Distel M, Mueller C, Bluhmki E, Fries J
Medical Department, Boehringer Ingelheim GmbH, Biberach/Riss, Germany
Br J Rheumatol. 1996 Apr;35 Suppl 1:68-77. doi: 10.1093/rheumatology/35.suppl_1.68.
Meloxicam is a new preferential cyclooxygenase-2 (COX-2) inhibitor for the treatment of rheumatic disease. This paper presents a global safety analysis of data from meloxicam clinical studies, focusing on gastrointestinal (GI) adverse events. Meloxicam 7.5 and 15 mg (n = 893 and 3282) were compared with piroxicam 20 mg (n = 906), diclofenac 100 mg slow release (n = 324) and naproxen 750-1000 mg (n = 243). With respect to all GI adverse events, meloxicam 7.5 and 15 mg were significantly better than all comparators in a pooled analysis of double-blind studies in rheumatoid arthritis (RA) and osteoarthritis (OA). When examining non-serious GI events, severe GI events, discontinuous due to GI events, dyspepsia, abdominal pain and upper GI events, both meloxicam doses were significantly better than comparator non-steroidal anti-inflammatory drugs (NSAIDs) in most cases. Where statistical significance was not demonstrated, there was generally a trend in favour of meloxicam. With respect to upper GI perforations, ulcerations and bleedings, the most serious of NSAID-associated side-effects, meloxicam was better tolerated than the comparators, reaching statistical significance for piroxicam and naproxen. Meloxicam's improved GI safety profile is likely to be due to its preferential inhibition of inducible COX-2 relative to constitutive COX-1.
美洛昔康是一种用于治疗风湿性疾病的新型选择性环氧化酶-2（COX-2）抑制剂。本文对美洛昔康临床研究数据进行了全面安全性分析，重点关注胃肠道（GI）不良事件。将7.5毫克和15毫克美洛昔康（n = 893和3282）与20毫克吡罗昔康（n = 906）、100毫克缓释双氯芬酸（n = 324）和750 - 1000毫克萘普生（n = 243）进行比较。在类风湿性关节炎（RA）和骨关节炎（OA）的双盲研究汇总分析中，就所有胃肠道不良事件而言，7.5毫克和15毫克美洛昔康显著优于所有对照药物。在检查非严重胃肠道事件、严重胃肠道事件、因胃肠道事件而停药、消化不良、腹痛和上胃肠道事件时，在大多数情况下，两种剂量的美洛昔康均显著优于对照非甾体抗炎药（NSAIDs）。在未显示统计学显著性的情况下，通常也有支持美洛昔康的趋势。关于上胃肠道穿孔、溃疡和出血，这是NSAID相关最严重的副作用，美洛昔康的耐受性优于对照药物，与吡罗昔康和萘普生相比达到统计学显著性。美洛昔康改善的胃肠道安全性可能归因于其相对于组成型COX-1对诱导型COX-2的选择性抑制作用。
