Experience of rofecoxib in patients with osteoarthritis previously treated with traditional non-steroidal antiinflammatory drugs in Spain:: results of phase 2 of the VICOXX study

Objectives: To compare patient and physician attitudes to osteoarthritis (OA) treatment with rofecoxib or traditional non-steroidal anti-inflammatory drugs (tNSAIDs). Methods: A 6-month prospective study involving 562 OA patients enrolled at 29 Spanish primary-care centres. Patients were continued on established NSAID therapy for the first 3 months then switched to rofecoxib 12.5 or 25 mg/day. Results: Both patients and physicians were significantly more likely to be satisfied with rofecoxib treatment than with tNSAIDs (p<0.001) and assessments of overall health status improved significantly during rofecoxib therapy (p<0.001). Adherence to therapy was significantly better with rofecoxib than during tNSAID treatment (p<0.001). Use of rofecoxib was associated with a significant reduction in the proportion of discontinuations attributed to lack of effectiveness (p<0.001) or gastrointestinal (GI) adverse events (p<0.001 compared with tNSAIDs). Rofecoxib was also associated with a >60% reduction in the proportion of patients experiencing a GI adverse event and a halving in the proportion of patients who received GI co-medications; concomitant analgesic use decreased by one-third during rofecoxib therapy. Conclusions: Use of rofecoxib was associated with marked improvements in several indices of treatment effectiveness and tolerability, and in patient and physician satisfaction and perception of general health status compared with tNSAIDs. Rofecoxib is a valuable additional medication for relieving the symptoms of OA and its use in place of tNSAIDs may lead to a reduction in the prescription of concomitant medications.