Bempedoic Acid Pregnancy Surveillance Program

Study Overview
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Brief Summary
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Bempedoic acid pregnancy surveillance program

Detailed Description
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A surveillance study of females exposed to bempedoic acid or bempedoic acid/ezetimibe fixed combination drug product (FCDP) during pregnancy. Observational outcome data will be collected on pregnant females through pregnancy and infants through the first year of life.

Official Title
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A Post-marketing, Long-term, Observational, Descriptive Study to Assess the Risk of Pregnancy and Maternal Complications and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Women Exposed to Bempedoic Acid or Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) During Pregnancy

Conditions
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Pregnancy, Hyperlipidemias

Intervention / Treatment
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* Drug: Bempedoic Acid
* Drug: Bempedoic Acid / Ezetimibe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Exposure to at least 1 dose of bempedoic acid or bempedoic acid/ezetimibe FCDP at any time during pregnancy (from first day of last menstrual period [LMP] to pregnancy outcome Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bempedoic Acid|Bempedoic Acid 180 MG|
|Drug: Bempedoic Acid / Ezetimibe|Bempedoic Acid 180 MG / Ezetimibe 10 MG|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major congenital malformations (MCM) | An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention (CDC 2019a). MCMs will be defined and coded with criteria specified by US CDC Metropolitan Atlanta Congenital Defects Program (MACDP). | Birth up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor congenital malformation | An anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e., birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual (CDC 2019a). The surveillance program defines and codes minor congenital malformations with criteria specified as defined by CDC (CDC 2017). | Birth up to 12 months | 
| Spontaneous abortion | An involuntary fetal loss or the expulsion of the products of conception occurring at < 20 gestational weeks. | Time of conception up to birth | 
| Stillbirth | As defined by the American College of Obstetricians and Gynecologists (ACOG), an involuntary fetal loss occurring at ≥ 20 gestational weeks or, if gestational age is unknown, a fetus weighing ≥ 350 g. | Time of conception up to birth | 
| Elective termination | A voluntary fetal loss or interruption of pregnancy, including pregnancy termination that occurs electively, to preserve maternal health or due to fetal abnormalities. | Time of conception up to birth | 
| Preterm birth | A live birth occurring at < 37 gestational weeks. | Time of conception up to birth | 
| Small for gestational age (SGA) | Weight at birth in < 10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants (Battaglia 1967). For the determination of SGA, the surveillance program will utilize the sex-specific international growth reference standards from the International Fetal and Newborn Growth Consortium for the 21st Century (INTERGROWTH-21st) for those born between 240/7 and 426/7 gestational weeks (Villar 2014; Villar 2016). The INTERGROWTH-21st standards are the latest available global reference standards, representing contemporary information from an international, multiethnic, diverse population, and have been specifically developed for modern research. | Birth up to 12 months | 
| Postnatal growth deficiency | Weight in < 10th percentile for sex and chronological age using standard growth charts. Postnatal growth deficiency will be evaluated at 4 and 12 months of infant age. For the determination of postnatal growth deficiency, the surveillance program will utilize the sex-specific international growth reference standards from the World Health Organization for children ages 0 to 24 months. The World Health Organization growth standards are recommended for use in the US for infants and children 0 to 2 years of age (CDC 2010). | Birth up to 12 months | 
| Infant development deficiency | Failure to achieve the developmental milestones for chronological age, as defined by the CDC (CDC 2019b). Infant developmental deficiency will be evaluated at 4 and 12 months of infant age for each CDC-defined category (social/emotional, language/communication, cognitive, and movement/physical development), separately. | Birth up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bempedoic acid