Table 3 Clinical variables related to drug safety assessment of patients (enrolled n = 42, or completed the study n = 33), Cali-Colombia, 2011–2012
Baseline | 6 months | 12 months | p valuea | ||
|---|---|---|---|---|---|
Clinical variable | n = 42 | n = 33 | n = 33 | n = 33 | |
Transaminase (ALT) U/L | |||||
Median (Q1–Q3) | 23 (18–32) | 23.0 (17–32) | 26.0 (18–41) | 30.0 (20–44) | 0.0452 |
Transaminase (AST) U/L | |||||
Median (Q1–Q3) | 22 (19–34) | 22.0 (20–36) | 25.0 (20–29) | 26.0 (20–32) | 0.8792 |
Serum creatinine (mg/dL) | |||||
Median (Q1–Q3) | 1.04 (0.97–1.17) | 1.05 (0.98–1.17) | 0.97 (0.90–1.06) | 0.98 (0.90–1.09) | 0.0895 |
Hemoglobin (g/dL) | |||||
Median (Q1–Q3) | 14.9 (13.1–15.8) | 14.4 (12.9–15.5) | 14.7 (13.5–15.2) | 14.6 (13.4–15.8) | 0.1983 |
Fasting total cholesterol (mg/dL) | |||||
Median (Q1–Q3) | 161.0 (140.0–177.0) | 164.0 (140–179) | 212.0 (191–231) | 226.0 (200–246) | <0.001 |
≤ 200, n (%) | 39 (92.9) | 30 (90.9) | 13 (39.4) | 9 (27.3) | <0.001 |
200–240, n (%) | 2 (4.8) | 2 (6.1) | 15 (45.4) | 14 (42.4) | |
> 240, n (%) | 1 (2.4) | 1 (3.0) | 5 (15.2) | 10 (30.3) | |
Low-density lipoprotein cholesterol –[LDL-C]– (mg/dL) | |||||
Median (Q1–Q3) | 99.8 (87.4–114.9) | 97.3 (87.4–114.9) | 132.2 (116.1–152.3) | 136.6 (115.3–155.1) | <0.001 |
≤ 130, n (%) | 37 (88.1) | 29 (87.9) | 16 (48.5) | 13 (39.4) | <0.001 |
130–160, n (%) | 5 (11.9) | 4 (12.1) | 11 (33.3) | 13 (39.4) | |
> 160, n (%) | 0 (0.0) | 0 (0.0) | 6 (8.2) | 7 (21.2) | |
High-density lipoprotein cholesterol –[HDL-C]– (mg/dL) | |||||
Median (Q1–Q3) | 38.4 (32.7–44.5) | 38.4 (33.4–46.1) | 47.0 (38.6–56.6) | 51.7 (42.8–60.3) | <0.001 |
< 40for men or <50 for women, n (%) | 27 (64.3) | 18 (54.6) | 9 (27.3) | 6 (18.1) | 0.0005 |
≥ 40 for men or ≥50 for women, n (%) | 15 (35.7) | 15 (45.4) | 24 (72.3) | 27 (81.8) | |
Total cholesterol/ HDL-cholesterol | |||||
Median (Q1–Q3) | 4.2 (3.7–5) | 4.0 (3.7–4.9) | 4.4 (3.8–5.0) | 4.3 (3.5–5.1) | 0.2348 |
< 5, n (%) | 32 (76.2) | 25 (75.8) | 25 (75.8) | 25 (75.8) | |
≥ 5, n (%) | 10 (23.8) | 8 (24.2) | 8 (24.2) | 8 (24.2) | |
Triglycerides (mg/dL) | |||||
Median (Q1–Q3) | 91 (76–126) | 95 (76–126) | 139 (99–179) | 146 (105–208) | <0.001 |
< 200, n (%) | 40 (95.2) | 32 (97.0) | 27 (81.8) | 24 (72.7) | 0.0047 |
≥ 200, n (%) | 2 (4.8) | 1 (3.0) | 6 (18.2) | 9 (27.3) | |
High-sensitivity C-reactive protein (mg/L) | |||||
Median (Q1–Q3) | 1.6 (1.1–3.4) | 1.8 (1.2–3.4) | 2.6 (1.1–4.5) | 2.3 (1–5.1) | 0.0635 |
Glycemia (mg/L) | |||||
Median (Q1–Q3) | 88 (82–94) | 88 (81–95) | 89 (86–95) | 91 (85–97) | 0.0106 |
Waist circumference (cm) | |||||
Median (interquartile range) | 85 (77–91) | 85 (77–91) | 84 (78–89) | 84 (76–90) | 0.6888 |
Cardiovascular risk according to Framingham score | |||||
Median (Q1–Q3) | −1 (−1-1) | −1 (−1-1) | 1 (−1–2) | 1 (−1–3) | 0.0002 |
< 1, n (%) | 26 (63.4) | 20 (60.6) | 14 (42.4) | 16 (48.5) | 0.0002 |
1, n (%) | 9 (21.9) | 8 (24.2) | 9 (27 .3) | 5 (15.2) | |
2, n (%) | 4 (9.8) | 3 (9.1) | 5 (15.2) | 3 (9.1) | |
3, n (%) | 1 (2.4) | 1(3.0) | 1 (3.0) | 3 (9.1) | |
4, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.0) | |
5, n (%) | 0 (0.0) | 0 (0.0) | 1 (3.0) | 2 (6.1) | |
6, n (%) | 1 (2.4) | 1 (3.0) | 3 (9.1) | 1 (3.0) | |
8, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.0) | |
10, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.0) | |