Table 4.
High placebo responsea
|
Difference | Low placebo responseb
|
Difference | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Pregabalin (n=709) |
Placebo (n=353) |
Pregabalin (n=2,290) |
Placebo (n=1,161) |
|||||||
n | Mean (SD)c | n | Mean (SD)c | n | Mean (SD)c | n | Mean (SD)c | |||
DPN | ||||||||||
Age, y | ||||||||||
18–52 | 195 | −2.59 (2.23) | 98 | −2.36 (2.31) | −0.23 | 319 | −2.35 (2.21) | 172 | −1.80 (2.02) | −0.56 |
53–59 | 194 | −2.74 (2.23) | 92 | −2.02 (2.06) | −0.71 | 292 | −2.54 (2.42) | 138 | −1.39 (1.99) | −1.15 |
60–66 | 163 | −2.98 (2.32) | 94 | −2.49 (2.00) | −0.49 | 347 | −2.35 (2.20) | 191 | −1.28 (2.05) | −1.08 |
67–89 | 157 | −2.21 (2.25) | 69 | −2.30 (2.51) | 0.10 | 348 | −2.37 (2.48) | 184 | −1.33 (2.20) | −1.04 |
Sex | ||||||||||
Female | 372 | −2.76 (2.33) | 190 | −2.31 (2.07) | −0.45 | 516 | −2.55 (2.37) | 276 | −1.54 (2.27) | −1.02 |
Male | 337 | −2.50 (2.19) | 163 | −2.28 (2.37) | −0.22 | 790 | −2.30 (2.29) | 409 | −1.38 (1.94) | −0.92 |
PHNd | ||||||||||
Age, y | ||||||||||
18–52 | – | – | – | – | – | 57 | −1.66 (2.24) | 33 | −2.19 (2.29) | 0.53 |
53–59 | – | – | – | – | – | 85 | −1.76 (2.36) | 38 | −1.25 (1.54) | −0.51 |
60–66 | – | – | – | – | – | 158 | −2.56 (2.14) | 79 | −1.18 (2.06) | −1.38 |
67–89 | – | – | – | – | – | 679 | −2.05 (2.18) | 324 | −0.83 (1.77) | −1.22 |
>89 | – | – | – | – | – | 5 | −2.08 (4.35) | 2 | 0.14 (0.20) | −2.22 |
Sex | ||||||||||
Female | – | – | – | – | – | 506 | −2.35 (2.32) | 231 | −1.12 (1.92) | −1.23 |
Male | – | – | – | – | – | 478 | −1.81 (2.07) | 245 | −0.91 (1.82) | −0.89 |
Notes:
Pooled placebo patients from DPN studies A0081030, A0081071, and A0081081 (DPN);
pooled placebo patients from DPN studies 1008-014,1008-029, 1008-040, 1008-131, 1008-149, 1008-155 (DPN), A0081060, and A0081163;
mean change (SD) from baseline in pain score at endpoint;
pooled placebo patients from PHN studies 1008-030, 1008-045, 1008-127, 1008-155 (PHN), 1008-196, A0081004, and A0081081 (PHN).
Abbreviations: DPN, diabetic peripheral neuropathy; PHN, postherpetic neuralgia; SD, standard deviation; y, years.