Although low-dose acetylsalicylic acid (ASA) is recommended for prevention of cardiovascular events in at-risk patients, its long-term use can be associated with the risk of peptic ulcer and upper gastrointestinal (GI) symptoms that may impact treatment compliance. This prespecified secondary analysis of the OBERON study (NCT00441727) determined the efficacy of esomeprazole for prevention/resolution of low-dose ASA-associated upper GI symptoms. A post hoc analysis of predictors of symptom prevention/resolution was also conducted. Helicobacter pylori-negative patients taking low-dose ASA (75-325 mg) for cardiovascular protection who had ≥1 upper GI risk factor were eligible. The patients were randomized to once-daily esomeprazole 40 mg, 20 mg, or placebo, for 26 weeks; 2303 patients (mean age 67.6 years; 36% aged >70 years) were evaluable for upper GI symptoms. The proportion of patients with dyspeptic or reflux symptoms (self-reported Reflux Disease Questionnaire) was significantly lower (P < 0.0001) in those treated with esomeprazole versus in those treated with placebo. Treatment with esomeprazole (P < 0.0001), age >70 years (P < 0.01), and the absence of upper GI symptoms at baseline (P < 0.0001) were all factors associated with prevention/resolution of upper GI symptoms. Together, these analyses demonstrate that esomeprazole is effective in preventing and resolving patient-reported upper GI symptoms in low-dose ASA users at increased GI risk.

译文

尽管低剂量乙酰水杨酸 (ASA) 被推荐用于预防高危患者的心血管事件,但长期使用可能与消化性溃疡和上消化道 (GI) 症状的风险有关,这可能会影响治疗依从性。这项预先设定的OBERON研究 (NCT00441727) 的二次分析确定了埃索美拉唑预防/缓解低剂量ASA相关上消化道症状的疗效。还对症状预防/解决的预测因素进行了事后分析。幽门螺杆菌阴性患者服用低剂量ASA (75-325 mg) 进行心血管保护,且上消化道危险因素 ≥ 1。患者被随机分配至每日一次埃索美拉唑40 mg、20 mg或安慰剂,持续26周; 2303患者 (平均年龄67.6岁; 36% 年龄> 70岁) 可评估上消化道症状。与安慰剂组相比,使用埃索美拉唑治疗的患者有消化不良或反流症状 (自我报告的反流疾病问卷) 的比例显著降低 (P <0.0001)。埃索美拉唑治疗 (P < 0.0001) 、年龄> 70岁 (P < 0.01) 和基线时没有上消化道症状 (P < 0.0001) 都是与预防/缓解上消化道症状相关的因素。总之,这些分析表明,埃索美拉唑可有效预防和解决患者报告的上消化道症状,在胃肠道风险增加的低剂量ASA使用者中。

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