The COX-2 inhibitor rofecoxib is safer than the non-steroidal anti-inflammatory drug naproxen, according to the results of a large trial. Rofecoxib (Vioxx) significantly reduced the risk of serious gastrointestinal events compared with naproxen, the study found.
Dr Alise Reicin (director of clinical research, Merck Research Laboratories, New Jersey, US) said that the "unambiguous result" of the VIGOR (Vioxx gastrointestinal outcomes research) study was that "rofecoxib provided improved GI safety compared with NSAIDs."
Preliminary data from this and another trial, comparing celecoxib to traditional NSAIDs, were discussed at a British Society of Rheumatology meeting last month (PJ, May 13, p717).
The final results of the VIGOR study were announced on May 25 at a Digestive Disease Week conference in San Diego, US. In the randomised, double-blind study, 4,047 patients with rheumatoid arthritis were assigned rofecoxib 50mg once daily and 4,029 naproxen 500mg twice a day. Dr Reicin commented that this dose of rofecoxib was twice the approved dose for osteoarthritis. There was no placebo group. Seventy-one per cent of patients completed the study for a median of nine months (range 0.5 to 13 months).
Presenting the study results, Professor Clair Bombardier (professor of medicine, University of Toronto) said that, compared with naproxen, rofecoxib reduced the risk of clinically important upper GI events (ulcers, perforations, obstructions and bleeding in the upper GI tract) by 54 per cent (2.1 per 100 patient years for rofecoxib compared with 4.5 for naproxen). Rofecoxib also reduced the risk of complicated upper GI events (perforations, obstructions and upper GI bleeds) by 57 per cent (0.6 and 1.4 per 100 patient years for rofecoxib and naproxen, respectively). GI "nuisance" symptoms, such as dyspepsia and abdominal pain, were also reduced in the rofecoxib group.
The treatment benefit of rofecoxib was maintained regardless of factors such as gender, age, race, previous history of serious GI events or Helicobacter pylori status, said Professor Bombardier.
Professor Paul Emery (professor of rheumatology, University of Leeds) said at a press conference on May 25 that cost of drugs was always a consideration in the UK. In a "high risk" patient, a doctor prescribing a traditional NSAID rather than rofecoxib would be on "dubious ground". The question was where did the risk become acceptable. All patients would benefit from being prescribed rofecoxib but some level of risk had to be accepted. The National Institute for Clinical Excellence was currently evaluating the situation, he said.