Key result
Concomitant use of gastroprotective agents in NSAID users significantly reduced the risk of occult gastrointestinal bleeding by 37% (HR 0.63) compared to NSAID monotherapy.
Why the study?
Despite the effectiveness of acid suppressants in preventing NSAID-related GI bleeding, concerns remain regarding long-term use, prompting evaluation of alternative gastroprotective agents.
Do gastroprotective agents reduce the risk of occult GI bleeding in patients with osteoarthritis or rheumatoid arthritis using NSAIDs?
Cohort (n=9,133)
No
Do gastroprotective agents reduce the risk of occult GI bleeding in patients with osteoarthritis or rheumatoid arthritis using NSAIDs?
Hazard Ratio: 0.63 (95% CI 0.56–0.71)
Absolute Event Rate: 10.9% vs 18.3%
p-value: p=<0.001
Mucoprotective agents like rebamipide and misoprostol, as well as acid suppressants, are effective in reducing the risk of occult GI bleeding in chronic NSAID users.
Rebamipide and misoprostol were associated with reduced occult GI bleeding in NSAID users; leaves open comparative efficacy versus PPIs in randomized trials.
Acid suppressants such as histamine-2 receptor antagonists (H2RAs) and proton pump inhibitors (PPIs) are effective in preventing gastrointestinal (GI) bleeding in nonsteroidal anti-inflammatory drugs (NSAIDs) users. Despite widespread acid suppressant use, there remain concerns about several potential risks of long-term use. Therefore, we investigated whether gastroprotective agents (GPAs) other than acid suppression therapy are effective in preventing NSAID-related GI injury. To this end, we studied 9,133 patients with osteoarthritis or rheumatoid arthritis who used NSAIDs for ≥1 month. A decrease of 2 g/dL or more in the hemoglobin level was considered a GI injury indicator. The GPAs included acid suppressants and other mucoprotective agents. Acid suppressants included PPIs and H2RAs. Other mucoprotective agents included misoprostol, rebamipide, and eupatilin. During a median follow-up period of 27 (range, 4.3-51.3) weeks, occult GI bleeding occurred in 1,191 (13%) patients. A comparison of patients who used GPAs concomitantly with that of nonusers in a multivariable analysis revealed the hazard ratios (HRs; 95% confidence intervals [CIs]) for occult GI bleeding were 0.30 (0.20-0.44), 0.35 (0.29-0.43), 0.47 (0.23-0.95), 0.43 (0.35-0.51), and 0.98 (0.86-1.12) for PPIs, H2RAs, misoprostol, rebamipide, and eupatilin, respectively. Compared to PPI co-treatment, H2RA, misoprostol, rebamipide, and eupatilin co-treatments were associated with occult GI bleeding HRs (95% CIs) of 1.19 (0.79-1.79), 1.58 (0.72-3.46), 1.44 (0.96-2.16), and 3.25 (2.21-4.77), respectively. Our findings suggest that mucoprotective agents, such as rebamipide and misoprostol, as well as acid suppressants, are effective in reducing the risk for GI injury in NSAID users.
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Kim et al. (2019) conducted a cohort in Osteoarthritis or rheumatoid arthritis (n=9,133). Gastroprotective agents (GPAs) vs. NSAID monotherapy (no GPA) was evaluated on Occult gastrointestinal bleeding (decrease of ≥2 g/dL in hemoglobin) (HR 0.63, 95% CI 0.56-0.71, p=<0.001). Concomitant use of gastroprotective agents in NSAID users significantly reduced the risk of occult gastrointestinal bleeding by 37% (HR 0.63) compared to NSAID monotherapy.
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