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

Table 4

Treatment-emergent adverse events in ≥10% of patients in the duloxetine treatment arms in Studies 1 through 4.

TEAEs, 𝑛 (%)	Study 1 [13, 20]		Study 2 [14, 20]		Study 3 [15, 20]		Study 4 [16]
	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)
≥1 TEAE	100 (97.7)	90 (79.1)	102 (89.5)	79 (73.1)	71 (61.2)	57 (49.1)	71 (83.5)	73 (84.9)	121 (72.5)
Discontinuation due to TEAEs	15 (13.2)	6 (5.2)	17 (14.9)	8 (7.4)	5 (4.3)	3 (2.6)	9 (10.6)	10 (11.6)	9 (5.4)
Nausea	19 (16.7)	11 (9.6)	32 (28.1)	7 (6.5)	32 (27.6)	10 (8.6)	10 (11.8)	14 (16.3)	3 (1.8)
Somnolence	23 (20.2)	9 (7.8)	9 (7.9)	1 (0.9)	19 (16.4)	5 (4.3)	16 (18.8)	21 (24.4)	14 (8.4)
Headache	16 (14.0)	11 (9.6)	12 (10.5)	7 (6.5)	12 (10.3)	7 (6.0)	4 (4.7)	2 (2.3)	6 (3.6)
Dizziness	11 (9.6)	8 (7.0)	18 (15.8)	6 (5.6)	6 (5.2)	4 (3.4)	6 (7.1)	4 (4.7)	2 (1.2)
Insomnia	13 (11.4)	12 (10.4)	6 (5.3)	2 (1.9)	8 (6.9)	2 (1.7)	NA^a	NA^a	NA^a
Diarrhea	11 (9.6)	11 (9.6)	13 (11.4)	2 (1.9)	8 (6.9)	6 (5.2)	4 (4.7)	7 (8.1)	6 (3.6)
Constipation	17 (14.9)	4 (3.5)	8 (7.0)	2 (1.9)	2 (1.7)	1 (0.9)	6 (7.1)	5 (5.8)	9 (5.4)

DLX: duloxetine; 𝑛: number of affected patients; NA: not available; PLB: placebo; QD: once daily; TEAE: treatment-emergent adverse event.
^aInsomnia was not analyzed as a TEAE in study 4; insomnia was reported as an adverse events in 1 patient receiving placebo, 2 patients receiving duloxetine 40 mg QD, and 1 patient receiving duloxetine 60 mg QD in study 4; insomnia was reported as adverse drug reaction in 1 patient receiving duloxetine 40 mg QD in study 4.