Table 1.
Baseline Characteristics of Patients by Treatment Group
| Treatment Arm | ||||
|---|---|---|---|---|
| Characteristic | Arm A (N = 105)a | Arm B (N = 84) | Arm C (N = 82) |
Arm D (N = 106)a |
| Age, y | ||||
| Median (IQR) | 47.2 (39.8–52.4) | 46.0 (41.0–52.2) | 47.9 (43.3–51.5) | 45.8 (38.2–51.7) |
| [min–max] | [20.4–70.5] | [21.6–74.6] | [31.5–70.8] | [22.5–67.3] |
| Gender, n (%) | ||||
| Female | 20 (19.0) | 15 (17.9) | 13 (15.9) | 17 (16.0) |
| Male | 85 (81.0) | 69 (82.1) | 69 (84.1) | 89 (84.0) |
| BMI, n | 103 | 81 | ||
| Median (IQR), kg/m2 | 25.4 (23.1–29.2) | 25.6 (23.3–29.2) | 26.3 (24.4–29.6) | 25.4 (23.0–27.8) |
| [min–max], kg/m2 | [16.7–42.0] | [18.8–52.2] | [16.7–46.3] | [17.9–43.7] |
| Systolic blood pressure, n | 81 | |||
| Mean (SD), mm Hg | 126.8 (13.9) | 124.4 (14.2) | 126.9 (14.3) | 124.8 (15.4) |
| [min–max], mm Hg | [100.0–160.0] | [100.0–162.0] | [92.0–158.0] | [100.0–172.0] |
| Diastolic blood pressure, mmHg | ||||
| Mean (SD) | 80.0 (10.7) | 78.2 (11.2) | 79.7 (9.9) | 78.6 (11.1) |
| [min–max] | [60.0–122.0] | [56.0–107.0] | [54.0–102.0] | [55.0–107.0] |
| Respiratory rate, n | 102 | 83 | 76 | 103 |
| Mean (SD), breaths/min | 15.6 (2.9) | 15.9 (4.0) | 16.0 (4.2) | 16.5 (3.4) |
| [min–max], breaths/min | [10.0–28.0] | [10.0–41.0] | [10.0–37.0] | [10.0–28.0] |
| Waist circumference, n | 101 | 83 | 79 | 102 |
| Mean (SD), cm | 93.5 (11.8) | 94.6 (14.7) | 97.1 (12.2) | 93.0 (11.6) |
| [min–max], cm | [65.0–137.0] | [66.0–145.0] | [70.0–143.0] | [67.5–122.0] |
| Thigh circumference, n | 101 | 82 | 77 | 102 |
| Mean (SD), cm | 50.8 (7.5) | 52.3 (7.7) | 51.8 (6.0) | 49.6 (8.5) |
| [min–max], cm | [33.5–80.0] | [39.0–90.5] | [37.0–69.0] | [22.7–84.0] |
| eGFR,b n | 50 | 41 | 38 | 54 |
| Mean (SD) [min–max] mL/min per 1.73m2 | 79.8 (13.6) [45.0–129.0] | 79.9 (10.8) [60.0–105.0] | 77.9 (10.5) [62.0 –107.6] | 81.4 (14.5) [53.0 –‑ 122.0] |
| <60, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.9) |
| <90, n (%) | 0 (1.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| >60, n (%) | 24 (22.9) | 23 (27.4) | 25 (30.5) | 22 (20.8) |
| >90, n (%) | 28 (26.7) | 19 (22.6) | 19 (23.2) | 28 (26.4) |
Abbreviations: BMI, body mass index; eGFR, estimated glomerular filtration rate; IQR, interquartile range; min–max, minimum–maximum; SD, standard deviation.
aArm A and arm D were continued into the second stage of the trial; hence, the difference in sample size between these arms and the other 2 arms (arms B and C) of the trial.
bSome data are presented in both continuous and categorical form due to there being upper and lower limits of measurement.