Table 2.
Patients in each pain severity category at endpoint
| Treatment | N | Baseline pain category | Mild pain at endpoint, n (%) | Moderate pain at endpoint, n (%) | Severe pain at endpoint, n (%) | P-value versus placebo | |
|---|---|---|---|---|---|---|---|
| FM | Pregabalin 300 mg/d | 686 | Moderate | 83 (26.9) | 200 (64.7) | 26 (8.4) | 0.013 |
| Severe | 68 (18.3) | 108 (29.0) | 196 (52.7) | ||||
| Pregabalin 450 mg/d | 687 | Moderate | 99 (30.3) | 208 (63.6) | 20 (6.1) | <0.001 | |
| Severe | 69 (19.9) | 108 (31.1) | 170 (49.0) | ||||
| Pregabalin Flexa | 250 | Moderate | 57 (38.3) | 80 (53.7) | 12 (8.0) | 0.138 | |
| Severe | 16 (15.8) | 29 (28.7) | 56 (55.4) | ||||
| Placebo | 937 | Moderate | 133 (26.4) | 320 (63.5) | 51 (10.1) | – | |
| Severe | 57 (13.4) | 120 (28.2) | 248 (58.3) | ||||
| DPN/PHN | Pregabalin 150 mg/d | 427 | Moderate | 104 (42.6) | 129 (52.9) | 11 (4.5) | 0.001 |
| Severe | 33 (19.3) | 46 (26.9) | 92 (53.8) | ||||
| Pregabalin 300 mg/d | 875 | Moderate | 233 (44.1) | 270 (51.1) | 25 (4.7) | <0.001 | |
| Severe | 93 (27.8) | 88 (26.3) | 153 (45.8) | ||||
| Pregabalin 600 mg/d | 861 | Moderate | 234 (46.6) | 247 (49.2) | 21 (4.2) | <0.001 | |
| Severe | 126 (37.2) | 75 (22.1) | 138 (40.7) | ||||
| Pregabalin Flexb | 704 | Moderate | 235 (59.5) | 152 (38.5) | 8 (2.0) | <0.001 | |
| Severe | 104 (36.0) | 94 (32.5) | 91 (31.5) | ||||
| Placebo | 1,532 | Moderate | 366 (41.4) | 464 (52.4) | 55 (6.2) | – | |
| Severe | 102 (16.6) | 173 (28.2) | 339 (55.2) | ||||
| SCI | Pregabalin Flexb | 174 | Moderate | 39 (38.6) | 61 (60.4) | 1 (1.0) | 0.010 |
| Severe | 10 (14.3) | 25 (35.7) | 35 (50.0) | ||||
| Placebo | 173 | Moderate | 25 (27.2) | 61 (66.3) | 6 (6.5) | – | |
| Severe | 6 (7.7) | 22 (28.2) | 50 (64.1) |
Notes:
a
300–450 mg/d;
b
150–600 mg/d.
Abbreviations: DPN, diabetic peripheral neuropathy; Flex, flexible dosing; FM, fibromyalgia; PHN, postherpetic neuralgia; SCI, spinal cord injury; d, day.