Table 1.
Demographic and other characteristics of participants randomized into the double-blind treatment period of the RELIEF-DPN 1 study
| LX9211 10 mg | LX9211 20 mg | Placebo | Total | |
|---|---|---|---|---|
| N | 106 | 106 | 107 | 319 |
| Demographics | ||||
| Age (years), mean (SD) | 63 (9) | 62 (11) | 62 (10) | 62 (10) |
| Sex, n (%) | ||||
| Male | 58 (54.7) | 63 (59.4) | 66 (61.7) | 187 (58.6) |
| Female | 48 (45.3) | 43 (40.6) | 41 (38.3) | 132 (41.4) |
| Race, n (%) | ||||
| White | 79 (74.5) | 83 (78.3) | 82 (76.6) | 244 (76.5) |
| Black | 22 (20.8) | 18 (17.0) | 19 (17.8) | 59 (18.5) |
| Asian | 3 (2.8) | 1 (0.9) | 1 (0.9) | 5 (1.6) |
| Other | 2 (1.9) | 4 (3.8) | 5 (4.7) | 11 (3.4) |
| BMI (kg/m2), mean (SD) | 32.1 (4.27) | 32.1 (4.58) | 32.0 (4.53) | 32.1 (4.45) |
| Diabetes characteristics | ||||
| Type 1, n (%) | 5 (4.7) | 5 (4.7) | 5 (4.7) | 15 (4.7) |
| Type 2, n (%) | 87 (82.1) | 83 (78.3) | 87 (81.3) | 257 (80.6) |
| Type not reported, n (%) | 14 (13.2) | 18 (17.0) | 15 (14.0) | 47 (14.7) |
| HbA1c, % (mmol/mol), mean (SD) | 7.7 (61) | 7.6 (60) | 7.7 (61) | 7.7 (61) |
| Duration of NP (years), mean (SD) | 7.0 (6.15) | 6.5 (5.48) | 6.4 (4.62) | 6.6 (5.43) |
| Medication use for NP at baseline, n (%) | 44 (41.5) | 42 (39.6) | 59 (55.1) | 145 (45.5) |
| Gabapentin | 41 (38.7) | 38 (35.8) | 54 (50.5) | 133 (41.7) |
| Pregabalin | 2 (1.9) | 2 (1.9) | 3 (2.8) | 7 (2.2) |
| Duloxetine | 4 (3.8) | 3 (2.8) | 7 (6.5) | 14 (4.4) |
| Other | 2 (1.9) | 2 (1.9) | 4 (3.7) | 8 (2.5) |
| Pain intensity*† | ||||
| ADPS, mean (SD) | 6.6 (1.09) | 6.5 (1.03) | 6.5 (1.15) | 6.6 (1.09) |
| Moderate pain, n (%)‡ | 82 (77.4) | 82 (77.4) | 82 (76.6) | 246 (77.1) |
| Severe pain, n (%)‡ | 24 (22.6) | 24 (22.6) | 25 (23.4) | 73 (22.9) |
*
N = 106, N = 104, and N = 106 for the low-dose LX9211, high-dose LX9211, and placebo groups, respectively.
†
Scale of 0–10 based on patient’s answer to question no. 5 of BPI-DPN; higher scores indicate greater pain intensity.
‡
Moderate, 5–7; severe, 8–9.