A framework for evaluating the clinical consequences of initial therapy with NSAIDs, NSAIDs plus gastroprotective agents, or celecoxib in the treatment of arthritis

Objective: The purpose of this study is to provide a framework for estimati ng the economic efficiency of nonselective nonsteroidal anti-inflammatory d rugs (NSAIDs), concomitant gastroprotective agents (GPAs) to reduce the ris k of NSAID toxicity, and celecoxib, a specific cyclo-oxygenase-2 inhibitor. Concomitant GPA therapies considered include one of the following: proton pump inhibitors (PPIs) plus NSAIDs, histamine H-2 receptor antagonists (H2R As) plus NSAIDs, misoprostol plus NSAIDs, and a single tablet formulation o f diclofenac/misoprostol. Design: The study employs a decision-tree framework to establish probabilit ies of upper gastrointestinal (GI) adverse events occurring over a 6-month time frame. Celecoxib clinical trial data are used to establish probabiliti es of upper GI events for celecoxib and NSAIDs, and published literature is used to predict upper GI events for the other concomitant therapies. Upper GI adverse events included in the decision-tree are as follows: GI discomf ort, symptomatic ulcer, serious GI complications (with and without death), and anaemia with occult bleeding. Main outcome measures and results: Clinical probabilities indicate celecoxi b has significant tolerability and safety advantages compared with nonselec tive NSAIDs. Celecoxib also reduces the risk of GI adverse events to a simi lar or superior degree when compared with reductions observed with NSAIDs w ith concomitant GPAs. Conclusion: Use of celecoxib is expected to significantly reduce the econom ic costs of GI toxicity and its associated morbidity.