Lomitapide Observational Worldwide Evaluation Registry (LOWER)
LOWER is a “registry” that will gather information on the long-term safety and effectiveness of Juxtapid® (lomitapide) capsules in patients taking Juxtapid as part of usual medical care. A registry is an observational study where routine data is collected as part of your usual doctor visits. There are no study-required procedures or tests and no study medication is provided. All decisions about your health and treatment will be made by your regular doctor and other healthcare providers. The registry will collect information concerning your health, medications, and other therapies, as well as procedures or tests you have had performed. The study period for data collection will be a minimum of 10 years.
If you stop taking Juxtapid for any reason, this does not affect your participation in the registry. Your health information will still be collected as part of your usual care for a minimum of 10 years. Before you join LOWER, you will be asked to read and sign an informed consent form. This form will describe the study in more detail and also discusses how privacy of participants will be protected and how medical information is kept confidential.
Who can participate in LOWER?
If the healthcare provider that prescribed you Juxtapid is participating in LOWER you may be eligible to participate. Your decision to participate in this study is voluntary. Full detailed information about the study is described in the informed consent form.
To participate in LOWER, you must be 18 years of age or older and meet 1 of the following 2 criteria:
- Starting treatment with Juxtapid at the time of registry enrollment, or
- Started treatment with Juxtapid within 36 months before joining LOWER
Learn more about LOWER
To learn more about LOWER, talk to your healthcare provider who prescribed Juxtapid for you or call our Registry Call Center at our toll-free number, 1-877-902-4099.
Pregnancy exposure registry
The purpose of this registry is to collect information on pregnancies and babies whose mothers were treated with Juxtapid during pregnancy or within 30 days prior to the first day of their last menstrual period before a positive pregnancy test. Juxtapid should not be used in women who are pregnant, possibly pregnant or are planning to become pregnant because it may harm the unborn baby. Women who are capable of becoming pregnant should have a negative pregnancy test before starting Juxtapid and should use an effective method of birth control during therapy with Juxtapid. However, any woman who becomes pregnant while taking Juxtapid will be asked to enroll into this pregnancy exposure registry. If you become pregnant while taking Juxtapid, stop taking Juxtapid and call your doctor right away. You are also encouraged to volunteer to participate in the pregnancy exposure registry.
Learn more about the pregnancy exposure registry
To learn more about the pregnancy exposure registry, call the Registry Call Center at our toll-free number, 1-877-902-4099.