Gastrointestinal tolerability and effectiveness of @entity13586 versus @entity1623 in the treatment of XXXX : a randomized, controlled trial.

@entity1 @entity13586 @entity137 @entity571 @entity625 @entity117 @entity344 @entity1623 @entity9859 @entity2247
BACKGROUND: Gastrointestinal (GI) @entity137 mediated by dual @entity9859 and @entity2247 inhibition of nonsteroidal anti-inflammatory drugs (NSAIDs) can cause serious alterations of mucosal integrity or, more commonly, intolerable @entity344 that may necessitate discontinuation of therapy. Unlike NSAIDs, @entity13586 targets only the @entity2247 isoform. OBJECTIVE: To assess the tolerability of @entity13586 compared with @entity1623 for treatment of @entity571 . DESIGN: Randomized, controlled trial. SETTING: 600 office and clinical research sites. @entity1 : 5557 @entity1 (mean age, 63 years) with a baseline diagnosis of @entity571 of the knee, hip, hand, or spine. INTERVENTION: @entity13586 , 25 mg/d, or @entity1623 , 500 mg twice daily. Use of routine medications, including @entity117 , was permitted. MEASUREMENTS: Discontinuation due to GI adverse events (primary end point) and use of concomitant medication to treat @entity344 (secondary end point). Efficacy was determined by @entity1 -reported global assessment of disease status and the Australian/Canadian @entity571 Hand Index, as well as discontinuations due to lack of efficacy. @entity1 were evaluated at baseline and at weeks 6 and 12. RESULTS: Rates of cumulative discontinuation due to GI adverse events were statistically significantly lower in the @entity13586 group than in the @entity1623 group (5.9% vs. 8.1%; relative risk, 0.74 [95% CI, 0.60 to 0.92]; P = 0.005), as were rates of cumulative use of medication to treat @entity344 (9.1% vs. 11.2%; relative risk, 0.79 [CI, 0.66 to 0.96]; P = 0.014]). Subgroup analysis of @entity1 who used low-dose @entity117 (13%) and those who previously discontinued using @entity625 medication because of @entity344 (15%) demonstrated a relative risk similar to the overall sample for discontinuation due to GI adverse events (relative risk, 0.56 [CI, 0.31 to 1.01] and 0.53 [CI, 0.34 to 0.84], respectively). No statistically significant difference was observed between treatments for efficacy in treating @entity571 or for occurrence of other adverse events. CONCLUSIONS: In @entity1 with @entity571 treated for 12 weeks, @entity13586 , 25 mg/d, was as effective as @entity1623 , 500 mg twice daily, but had statistically significantly superior GI tolerability and led to less use of concomitant GI medications. Benefits of @entity13586 in subgroup analyses were consistent with findings in the overall sample.
