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Gastrointestinal tolerability of etoricoxib in rheumatoid arthritis patients: results of the etoricoxib vs diclofenac sodium gastrointestinal tolerability and effectiveness trial (EDGE-II)
  1. Klaus Krueger
  1. Praxiszentrum St. Bonifatius, Germany
    1. Leticia Lino
    1. Hospital General de Mexico, Mexico
      1. Robin Dore
      1. University of California, United States
        1. Sebastiao Radominski
        1. Hospital de Clinicas, Brazil
          1. Yanqiong Zhang
          1. Merck & Co., Inc., United States
            1. Amarjot Kaur
            1. Merck & Co., Inc., United States
              1. Roger Simpson
              1. Merck & Co., Inc., United States
                1. Sean Curtis (sean_curtis{at}
                1. Merck & Co., Inc., United States


                  Objective: The objective of this randomized, double-blind study was to compare the gastrointestinal (GI) tolerability, safety, and efficacy of etoricoxib and diclofenac in patients with rheumatoid arthritis (RA).

                  Patients and Methods: 4086 patients (mean age 60.8 years) diagnosed with RA were enrolled and received etoricoxib 90 mg qd (n=2032) or diclofenac 75 mg bid (n=2054). Use of gastroprotective agents and low-dose aspirin was allowed. The prespecified primary endpoint consisted of the cumulative rate of patient discontinuations due to clinical and laboratory GI adverse experiences (AEs). General safety was also assessed, including adjudicated thrombotic cardiovascular event data. Efficacy was evaluated using the Patient Global Assessment of Disease Status (PGADS; 0-4 point scale).

                  Results: Mean (SD; maximum) duration of treatment was 19.3(10.3; 32.9) and 19.1(10.4; 33.1) months in the etoricoxib and diclofenac groups, respectively. The cumulative discontinuation rate due to GI AEs was significantly lower with etoricoxib than diclofenac (5.2 vs. 8.5 events per 100 patient-years (PYs), respectively; hazard ratio (HR) 0.62 [95%CI: 0.47,0.81; p=<0.001]). The incidence of discontinuations for hypertension-related and edema-related AEs were significantly higher with etoricoxib (2.5% and,1.1% respectively) compared with diclofenac (1.5% and 0.4% respectively; p<0.001 for hypertension and p<0.01 for edema). Etoricoxib and diclofenac treatment resulted in similar efficacy (PGADS mean changes from baseline -0.62 vs. -0.58, respectively).

                  Conclusion: Etoricoxib 90 mg demonstrated a significantly lower risk for discontinuation of treatment due to GI AEs compared with diclofenac 150 mg. Discontinuations from renovascular AEs, although less common than discontinuations from GI AEs, were significantly higher with etoricoxib.

                  • etoricoxib
                  • gastrointestinal tolerability
                  • non-steroidal anti-inflammatory drugs
                  • rheumatoid arthritis
                  • selective COX-2 inhibitors

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                    BMJ Publishing Group Ltd and European League Against Rheumatism