Pravastatin Versus Placebo in Pregnancies at High Risk of Term Preeclampsia
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Pravastatin Versus Placebo in Pregnancies at High Risk of Term Preeclampsia. / Döbert, Moritz; Varouxaki, Anna Nektaria; Mu, An Chi; Syngelaki, Argyro; Ciobanu, Anca; Akolekar, Ranjit; De Paco Matallana, Catalina; Cicero, Simona; Greco, Elena; Singh, Mandeep; Janga, Deepa; Del Mar Gil, Maria; Jani, Jacques C; Bartha, José Luis; Maclagan, Kate; Wright, David; Nicolaides, Kypros H.
in: CIRCULATION, Jahrgang 144, Nr. 9, 31.08.2021, S. 670-679.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Pravastatin Versus Placebo in Pregnancies at High Risk of Term Preeclampsia
AU - Döbert, Moritz
AU - Varouxaki, Anna Nektaria
AU - Mu, An Chi
AU - Syngelaki, Argyro
AU - Ciobanu, Anca
AU - Akolekar, Ranjit
AU - De Paco Matallana, Catalina
AU - Cicero, Simona
AU - Greco, Elena
AU - Singh, Mandeep
AU - Janga, Deepa
AU - Del Mar Gil, Maria
AU - Jani, Jacques C
AU - Bartha, José Luis
AU - Maclagan, Kate
AU - Wright, David
AU - Nicolaides, Kypros H
PY - 2021/8/31
Y1 - 2021/8/31
N2 - BACKGROUND: Effective screening for term preeclampsia is provided by a combination of maternal factors with measurements of mean arterial pressure, serum placental growth factor, and serum soluble fms-like tyrosine kinase-1 at 35 to 37 weeks of gestation, with a detection rate of ≈75% at a screen-positive rate of 10%. However, there is no known intervention to reduce the incidence of the disease.METHODS: In this multicenter, double-blind, placebo-controlled trial, we randomly assigned 1120 women with singleton pregnancies at high risk of term preeclampsia to receive pravastatin at a dose of 20 mg/d or placebo from 35 to 37 weeks of gestation until delivery or 41 weeks. The primary outcome was delivery with preeclampsia at any time after randomization. The analysis was performed according to intention to treat.RESULTS: A total of 29 women withdrew consent during the trial. Preeclampsia occurred in 14.6% (80 of 548) of participants in the pravastatin group and in 13.6% (74 of 543) in the placebo group. Allowing for the effect of risk at the time of screening and participating center, the mixed-effects Cox regression showed no evidence of an effect of pravastatin (hazard ratio for statin/placebo, 1.08 [95% CI, 0.78-1.49]; P=0.65). There was no evidence of interaction between the effect of pravastatin, estimated risk of preeclampsia, pregnancy history, adherence, and aspirin treatment. There was no significant between-group difference in the incidence of any secondary outcomes, including gestational hypertension, stillbirth, abruption, delivery of small for gestational age neonates, neonatal death, or neonatal morbidity. There was no significant between-group difference in the treatment effects on serum placental growth factor and soluble fms-like tyrosine kinase-1 concentrations 1 and 3 weeks after randomization. Adherence was good, with reported intake of ≥80% of the required number of tablets in 89% of participants. There were no significant between-group differences in neonatal adverse outcomes or other adverse events.CONCLUSIONS: Pravastatin in women at high risk of term preeclampsia did not reduce the incidence of delivery with preeclampsia. Registration: URL: https://www.isrctn.com; Unique identifier ISRCTN16123934.
AB - BACKGROUND: Effective screening for term preeclampsia is provided by a combination of maternal factors with measurements of mean arterial pressure, serum placental growth factor, and serum soluble fms-like tyrosine kinase-1 at 35 to 37 weeks of gestation, with a detection rate of ≈75% at a screen-positive rate of 10%. However, there is no known intervention to reduce the incidence of the disease.METHODS: In this multicenter, double-blind, placebo-controlled trial, we randomly assigned 1120 women with singleton pregnancies at high risk of term preeclampsia to receive pravastatin at a dose of 20 mg/d or placebo from 35 to 37 weeks of gestation until delivery or 41 weeks. The primary outcome was delivery with preeclampsia at any time after randomization. The analysis was performed according to intention to treat.RESULTS: A total of 29 women withdrew consent during the trial. Preeclampsia occurred in 14.6% (80 of 548) of participants in the pravastatin group and in 13.6% (74 of 543) in the placebo group. Allowing for the effect of risk at the time of screening and participating center, the mixed-effects Cox regression showed no evidence of an effect of pravastatin (hazard ratio for statin/placebo, 1.08 [95% CI, 0.78-1.49]; P=0.65). There was no evidence of interaction between the effect of pravastatin, estimated risk of preeclampsia, pregnancy history, adherence, and aspirin treatment. There was no significant between-group difference in the incidence of any secondary outcomes, including gestational hypertension, stillbirth, abruption, delivery of small for gestational age neonates, neonatal death, or neonatal morbidity. There was no significant between-group difference in the treatment effects on serum placental growth factor and soluble fms-like tyrosine kinase-1 concentrations 1 and 3 weeks after randomization. Adherence was good, with reported intake of ≥80% of the required number of tablets in 89% of participants. There were no significant between-group differences in neonatal adverse outcomes or other adverse events.CONCLUSIONS: Pravastatin in women at high risk of term preeclampsia did not reduce the incidence of delivery with preeclampsia. Registration: URL: https://www.isrctn.com; Unique identifier ISRCTN16123934.
KW - Adult
KW - Biomarkers
KW - Comorbidity
KW - Female
KW - Gestational Age
KW - Humans
KW - Incidence
KW - Kaplan-Meier Estimate
KW - Mass Screening
KW - Medication Adherence
KW - Placebos/administration & dosage
KW - Pravastatin/administration & dosage
KW - Pre-Eclampsia/diagnosis
KW - Pregnancy
KW - Pregnancy Outcome
KW - Prognosis
KW - Risk Assessment
KW - Risk Factors
KW - Treatment Outcome
KW - Young Adult
U2 - 10.1161/CIRCULATIONAHA.121.053963
DO - 10.1161/CIRCULATIONAHA.121.053963
M3 - SCORING: Journal article
C2 - 34162218
VL - 144
SP - 670
EP - 679
JO - CIRCULATION
JF - CIRCULATION
SN - 0009-7322
IS - 9
ER -