Lomitapide Observational Worldwide Evaluation Registry (LOWER)
As part of an ongoing commitment to further the understanding of Juxtapid® (lomitapide) capsules, Aegerion has initiated a global registry to evaluate the long-term safety, effectiveness and patterns of use of Juxtapid in routine clinical practice.
LOWER is currently open to enrollment to patients in the US who are or who have been treated with Juxtapid. At least 300 adult patients treated with Juxtapid will be enrolled globally. US participation will continue for 10 years after the enrollment of 300 patients has been completed.
- LOWER is a global observational registry that will enroll adult patients who are or have been treated with Juxtapid
- All prescribers of Juxtapid for adult patients are eligible to participate
- LOWER is non-interventional with no study medication provided
- There are no protocol mandated procedures or diagnostic tests. All treatment decisions will be made at the discretion of the patient’s physician or healthcare provider
- Electronic data collection has been designed to minimize the burden on participating physicians and site personnel
- Educational materials for prescribers and patients will be provided to aid registry enrollment and participation
- LOWER is supported by a toll-free help line for investigators and site personnel
- Investigators will be reimbursed at fair market value for data collection and other costs associated with completing registry requirements
Benefits of Participation
As a LOWER investigator, here are a few of the opportunities that will be available to you:
- Help advance the scientific community’s understanding of Juxtapid by contributing clinically relevant information
- Further the understanding of HoFH
- Discuss learnings at regular investigator meetings
- Access to patient-specific reports and longitudinal data graphs at your site
- Publication opportunities
Global lomitapide Pregnancy Exposure Registry
The objective of this registry is to evaluate the outcomes of pregnancy in women treated with Juxtapid at any time within 30 days prior to the first day of last menstrual period before a positive pregnancy test or during pregnancy. Juxtapid is contraindicated for use during pregnancy due to the risk of fetal harm. Females of reproductive potential should have a negative pregnancy test before starting Juxtapid and should use effective contraception during therapy with Juxtapid. However, women who do become pregnant while exposed to Juxtapid should be encouraged to enroll into the Global Lomitapide Pregnancy Exposure Registry. Enrolled patients will be followed to pregnancy outcome; for live births, follow up of pediatric patients will occur through 12 months of age.
To learn more about LOWER, including how to become an investigator, or the Pregnancy Exposure Registry, please call the Registry Call Center at our toll-free number, 1-877-902-4099, or send an email to firstname.lastname@example.org.