SAT0253 Less use of gastrointestinal (gi) protective agents and gi-related procedures with rofecoxib vs. naproxen in the vigour (vioxx gi outcomes research) study
Authors: L Laine, C Bombardier, DR Ramey, DJ Watson, JM Pellissier, A Reicin
Journal: Annals of the Rheumatic Diseases (2001)

<h3>Background</h3> 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 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; 56% took concomitant corticosteroids for their RA; the treatment groups were not different in these respects. The median duration of follow-up was 9.0 months, the maximum was 13 months. <h3>Objectives</h3> To compare the rates of usage of gastroprotective agents (GPAs) and upper GI diagnostic procedures in patients treated with rofecoxib, a highly selective COX-2 inhibitor, compared to naproxen in the VIGOUR Study. <h3>Methods</h3> We compared the treatment groups on their rates of new GPA usage (H2 receptor antagonists [H2RAs], proton pump inhibitors [PPIs], sucralfate, and prostaglandin analogues initiated after randomization), and investigator-initiated upper GI diagnostic radiologic and endoscopic procedures. Study participants were permitted to take OTC doses of H2RA’s; however, use of prescription GPA’s required discontinuation from the study. Use of upper GI diagnostic procedures was based on the investigators’ clinical judgment; there were no guidelines or restrictions on their use. Additional analyses were done in the subset of patients (n = 2937) reporting GI adverse experiences (AEs). 95% confidence intervals on rate ratios (RR) of rofecoxib to naproxen were calculated. <h3>Results</h3> The incidence of confirmed intestinal perforations, ulcerations, and bleeds (PUBs), the primary endpoint in VIGOUR, was significantly lower with rofecoxib compared to naproxen (2.1% vs 4.5% per year; p &lt; 0.001, relative risk 0.46). Patients treated with rofecoxib had lower rates of new GPA usage (11.2% vs 14.5%, RR = 0.77, CI: 0.68–0.87) than those treated with naproxen. Less use of H2RAs and PPIs occurred in the rofecoxib group than the naproxen group (H2RAs: 8.2% vs. 10.6%, RR = 0.77, CI: 0.67–0.89; PPIs: 3.8% vs. 5.6%, RR = 0.68, CI: 0.56–0.84). There were no significant differences between treatment groups in new prescriptions of prostaglandin analogues and sucralfate; few patients received these medications. Use of upper GI procedures was lower (4.3% vs. 5.9%, RR = 0.74, CI: 0.61–0.90) for patients treated with rofecoxib than for patients treated with naproxen. Among patients reporting GI AEs, those treated with rofecoxib required fewer new GPAs (25.5% vs. 32.2%, RR = 0.76, CI: 0.67–0.87) and upper GI procedures (11.5% vs. 14.7%, RR = 0.77, CI: 0.63–0.94) than did those treated with naproxen. <h3>Conclusion</h3> In the VIGOUR Study, RA patients treated with the highly selective COX-2 inhibitor rofecoxib for up to 13 months had significantly fewer PUBs, required fewer new prescriptions for PPIs and H2RAs, and had fewer GI procedures than patients treated with naproxen.