A major goal of osteoarthritis (OA) treatment is pain management to improve function and maximise quality of life. Rofecoxib is a highly selective inhibitor of cyclooxygenase-2 used in symptomatic treatment of inflammation and pain in patients with osteoarthritis of the hip or knee. Aim: The primary aim of this study was to assess the effects of rofecoxib on quality of life in elderly patients with painful osteoarthritis flares of the hip or knee, who were not responsive to or had adverse reactions to previous NSAID therapy. In addition the switch pattern of NSAIDs in these patients was recorded. Methods: A 3-week prospective open label multicentre study with rofecoxib 25 mg daily in 134 male and female outpatients with painful osteoarthritis flares of the knee or the hip (mean age 69 years, SD ± 8). On day 1 the patients were all switched from their previous NSAID to rofecoxib, followed by continuous daily treatment with rofecoxib 25mg daily over 3 weeks. On day 21 the patients discontinued daily treatment with rofecoxib and had the choice between either staying on rofecoxib, switching back to their previous NSAID, trying another NSAID or stopping drug treatment. The impact on quality of life was measured by the difference in SF-12 between day 0 and day 21. Further endpoints included changes in selfreported pain, stiffness and functional ability as measured by the WOMAC index (Western Ontario McMaster Universities Osteoarthritis Index). Correlation studies were performed between the WOMAC pain subscale and quality of life as measured by the SF-12 at baseline and over the course of the study. Patients' report of general health status and overall assessment of pain intensity, as measured by visual analogue scale (VAS), was correlated with physicians' and patients' assessment of the efficacy of rofecoxib treatment. Results: Quality of life improved with rofecoxib: the physical component summary score (SF-12 PCS) was improved by a statistically significant +16.2% (p < 0.0001) after 3 weeks, while the mental health component summary score (MCS) was improved by +3.0% (n.s.). Disease-specific symptoms measured by the WOMAC questionnaire were significantly improved under rofecoxib after 3 weeks: pain decreased by 29% (p < 0.0001) and stiffness by 25% (p < 0.0001), while functional ability increased by 24% (p < 0.0001). The improvement in SF-12 PCS correlated negatively with the decrease in WOMAC scores (r = -0.54, p < 0.0001; r = -0.46, p < 0.0001 and r = -0.64, p < 0.0001 respectively). General health was significantly improved by +30.5% (or 15.96 mm, p < 0.0001) between baseline and day 21, while pain was significantly reduced by -35.2% (or 17.67 mm, p < 0.0001) on the VAS scales. At the end of the 3-week study 75% of the patients and 84% of the treating physicians rated the efficacy of rofecoxib from good to excellent. Two weeks after study end the planned telephone survey revealed that 54% of the patients preferred to stay on therapy with rofecoxib, 19% had decided to switch back to their previous NSAID (this observation being most marked for diclofenac, where 38% of initial diclofenac patients had decided to switch back to their initial therapy), 9% had been switched to another NSAID and 7.5% had discontinued treatment. The switch pattern is unknown in the remaining 7.5%. Conclusion: Rofecoxib significantly improves quality of life, as measured by the SF-12, in OA patients who were either unresponsive to or presented with adverse reactions to previous NSAID therapy (including celecoxib). In addition, rofecoxib significantly improved pain, stiffness and function, as assessed by the WOMAC questionnaire.
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