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Prevention of gastroduodenal damage with omeprazole in patients receiving continuous NSAIDs treatment. A double blind
G Bianchi Porro1, M Lazzaroni, M Petrillo
1Gastro-intestinal Unit, L. Sacco University Hospital, Milano, Italy.
Aim:
The aim of this study was to compare omeprazole (20 mg once daily) with placebo in the long-term prevention of gastroduodenal lesions induced by indomethacin, diclofenac and ketoprofen.
Patients And Methods:
114 patients with arthritic disorders and requiring indomethacin, diclofenac or ketoprofen were randomized in a double blind manner to receive omeprazole-20 mg once daily- or identical placebo for three weeks. The gastroduodenal mucosa damage was scored according to a 0-4 point endoscopic scale.
Results:
Of the 114 patients, 103 (50 in the omeprazole group, 53 in the placebo group) were submitted to endoscopy, while 11 patients dropped out for non-medical reasons. At the final endoscopy, 26/57 (46%) of omeprazole group, and 20/57 (35%) of the placebo group had normal gastroduodenal mucosa (score = 0) (p ns; 95% IC -0.073 + 0.284). A gastric ulcer was observed in 7/57 (12%) patients, all in the placebo group (p < 0.01 vs omeprazole); 2 patients (1 in the omeprazole group and 1 in the placebo group) developed a duodenal ulcer. Dyspeptic symptoms developed in 10% of the patients treated with omeprazole and 29% of those receiving placebo (p ns).
Conclusions:
Omeprazole, 20 mg once daily, provides effective prophylactic therapy in patients at risk of developing NSAID-associated gastric and duodenal ulcer.
Insights
Omeprazole significantly reduced NSAID-induced ulcers compared to placebo. This proton pump inhibitor offers effective prevention for patients at risk of gastroduodenal damage from nonsteroidal anti-inflammatory drugs.
Area of Science:
- Gastroenterology
- Pharmacology
Background:
- Nonsteroidal anti-inflammatory drugs (NSAIDs) like indomethacin, diclofenac, and ketoprofen are commonly used for arthritis.
- NSAID use can lead to significant gastroduodenal lesions, including ulcers, impacting patient health and treatment adherence.
Purpose of the Study:
- To evaluate the efficacy of omeprazole (20 mg daily) versus placebo in preventing NSAID-induced gastroduodenal lesions.
- To compare the incidence of gastric and duodenal ulcers in patients receiving NSAIDs with or without omeprazole prophylaxis.
Main Methods:
- A double-blind, randomized study involving 114 patients with arthritic disorders requiring NSAIDs.
- Patients received either omeprazole (20 mg daily) or placebo for three weeks, with gastroduodenal mucosa damage assessed endoscopically using a 0-4 scale.
Main Results:
- Omeprazole prophylaxis resulted in a higher proportion of patients with normal gastroduodenal mucosa (46%) compared to placebo (35%), though not statistically significant (p ns).
- A significant reduction in gastric ulcers was observed in the omeprazole group (0%) compared to the placebo group (12%) (p < 0.01).
- Fewer patients in the omeprazole group experienced dyspeptic symptoms (10%) compared to the placebo group (29%) (p ns).
Conclusions:
- Omeprazole (20 mg daily) is an effective prophylactic treatment for preventing NSAID-associated gastric ulcers.
- The findings support the use of omeprazole in patients at risk of developing NSAID-induced gastroduodenal ulcers.
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