost benefit but only ¼ women treated -> less risk
• Adverse event of GI bleed, abruption, aspirin exacerbated respiratory disease
Werner et al. 2015
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New Areas of Research• Statins
• Metformin
• Enoxaparin
• Exercise
• Vitamin D
• Screening algorithms
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Statins in Pregnancy?Costantine et al. 2016
•Pravastatin – cat X due to lack of indication rather than documented risk
•Animal preeclampsia models: statins help angiogenic balance and endothelial function.
Costantine et al. 2016
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Statins in Pregnancy?• Pilot study, first of a series of studies
• FDA-approved investigational new drug study
• Collaborated with NICHD
• Double blind placebo controlled RCT focused on safety and pharmakineticsof 10mg pravastatin
• 20 women 12.0-16.6 wk at high preeclampsia risk
• Randomized to daily pravastatin 10mg vs placebo
• Took statin until delivery or a condition developed that required the drug be discontinued
Costantine et al. 2016
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Statins in Pregnancy?• Side Effects: musculoskeletal pain and heartburn
• No myopathy, rhabdo or liver injury
• Reduced maternal cholesterol but not fetal
Costantine et al. 2016
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Statins in Pregnancy?• No maternal, fetal or infant deaths
• No identified safety risks associated with 10mg pravastatin
Pravastatin Placebo
Preeclampsia 0 4 (3 with SF)
Preterm del (<37) 1 5
Small for GA 0 1
NICU 2 5
Fetal anomalies Hypospadias Polydactyly
Coarctation of the aorta
Ventriculomegaly
Maternal compl. none Postpartum hysterectomy 2/2 to placenta previaand atony
Costantine et al. 2016
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Statins in Pregnancy?• Promising findings – justifies larger study, dose evaluation
• Potential to be more effective than aspirin
• Follow up with infants planned at 5 yr of age
Costantine et al. 2016
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Public Health SignificanceMain et al. 2015
•207 pregnancy related deaths over 2002-2005 in CA
•Preeclampsia/ecclampsia is 2nd leading cause – 17% cases (second to cardiovascular)
•Concluded 60% preeclampsia deaths could have been prevented
•Aspirin prophylaxis can influence maternal death rate (Norton 2016)
Main et al. 2015
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Objectives1. Understand current guidelines for preeclampsia prevention.
2. Review studies on the efficacy of low dose aspirin use for preeclampsia prevention.
3. Discuss new areas of research in preeclampsia prevention.
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Conclusions• Aspirin 81mg daily starting at 12-16wk gestation in high risk patients
• Aspirin is safe
• Need further study on long-term impact on childhood development
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Conclusions continued• Calcium supplement benefit in calcium deficient women in
developing countries
• New areas of research: statins, metformin, enoxaparin, exercise, vitamin D and screening algorithms.
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Why prevent preeclampsia?
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Conclusions continued• Preeclampsia prevention clinical and public health impact: can
greatly benefit maternal and infant morbidity and mortality
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QUESTIONS?
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References• American College of Obstetricians and Gynecologists. Hypertension in pregnancy. Report of the American College of Obstetricia ns and Gynecologists’ Task
Force on Hypertension in Pregnancy. 2013. 1- 11, 27-30. http://www.acog.org/Resources-And-Publications/Task-Force-and-Work-Group-Reports/Hypertension-in-Pregnancy. Accessed 2/6/17.
• Brownfoot FC, Hastie R, Hannan NJ, et al. Metformin as a prevention and treatment for pre -eclampsia: effects on soluble fms-like tyrosine kinase 1 and soluble endoglin secretion and endothelial dysfunction. American Journal of Obstetrics & Gynecology 2016;214:356.e1 -15.
• Costantine MM, Cleary K, Hebert MF, et al. Safety and pharmacokinetics of pravastatin used for the prevention of preeclampsia in high-risk pregnant women: a pilot randomized controlled trial. American Journal of Obstetrics & Gynecology 2016;214:720.e1 -17.
• Duley L, Henderson-Smart DJ, Meher S, King JF. Antiplatelet agents for preventing pre-eclampsia and its complications. Cochrane Database of Systematic Reviews 2007, Issue 2. Art. No.: CD004659. DOI: 10.1002/14651858.CD004659.pub2.
• Final Recommendation Statement: Low-Dose Aspirin Use for the Prevention of Morbidity and Mortality From Preeclampsia: Preventive Medication . U.S. Preventive Services Task Force. 2014. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFina l/low-dose-aspirin-use-for-the-prevention-of-morbidity-and-mortality-from-preeclampsia-preventive-medication. Accessed 2/6/17.
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