This global product exposure registry is a multicentre, long-term, prospective, observational cohort study (exposure registry), designed to evaluate the long term safety and effectiveness of lomitapide.
To evaluate the occurrence of adverse events of special interest, long term effectiveness of lomitapide, and to evaluate whether prescribers of lomitapide are following screening and monitoring recommendations as specified in product labeling.
Study Type
OBSERVATIONAL
Enrollment
260
As prescribed by Physician.
Hepatic Abnormalities
to evaluate the occurrence of hepatic abnormalities
Time frame: patients will be followed for 10 years
Gastrointestinal (GI) Events
to evaluate the occurrence of GI events
Time frame: patients will be followed for 10 years
Tumors
to evaluate any occurrence of tumors (small bowel, hepatic, colorectal or pancreatic)
Time frame: patients will be followed for 10 years
Events associated with coagulopathy
to evaluate the occurrence of events associated with coagulopathy (abnormal bleeding, cerebral haemorrhage or GI bleeding)
Time frame: patients will be followed for 10 years
Major Adverse Cardiovascular Events (MACE) events
to evaluate the occurrence of MACE events
Time frame: patients will be followed for 10 years
Death, including cause of death
to evaluate the occurrence and cause of death
Time frame: patients will be followed for 10 years
Pregnancy
to evaluate the occurrence and outcomes of pregnancy in females of reproductive potential treated with lomitapide. Patients who become pregnant will be offered enrolment into a separate Pregnancy Exposure Registry (PER).
Time frame: patients will be followed for 10 years
Serum lipid levels
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Brookwood Baptist Medical Center
Birmingham, Alabama, United States
Springhill Physician Practices
Mobile, Alabama, United States
Northern Arizona Healthcare
Cottonwood, Arizona, United States
Scottsdale Family Health
Phoenix, Arizona, United States
Pima Heart
Tucson, Arizona, United States
Arkansas Heart Center
Fort Smith, Arkansas, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of Colorado Health
Aurora, Colorado, United States
Alfieri Cardiology
Newark, Delaware, United States
Preventative Cardiology, Inc.
Boca Raton, Florida, United States
...and 61 more locations
to evaluate the long-term effectiveness of lomitapide in maintaining control of serum lipid levels in a clinical practice setting.
Time frame: patients will be followed for 10 years
Prescriber behavior
to evaluate whether prescribers of lomitapide enrolled at registry sites are following the screening and monitoring recommendations as specified in the PI and the prescriber educational materials aimed at risk minimization.
Time frame: patients will be followed for 10 years