Background Osteoarthritis (OA), particularly knee OA, represents a major cause of disability and pain. Selective COX-2 inhibitors are frequently used in the treatment of OA to control pain and inflammation. These drugs, even though associated with less upper gastrointestinal (GI) tract toxicity, still pose potential GI threats. Rebamipide, an anti-ulcer drug increases mucous and stimulates the production of prostaglandins and is frequently described as a gastroprotective agent.
Objectives The aim of the present study was to assess the efficacy of combining rebamipide and celocoxib (a selective COX-2 inhibitor) versus celocoxib alone in the prevention of GI adverse threats.
Methods This 12 week randomized placebo-controlled trial, allocation ratio 2:1, was designed to assess the efficacy of combination rebamipide and celocoxib (a selective COX-2 inhibitor) versus celocoxib alone in the prevention of GI adverse events in older adults with knee OA. Patients with American College of Rheumatology (ACR) clinical and radiographic criteria of primary knee OA with knee pain, [>4 on the 24-hour average pain severity scale (0-10) using mean of daily ratings from week preceding randomization] for >14 days/month during 3 consecutive months preceding enrolment were included in the study. Exclusion criteria included patients with GI and PUD symptoms and patients who tested positive for Helicobacter pylori. Patients were randomized into 2 groups; group 1 were given celocoxib only 200mg daily and group 2 received a combination of 200mg of celocoxib once daily and 100mg of rebamipide three times a day. The primary endpoint was endoscopic documentation of GI injury or peptic ulcer disease (PUD) after 12 weeks therapy. Symptoms of GI injury were recorded during treatment. Endoscopy was performed at baseline and after 12 weeks. Safety and tolerability were also assessed.
Results Two hundred and sixty seven patients were eligible; 89 were assigned to celocoxib 200mg once daily and 178 were given a combination of 200mg of celocoxib once daily and 100mg of rebamipide three times a day. At baseline the 2 groups were similar in demographics including age, sex, duration of disease, OA severity, concomitant therapy and past history of PUD. Subjective symptoms were recorded in 41% of the rebamipide group and 79% of the celocoxib alone group, p=0.014. The incidence of gastric lesions (modified Lanza score 2 or more) was 11% in the rebamipide group compared to 38% in the celecoxib alone group, p=0.051.
Conclusions Combination therapy proved to be more effective in gastroprotection than celocoxib alone for prevention of GI events. Rebamipide may thus be a suitable drug to use in the prevention of non-steroidal anti-inflammatory drug–induced gastropathy in older adults with knee OA.
Disclosure of Interest None Declared
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