Table 1 Study design and patient baseline characteristics.*
Study | Druga | Dose | Titration | Randomised patients (N) | Treatment duration (weeks) | Baseline severity (24-hour pain intensity score) Mean (sd) | Diabetes type (% Type 2) | Diabetes Duration (years) Mean (sd) | Diabetes Duration (years) Median | DPNP Duration (years) Mean | Age (years) Mean (sd) | Gender (% male) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
Duloxetine | ||||||||||||
HMAW | Duloxetine | 60 mg QD | 112 | 12 | 6.01 (1.69) | 87.7 | 11.42 (8.20) | 9.87 | 3.81 | 59.21 (11.61) | 69.3 | |
Duloxetine | 60 mg BID | 3 days | 109 | 5.85 (1.38) | 90.3 | 10.06 (8.95) | 7.49 | 3.45 | 60.5 (10.84) | 60.2 | ||
Placebo | 115 | 5.73 (1.52) | 90.4 | 11.44 (11.26) | 7.52 | 4.03 | 60.42 (10.5) | 51.3 | ||||
HMAVa | Duloxetine | 60 mg QD | 114 | 12 | 6.12 (1.62) | 91.2 | 9.74 (9.55) | 6.35 | 3.59 | 59.71 (11.17) | 64.9 | |
Duloxetine | 60 mg BID | 3 days | 112 | 6.21 (1.54) | 92 | 9.88 (10.01) | 6.65 | 4.38 | 61.46 (9.94) | 54.5 | ||
Placebo | 108 | 5.85 (1.42) | 89.8 | 11.08 (9.09) | 9.11 | 3.53 | 60.81 (10.57) | 63.9 | ||||
HMAVb | Duloxetine | 60 mg QD | 116 | 12 | 5.55 (1.12) | 80.2 | 14.64 (8.92) | 14.06 | 4.52 | 58.29 (10.88) | 41.4 | |
Duloxetine | 60 mg BID | 3 days | 116 | 5.65 (1.29) | 85.3 | 13.93 (9.72) | 11.35 | 4.47 | 58.98 (9.58) | 52.6 | ||
Placebo | 116 | 5.47 (1.25) | 87.9 | 12.83 (8.64) | 11.32 | 3.98 | 59.2 (9.84) | 45.7 | ||||
Pregabalin | ||||||||||||
DPN-029 | Pregabalin | 100 mg TID | 1 wk | 82 | 5 | 6.2 (1.4) | 93.8 | 7 | 59 (9.2) | 59.3 | ||
Pregabalin | 200 mg TID | 1 wk | 82 | 6.2 (1.5) | 92.7 | 6.5 | 62 (9.7) | 63.4 | ||||
Placebo | 1 wk | 97 | 6.6 (1.5) | 85.6 | 8 | 57.8 (11.6) | 60.8 | |||||
DPN-131 | Pregabalin | 100 mg TID | 76 | 8 | 6.5 | 84.2 | 9.4 (10.3) | 6 | 59.2 (12.3) | 55.3 | ||
Placebo | 70 | 6.1 | 90 | 9.3 (10.5) | 5.5 | 60.3 (10.3) | 57.1 | |||||
DPN-014 | Pregabalin | 50 mg TID | 2 wks | 79 | 6 | 6.5 | 91.1 | 4 | 56.3 (9.4) | |||
Pregabalin | 200 mg TID | 2 wks | 82 | 6.7 | 97.6 | 6.5 | 57.8 (9.5) | |||||
Placebo | 2 wks | 85 | 6.9 | 83.5 | 9 | 57.1 (10.3) | ||||||
DPN-040 | Pregabalin | 200 mg TID | 2 wks | 87 | 8 | 6.9 | 87.2 | 10.5 | 62 (9.4) | |||
Amitriptyline | 25 mg TID | 2 wks | 88 | 6.4 | 82.8 | 9 | 57.8 (12.0) | |||||
Placebo | 2 wks | 81 | 6.3 | 87.7 | 11 | 60.6 (11.5) | ||||||
DPN-149 | Pregabalin | 75 mg BID | 1 wks | 99 | 12 | 6.2 | 86 | 12 | 58.5 (12.6) | |||
Pregabalin | 150 mg BID | 1 wks | 99 | 6.4 | 84 | 12.5 | 57.6 (10.5) | |||||
Pregabalin | 150/300 mg BID | 1 wk | 101 | 6.6 | 86 | 11 | 59.5 (11.4) | |||||
Placebo | 1 wk | 97 | 6.4 | 86 | 11 | 58.8 (11.8) | ||||||
DPN-155 | Pregabalin | 600 mg QID | 1 wk | 96 | 8 | 6.67 | 82.3 | 13.2 | 11.4 | 61.8 (11) | 54.5 | |
Pregabalin | Flexible dose 150 – 600 mg | 1 wk | 105 | 6.67 | 84.8 | 13.8 | 10.4 | 62.7 (10.6) | 52.5 | |||
Placebo | 48 | 6.55 | 81.3 | 13.6 | 11.5 | 61.7 (12.6) | 56.9 | |||||
Gabapentin | ||||||||||||
Backonja 1998 | Gabapentin | 1200 mg TID | 4 wks | 84 | 8 | 6.4 | 75 | 12 (9.6) | 53 (10.5) | 58.3 | ||
Placebo | 4 wks | 81 | 6.5 | 75 | 11.2 (8.7) | 53 (10.5) | 61.7 | |||||
Simpson 2001 | Gabapentin | 1200 mg TID | 4 wks | 30 | 8 | 6.4 | 80 | 8 (7.4) | 48 (8.2) | 60 | ||
Placebo | 4 wks | 30 | 6.5 | 83 | 9 (7.8) | 52 (9.8) | 60 |