The primary objective of the study was to evaluate the long term safety of PRALUENT in participants with heterozygous familial hypercholesterolemia (heFH) or non-familial hypercholesterolemia (FH) participants at high or very high cardiovascular risk who completed the neurocognitive function study R727-CL-1532 (NCT02957682). The secondary objectives of the study were: * To evaluate the effect of PRALUENT on low-density lipoprotein cholesterol (LDL-C) * To evaluate the effect of PRALUENT on other lipid parameters * To evaluate the effect of PRALUENT on gonadal steroid hormones
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,389
Subcutaneous (SC) administration
Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks
An AE is any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. AEs include serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of special interest (AESI). AESI include local injection site reactions, general allergic events, elevated alanine aminotransferase (ALT) levels greater than or equal to (≥) 3 upper limit normal (ULN) (if baseline is less than (\<) ULN)/ALT ≥2 x ULN (if baseline ≥ ULN), neurologic events, neurocognitive events (according to Customized Medical Dictionary for Regulatory Activities \[MedDRA\] Query \[CMQ\] by Sponsor grouping and CMQ by FDA grouping), cataract, new onset diabetes (NOD), hepatic disorders, and diabetes mellitus (DM)/diabetic complications.
Time frame: After first administration of study drug through the last dose of study drug plus 2 weeks, up to 80 weeks
Calculated Low-density Lipoprotein Cholesterol (LDL-C) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Percent Change in LDL-C From Baseline Over Time
Time frame: Up to week 72
Total Cholesterol (Total-C) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Percent Change From Baseline in Total-C Over Time
Time frame: Up to week 72
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Regeneron Research Site
Auburn, Alabama, United States
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Mobile, Alabama, United States
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Beverly Hills, California, United States
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Los Gatos, California, United States
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North Hollywood, California, United States
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Port Hueneme, California, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Lake Worth, Florida, United States
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Miami Springs, Florida, United States
...and 113 more locations
Lipoprotein a (Lp(a)) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Percent Change From Baseline in Lp(a) Over Time
Time frame: Up to week 72
Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Percent Change From Baseline in Non-HDL-C Over Time
Time frame: Up to week 72
High-density Lipoprotein Cholesterol (HDL-C) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Percent Change From Baseline in HDL-C Over Time
Time frame: Up to week 72
Fasting Triglycerides (TGs) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Percent Change From Baseline in Fasting TGs Over Time
Time frame: Up to week 72
Apolipoprotein B (Apo B) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Percent Change From Baseline in Apo B Over Time
Time frame: Up to week 72
Apolipoprotein-A1 (Apo A1) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Percent Change From Baseline in Apo A1 Over Time
Time frame: Up to week 72
Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time
Time frame: Up to week 72
Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time
Time frame: Up to week 72
Gonadotropin (Estradiol) Values for Female Participants From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Change From Baseline in Gonadotropins (Estradiol) for Female Participants Over Time
Time frame: Up to week 72
Gonadotropin (Testosterone) Values for Male Participants From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Change From Baseline in Gonadotropins (Testosterone) for Male Participants Over Time
Time frame: Up to week 72
Alanine Aminotransferase Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Change From Baseline in Alanine Aminotransferase Over Time
Time frame: Up to week 72
Aspartate Aminotransferase Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Change From Baseline in Aspartate Aminotransferase Over Time
Time frame: Up to week 72
Alkaline Phosphatase Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Change From Baseline in Alkaline Phosphatase Over Time
Time frame: Up to week 72
Total Bilirubin Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Change From Baseline in Total Bilirubin Over Time
Time frame: Up to week 72