OP0137 Less healthcare resource utilisation for perforations, ulcers and bleeds with rofecoxib vs. naproxen in the vigour (vioxx gi outcomes research) study

Background The VIGOUR Study was a randomised, double-blind, clinical trial assessing the GI safety of rofecoxib 50 mg. once daily (n = 4047) versus naproxen 500 mg twice daily (n = 4029) in the patients with rheumatoid arthritis. The mean age was 58 years; 80% of patients were female; 8% had a prior history of a GI ulcer or bleed; 82% reported NSAID use at baseline; 21% reported dyspepsia within 14 days prior to baseline; the treatment groups were not different in these respects. The median duration of follow-up 9.0 months, the maximum was 13 months. Objectives To compare the rates of hospitalisation and mean number of outpatient healthcare contacts associated with upper GI perforation, ulcer, or bleeding (PUB) in patients treated with rofecoxib, a highly selective COX-2 inhibitor, vs. naproxen in the VIGOUR Study. Methods The proportions of patients with hospitalizations for PUB in the two treatment groups were compared for all randomised patients. All PUBs were confirmed by an outside adjudication committee. The proportions of patients hospitalised for PUB, and the rates of PUB hospitalisation (per 100 patient-years, and based on the Kaplan-Meier method) were compared between treatment groups. Additional analyses compare proportions of PUB patients hospitalised and the mean number of outpatient contacts given a PUB event. Results The incidence of confirmed PUBs, the primary endpoint in VIGOUR, was significantly lower with rofecoxib compared to naproxen (2.1 vs 4.5% per year; p Conclusion In the VIGOUR Study, RA patients treated with the highly selective COX-2 inhibitor rofecoxib for up to 13 months had significantly fewer PUBs and required fewer hospitalizations for PUBs than patients treated with naproxen.