Table 1. Baseline Characteristics of Participants.
| Characteristic | Multiple-dose group | Single-dose group | |||||
|---|---|---|---|---|---|---|---|
| 200 mg Every 4 wk ×2 (n = 9) | 300 mg Every 8 wk ×2 (n = 9) | 450 mg Every 8 wk ×2 (n = 9) | Placebo (n = 9) | 300 mg (n = 5) | 600 mg (n = 6) | Placebo (n = 3) | |
| Demographics | |||||||
| Age, mean (SD), y | 59.8 (8.6) | 61.3 (6.8) | 56.9 (12.2) | 47.0 (8.2) | 57.8 (14.6) | 43.7 (17.5) | 54.3 (17.0) |
| Sex, No. (%) | |||||||
| Female | 2 (22.2) | 5 (55.6) | 4 (44.4) | 4 (44.4) | 3 (60.0) | 3 (50.0) | 3 (100.0) |
| Male | 7 (77.8) | 4 (44.4) | 5 (55.6) | 5 (55.6) | 2 (40.0) | 3 (50.0)0 | 0 |
| Individuals of childbearing potential, No. (%) | 0 | 1 (11.1) | 0 | 2 (22.2) | 0 | 0 | 1 (33.3) |
| Body mass index, mean (SD)a | 29.3 (5.4) | 29.9 (3.4) | 28.3 (4.7) | 29.6 (4.0) | 27.7 (3.3) | 26.8 (4.0) | 28.0 (4.1) |
| Race No. (%)b | |||||||
| Asian | 1 (11.1) | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 (11.1) | 0 | 1 (11.1) | 2 (40.0) | 1 (16.7) | 0 |
| White | 8 (88.9) | 8 (88.9) | 9 (100.0) | 7 (77.8) | 3 (60.0) | 5 (83.3) | 3 (100.0) |
| Multiracial | 0 | 0 | 0 | 1 (11.1) | 0 | 0 | 0 |
| Past medical history, No. (%)c | |||||||
| Hypertension | 3 (33.3) | 6 (66.7) | 4 (44.4) | 4 (44.4) | 2 (40.0) | 1 (16.7) | 0 |
| Diabetes | 0 | 1 (11.1) | 0 | 3 (33.3) | 0 | 0 | 0 |
| Medications, No. (%) | |||||||
| Statin use | 9 (100) | 8 (88.9) | 8 (88.9) | 9 (100) | 3 (60.0) | 3 (50.0) | 1 (33.3) |
| PCSK9i use | 1 (11.1) | 3 (33.3) | 2 (22.2) | 0 | 0 | 0 | 0 |
| Laboratory findingsd | |||||||
| Lipoprotein(a), median (IQR), nmol/L | 266 (194-295) | 316 (276-377) | 247 (183-350) | 292 (217-389) | 313 (257-338) | 231 (179-276) | 211 (181-259) |
| Total cholesterol, mean (SD), mg/dL | 145 (53) | 137 (28) | 150 (50) | 137 (35) | 165 (18) | 180 (51) | 192 (90) |
| LDL-C, mean (SD), mg/dL | 69 (38.0) | 56 (19.5) | 77 (39.7) | 67 (23.9) | 96 (25) | 108 (54) | 111 (75) |
| HDL-C, mean (SD), mg/dL | 46 (14.8) | 59 (21.4) | 55 (13.0) | 50 (10.4) | 44 (9) | 55 (9) | 58 (16) |
| Triglycerides, median (IQR), mg/dL | 93 (77-129) | 85 (60-132) | 93 (74-106) | 73 (58-128) | 93 (76-179) | 75 (42-115) | 123 (79-139) |
| Apolipoprotein B100, mean (SD), md/dL | 71 (34) | 59 (14) | 69 (23) | 69 (23) | 89 (7) | 81 (25) | 87 (46) |
| Oxidized low-density lipoprotein, mean (SD) U/L | 48 (25.1) | 42 (12.5) | 57 (40.7) | 49 (16.5) | 55 (8) | 50 (15) | 63 (35) |
| C-reactive protein, median (IQR), mg/L | 0.5 (0.3-0.7) | 1.2 (1.0-1.4) | 0.4 (0.3-0.5) | 0.4 (0.3-1.0) | 1.7 (1.6-12.2) | 1.0 (0.4-2.1) | 0.4 (0.4-0.4) |
Abbreviations: PCSK9i, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor; LDL-C, low-density lipoprotein cholesterol; HDL-C, high-density lipoprotein cholesterol.
SI conversion factors: To convert total cholesterol, LDL-C, and HDL-C values to mmol/L, multiply by 0.0259; triglyceride values to mmol/L, multiply by 0.0113.
Calculated as weight in kilograms divided by square of height in meters.
Race was self-identified by patients and collected because lipoprotein(a) levels are known to vary among racial groups. “Multiracial” indicates self-reported as multiracial Black, White, and Asian.
Participants reported medical history, which was verified by either primary care physician or provided directly by specialist.
Reference ranges: lipoprotein(a), less than 75 nmol/L; total cholesterol, 100 to 200 mg/dL; LDL-C, 50 to 130 mg/dL; HDL-C, 35 to 60 mg/dL; triglycerides, 50 to 150 mg/dL; apolipoprotein B100, 55 to 105 mg/dL; oxidized LDL-C, 24.6 to 97.0 U/L; C-reactive protein, 0 to 3 mg/L.