Sz. Zhao et al., Health-related quality-of-life effects of oxaprozin and nabumetone in patients with osteoarthritis of the knee, CLIN THER, 21(1), 1999, pp. 205-217
Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed for t
he treatment of signs and symptoms of osteoarthritis (OA). Nabumetone and o
xaprozin are 2 of the newer NSAIDs and have been shown to have similar safe
ty and efficacy profiles. Nabumetone 1000 mg to 1500 mg once a day (QD) and
oxaprozin 1200 mg QD are commonly recommended doses. This study compared t
he health-related quality of life (HRQOL) of patients receiving oxaprozin 1
200 mg QD with that of patients receiving nabumetone 1000 mg QD or nabumeto
ne 1500 mg QD for the treatment of signs and symptoms of OA of the knee. Tw
o similarly designed, independent, randomized, double-masked, placebo-contr
olled clinical trials were conducted. In trial 1, patients were randomized
to receive oxaprozin 1200 mg QD (n = 109) nabumetone 1000 mg QD (n = 110),
or placebo (n = 109); in trial 2, patients received oxaprozin 1200 mg QD (n
= 116), nabumetone 1500 mg QD (n = 115), or placebo (n = 116). HRQOL was m
easured by the Medical Outcomes Study Short-Form-36 Health Survey (I-week r
ecall period) at baseline and weeks 2 and 6. Data from the 2 trials were co
mbined to assess differences across the 4 groups in 8 domains and 2 summary
scores at baseline, and changes in HRQOL scores at weeks 2 and 6. At week
2, the oxaprozin group showed significantly greater improvement than the pl
acebo group in role physical, vitality, and mental component summary (MCS)
scores (P < 0.05), and in physical functioning, bodily pain, social functio
ning, and physical component summary (PCS) scores (P < 0.01). The nabumeton
e 1500-mg group showed significantly greater improvement than the placebo g
roup in bodily pain and social functioning (P < 0.05), and in vitality and
MCS score (P < 0.01). No significant differences were observed between the
nabumetone 1000-mg and placebo groups. At week 2, the oxaprozin group showe
d a greater change than the nabumetone 1000-mg group in PCS score (P < 0.05
). At week 6, oxaprozin treatment resulted in significantly greater improve
ment than placebo in physical functioning, role physical, and bodily pain (
P < 0.05); social functioning, role emotional, and mental health (P < 0.01)
; and vitality and MCS score (P < 0.001). The nabumetone 1500-mg group show
ed significantly greater responses than the placebo group in vitality (P <
0.05), mental health (P < 0.01), and MCS score (P < 0.001). The oxaprozin g
roup had significantly better scores than the nabumetone 1500-mg group in t
he PCS (P < 0.05), and it showed significantly greater improvement than the
nabumetone 1000 mg group in role physical and PCS score (P < 0.01) and in
role emotional (P < 0.05). No statistically significant differences were fo
und between placebo and nabumetone 1000 mg at week 6. Results of this study
suggest that oxaprozin 1200 mg QD has a significant positive impact on the
HRQOL of patients with OA of the knee compared with nabumetone 1000 mg QD
and placebo.