Yeomans Neville, Lanas Angel, Labenz Joachim, van Zanten Sander Veldhuyzen, van Rensburg Christoffel, Rácz Istvan, Tchernev Konstantin, Karamanolis Dimitrios, Roda Enrico, Hawkey Chris, Nauclér Emma, Svedberg Lars-Erik
School of Medicine, University of Western Sydney, Sydney, Australia.
Am J Gastroenterol. 2008 Oct;103(10):2465-73. doi: 10.1111/j.1572-0241.2008.01995.x. Epub 2008 Jul 12.
Low-dose aspirin is standard treatment for prevention of cardiovascular events in at-risk patients. However, long-term administration of low-dose aspirin is associated with a greater risk of adverse events, including gastroduodenal ulcers. This study determined the efficacy of esomeprazole for reducing the risk of gastric and/or duodenal ulcers and dyspeptic symptoms in patients receiving continuous, low-dose aspirin therapy.
Patients aged > or =60 yr, without baseline gastroduodenal ulcer at endoscopy, who were receiving aspirin 75-325 mg once daily, were randomized to esomeprazole 20 mg once daily or placebo for 26 wk. The presence of endoscopic gastric and/or duodenal ulcers and esophageal lesions was assessed at weeks 8 and 26. Upper gastrointestinal symptoms were assessed at weeks 8, 16, and 26.
The intention-to-treat population comprised 991 patients (esomeprazole, N = 493; placebo, N = 498). Twenty-seven patients (5.4%) in the placebo group developed a gastric or duodenal ulcer during 26 weeks' treatment compared with eight patients (1.6%) in the esomeprazole group (life-table estimates: 6.2%vs 1.8%; P= 0.0007). At 26 wk, the cumulative proportion of patients with erosive esophagitis was significantly lower for esomeprazole versus placebo (4.4% and 18.3%, respectively; P < 0.0001). At 26 wk, esomeprazole-treated patients were more likely to experience resolution of heartburn, acid regurgitation, and epigastric pain (P < 0.05).
Esomeprazole 20 mg once daily reduces the risk of developing gastric and/or duodenal ulcers and symptoms associated with the continuous use of low-dose aspirin in patients aged > or =60 yr without preexisting gastroduodenal ulcers.
低剂量阿司匹林是高危患者预防心血管事件的标准治疗方法。然而，长期服用低剂量阿司匹林会增加不良事件的风险，包括胃十二指肠溃疡。本研究确定了埃索美拉唑在接受持续低剂量阿司匹林治疗的患者中降低胃和/或十二指肠溃疡及消化不良症状风险的疗效。
年龄≥60岁、内镜检查时无基线胃十二指肠溃疡、每日服用75 - 325mg阿司匹林的患者，被随机分为每日一次服用20mg埃索美拉唑或安慰剂，疗程26周。在第8周和第26周评估内镜下胃和/或十二指肠溃疡及食管病变的存在情况。在第8周、第16周和第26周评估上消化道症状。
意向性治疗人群包括991例患者（埃索美拉唑组，N = 493；安慰剂组，N = 498）。安慰剂组27例患者（5.4%）在26周治疗期间发生胃或十二指肠溃疡，而埃索美拉唑组为8例患者（1.6%）（生命表估计：6.2%对1.8%；P = 0.0007）。在第26周时，埃索美拉唑组糜烂性食管炎患者的累积比例显著低于安慰剂组（分别为4.4%和18.3%；P < 0.0001）。在第26周时，接受埃索美拉唑治疗的患者更有可能缓解烧心、反酸和上腹部疼痛（P < 0.05）。
对于年龄≥60岁且无既往胃十二指肠溃疡的患者，每日一次服用20mg埃索美拉唑可降低发生胃和/或十二指肠溃疡的风险以及与持续使用低剂量阿司匹林相关的症状。
