To evaluate the efficacy of subcutaneous (SC) evolocumab, compared to regularly scheduled low-density lipoprotein cholesterol (LDL-C) apheresis, on reducing the need for future apheresis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Administered by subcutaneous injection once every 2 weeks
Participants received apheresis for LDL-C according the their physician's prescription and local custom.
Research Site
Boca Raton, Florida, United States
Research Site
Kansas City, Kansas, United States
Research Site
Grandville, Michigan, United States
Percentage of Participants With Apheresis Avoidance at the End of Randomized Therapy
Avoidance of apheresis at end of randomized therapy was defined as no apheresis at week 5 and week 6. Aperesis at weeks 5 or 6 was based on LDL-C level at week 4: participants with LDL-C ≥ 100 mg/dL at week 4 received apheresis at week 5 (participants who received apheresis QW before study entry) or week 6 (participants who received apheresis Q2W prior to study entry). If LDL-C was \< 100 mg/dL at week 4, no apheresis was performed at week 5 or week 6, irrespective of assigned treatment group. Participants who ended the study prior to week 6 were considered as not achieving apheresis avoidance.
Time frame: Week 5 and week 6
Percent Change From Baseline in Low-density Lipoprotein Cholesterol
Time frame: Baseline and week 4
Percent Change From Baseline in Non-high-density Lipoprotein-Cholesterol
Time frame: Baseline and Week 4
Percent Change From Baseline in Total Cholesterol/High-density Lipoprotein Cholesterol Ratio
Time frame: Baseline and Week 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Portland, Oregon, United States
Research Site
Heidelberg, Victoria, Australia
Research Site
Hradec Králové, Czechia
Research Site
Bron, France
Research Site
Nantes, France
Research Site
Berlin, Germany
Research Site
Dresden, Germany
...and 7 more locations