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 4

Bleeding-related or cardiac-related treatment-emergent adverse events.

	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
Bleeding-related
Tendency to bruise	1 (0.7)	0	.52	0	0	—
Eye hemorrhage	0	0	—	1 (0.5)	1 (0.6)	.70
Hemorrhagic cyst	0	0	—	1 (0.5)	0	.31
Rectal hemorrhage	0	0	—	1 (0.5)	0	.44
Cardiac-related
Palpitations	5 (3.7)	0	.14	1 (0.5)	1 (0.6)	.86
Hypertension	3 (2.2)	1 (1.2)	.84	4 (1.9)	2 (1.3)	.76
Myocardial infarction	1 (0.7)	0	.52	0	1 (0.6)	.32
Tachycardia	1 (0.7)	0	.29	2 (1.0)	0	.15
Transient ischemic attack	1 (0.7)	0	.52	1 (0.5)	0	.31
Heart rate increased	0	0	—	1 (0.5)	0	.44
Hypertensive crisis	0	0	—	1 (0.5)	0	.44
Carotid artery stenosis	1 (0.7)	0	.52	0	0	—

Abbreviation: APAP, acetaminophen; NSAID, nonsteroidal anti-inflammatory drugs.