Long-term safety of proton pump inhibitor therapy assessed under controlled, randomised clinical trial conditions: data from the SOPRAN and LOTUS studies
Long-term safety of proton pump inhibitor therapy assessed under controlled, randomised clinical trial conditions: data from the SOPRAN and LOTUS studies
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DOI：
10.1111/apt.13194
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发表时间：
2015-06-01
影响因子：
7.6
通讯作者：
Lundell, L.
中科院分区：
文献类型：
--
作者：
Attwood, S. E.;Ell, C.;Lundell, L.
背景慢性胃食管反流病的控制可以通过抗反流手术（ARS）或质子泵抑制剂（PPI）的长期药物治疗来实现。已报告SOPRAN研究（比较长期使用奥美拉唑与开放式ARS）和LOTUS研究（比较长期使用埃索美拉唑与腹腔镜ARS）的主要疗效结果。这些研究的次要目的是解决这些各自的治疗策略的长期安全性，从而为评估长期PPI safety.AimTo评估通过随机SOPRAN和LOTUS研究的数据分析奥美拉唑和埃索美拉唑长期PPI治疗的安全性提供有效的科学平台。298）和5年的LOTUS研究（n=514）。报告的严重不良事件（SAE）和实验室变量的变化进行了analysed.ResultsAcross这两项研究中，SAE的PPI和ARS治疗组的报告频率相似。考虑到时间范围，两项研究中两个治疗组的致死性SAE数量均较低。实验室检查结果，包括常规血液学和肝酶、电解质、维生素D、维生素B-12、叶酸和同型半胱氨酸检查，显示随时间推移无临床相关变化。正如预期的那样，胃泌素和嗜铬粒蛋白A在PPI组升高，在第一年观察到的最大增幅。ConclusionNo重大安全问题出现在5- 12年的连续PPI治疗。（ClinicalTrials.gov：NCT 00251927和NCT 00256737）。
BackgroundControl of chronic gastro-oesophageal reflux disease may be achieved either by anti-reflux surgery (ARS) or by long-term medical therapy with proton pump inhibitors (PPIs). The primary efficacy results of the SOPRAN study, comparing long-term omeprazole use with open ARS, and the LOTUS study, comparing long-term esomeprazole use with laparoscopic ARS, have been reported. A secondary objective of these studies was to address the long-term safety of these respective therapeutic strategies and thereby provide a valid scientific platform for assessing long-term PPI safety.AimTo assess the safety of long-term PPI therapy with omeprazole and esomeprazole through analyses of data from the randomised SOPRAN and LOTUS studies.MethodsSafety data were collected from patients during the 12-year period of the SOPRAN study (n=298) and the 5-year period of the LOTUS study (n=514). Reported serious adverse events (SAEs) and changes in laboratory variables were analysed.ResultsAcross both studies, SAEs were reported at a similar frequency in the PPI and ARS treatment groups. Taking the time frames into consideration, the number of fatal SAEs in the two studies was low in both treatment groups. Laboratory results, including routine haematology and tests for liver enzymes, electrolytes, vitamin D, vitamin B-12, folate and homocysteine, showed no clinically relevant changes over time. As expected, gastrin and chromogranin A were elevated in the PPI groups, with the greatest increases observed in the first year.ConclusionNo major safety concerns arose during 5-12years of continuous PPI therapy. (ClinicalTrials.gov: NCT00251927 and NCT00256737).