Table 4

Fat-Soluble Vitamin Levels as Measured in ODYSSEY LONG TERM (Safety Population)

Placebo (n = 788)Alirocumab
Overall Alirocumab (n = 1,550)LDL-C ≥25 mg/dl (n = 975)LDL-C <25 mg/dl (n = 575)LDL-C <15 mg/dl (n = 234)
Vitamin E/calculated LDL-C ratio, baseline11.9 ± 4.012.0 ± 4.111.1 ± 3.413.6 ± 4.514.6 ± 5.3
Vitamin E/calculated LDL-C ratio, week 5212.0 ± 4.233.7 ± 43.820.8 ± 16.154.2 ± 62.477.7 ± 83.4
Vitamin A <LLN regardless of baseline status2.2 (17/762)2.7 (40/1,496)3.0 (29/975)1.9 (11/575)1.3 (3/234)
Vitamin D <LLN regardless of baseline status89.7 (681/759)88.0 (1,315/1,494)82.2 (801/975)89.4 (514/575)89.7 (210/234)
Vitamin K <LLN regardless of baseline status6.8 (52/762)9.4 (141/1,496)8.9 (87/975)9.4 (54/575)8.5 (20/234)

Values are mean ± SD or % (n/N). Vitamin E levels were adjusted for LDL-C to more accurately assess vitamin E levels (25). Reference range for vitamin D (men and women): <25.0 nmol/l represents severe deficiency. The proportion of patients with vitamin D <LLN who had normal vitamin D at baseline, or were missing values, was 75.8% (216 of 285) for placebo and 73.3% (411 of 561) for alirocumab; the smaller denominators here compared with the total (regardless of baseline) suggests that a large proportion of patients were not normal (probably <LLN) at baseline.

LDL-C = low-density lipoprotein cholesterol; LLN = lower limit of normal; ODYSSEY LONG TERM = Long-Term Safety and Tolerability of Alirocumab [SAR236553/REGN727] Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia.