Department of Medicine, Michael E. DeBakey VAMC and Baylor College of Medicine, Houston, Texas 77030, USA.
Am J Med Sci. 2011 Nov;342(5):356-64. doi: 10.1097/MAJ.0b013e3182113658.
On the basis of published data, it is widely believed and cited that rofecoxib use is associated with approximately a 50% reduction in significant gastrointestinal (GI) complications such as bleeding.
Data made available as part of litigation, including the Vioxx Gastrointestinal Outcomes Research trial and an Alzheimer's study, allow a reassessment of the reported benefits of rofecoxib in terms of a significant reduction in complicated GI events and in lower GI bleeding.
During the review process of the Vioxx Gastrointestinal Outcomes Research study, it was suggested that rofecoxib might have little benefit, with regard to GI toxicity, for patients with rheumatoid arthritis not treated with corticosteroids. Reanalysis of the original Merck data set showed 9 complicated confirmed events in the rofecoxib group compared with 10 in the naproxen group among corticosteroid nonusers and 7 versus 27 among corticosteroid users so that the difference between rofecoxib and naproxen in the occurrence of confirmed complicated perforations, ulcers or bleeds seemed to be entirely because of the effects within corticosteroid users. The claim that serious lower GI events were 54% lower with the use of the selective cyclooxygenase-2 inhibitor rofecoxib was stated to be based on an assessment blinded to treatment allocation. In fact, the choice did not represent the original blinded analysis that showed a nonsignificant difference, but rather was based on an assessment after treatment allocation was disclosed.
Examination and reanalysis of unpublished data regarding rofecoxib has failed to confirm a safety advantage of rofecoxib over traditional nonsteroidal anti-inflammatory drugs in terms of complicated upper or lower GI events.
基于已发表的数据，人们普遍认为并引用罗非昔布的使用与减少约 50%的重大胃肠道（GI）并发症相关，如出血。
作为诉讼的一部分提供的数据，包括 Vioxx 胃肠道结局研究试验和阿尔茨海默病研究，允许重新评估罗非昔布报告的益处，即在减少复杂的胃肠道事件和降低下胃肠道出血方面。
在 Vioxx 胃肠道结局研究的审查过程中，有人提出罗非昔布对未接受皮质类固醇治疗的类风湿关节炎患者的胃肠道毒性可能没有好处。对原始默克数据集的重新分析显示，在未使用皮质类固醇的患者中，罗非昔布组有 9 例复杂的确诊事件，而萘普生组有 10 例；在使用皮质类固醇的患者中，罗非昔布组有 7 例，而萘普生组有 27 例，因此罗非昔布和萘普生在确诊穿孔、溃疡或出血的复杂事件发生率方面的差异似乎完全是由于皮质类固醇使用者的影响。声称使用选择性环氧化酶-2 抑制剂罗非昔布可使严重下胃肠道事件降低 54%，这一说法是基于对治疗分配情况不知情的评估。事实上，这种选择并没有代表最初的盲法分析结果，即没有显著差异，而是基于在治疗分配情况披露后的评估。
对罗非昔布的未发表数据的检查和重新分析未能证实罗非昔布在复杂的上或下胃肠道事件方面相对于传统的非甾体抗炎药具有安全性优势。
