| Cluster (N = 1528)a | |||||
---|---|---|---|---|---|---|
 | 1 | 2 | 3 | 4 | 5 | 6 |
n | 343 | 306 | 245 | 195 | 237 | 202 |
Females (%)b | 0.0 | 30.1 | 29.8 | 98.5 | 31.7 | 43.1 |
Age (years), mean (SD) | 60.4 (8.1) | 61.0 (7.7) | 62.5 (7.4) | 61.2 (7.6) | 60.5 (9.0) | 61.2 (8.5) |
Age group (years), %b | ||||||
 0–44 | 2.0 | 1.6 | 0.0 | 0.0 | 2.5 | 1.0 |
 45–64 | 69.7 | 63.4 | 65.3 | 70.3 | 65.4 | 66.3 |
 65–74 | 26.0 | 33.0 | 29.8 | 26.7 | 28.7 | 27.2 |
 75+ | 2.3 | 2.0 | 4.9 | 3.1 | 3.4 | 5.5 |
BMI (mg/m2)c | ||||||
 Mean (SD) | 28.8 (3.4) | 30.5 (4.4) | 30.0 (4.3) | 30.6 (4.8) | 30.9 (5.0) | 31.3 (5.8) |
 Normal (%) | 6.4 | 3.3 | 6.5 | 6.7 | 3.0 | 6.4 |
 Overweight (%) | 66.8 | 49.4 | 50.2 | 38.0 | 50.2 | 39.1 |
 Obese (%) | 26.8 | 47.4 | 43.3 | 55.4 | 46.8 | 54.5 |
Baseline painb | ||||||
 Mean (SD) | 6.3 (1.3) | 6.5 (1.4) | 6.3 (1.4) | 6.5 (1.5) | 6.5 (1.3) | 7.0 (1.3) |
 Pain score (%) | ||||||
 0–3 | 1.5 | 1.0 | 1.6 | 2.1 | 1.3 | 0.5 |
 4–5 | 27.7 | 21.6 | 30.6 | 23.1 | 20.7 | 15.4 |
 6–7 | 52.5 | 54.3 | 47.8 | 50.8 | 58.2 | 46.0 |
 8–10 | 18.4 | 23.2 | 20.0 | 24.1 | 19.8 | 38.1 |
Baseline sleep interferenceb | ||||||
 Mean (SD) | 5.4 (2.2) | 5.7 (2.2) | 5.4 (2.4) | 5.6 (2.3) | 5.7 (2.1) | 6.7 (2.2) |
Sleep interference score | ||||||
 0–3 | 22.2 | 16.3 | 22.0 | 19.5 | 14.4 | 10.9 |
 4–5 | 26.5 | 30.1 | 26.1 | 25.6 | 30.0 | 15.4 |
 6–7 | 33.8 | 28.4 | 29.4 | 33.9 | 38.4 | 34.2 |
 8–10 | 17.5 | 25.2 | 22.5 | 21.0 | 17.3 | 39.6 |
Cross-correlation between sleep interference and paind | ||||||
 2 weeks prior based on pain in the current week (lag -2) | 0.70 |  |  |  | 0.70 |  |
 1 week prior based on pain in the current week (lag -1) | 0.75 | 0.70 |  | 0.76 | 0.78 |  |
 Based on pain in the current week (Lag 0) | 0.85 | 0.81 | 0.77 | 0.85 | 0.87 | 0.81 |
 1 week after based on pain in the current week (lag +1) | 0.71 | 0.71 |  | 0.73 | 0.79 | 0.72 |
 2 weeks after based on Pain in the current week (lag +2) |  |  |  |  | 0.71 |  |
Duration of pDPN (years), %c | ||||||
 0 to ≤5 | 28.9 | 21.9 | 24.4 | 29.6 | 22.9 | 20.8 |
  > 5 to ≤10 | 18.7 | 23.7 | 20.4 | 18.5 | 32.4 | 21.6 |
  > 10 to ≤15 | 28.9 | 24.4 | 23.9 | 25.9 | 19.1 | 23.2 |
  > 15 to ≤20 | 12.4 | 13.3 | 15.4 | 18.5 | 12.4 | 13.6 |
  > 20 to ≤25 | 3.6 | 5.7 | 6.0 | 3.1 | 3.8 | 4.8 |
  > 25 | 7.5 | 11.1 | 10.0 | 4.3 | 9.5 | 16.0 |
 History of depression (%)c | 0.0 | 0.0 | 0.0 | 0.0 | 18.1 | 100.0 |
Prior or current therapy (%)c | ||||||
 Pregabalin monotherapy | 100.0 | 59.5 | 0.0 | 100.0 | 58.1 | 40.8 |
 Gabapentin | 0.0 | 0.0 | 0.0 | 0.0 | 100.0 | 0.0 |
 Insulin | 3.2 | 100.0 | 18.0 | 16.9 | 78.1 | 57.4 |
Full of energy at baseline (%) | ||||||
 Always | 1.2 | 0.7 | 1.5 | 0.6 | 0.0 | 0.0 |
 Mostly | 8.1 | 7.9 | 5.0 | 3.7 | 4.8 | 4.8 |
 Fairly often | 11.1 | 6.5 | 11.0 | 11.7 | 8.6 | 8.6 |
 Sometimes | 32.8 | 30.5 | 19.9 | 28.4 | 30.5 | 30.5 |
 Seldom | 40.1 | 40.5 | 56.7 | 44.4 | 39.1 | 39.1 |
 Never | 6.6 | 13.3 | 6.0 | 10.5 | 16.2 | 16.2 |
Calm and relaxed at baseline (%) | ||||||
 Always | 2.4 | 2.5 | 2.0 | 0.0 | 2.9 | 3.2 |
 Mostly | 13.6 | 15.1 | 16.4 | 14.2 | 12.4 | 4.8 |
 Fairly often | 18.1 | 14.7 | 13.9 | 17.3 | 16.2 | 7.2 |
 Sometimes | 31.9 | 30.8 | 27.4 | 26.5 | 27.6 | 17.6 |
 Seldom | 32.5 | 30.5 | 37.8 | 35.8 | 32.4 | 50.4 |
 Never | 1.5 | 5.7 | 2.5 | 5.6 | 8.6 | 16.8 |
Sad and discouraged at baseline (%) | ||||||
 Always | 1.2 | 2.5 | 3.0 | 3.1 | 5.7 | 9.6 |
 Mostly | 15.1 | 14.7 | 13.4 | 16.1 | 12.4 | 42.4 |
 Fairly often | 27.1 | 29.0 | 33.3 | 26.5 | 26.7 | 28.8 |
 Sometimes | 32.5 | 29.1 | 29.9 | 23.5 | 27.6 | 7.2 |
 Seldom | 18.1 | 16.9 | 16.4 | 25.9 | 22.9 | 11.2 |
 Never | 6.0 | 7.2 | 3.5 | 3.7 | 4.8 | 0.8 |
 Responders at 50% threshold at end (%)c | 86.0 | 76.9 | 70.1 | 78.1 | 52.3 | 59.7 |
Daily treatment dose (mg) | ||||||
 75 | 9.0 | 14.1 | 15.5 | 10.8 | 16.0 | 13.4 |
 150 | 79.6 | 74.8 | 65.3 | 72.8 | 56.1 | 61.9 |
 300 | 5.5 | 5.6 | 12.2 | 9.7 | 14.8 | 16.8 |
 600 | 0.3 | 1.3 | 2.9 | 3.6 | 11.0 | 3.5 |
 Other (30–500 mg, excluding doses above) | 5.5 | 4.3 | 4.1 | 3.1 | 2.1 | 4.5 |