Efficacy and Safety of Duloxetine in Patients with Chronic Low Back Pain Who Used versus Did Not Use Concomitant Nonsteroidal Anti-Inflammatory Drugs or Acetaminophen: A Post Hoc Pooled Analysis of 2 Randomized, Placebo-Controlled Trials

Table 3

Treatment-emergent adverse events within either NSAID/APAP use subgroups that occurred at a rate of at least 5% with duloxetine treatment and were significantly more frequent than with placebo.

	NSAID/APAP User			NSAID/APAP Nonuser
	Duloxetine; 𝑁=137; n (%)	Placebo; 𝑁=82; n (%)	P value	Duloxetine; 𝑁=206; n (%)	Placebo; 𝑁=156; n (%)	P value
At least 1 adverse event	92 (67.2)	51 (62.2)	.850	141 (68.5)	77 (49.4)	<.001
Nausea	25 (18.3)	3 (3.7)	.006	26 (12.6)	4 (2.6)	<.001
Dry mouth	14 (10.2)	1 (1.2)	.018	21 (10.2)	4 (2.6)	.004
Constipation	13 (9.5)	1 (1.2)	.041	17 (8.3)	1 (0.6)	.001
Somnolence	13 (9.5)	0	.006	12 (5.8)	1 (0.6)	.012
Fatigue	10 (7.3)	0	.012	15 (7.3)	1 (0.6)	.003
Insomnia	13 (9.5)	4 (4.9)	.346	23 (11.2)	4 (2.6)	.004
Dizziness	10 (7.3)	2 (2.4)	.197	15 (7.3)	3 (1.9)	.023

P values from Cochran-Mantel-Haenszel test.
Abbreviation: APAP, acetaminophen; NSAID, nonsteroidal anti-inflammatory drugs.