Similar Efficacy of Proton-Pump Inhibitors vs H2-Receptor Antagonists in Reducing Risk of Upper Gastrointestinal Bleeding or Ulcers in High-Risk Users of Low-Dose Aspirin

被引:47
作者
Chan, Francis K. L. [1 ]
Kyaw, Moe [1 ]
Tanigawa, Tetsuya [3 ]
Higuchi, Kazuhide [4 ]
Fujimoto, Kazuma [5 ]
Cheong, Pui Kuan [1 ]
Lee, Vivian [2 ]
Kinoshita, Yoshikazu [6 ]
Naito, Yuji [7 ]
Watanabe, Toshio [3 ]
Ching, Jessica Y. L. [1 ]
Lam, Kelvin [1 ]
Lo, Angeline [1 ]
Chan, Heyson [1 ]
Lui, Rashid [1 ]
Tang, S. Y. [1 ]
Sakata, Yasuhisa [5 ]
Tse, Yee Kit [1 ]
Takeuchi, Toshihisa [4 ]
Handa, Osamu [7 ]
Nebiki, Hiroko [8 ]
Wu, Justin C. Y. [1 ]
Abe, Takashi [9 ]
Mishiro, Tsuyoshi [6 ]
Ng, Siew C. [1 ]
Arakawa, Tetsuo [3 ]
机构
[1] Chinese Univ Hong Kong, Inst Digest Dis, Dept Med & Therapeut, Hong Kong, Hong Kong, Peoples R China
[2] Chinese Univ Hong Kong, Sch Pharm, Hong Kong, Hong Kong, Peoples R China
[3] Osaka City Univ, Grad Sch Med, Dept Gastroenterol, Osaka, Japan
[4] Osaka Med Coll, Dept Internal Med 2, Takatsuki, Osaka, Japan
[5] Saga Med Sch, Dept Internal Med & Gastroenterol, Saga, Japan
[6] Shimane Univ, Fac Med, Dept Internal Med 2, Izumo, Shimane, Japan
[7] Kyoto Prefectural Univ Med, Dept Mol Gastroenterol & Hepatol, Kyoto, Japan
[8] Osaka City Gen Hosp, Dept Gastroenterol, Osaka, Japan
[9] Takarazuka Municipal Hosp, Dept Gastroenterol, Takarazuka, Hyogo, Japan
关键词
Acid-Suppressive Drugs; Hemorrhage; ASA; Antiplatelet; NONSTEROIDAL ANTIINFLAMMATORY DRUGS; HELICOBACTER-PYLORI INFECTION; PEPTIC-ULCERS; CLOPIDOGREL; ESOMEPRAZOLE; MORTALITY; DISEASE; COMPLICATIONS; METAANALYSIS; PREVENTION;
D O I
10.1053/j.gastro.2016.09.006
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
BACKGROUND & AIMS: It is not clear whether H-2-receptor antagonists (H2RAs) reduce the risk of gastrointestinal (GI) bleeding in aspirin users at high risk. We performed a double-blind randomized trial to compare the effects of a proton pump inhibitor (PPI) vs a H2RA antagonist in preventing recurrent upper GI bleeding and ulcers in high-risk aspirin users. METHODS: We studied 270 users of low-dose aspirin (<= 325 mg/day) with a history of endoscopically confirmed ulcer bleeding at 8 sites in Hong Kong and Japan. After healing of ulcers, subjects with negative results from tests for Helicobacter pylori resumed aspirin (80 mg) daily and were assigned randomly to groups given a once-daily PPI (rabeprazole, 20 mg; n = 138) or H2RA (famotidine, 40 mg; n = 132) for up to 12 months. Subjects were evaluated every 2 months; endoscopy was repeated if they developed symptoms of upper GI bleeding or had a reduction in hemoglobin level greater than 2 g/dL and after 12 months of follow-up evaluation. The adequacy of upper GI protection was assessed by end points of recurrent upper GI bleeding and a composite of recurrent upper GI bleeding or recurrent endoscopic ulcers at month 12. RESULTS: During the 12-month study period, upper GI bleeding recurred in 1 patient receiving rabeprazole (0.7%; 95% confidence interval [CI], 0.1%-5.1%) and in 4 patients receiving famotidine (3.1%; 95% CI, 1.2%-8.1%) (P = .16). The composite end point of recurrent bleeding or endoscopic ulcers at month 12 was reached by 9 patients receiving rabeprazole (7.9%; 95% CI, 4.2%-14.7%) and 13 patients receiving famotidine (12.4%; 95% CI, 7.4%-20.4%) (P = .26). CONCLUSIONS: In a randomized controlled trial of users of low-dose aspirin at risk for recurrent GI bleeding, a slightly lower proportion of patients receiving a PPI along with aspirin developed recurrent bleeding or ulcer than of patients receiving an H2RA with the aspirin, although this difference was not statistically significant.
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页码:105 / +
页数:7
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