Authors: Watson, D.J.¹; Bolognese, J.A.²; Yu, C.³; Krupa, D.²; Curtis, S.⁴

Source: Current Medical Research and Opinion, Volume 20, Number 12, December 2004 , pp. 1899-1908(10)

Publisher: Informa Healthcare

Abstract:

Background: Most nonsteroidal anti-inflammatory drugs (NSAIDs) are non-selective cyclooxygenase-1 (COX-1) and COX-2 inhibitors and are associated with upper gastrointestinal (GI) dyspeptic symptoms often resulting in GI co-medication usage or treatment discontinuation.

Objective: To compare the rates of new use of gastroprotective agents and discontinuations due to dyspepsia with the COX-2 selective inhibitor etoricoxib compared with non-selective NSAIDs.

Research design and methods: This pre-specified combined analysis used data from nine randomized, double-blind, controlled, clinical trials with etoricoxib in patients with osteoarthritis, rheumatoid arthritis, chronic low back pain, or ankylosing spondylitis. The cumulative incidences of (1) new use (new prescription or increased dose) of gastroprotective agents (GPA) and (2) discontinuation due to dyspeptic symptoms were compared among patients treated with etoricoxib (60 mg, 90 mg, or 120 mg daily) vs. non-selective NSAIDs (diclofenac 50 mg. t.i.d. or naproxen 500 mg. b.i.d.).

Results: The overall rates/100 patient-years for new use of GPAs were 9.1 and 13.0 for etoricoxib and NSAIDs, respectively (RR = 0.75; 95% confidence interval [CI] 0.64, 0.89; p < 0.001). A benefit with etoricoxib was seen in the first 6 months when most new GPA usage occurred; after 6 months new use of GPAs was similar between etoricoxib and NSAIDs. The rates/100 patient-years of treatment discontinuation due to dyspeptic symptoms with etoricoxib and NSAIDs were 1.5 and 2.7, respectively (RR = 0.60; 95% CI 0.41, 0.87; p = 0.007). Analyses of placebo-controlled treatment periods showed significantly more new GPA use and more discontinuations due to dyspeptic symptoms with NSAIDs vs. placebo, but not with etoricoxib vs. placebo.

Conclusion: In this combined analysis of clinical trials of patients with OA, RA, chronic low back pain, or AS, new use of gastroprotective agents was significantly lower with etoricoxib than with the comparator non-selective NSAIDs during the initial 6 months of treatment and similar thereafter. There were significantly fewer discontinuations for dyspeptic symptoms with etoricoxib than with NSAIDs over the entire follow-up period.

Keywords: ADVERSE EVENTS; CYCLOOXYGENASE-2 INHIBITORS; ETORICOXIB; GASTROINTESTINAL; GASTROPROTECTIVE AGENTS; NONSTEROIDAL ANTI-INFLAMMATORY DRUGS

Document Type: Research article

DOI: http://dx.doi.org/10.1185/030079904X12681

Affiliations: 1: Epidemiology, Merck Research Laboratories, West Point, PA 19486, USA 2: Clinical Biostatistics, Merck Research Laboratories, Rahway, NJ, 07065, USA 3: Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN 37232, USA 4: Clinical Research, Merck Research Laboratories, Rahway, NJ, 07065, USA

Publication date: 2004-12-01

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