Misoprostol for small bowel ulcers in patients with obscure bleeding taking aspirin and non-steroidal anti-inflammatory drugs (MASTERS): a randomised, double-blind, placebo-controlled, phase 3 trial

Taha, A S; McCloskey, Caroline; McSkimming, Paula; McConnachie, Alex

doi:10.1016/s2468-1253(18)30119-5

Cited by 47 publications

(39 citation statements)

References 15 publications

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“…Recently, Kyaw et al 21 performed an RCT of 84 aspirin users with small bowel bleeding who required aspirin therapy and found that misoprostol (200 µg given 4 times daily) for 8 weeks was superior to placebo in healing of small bowel ulcers. Similar results were also reported in another randomized trial by Taha et al 22 Though the potential protective effects of misoprostol were observed in these studies, large clinical trials with long-term outcomes are lacking. Furthermore, significantly increased risk of drug-related adverse effects like abdominal pain, nausea or vomiting, diarrhea and high dropout rate related to the use of misoprostol were observed in clinical trials.…”

Section: Misoprostolsupporting

confidence: 87%

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Potential Strategies in the Prevention of Nonsteroidal Anti-inflammatory Drugs-Associated Adverse Effects in the Lower Gastrointestinal Tract

Guo

Leung

2020

Gut and Liver

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With the increasing use of nonsteroidal anti-inflammatory drugs (NSAIDs), the incidence of lower gastrointestinal (GI) complications is expected to increase. However, unlike upper GI complications, the burden, pathogenesis, prevention and treatment of NSAID-associated lower GI complications remain unclear. To date, no cost-effective and safe protective agent has been developed that can completely prevent or treat NSAID-related lower GI injuries. Selective COX-2 inhibitors, misoprostol, intestinal microbiota modulation, and some mucoprotective agents have been reported to show protective effects on NSAID-induced lower GI injuries. This review aims to provide an overview of the current evidence on the prevention of NSAID-related lower GI injuries. (Gut Liver 2020;14:179-189)

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Section: Misoprostolsupporting

confidence: 87%

“…Furthermore, significantly increased risk of drug-related adverse effects like abdominal pain, nausea or vomiting, diarrhea and high dropout rate related to the use of misoprostol were observed in clinical trials. 18,22…”

Section: Misoprostolmentioning

confidence: 99%

Potential Strategies in the Prevention of Nonsteroidal Anti-inflammatory Drugs-Associated Adverse Effects in the Lower Gastrointestinal Tract

Guo

Leung

2020

Gut and Liver

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“…Furthermore, this drug also exerted a prophylactic effect against small intestinal lesions caused by a 2-week administration of diclofenac [23]. Recently, a randomized trial reported that misoprostol was effective in healing small-bowel ulcers [100]. However, this study recruited both NSAIDs and aspirin users with occult bleeding only.…”

Section: Misoprostolmentioning

confidence: 99%

Current knowledge on non-steroidal anti-inflammatory drug-induced small-bowel damage: a comprehensive review

2019

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Recent advances in small-bowel endoscopy such as capsule endoscopy have shown that non-steroidal antiinflammatory drugs (NSAIDs) frequently damage the small intestine, with the prevalence rate of mucosal breaks of around 50% in chronic users. A significant proportion of patients with NSAIDs-induced enteropathy are asymptomatic, but some patients develop symptomatic or complicated ulcers that need therapeutic intervention. Both inhibition of prostaglandins due to the inhibition of cyclooxygenases and mitochondrial dysfunction secondary to the topical effect of NSAIDs play a crucial role in the early process of injury. As a result, the intestinal barrier function is impaired, which allows enterobacteria to invade the mucosa. Gram-negative bacteria and endogenous molecules coordinate to trigger inflammatory cascades via Toll-like receptor 4 to induce excessive expression of cytokines such as tumor necrosis factor-a and to activate NLRP3 inflammasome, a multiprotein complex that processes pro-interleukin-1b into its mature form. Finally, neutrophils accumulate in the mucosa, resulting in intestinal ulceration. Currently, misoprostol is the only drug that has a proven beneficial effect on bleeding small intestinal ulcers induced by NSAIDs or low-dose aspirin, but its protection is insufficient. Therefore, the efficacy of the combination of misoprostol with other drugs, especially those targeting the innate immune system, should be assessed in the next step. Keywords Non-steroidal anti-inflammatory drug Á Lowdose aspirin Á Enteropathy Á Innate immunity Á Misoprostol Abbreviations NSAID Non-steroidal anti-inflammatory drug RA Rheumatoid arthritis

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“…Recently, a randomized trial reported that misoprostol was effective in healing small bowel ulcers (ulcer healing rate of 54%). 22 This study recruited both NSAIDs and aspirin users with occult bleeding only. Furthermore, it is unclear whether patients in this study continued aspirin or NSAIDs during the ulcer healing period.…”

Section: Discussionmentioning

confidence: 99%

Misoprostol Heals Small Bowel Ulcers in Aspirin Users With Small Bowel Bleeding

et al. 2018

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Misoprostol for small bowel ulcers in patients with obscure bleeding taking aspirin and non-steroidal anti-inflammatory drugs (MASTERS): a randomised, double-blind, placebo-controlled, phase 3 trial

Abstract: National Health Service (NHS) Greater Glasgow and Clyde and NHS Ayrshire and Arran.

Cited by 47 publications

References 15 publications

Potential Strategies in the Prevention of Nonsteroidal Anti-inflammatory Drugs-Associated Adverse Effects in the Lower Gastrointestinal Tract

Potential Strategies in the Prevention of Nonsteroidal Anti-inflammatory Drugs-Associated Adverse Effects in the Lower Gastrointestinal Tract

Current knowledge on non-steroidal anti-inflammatory drug-induced small-bowel damage: a comprehensive review

Misoprostol Heals Small Bowel Ulcers in Aspirin Users With Small Bowel Bleeding

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