Improved control of osteoarthritis pain and self-reported health status in non-responders to celecoxib switched to rofecoxib: results of PAVIA, an open-label post-marketing survey in Spain.

摘要

METHODS: An open-label multicentre study was conducted in primary care centres in Spain to investigate the effect of a switch from celecoxib to rofecoxib among patients with osteoarthritis and to identify factors associated with a good response to rofecoxib treatment. Patients were eligible to participate in this study if their physicians considered that they might benefit from such a change of therapy. A total of 2,228 patients (1481 women) were enrolled in the study: participants' mean age was 66.37 years (SD 9.04). Mean duration of OA was 7.44 (6.38) years. Predominant sites of OA included the knee (1,132 patients, 50.8%), lumbar spine (977 patients, 43.9%) and cervical spine (739 patients, 33.2%). At baseline, most patients (77%) were being prescribed celecoxib 200 mg/day; during the study most (92.5%) received rofecoxib 25 mg/day. The mean interval between switch to rofecoxib and follow-up interview was 33 days. Principal results: Patients considered the therapeutic response to rofecoxib substantially and significantly superior to that previously obtained with celecoxib for the management of OA-related pain and OA-related health status (p < 0.001). Seventy-two percent of patients classified their response to rofecoxib therapy as 'good' or 'very good' (vs 6.6% of patients at baseline with celecoxib) and 89.3% of patients expressed satisfaction with rofecoxib (vs 28.9% at baseline with celecoxib). Improvements reported in patient self-assessments following rofecoxib therapy were complemented by similar changes in physician perceptions. The number of patients considered by their doctors to have 'good' or 'very good' OA-related health status rose from 10.1% at baseline to 80.0% on completion of rofecoxib therapy. Ancillary indices such as the proportion of patients with self-reported depression were also favourably influenced by the switch to rofecoxib from celecoxib. Determinants of response: Patient characteristics identified in multivariate analysis as predictive of a favourable response to rofecoxib comprised age, obesity, depression, diabetes and OA-related overall health status. CONCLUSIONS: The results of this observational study indicate that rofecoxib 25 mg/day is likely to be more effective in patients with OA who do not respond well to celecoxib 200 mg/day and satisfies a large proportion of both patients and physicians. These data are of practical interest because they indicate that, at the doses most often used in primary practice in Spain to treat OA, many patients who are dissatisfied with the effects of celecoxib 200 mg/day may benefit from a switch to rofecoxib 25 mg/day. The data obtained in this study also reveal that younger OA patients with relatively uncomplicated clinical circumstances (a population in which use of Coxibs is relatively low at present) are likely to derive substantial benefit from a switch to rofecoxib therapy.