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

The Lancet. Gastroenterology & Hepatology
Ali S TahaAlex McConnachie

Abstract

The incidence of obscure gastrointestinal bleeding, which originates from the small bowel and is mainly associated with the use of aspirin and non-steroidal anti-inflammatory drugs (NSAIDs), is rising. We assessed the efficacy and safety of misoprostol for the treatment of small bowel ulcers and erosions in patients taking low-dose aspirin or NSAIDs with obscure gastrointestinal bleeding. In this randomised, double-blind, placebo-controlled, phase 3 trial, we recruited patients (aged ≥18 years) with small bowel ulcers who were taking low-dose aspirin, NSAIDs, or both for a minimum of 4 weeks, at University Hospital Crosshouse (Kilmarnock, UK). Eligible patients had evidence of obscure gastrointestinal bleeding (iron deficiency anaemia, a decrease in haemoglobin concentration of ≥20 × 103 mg/L, or positive faecal occult blood test) and normal upper endoscopy and colonoscopy. Patients were randomly assigned (1:1) using an interactive voice response system to receive 200 μg oral misoprostol or placebo four times daily for 8 weeks. Patients, investigators, and assessors were masked to treatment allocation. The primary endpoint was the complete healing of small bowel ulcers and erosions, assessed by video capsule endoscopy after 8 w...Continue Reading

Citations

Mar 14, 2019·Current Opinion in Gastroenterology·Martin KeuchelPeter Baltes
Jul 18, 2019·Expert Opinion on Drug Safety·Duan-Fang FanXiao-Ling Wang
Nov 14, 2019·Current Gastroenterology Reports·Carmelo Scarpignato, Ingvar Bjarnason
Nov 26, 2019·Andrologia·Saleem A Banihani
Mar 15, 2019·Alimentary Pharmacology & Therapeutics·Ali S Taha
Aug 28, 2020·Frontiers in Pharmacology·Damian Maseda, Emanuela Ricciotti
Dec 23, 2019·Journal of Gastroenterology·Toshio WatanabeFrancis K L Chan
Nov 18, 2020·Current Treatment Options in Gastroenterology·Takeshi Kanno, Paul Moayyedi
Jul 4, 2018·Gastroenterology·Moe H KyawFrancis K L Chan
Aug 12, 2021·Expert Opinion on Drug Safety·María-José Domper ArnalAngel Lanas

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