Efficacy and tolerability of celecoxib and naproxen versus placebo in Hispanic patients with knee osteoarthritis

Figures & data

Figure 1 Patient disposition.

Notes: ^aIncludes “lost to follow-up” and “patient no longer willing to participate”; ^bincludes “protocol violation”.
Abbreviations: AE, adverse events; mITT, modified intent-to-treat; qd, once daily; bid, twice daily.

Table 1 Baseline demographic and clinical characteristics

	Celecoxib 200 mg qd (n=127)	Naproxen 500 mg bid (n=129)	Placebo (n=62)	P-value
Age, years, mean (SD) (range)	59.6 (10.6) (44–88)	60.5 (10.1) (40–82)	61.7 (11.2) (45–85)	0.396
Sex, n (% female)a	92 (72)	82 (64)	37 (60)	0.166
Duration of OA, years, mean (SD)	5.3 (5.1)	6.4 (6.9)	6.6 (7.1)	0.193
Patient’s Global Assessment, n (%)b
Very good	0	0	0	0.127
Good	1 (<1)	1 (<1)	0
Fair	18 (14)	10 (8)	2 (3)
Poor	93 (73)	98 (76)	52 (84)
Very poor	15 (12)	20 (16)	8 (13)
Physician’s Global Assessment, n (%)b
Very good	0	0	0	0.278
Good	1 (<1)	1 (<1)	0
Fair	17 (13)	12 (9)	3 (5)
Poor	103 (81)	109 (85)	56 (90)
Very poor	6 (5)	7 (5)	3 (5)
Functional capacity classification, n (%)b
I	2 (2)	7 (5)	3 (5)	0.213
II	90 (71)	95 (74)	41 (68)
III	34 (27)	27 (21)	16 (27)
IV	0	0	0
VAS score, mm, mean (SD)	67.3 (13.0)	67.0 (12.6)	67.5 (11.5)	0.975
WOMAC total score, mean (SD)c	57.4 (14.4)	55.7 (15.8)	58.6 (13.1)	0.335

a Notes: Two patients were younger than the protocol-specified 45 years of age; a 40-year-old naproxen patient was discontinued from the study due to this protocol violation and a 44-year-old celecoxib patient completed the study;

b percentages are calculated based on the number of randomized patients;

c WOMAC total domain score is the sum of pain, stiffness, and physical function domain scores.

Abbreviations: qd, once daily; bid, twice daily; OA, osteoarthritis; SD, standard deviation; VAS, visual analog scale; WOMAC, Western Ontario and McMaster Universities OA Index.

Table 2 Patient’s assessment of arthritis pain (VAS) at week 6 (efficacy evaluable population)

	Celecoxib 200 mg qd (n=96)	Naproxen 500 mg bid (n=96)	Placebo (n=47)
Baseline, mean (SE)	65.5 (1.3)	66.8 (1.2)	69.7 (1.5)
Week 6, mean (SE)	24.3 (2.4)	25.2 (2.4)	35.4 (3.9)
Change from baseline, LSM (SE)	−39.7 (2.7)	−36.9 (2.6)	−28.6 (3.6)
	Naproxen – Celecoxib	Naproxen – Placebo	Celecoxib – Placebo
LSM (SE)	−2.8 (3.3)	−8.4 (4.1)	−11.1 (4.1)
95% CI	−3.8 to 9.3	−16.3 to −0.4	−19.3 to −3.0
P-value	0.4028	0.0407	0.0077

Abbreviations: CI, confidence interval; LSM, least squares mean; SE, standard error; VAS, visual analog scale; qd, once daily; bid, twice daily.

Figure 2 Patient’s Global Assessment of Arthritis: modified intent-to-treat population.

Abbreviations: qd, once daily; bid, twice daily.

Figure 3 Physician’s Global Assessment of Arthritis: overall ratings (modified intent-to-treat population).

Abbreviations: qd, once daily; bid, twice daily.

Table 3 WOMAC, upper gastrointestinal tolerability, and APS pain scores

	Celecoxib 200 mg qd n=125		Naproxen 500 mg bid n=129	Placebo n=61
Change from baseline in week 6/early termination WOMAC: mITT population
Total
LSM (SE)	−23.1 (2.0)		−23.0 (1.9)	−16.0 (2.6)
Pain
LSM (SE)	−5.2 (0.4)		−5.1 (0.4)	−4.0 (0.6)
Stiffness
LSM (SE)	−1.9 (0.2)		−1.9 (0.2)	−1.6 (0.2)
Physical function
LSM (SE)		−16.3 (1.4)	−16.0 (1.4)	−11.1 (1.9)
		Celecoxib versus naproxen	Celecoxib versus placebo	Naproxen versus placebo
P-values
Total		0.9402	0.0232	0.0252
Pain		0.9246	0.0089	0.0100
Stiffness		0.9690	0.2173	0.2000
Physical function		0.8857	0.0245	0.0307
UGI tolerability during study (safety population)
UGI event, n (%)	3 (2.4)		4 (3.1)	1 (1.6)
	Celecoxib versus naproxen		Celecoxib versus placebo	Naproxen versus placebo
P-values	1.0		1.0	1.0
Mean change from baseline to day 7 in APS pain score – total pain interference (mITT population)
Baseline, n	124		128	61
Mean (SEM)	41.3 (1.30)		42.5 (1.21)	42.5 (1.71)
Day 7, n	107		96	55
Mean (SEM)	−16.0 (1.61)		−17.0 (1.60)	−8.3 (1.96)
	Celecoxib versus naproxen		Celecoxib versus placebo	Naproxen versus placebo
P-value (day 7)	0.947		<0.001	<0.001

Abbreviations: APS, American Pain Society; LSM, least squares mean; mITT, modified intent-to-treat; SE, standard error; SEM, standard error of the mean; UGI, upper gastrointestinal; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index; bid, twice daily; qd, once daily.

Table 4 Treatment-related adverse events occurring in ≥2% of patients (in decreasing order of occurrence)

	Celecoxib 200 mg qd (n=125)	Naproxen 500 mg bid (n=129)	Placebo (n=61)
AE by preferred term, n (%)
Dyspepsia	4 (3)	5 (4)	1 (2)
Depression	4 (3)	4 (3)	3 (5)
Abdominal pain	2 (2)	4 (3)	0

Abbreviations: AE, adverse event; bid, twice daily; qd, once daily.