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 2
Baseline characteristics.
NSAID/APAP user
NSAID/APAP nonuser
Duloxetine
Placebo
Duloxetine
Placebo
Age in years, mean (SD)
53.1 (14.7)
51.4 (13.3)
53.5 (14.9)
53.1 (13.6)
Female, n (%)
89 (65.0)
52 (63.4)
114 (55.3)
85 (54.5)
Ethnicity, n (%)
African American
3 (2.2)
3 (3.7)
19 (9.2)
13 (8.3)
Caucasian
108 (78.8)
61 (74.4)
160 (77.7)
123 (78.9)
East Asian
0
0
2 (1.0)
3 (1.9)
Hispanic
25 (18.3)
17 (20.7)
22 (10.7)
15 (9.6)
Native American
0
0
1 (0.5)
2 (1.3)
West Asian
1 (0.7)
1 (1.2)
2 (1.0)
0
CLBP duration since onset, years, mean (SD)
11.4 (11.5)
9.2 (9.1)
10.8 (11.1)
10.3 (9.0)
QT F class 1, n (%)
94 (72.9)
63 (79.8)
150 (75.4)
99 (68.3)
BPI average pain, mean (SD)
6.1 (1.6)
6.0 (1.6)
5.9 (1.6)
6.1 (1.7)
RMDQ-24, mean (SD)
9.6 (5.0)
8.6 (4.8)
9.1 (4.5)
9.8 (5.3)
There was a statistically significant difference in RMDQ-24 scores between treatments in the nonuser subgroup, but this difference was not considered clinically significant. Abbreviations: APAP, acetaminophen; BPI, Brief Pain Inventory; CLBP, chronic low back pain; NSAID, nonsteroidal anti-inflammatory drugs; QTF, Quebec Task Force; RMDQ-24, Roland-Morris Disability Questionnaire, SD, standard deviation.
