Patient and physician satisfaction with rofecoxib in osteoarthritis: Results of a post-marketing surveillance study in primary care in Germany

A post-marketing surveillance study was conducted in Germany to assess the efficacy and tolerability of rofecoxib in the treatment of osteoarthritis (OA). Patients were eligible for inclusion in this study if they were being treated for the first time or being switched from other medications. More than three-quarters of the 80371 patients enrolled in the study reported improved pain relief and function during treatment with rofecoxib (12.5 or 25 mg/day), including a reduction in pain experienced when walking on a flat surface or climbing or descending stairs. A majority of patients also considered that the duration of analgesia provided by rofecoxib was longer than with previous medications (predominantly non-steroidal anti-inflammatory drugs). Some 85% of patients reported an improvement in quality of life during rofecoxib therapy and a similar proportion considered once-daily rofecoxib to be a simpler regimen than their previous medications. Tolerability of rofecoxib was consistent with previous experience in controlled trials, with adverse events recorded in less than 1.5% of patients (n = 1090). No new or unexpected types of adverse events were recorded. A total of 81 serious adverse events were reported, corresponding to an event rate of approximately one per 1000 patient-years of treatment. Most of these serious events were not considered attributable to rofecoxib use. Physicians considered that rofecoxib provided better and more prolonged analgesia than previous medications and improved quality of life for more than 80% of patients, and regarded once-daily rofecoxib as a simpler treatment regimen than previous therapies in more than 90% of patients. Patient and physician satisfaction with rofecoxib was high in this survey. Most respondents regarded the drug as effective, easy to use, and a well-tolerated medication for the treatment of OA.