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=113)	PLB (𝑁=112)	DLX 60 mg QD (𝑁=112)	PLB (𝑁=106)	DLX 60 mg QD (𝑁=113)	PLB (𝑁=113)	DLX 40/60 mg QD (𝑁=171)	PLB (𝑛=167)
Weekly mean of 24 hour	−2.81^∗∗	−2.04	−2.72^∗∗∗	−1.39	−2.50^∗∗∗	−1.60	−2.47^∗∗∗	−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]	−2.33^∗∗	−1.73	−2.36^∗	−1.72	−2.43^∗∗∗	−1.56	−2.04^∗	−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]	2.21^∗∗∗	2.91	2.61^∗∗	3.17	2.50^∗∗∗	3.04	2.53^∗∗	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	57.7%^a∗∗∗	31.5%^a	58.0%^∗∗∗	32.4%^d	52.3%^f∗∗∗	29.5%^g	NA	NA
Percentage of patients with PGI ratings ≤3 at 12 weeks	78.4%^a∗∗	61.3%^a	75.0%^∗	60.0%^d	85.3%^f∗	71.4%^g	NA	NA
Response rate
30% pain; Reduction [14, 15]	64%^g	47%^a	63%^∗∗	42%	68%^∗∗∗	43%	57%^∗∗∗	35%
50% pain; Reduction [14, 15, 19]	49%^g	26%^a	43%^b∗	27%	50%	30%	39%^∗∗∗	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≤.05 versus placebo; ^∗∗𝑃≤.01 versus placebo; ^∗∗∗𝑃≤.001 versus placebo
^a𝑛=111; ^b𝑛=110; ^c𝑛=104; ^d𝑛=105; ^e𝑛=108; ^f𝑛=109; ^g𝑛=112; ^h𝑛=165; ⁱ𝑛=85; ^j𝑛=114; ^k𝑛=116; ^l𝑛=165
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.