Combination of a cyclo-oxygenase-2 inhibitor and a proton-pump inhibitor for prevention of recurrent ulcer bleeding in patients at very high risk: a double-blind, randomised trial

Chan, Francis K.L.; Wong, Vincent W. S.; Suen, Bing Yee; Wu, Justin Che Yuen; Ching, Jessica; Hung, Lawrence Cheung–Tsui; Hui, Aric Josun; Leung, Vyl; Lee, Vivian; Lai, Lihui; Wong, Grace Lai Hung; Chow, Dorothy Kai Lai; To, KF; Leung, Wai Keung; Chiu, Philip Wai Yan; Lee, Yuk Tong; Lau, James Y.; Chan, Henry Lik Yuen; Ng, Enders Kwok Wai; Sung, Joseph J.Y.

doi:10.1016/s0140-6736(07)60749-1

Cited by 300 publications

(156 citation statements)

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“…One study showed that when the NSAID-induced ulcer was healed, all patients started a combination of celecoxib plus esomeprazole or placebo. Over a 13-month observation period, the ability to prevent hemorrhagic ulcers was significantly higher with the combination of celecoxib plus esomeprazole [114].…”

Section: Commentmentioning

confidence: 99%

Evidence-based clinical practice guidelines for peptic ulcer disease 2015

et al. 2016

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The Japanese Society of Gastroenterology (JSGE) revised the evidence-based clinical practice guidelines for peptic ulcer disease in 2014 and has created an English version. The revised guidelines consist of seven items: bleeding gastric and duodenal ulcers, Helicobacter pylori (H. pylori) eradication therapy, non-eradication therapy, drug-induced ulcer, non-H. pylori, non-nonsteroidal anti-inflammatory drug (NSAID) ulcer, surgical treatment, and conservative therapy for perforation and stenosis. Ninety clinical questions (CQs) were developed, and a literature search was performed for the CQs using the Medline, Cochrane, and Igaku Chuo Zasshi databases between 1983 and June 2012. The guideline was developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Therapy is initially provided for ulcer complications. Perforation or stenosis is treated with surgery or conservatively. Ulcer bleeding is first treated by endoscopic hemostasis. If it fails, surgery or interventional radiology is chosen. Second, medical therapy is provided. In cases of NSAID-related ulcers, use of NSAIDs is stopped, and anti-ulcer therapy is provided. If NSAID use must continue, the ulcer is treated with a proton pump inhibitor (PPI) or prostaglandin analog. In cases with no NSAID use, H. pylori-positive patients receive eradication and anti-ulcer therapy. If first-line eradication therapy fails, second-line therapy is given. In cases of non-H. pylori, non-NSAID ulcers or H. pyloripositive patients with no indication for eradication therapy, non-eradication therapy is provided. The first choice is PPI therapy, and the second choice is histamine 2-receptor antagonist therapy. After initial therapy, maintenance therapy is provided to prevent ulcer relapse.

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Section: Commentmentioning

confidence: 99%

Evidence-based clinical practice guidelines for peptic ulcer disease 2015

et al. 2016

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“…В ходе клини-ческого испытания больные в течение 12 мес получали целекоксиб 400 мг в сутки, или целекоксиб 400 мг в сутки в комбинации с эзомепразолом 20 мг. В итоге рецидив кровотечения возник у 8,9% больных, принимавших толь-ко целекоксиб, и ни у кого среди лиц, получавших комби-нированную терапию (p<0,001) [162].…”

Section: рисunclassified

Clinical guidelines «Rational use of nonsteroidal anti-inflammatory drugs (NSAIDs) in clinical practice». Part II

2015

Z. nevrol. psikhiatr. im. S.S. Korsakova

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Профилактика осложнений со стороны верхних отделов ЖКТ и ССС Факторы рискаПодавляющее большинство осложнений, связанных с приемом НПВП, возникает у лиц, имеющих определен-ные факторы риска (ФР). Их определение составляет ос-нову для планирования рациональной профилактики.ФР неравноценны: одни ассоциируются с умеренной, другие -с высокой вероятностью развития осложнений; именно последние имеют наибольшее значение при пла-нировании стратегии применения НПВП в каждом кон-кретном случае. Наименьшая опасность лекарственной патологии соответственно должен быть признана для па-циентов, у которых отсутствуют какие-либо ФР. Такая за-висимость показана для ЖКТ-осложнений. Число эпизо-дов кровотечений, клинически выраженных язв и перфо-раций составляет для больных в группах высокого риска около 2-4 на 100 пациентов/лет, низкого -менее 0,5 эпизодов на 100 пациентов/лет [140,141].В табл. 1 указаны основные ФР, связанные с приме-нением НПВП-ассоциированных осложнений [140,[142][143][144].Наиболее важными ФР ЖКТ-осложнений является язвенный анамнез, под которым понимается наличие клинически выраженной язвы желудка и/или двенадца-типерстной кишки (ДПК), выявленной с помощью объ-ективных методов диагностики (эндоскопическое иссле-дование, рентгенография, визуальное обнаружение в ходе хирургической операции), наличие в анамнезе ЖКТ-кровотечения (включая те случаи, когда источник крово-течения не был выявлен) и сопутствующий прием препа-ратов, влияющих на свертывающую систему крови. Все другие ФР ассоциируются с меньшей вероятностью раз-вития осложнений.

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“…Clinically significant gastric bleeds from erosions (outside the ITU setting or in patients with severe clotting or platelet impairment) is very rare, indeed. However, data from the very few trials available that prospectively address patients at very high risk of gastrointestinal bleeding show that a combination of a COX-2 selective agent (celecoxib) and omeprazole (a proton pump inhibitor) prevented re-bleeds completely in these patients (Chan et al 2007).…”

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confidence: 99%

“…Epidemiologists (Chan et al 2007) would have prescribed no drugs, paracetamol (lacks efficacy in arthritic conditions) or NSAIDs at sub-therapeutic levels which may sound eminently sensible but for the fact that their patients are imaginary while many patients are in dire need of antiinflammatory analgesics. Pragmatic clinical trials show that the safest option for patients at risk for gastrointestinal bleeding due to NSAIDs is to prescribe the combination celecoxib and omeprazole which effectively prevents serious upper gastrointestinal bleeds (Chan et al 2007).…”

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confidence: 99%

“…Pragmatic clinical trials show that the safest option for patients at risk for gastrointestinal bleeding due to NSAIDs is to prescribe the combination celecoxib and omeprazole which effectively prevents serious upper gastrointestinal bleeds (Chan et al 2007). In addition, a COX-2 selective agent (celecoxib) is associated with fewer small intestinal complications as compared with the use of NSAIDs administered with a proton pump inhibitor (Chan et al 2010).…”

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confidence: 99%

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