Table 1.
Baseline Characteristics of Participants in the Post Hoc Analyses of Cardiometabolic Risk Factors in the ENLIGHTEN-2 Study
| Parameter | OLZ/SAM | Olanzapine |
|---|---|---|
| Randomized and received ≥1 dose, n | 274 | 276 |
| Completed, n (%) | 176 (64.2) | 176 (63.8) |
| Had ≥1 postbaseline weight assessment, n | 266 | 272 |
| Age (years), Mean (SD) | 40.3 (9.82) | 40.1 (10.05) |
| Male, n (%) | 188/266 (70.7) | 203/272 (74.6) |
| Race, n (%) | ||
| Black | 193/266 (72.6) | 190/272 (69.9) |
| White | 61/266 (22.9) | 64/272 (23.5) |
| BMI (kg/m2), Mean (SD) | 25.31 (3.1) | 25.48 (3.2) |
| BMI <30 kg/m2, n (%) | 266/266 (100.0) | 270/272 (99.3) |
| BMI ≥30 kg/m2, n (%) | 0/266 | 2/272 (0.7) |
| Body weight (kg), Mean (SD) | 77.00 (13.7) | 77.45 (13.5) |
| Waist circumference (cm), Mean (SD) | 90.8 (10.9) | 90.9 (10.6) |
| Waist circumference >80 cm (females) or >102 cm (males), n (%) | 75/265 (28.3) | 80/270 (29.6) |
| Metabolic syndrome, n (%) | 33/265 (12.5) | 23/270 (8.5) |
| Systolic blood pressure (mm Hg), Mean (SD)a | 121.4 (12.7) | 121.8 (11.9) |
| Diastolic blood pressure (mm Hg), Mean (SD)a | 77.2 (9.1) | 77.3 (9.6) |
| Hypertension, n (%) | ||
| Stage 1 (130–139/80–89 mm Hg) | 96/266 (36.1) | 86/272 (31.6) |
| Stage 2(≥140/≥90 mm Hg) | 35/266 (13.2) | 38/272 (14.0) |
| Plasma glucose (mg/dL), Mean (SD)b | 90.3 (11.6) | 91.4 (12.0) |
| HbA1c (%), Mean (SD)c | 5.40 (0.4) | 5.40 (0.4) |
| HOMA-IR, Mean (SD)d | 3.03 (6.4) | 2.88 (4.1) |
| Total cholesterol (mg/dL), Mean (SD)e | 183.4 (34.7) | 185.2 (37.3) |
| LDL cholesterol (mg/dL), Mean (SD)e | 109.6 (32.3) | 112.7 (34.0) |
| HDL cholesterol (mg/dL), Mean (SD)e | 62.4 (22.4) | 62.1 (21.0) |
| Triglycerides (mg/dL), Mean (SD)e | 114.4 (94.0) | 107.1 (62.1) |
aMeasured in supine position after 5 min at rest.
bUpper reference value in an otherwise healthy population for fasting plasma glucose is 100 mg/dL.62
cUpper reference value in an otherwise healthy population for HbA1c concentration is 5.7%.62
dUpper reference value in an otherwise healthy population for HOMA-IR is 2.0.63
eOptimal lipid levels are <150 mg/dL total cholesterol, <100 mg/dL LDL cholesterol, and <150 mg/dL triglycerides; the reference range for HDL cholesterol varies by gender.64
BMI, body mass index; HbA1c, glycosylated hemoglobin; HDL, high-density lipoprotein; HOMA-IR, homeostasis model assessment of insulin resistance; LDL, low-density lipoprotein; OLZ/SAM, combination of olanzapine and samidorphan.