Development of musculoskeletal toxicity without clear benefit after administration of PG-116800, a matrix metalloproteinase inhibitor, to patients with knee osteoarthritis: a randomized, 12-month, double-blind, placebo-controlled study

Table 4 One-year change from baseline in total WOMAC scores (intent-to-treat population)

Treatment group	Number^a	WOMAC total score at baseline	WOMAC total score at month 12	One-year change from baseline	P value^b (90% CI)
		Mean (SEM)	Mean (SEM)	Least square mean (SEM)
Placebo	67	41.8 (2.16)	32.9 (2.78)	-9.1^c (2.81)
25 mg	61	42.6 (2.90)	35.9 (3.21)	-6.7^c (2.78)	0.746 (-∞, 7.0)
50 mg	62	49.1 (2.46)	37.1 (3.20)	-10.0^c (2.88)	0.403 (-∞, 3.7)
100 mg	62	50.9 (2.66)	42.4 (3.10)	-5.8^c (2.92)	0.823 (-∞, 8.0)
200 mg	30	47.2 (3.70)	36.5 (4.54)	-9.3^c (3.96)	0.483 (-∞, 5.6)
25 mg versus placebo					0.485^d
50 mg versus placebo					0.631^d
100 mg versus placebo					0.374^d
200 mg versus placebo					0.610^d

^aNumber of patients with available data at baseline and month 12. ^bOne-sided P value: The mean change from baseline in each treatment group was compared to placebo by means of an analysis of variance after adjusting for pooled centers, baseline use of estrogen replacement therapy or selective estrogen receptor modulator drugs, and baseline total scores. ^cThe mean change from baseline was significantly different from zero using a paired t test within each treatment group. ^dOne-sided P value was based on between-group comparison of mean change from baseline by means of repeated-measures analysis adjusted for pooled centers, baseline total scores, and baseline use of estrogen replacement therapy or selective estrogen receptor modulator drugs.
CI, confidence interval for mean difference; SEM, standard error of the mean; WOMAC, Western Ontario and McMaster Universities osteoarthritis index.

ISSN: 1478-6362