Table 1.
Summary of the multicenter, double-blind, randomized placebo-controlled trials included in the base-case and sensitivity analyses.
| Individual Studies | |||||||
|---|---|---|---|---|---|---|---|
| Pregabalin Trials | Daily Dose (Titration Period) | No. of Patients | Gabapentin Trials | Daily Dose (Titration Period) | No. of Patients | ||
| ITT | Completers | ITT | Completers | ||||
| Beydoun et al 2005 [21] (Study 1008-009) | 600 mg (1 week) | 214 | 156 | UK Gabapentin Study Group, 1990 [27] (Study 877-210P) | 1200 mg (2 weeks) | 61 | 54 |
| Placebo | 98 | 81 | Placebo | 66 | 61 | ||
| Arroyo et al 2004 [20] (Study 1008-011) | 150 mg (3 days) | 99 | 88 | The US Gabapentin Study Group No. 5, 1993 [26] (Study 945-5)d | 1200 mg (2-3 days) | 101 | 95 |
| 600 mg (1 week) | 92 | 69 | 1800 mg (2-3 days) | 54 | 53 | ||
| Placebo | 96 | 84 | Placebo | 98 | 96 | ||
| French et al 2003 [23] (Study 1008-034)a,b | 150 mg | 86 | 81 | Anhut et al 1994 [24] (Study 945-6) | 900 mg (2 days) | 109 | 100 |
| 300 mg | 90 | 71 | |||||
| 600 mg | 89 | 61 | 1200 mg (2 days) | 52 | 50 | ||
| Placebo | 100 | 87 | Placebo | 109 | 100 | ||
| Elger et al 2005 [22] (Study 1008-157)b,c | 600 mg | 137 | 80 | Sivenius et al 1991 [25] (Study 945-9/10) | 900 mg (2 days) | 36 | 32 |
| 1200 mg (2 days) | 17 | 16 | |||||
| Placebo | 73 | 56 | Placebo | 34 | 30 | ||
| Aggregated Studies | |||||||
| Treatment in Pregabalin Trials | Daily Dose | No. of Patients | Treatment in Gabapentin Trials | Daily Dose | No. of Patients | ||
| ITT | Completers | ITT | Completers | ||||
| Placebo | 367 | 308 | Placebo | 307 | 287 | ||
| Low-Dose Pregabalin | 150 mg | 185 | 169 | Low-Dose Gabapentin | 900 mg | 145 | 132 |
| Mid-Dose Pregabalin | 300 mg | 90 | 71 | Mid-Dose Gabapentin | 1200 mg | 231 | 215 |
| High-Dose Pregabalin | 600 mg | 532 | 366 | High-Dose Gabapentin | 1800 mg | 54 | 53 |
All studies had a 12-week double-blind maintenance phase but the durations of the titration phases were variable.
aIn addition to the doses listed above, for trial 1008-034 patients were also recruited into a 50 mg dose group. This dose was not found to be therapeutic and is not registered for use in Australia.
bNo titration phase.
cIn addition to the doses listed above, for trial 1008-157 patients were also recruited into a titrated dose arm with total daily doses ranging from 150 mg to 600 mg, depending on individual requirement. This treatment group was not comparable with the other fixed-dose treatment groups and was excluded from the analyses.
dIn addition to the doses listed above, for trial 945-5 patients were also recruited into a 600 mg dose group. This dose was not found to be therapeutic and is not registered in Australia.
ITT = intention-to-treat.