Review of Efficacy and Safety of Duloxetine 40 to 60 mg Once Daily in Patients with Diabetic Peripheral Neuropathic Pain

Table 2

Demographics and baseline assessments in studies 1 through 5.

	Study 1 [13]		Study 2 [14]		Study 3 [15]		Study 4 [16, 18]			Study 5 [17]
	DLX 60 mg QD (𝑛=114)	PLB; (𝑛=115)	DLX 60 mg QD (𝑛=114)	PLB; (𝑛=108)	DLX 60 mg QD (𝑛=116)	PLB (𝑛=116)	DLX 40 mg QD (𝑛=85)	DLX 60 mg QD (𝑛=86)	PLB (𝑛=167)	DLX 60 mg QD (𝑛=216)
Mean Age, years (SD)	59.2 (11.6)	60.4 (10.5)	59.7 (11.2)	60.8 (10.6)	58.3 (10.9)	59.2 (9.8)	62.1 (9.3)	59.7 (12.1)	60.8 (9.2)	63.3 (9.5)
Female Gender, 𝑛 (%)	35 (30.7)	56 (48.7)	40 (35.1)	39 (36.1)	68 (58.6)	63 (54.3)	20 (23.5)	24 (27.9)	38 (22.8)	104 (48.2)
					Race
White, 𝑛 (%)	88 (77.2)	89 (77.4)	90 (78.9)	86 (79.6)	115 (99.1)	116 (100)	0	0	0	173 (80.1)
African, 𝑛 (%)	8 (7.0)	11 (9.6)	3 (2.6)	5 (4.6)	0	0	0	0	0	0
Hispanic, 𝑛 (%)	13 (11.4)	12 (10.4)	16 (14.0)	17 (15.7)	0	0	0	0	0	0
Asian, 𝑛 (%)	0	0	0	0	1 (0.9)	0	85 (100)	86 (100)	167 (100)	33 (15.3)
Other, 𝑛 (%)	5 (4.4)	3 (2.6)	5 (4.4)	0	0	0	0	0	0	10 (4.6)
Mean weight, kg (SD)	99 (24)	94 (22)	99.9 (22.0)	104.4 (24.8)	83.3 (19.6)	87.2 (16.5)	62.7 (13.4)	65.1 (10.2)	64.5 (11.9)	84.0 (18.4)
Type 2 DM, 𝑛 (%)	100 (87.7)	104 (90.4)	104 (91.2)	97 (89.8)	93 (80.2)	102 (87.9)	80 (94.1)	82 (95.3)	159 (95.2)	204 (94.4)
Mean duration of DM, years (SD)^a	11.4 (8.2)	11.4 (11.3)	9.7 (9.6)	11.1 (9.1)	14.6 (8.9)	12.8 (8.6)	<5: 20; 5–10: 18; ≥10: 47	<5: 16; 5–10: 14; ≥10: 56	<5: 33; 5–10: 32; ≥10: 97; not known: 5	14.4 (9.7)
Mean duration of DPNP, years (SD)	3.8 (4.4)	4.0 (4.1)	3.6 (3.5)	3.5 (3.2)	4.5 (4.4)	4.0 (3.5)	4.6 (3.9)	4.2 (3.7)	4.2 (4.4)	NA
Mean MNSI, score (SD)	5.1 (1.6)	5.1 (1.6)	5.5 (1.5)	5.9 (1.5)	4.9 (1.4)	5.2 (1.6)	NA	NA	NA	5.3 (1.3)
24-hour average pain severity, weekly mean (SD)	6.0 (1.7)	5.8 (1.5)	6.1 (1.6)	5.9 (1.4)	5.5 (1.1)	5.5 (1.3)	5.8 (1.2)	5.8 (1.2)	5.8 (1.2)	4.2 (4.0)

^aFor study 4, mean duration of years with diabetes was not available, displayed are the numbers of patients with a duration of diabetes of <5 years, 5–10 years, or ≥10 years for this study.
DPNP: diabetic peripheral neuropathic pain; MNSI: Michigan Neuropathy Screening Instrument; 𝑛: number of affected patients; NA: not available; QD: once daily; SD: standard deviation, DM: diabetes mellitus.