Table 1

Baseline Characteristics of Patients Included in This Analysis (Pooled Safety Population)

Pooled Control (n = 1,894)Alirocumab
Overall Alirocumab (n = 3,340)LDL-C ≥25 mg/dl (n = 2,501)LDL-C <25 mg/dl (n = 839)LDL-C <15 mg/dl§ (n = 314)
% of overall alirocumab groupNA10074.925.19.4
Median exposure (weeks)78.078.078.078.078.0
Characteristics (pool of phase 2 and 3)
 Age, yrs59.7 ± 10.859.5 ± 11.158.6 ± 11.461.9 ± 9.861.8 ± 9.9
 Male60.7 (1,150)61.8 (2,063)57.3 (1,434)75.0 (629)74.8 (235)
 Race, white88.8 (1,682)89.1 (2,977)88.5 (2,213)91.1 (764)89.8 (282)
 BMI, kg/m230.1 ± 5.630.0 ± 5.730.1 ± 6.029.7 ± 4.629.8 ± 4.4
 Calculated LDL-C, mg/dl126.3 ± 48.4125.7 ± 47.0134.3 ± 48.9100.3 ± 28.595.7 ± 28.3
 Non-HDL-C, mg/dl155.8 ± 53.5155.0 ± 51.0162.3 ± 53.2133.5 ± 35.7133.4 ± 36.1
 Apo B, mg/dl103.7 ± 29.5103.7 ± 29.2107.7 ± 30.191.6 ± 22.391.3 ± 22.8
 Lp(a), mg/dl22.0 (7.1–64.0)24.6 (8.0–68.6)28.0 (10.0–75.0)15.8 (5.8–47.5)12.0 (4.3–38.0)
 HDL-C, mg/dl49.9 ± 13.550.0 ± 13.751.1 ± 14.346.6 ± 11.045.1 ± 10.9
 Fasting TGs, mg/dl128.0 (93.0–180.5)128.0 (92.0–179.8)122.0 (88.0–170.8)146.9 (108.8–206.2)168.0 (126.5–231.0)
 Baseline HbA1c, %6.03 ± 0.886.03 ± 0.885.98 ± 0.846.17 ± 0.986.22 ± 0.94
Medical history (pool of phase 3)n = 1,792n = 3,182n = 2,371n = 811n = 305
 CHD64.4 (1,154)64.8 (2,061)60.6 (1,437)76.9 (624)73.4 (224)
 CHD risk equivalents31.5 (564)32.6 (1,037)29.9 (709)40.4 (328)45.9 (140)
 Type 2 diabetes#29.8 (534)30.3 (963)27.9 (662)37.1 (301)42.0 (128)
 HeFH25.7 (461)27.6 (877)33.5 (794)10.2 (83)9.5 (29)
 High-intensity statin∗∗52.8 (946)55.2 (1,755)55.9 (1,325)53.0 (430)49.5 (151)
 Other lipid-lowering therapy††29.0 (519)28.8 (916)30.6 (725)23.6 (191)23.3 (71)

Values are mean ± SD, % (n), or median (interquartile range).

Apo = apolipoprotein; BMI = body mass index; CHD = coronary heart disease; HbA1c = glycated hemoglobin; HDL-C = high-density lipoprotein cholesterol; HeFH = heterozygous familial hypercholesterolemia; LDL-C = low-density lipoprotein cholesterol; Lp(a) = lipoprotein (a); MI = myocardial infarction; NA = not applicable; TG = triglyceride.

  • p < 0.05 for comparison of LDL-C ≥25 vs. <25 mg/dl groups in pool of phase 3 studies.

  • Patients who did not have 2 or more consecutive LDL-C values <25 mg/dl during treatment.

  • Patients with at least 2 consecutive LDL-C values <25 mg/dl during treatment. Values are considered consecutive if spaced out by at least 21 days.

  • § Patients with at least 2 consecutive LDL-C values <15 mg/dl during treatment.

  • Excludes phase 2 studies.

  • CHD defined as acute MI, silent MI, unstable angina, coronary revascularization procedure, or other clinically significant CHD. CHD risk equivalents varied depending on study and included ischemic stroke, peripheral arterial disease, moderate chronic kidney disease, history of diabetes mellitus (type 1 or 2), and additional risk factors. Difference between LDL-C ≥25 and <25 mg/dl groups was tested by history of MI or ischemic stroke.

  • # Difference between LDL-C ≥25 and <25 mg/dl groups was tested by history of type 1 and 2 diabetes.

  • ∗∗ Atorvastatin 40 to 80 mg, rosuvastatin 20 to 40 mg, and simvastatin 80 mg per day.

  • †† Excluding nutraceuticals.