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


*Note: duloxetine trial arms with dose 20 mg QD and pregabalin trial arms with dose 25 mg TID were excluded from the meta-analysis;

aQD: Once daily; BID: Twice daily; TID: Three times daily.

Quilici et al. BMC Neurology 2009 9:6   doi:10.1186/1471-2377-9-6

Open Data