Bempedoic Acid Pregnancy Surveillance Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bempedoic Acid, Bempedoic Acid / Ezetimibe.
- Who it may be relevant to
- Registry conditions: Pregnancy, Hyperlipidemias. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
Bempedoic acid pregnancy surveillance program
Detailed description
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.
Interventions
- Drug Bempedoic Acid
Bempedoic Acid 180 MG - Drug Bempedoic Acid / Ezetimibe
Bempedoic Acid 180 MG / Ezetimibe 10 MG
Primary outcome measures
- Major congenital malformations (MCM) [Time frame: Birth up to 12 months]
Secondary outcome measures (8)
- Minor congenital malformation [Time frame: Birth up to 12 months]
- Spontaneous abortion [Time frame: Time of conception up to birth]
- Stillbirth [Time frame: Time of conception up to birth]
- Elective termination [Time frame: Time of conception up to birth]
- Preterm birth [Time frame: Time of conception up to birth]
- Small for gestational age (SGA) [Time frame: Birth up to 12 months]
- Postnatal growth deficiency [Time frame: Birth up to 12 months]
- Infant development deficiency [Time frame: Birth up to 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Evidera, PPD business unit — Morrisville
Publications
- Paponja K, Pecin I, Reiner Z, Banach M. Bempedoic acid: new evidence and recommendations on use. Curr Opin Lipidol. 2024 Feb 1;35(1):41-50. doi: 10.1097/MOL.0000000000000911. Epub 2023 Dec 8. PMID 38085172
Identifiers
NCT: NCT05103254 · 1002-074