Pain Research and Treatment / 2012 / Article / Tab 3 / Review Article
Review of Efficacy and Safety of Duloxetine 40 to 60 mg Once Daily in Patients with Diabetic Peripheral Neuropathic Pain Table 3 Efficacy results of duloxetine 40 and 60 mg QD versus placebo in placebo-controlled studies in patients with DPNP for studies 1 through 4.
Measure Study 1 Study 2 Study 3 Study 4 DLX 60 mg QD (
𝑁
=
1
1
3
) PLB (
𝑁
=
1
1
2
) DLX 60 mg QD (
𝑁
=
1
1
2
) PLB (
𝑁
=
1
0
6
) DLX 60 mg QD (
𝑁
=
1
1
3
) PLB (
𝑁
=
1
1
3
) DLX 40/60 mg QD (
𝑁
=
1
7
1
) PLB (
𝑛
=
1
6
7
) Weekly mean of 24 hour
−
2
.
8
1
∗
∗
−2.04
−
2
.
7
2
∗
∗
∗
−1.39
−
2
.
5
0
∗
∗
∗
−1.60
−
2
.
4
7
∗
∗
∗
−1.61 Average pain severity Rating, mean change (SE) [13 –16 ] (0.21) (0.21) (0.22)b (0.23) (0.18) (0.18) (0.18) (0.18) BPI-Interference, mean (SE) [13 –16 ]
−
2
.
3
3
∗
∗
−1.73
−
2
.
3
6
∗
−1.72
−
2
.
4
3
∗
∗
∗
−1.56
−
2
.
0
4
∗
−1.56 (0.17) (0.17) (0.19)a (0.19)c (0.18)e (0.18)f (0.20)i (0.20)l PGI-Improvement, mean (SE) [13 –16 ]
2
.
2
1
∗
∗
∗
2.91
2
.
6
1
∗
∗
3.17
2
.
5
0
∗
∗
∗
3.04
2
.
5
3
∗
∗
3.18 (0.12)a (0.12)a (1.44) (1.44)d (0.10)f (0.10)g (0.12) (0.12)h Percentage of patients with PGI ratings ≤2 at 12 weeks
5
7
.
7
%
a
∗
∗
∗
31.5%a
5
8
.
0
%
∗
∗
∗
32.4%d
5
2
.
3
%
f
∗
∗
∗
29.5%g NA NA Percentage of patients with PGI ratings ≤3 at 12 weeks
7
8
.
4
%
a
∗
∗
61.3%a
7
5
.
0
%
∗
60.0%d
8
5
.
3
%
f
∗
71.4%g NA NA Response rate 30% pain Reduction [14 , 15 ] 64%g 47%a
6
3
%
∗
∗
42%
6
8
%
∗
∗
∗
43%
5
7
%
∗
∗
∗
35% 50% pain Reduction [14 , 15 , 19 ] 49%g 26%a
4
3
%
b
∗
27% 50% 30%
3
9
%
∗
∗
∗
20% NNT Based on: 30% pain Reduction (95% CI) 5.7 (3.3, 21.5)g NA 4.7 (2.9, 12.2)b NA 4.0 (2.7, 8.2) NA 4.6 (2.7, 15.7) NA 50% pain Reduction (95% CI) [19 ] 4.3 (2.8, 9.4) NA 6.5 (3.6, 36.4) NA 5.1 (3.1, 14.3) NA 5.2 (2.7, 68.1) NA NNH based on discontinuations due to AEs (95% CI) 12.5 (6.5, 172.8)j NA 13.2 (−165, 6.3)j NA 58.8 (−33.4, 15.6)k NA 16.0 (−74.0, 7.2) NA
∗
𝑃
≤
.
0
5
versus placebo;
∗
∗
𝑃
≤
.
0
1
versus placebo;
∗
∗
∗
𝑃
≤
.
0
0
1
versus placebo
a
𝑛
=
1
1
1
; b
𝑛
=
1
1
0
; c
𝑛
=
1
0
4
; d
𝑛
=
1
0
5
; e
𝑛
=
1
0
8
; f
𝑛
=
1
0
9
; g
𝑛
=
1
1
2
; h
𝑛
=
1
6
5
; i
𝑛
=
8
5
; j
𝑛
=
1
1
4
; k
𝑛
=
1
1
6
; l
𝑛
=
1
6
5
AEs: adverse events; BPI: brief pain inventory; CI: confidence interval; DLX: duloxetine; NA: not applicable; NNH: number needed to harm; NNT: number needed to treat; PGI: patient global impression; PLB: placebo; QD: once daily.