Efficacy and safety of diclofenac sodium 2% topical solution for osteoarthritis of the knee: a randomized, double-blind, vehicle-controlled, 4 week study

Figures & data

Table 1. Demographics and baseline disease characteristics*.

Characteristics	Diclofenac Sodium 2% Topical Solution (n = 130)	Vehicle Control (n = 129)
Age, years, mean (SD)	60.2 (9.2)	61.9 (9.1)
Sex, n (%)
Male	46 (35.4)	39 (30.2)
Female	84 (64.6)	90 (69.8)
Race, n (%)
White	110 (84.6)	108 (83.7)
Black/African American	19 (14.6)	21 (16.3)
Asian	1 (0.8)	0 (0.0)
Ethnicity, n (%)
Hispanic/Latino	2 (1.5)	0 (0.0)
Not Hispanic/Latino	128 (98.5)	129 (100.0)
Height, cm, mean (SD)	169.7 (10.4)	167.8 (9.9)
Weight, kg, mean (SD)	93.3 (22.8)	89.8 (21.1)
BMI, kg/m^2, mean (SD)	32.5 (7.7)	31.8 (6.8)
Kellgren–Lawrence OA grade, n (%)
Grade 2	62 (47.7)	70 (54.3)
Grade 3	68 (52.3)	59 (45.7)
WOMAC subscale scores, mean (SD)
Pain	12.4 (3.1)	12.6 (3.4)
Physical function	42.9 (10.4)	43.3 (10.3)
Stiffness	5.3 (1.5)	5.4 (1.3)
PGA rating, n (%)
Very good	0 (0.0)	1 (0.8)
Good	2 (1.5)	2 (1.6)
Fair	23 (17.7)	23 (17.8)
Poor	79 (60.8)	76 (58.9)
Very poor	26 (20.0)	27 (20.9)
NRS score, mean (SD)
Screening	4.6 (1.6)	4.6 (1.7)
Pretreatment (Day 1)	7.6 (1.3)	7.6 (1.4)

*p > 0.05 for all comparisons.

BMI, body mass index; NRS, numeric rating scale; OA, osteoarthritis; PGA, patient global assessment; SD, standard deviation; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.

Table 2. Efficacy outcomes at week 4 (LOCF/BOCF)*.

Outcome	Diclofenac Sodium 2% Topical Solution (n = 130)	Vehicle Control (n = 129)	p-value
WOMAC – pain score
Baseline	12.4 (3.1)	12.6 (3.4)
Week 4	7.9 (4.5)	8.9 (4.4)	0.040**
Change from baseline	−4.5 (4.5)	−3.6 (4.2)
WOMAC – physical function score
Baseline	42.9 (10.4)	43.3 (10.3)
Week 4	28.6 (15.3)	31.8 (15.1)	0.061**
Change from baseline	−14.3 (14.7)	−11.5 (13.8)
WOMAC – stiffness score
Baseline	5.3 (1.5)	5.4 (1.3)
Week 4	3.6 (2.0)	4.0 (1.9)	0.097**
Change from baseline	−1.7 (1.8)	−1.4 (2.0)
PGA score
Baseline	4.0 (0.7)	4.0 (0.7)
Week 4	2.9 (1.1)	3.1 (1.1)	0.085**
Change from baseline	−1.1 (1.2)	−0.9 (1.1)
NRS score
Midday
Baseline	7.4 (1.5)	7.3 (1.6)
Week 4	4.5 (2.6)	4.8 (2.5)	0.143**
Change from baseline	−3.0 (2.5)	−2.5 (2.3)
Evening
Baseline	7.7 (1.3)	7.6 (1.5)
Week 4	4.5 (2.5)	4.8 (2.6)	0.179**
Change from baseline	−3.2 (2.5)	−2.8 (2.5)
Last 24 hours
Baseline	7.6 (1.3)	7.6 (1.4)
Week 4	4.6 (2.6)	5.1 (2.5)	0.128**
Change from baseline	−3.0 (2.6)	−2.5 (2.4)
Patients using rescue medication, n (%)
Week 4	68 (52.3)	82 (63.6)	0.067
Overall	95 (73.1)	99 (76.7)	0.496
Self-reported rescue medication use, days
Week 4	3.1 (3.9)	4.3 (4.3)	0.054**
Overall	6.9 (7.4)	8.8 (8.2)

Data are shown as mean (standard deviation) unless otherwise stated.

*LOCF and BOCF calculations were equivalent in direction.

**p-value is the result of comparison of least-squares means for each treatment group in the model.

BOCF, baseline observation carried forward; LOCF, last observation carried forward; NRS, numeric rating scale; PGA, patient global assessment; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.

Figure 1. Daily NRS pain intensity: average daily pain during the last 24 hours at final visit, reported in the evening (last observation carried forward/baseline observation carried forward). NRS, numeric rating scale.

Figure 2. Cumulative proportion of responders from no response to 100% response using reduction in average numeric rating scale pain intensity ratings over the last 24 hours at final visit in the two treatment groups as measure of response (last observation carried forward/baseline observation carried forward).

Table 3. Most common* TEAEs determined to be related or possibly related to study drug (n = 259).

TEAE†, n (%)	Diclofenac Sodium 2% Topical Solution (n = 130)	Vehicle Control (n = 129)
Dryness	26 (20.0)	28 (21.7)
Exfoliation	8 (6.2)	10 (7.8)
Erythema	4 (3.1)	15 (11.6)
Pruritus	3 (2.3)	18 (14.0)
Pain	2 (1.5)	4 (3.1)

*Occurred in ≥3% of patients in either treatment group.

†Application site.

TEAE, treatment-emergent adverse event.