Department and Chair of Gastroenterology, University of Milan, Italy.
Eur J Gastroenterol Hepatol. 2011 Oct;23(10):845-51. doi: 10.1097/MEG.0b013e32834991b7.
Increased BMI is associated with a higher risk of gastroesophageal reflux disease.
To investigate whether overweight/obesity (BMI≥25 kg/m(2)) affects rabeprazole clinical efficacy versus omeprazole in patients with erosive esophagitis (EE).
Post-hoc analysis of EE healing rate and symptom response stratified by patient BMI was performed on data from a multicenter, double-blind, randomized, 4-to-8-week trial comparing EE healing with rabeprazole (20 mg daily) and omeprazole (20 mg daily). Analysis of variance, two-sample t-test, Blackwelder's test for equivalence, log-rank, and Cochran-Mantel-Haenszel tests were used to analyze comparisons.
In the two BMI groups (<25 kg/m(2) and ≥25 kg/m(2) respectively), rabeprazole and omeprazole were equally effective for mucosal healing regardless of patient's BMI (N=542, P>0.05). However, in overweight/obese patients, rabeprazole was significantly faster than omeprazole in inducing heartburn relief during the first treatment week (P<0.0001).
Results of this study show that the clinical efficacy of rabeprazole is maintained in overweight/obese patients with gastroesophageal reflux disease and suggest that this subgroup of patients may derive, from rabeprazole, even greater benefit than lean patients.
BMI 增加与胃食管反流病风险增加相关。
研究超重/肥胖(BMI≥25kg/m2)是否影响雷贝拉唑相对于奥美拉唑治疗糜烂性食管炎(EE)患者的临床疗效。
对一项多中心、双盲、随机、4-8 周的临床试验数据进行了 EE 愈合率和症状缓解的事后分析,该试验比较了雷贝拉唑(每日 20mg)和奥美拉唑(每日 20mg)治疗 EE 的疗效。采用方差分析、两样本 t 检验、Blackwelder 等效性检验、对数秩检验和 Cochran-Mantel-Haenszel 检验对比较进行分析。
在两个 BMI 组(<25kg/m2 和≥25kg/m2)中,雷贝拉唑和奥美拉唑对黏膜愈合的疗效在患者 BMI 不同的情况下相当(N=542,P>0.05)。然而,在超重/肥胖患者中,雷贝拉唑在治疗的第一周内缓解烧心的速度明显快于奥美拉唑(P<0.0001)。
本研究结果表明,雷贝拉唑在超重/肥胖的胃食管反流病患者中的临床疗效得到维持,并提示该亚组患者可能比瘦患者获得更大的益处。