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.

Delahoy et al. BMC Neurology 2010 10:104   doi:10.1186/1471-2377-10-104

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