Management of gastroduodenal ulcers and gastrointestinal symptoms associated with nonsteroidal anti-inflammatory drug therapy : A summary of four comparative trials with omeprazole, ranitidine, misoprostol, and placebo

• Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) are effective in the treatment of systemic diseases such as rheumatoid arthritis but are associated with a range of adverse gastrointestinal (GI) side effects, including dyspepsia, peptic ulcer, and ulcer complications. Several studies have compared the relative efficacy and tolerability of omeprazole, ranitidine, and misoprostol in the management of NSAID-associated GI adverse events. Objective: The purpose of this paper is to summarize and evaluate the results of 4 clinical studies that compared the efficacy and tolerability of omeprazole, misoprostol, and ranitidine in the acute and maintenance treatment of NSAID-associated gastroduodenal ulcers and GI symptoms. Methods: The 4 trials, which included 1822 patients being treated continuously with NSAIDs, studied omeprazole (20 and 40 mg once daily) as acute treatment for healing gastroduodenal ulcers and erosions and as prophylaxis (20 mg once daily) over 3 to 6 months. Comparators were misoprostol 200 µg 4 times daily or ranitidine 150 mg twice daily in the acute phases and misoprostol 200 µg twice daily, ranitidine 150 mg twice daily, or placebo in the prophylactic phases. Results: Gastric and duodenal ulcer healing rates were higher with omeprazole than with either misoprostol (P = 0.004 for gastric ulcers, P < 0.001 for duodenal ulcers) or ranitidine (P < 0.001 for gastric ulcers, P = 0.032 for duodenal ulcers). A significantly larger percentage of patients taking misoprostol had the number of gastric or duodenal erosions reduced from >10 to <5 compared with patients taking omeprazole (P < 0.001), whereas a significantly larger percentage of patients taking omeprazole achieved the same reduction in number of erosions compared with patients taking ranitidine (P = 0.008). More patients taking omeprazole remained in remission than patients taking misoprostol (P = 0.001), ranitidine (P = 0.004), or placebo (P < 0.001). More patients taking misoprostol (16.9%) or ranitidine (14.1%) discontinued treatment because of adverse events, lack of efficacy, or other reasons compared with patients taking omeprazole (9.9% and 10.2% in 2 studies). Conclusions: Omeprazole was more effective in healing and prophylaxis of NSAID-associated gastroduodenal ulceration and symptoms than misoprostol and ranitidine in chronic NSAID users, and was better tolerated than misoprostol.

Nyckelord

Dyspepsia

Gastroduodenal ulcer

Misoprostol

Nonsteroidal anti-inflammatory drugs

Omeprazole

Ranitidine

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