Table 3.
Performance of candidate pain intensity and physical function composite outcomes in a random subsample of subjects (exploratory data set) from randomized, placebo-controlled trials of pregabalin for diabetic peripheral neuropathy and postherpetic neuralgia
| Criteria for candidate composite outcomes | No. of Pregabalin Responders (%) | No. of Placebo Responders (%) | Risk Ratio (95% CI) |
|---|---|---|---|
| Diabetic Peripheral Neuropathy (5 trials; Subsample, n=602) | |||
| 1. ≥30% improvement in pain intensity or physical function | 252 (66.1) | 122 (55.2) | 1.2 (1.0–1.4)* |
| 2. ≥30% improvement in pain intensity and physical function | 64 (16.8) | 29 (13.1) | 1.6 (0.8–2.1) |
| 3. ≥30% improvement in pain intensity and physical function and 10 point improvement in the physical function raw score | 61 (16.0) | 28 (12.7) | 1.3 (0.9–1.9) |
| 4. ≥40% improvement in pain intensity or physical function | 210 (55.1) | 99 (44.8) | 1.2 (1.2–1.3)* |
| 5. ≥40% improvement in pain intensity and physical function | 54 (14.2) | 20 (9.1) | 1.6 (0.8–2.9) |
| 6. ≥50% improvement in pain intensity or physical function | 191 (50.1) | 79 (35.8) | 1.4 (1.2–1.6)* |
| 7. ≥50% improvement in pain intensity and physical function | 36 (9.5) | 17 (7.7) | 1.2 (0.6–2.4) |
| 8. ≥30% improvement in pain intensity and ≥20% improvement in physical function, or ≥20% improvement in pain intensity and ≥30% improvement in physical function | 90 (23.6) | 40 (18.1) | 1.3 (1.0–1.7) |
| 9. ≥50% improvement in pain intensity and ≥20% improvement in physical function, or ≥20% improvement in pain intensity and ≥50% improvement in physical function | 79 (20.7) | 35 (15.8) | 1.3 (0.9–2.0) |
| 10. ≥50% improvement in pain intensity, or ≥20% improvement in pain intensity and ≥30% improvement in physical function | 164 (43.0) | 64 (29.0) | 1.5 (1.2–1.8)* |
| Postherpetic Neuralgia (5 trials; Subsample, n=476) | |||
| 1. ≥30% improvement in pain intensity or physical function | 191 (63.9) | 75 (42.4) | 1.5 (1.2–1.9)* |
| 2. ≥30% improvement in pain intensity and physical function | 43 (14.4) | 16 (9.0) | 1.6 (1.1–2.4)* |
| 3. ≥30% improvement in pain intensity and physical function and ≥10 point improvement in the physical function raw score | 42 (14.1) | 15 (8.5) | 1.7 (1.1–2.5)* |
| 4. ≥40% improvement in pain intensity or physical function | 163 (54.5) | 68 (38.4) | 1.4 (1.1–1.8)* |
| 5. ≥40% improvement in pain intensity and physical function | 32 (10.7) | 9 (5.1) | 2.1 (1.1–4.0)* |
| 6. ≥50% improvement in pain intensity or physical function | 149 (49.8) | 61 (34.5) | 1.4 (1.2–1.8)* |
| 7. ≥50% improvement in pain intensity and physical function | 23 (7.7) | 7 (4.0) | 1.9 (0.9–4.3) |
| 8. ≥30% improvement in pain intensity and ≥20% improvement in physical function, or ≥20% improvement in pain intensity and ≥30% improvement in physical function | 58 (19.4) | 18 (10.2) | 1.9 (1.5–2.4)* |
| 9. ≥50% improvement in pain intensity and ≥20% improvement in physical function, or ≥20% improvement in pain intensity and ≥50% improvement in physical function | 50 (16.7) | 17 (9.6) | 1.7 (1.3–2.4)* |
| 10. ≥50% improvement in pain intensity, or ≥20% improvement in pain intensity and ≥30% improvement in physical function | 116 (38.8) | 35 (19.8) | 2.0 (1.8–2.3)* |
*
P value<0.05