Université Victor Segalen, Bordeaux, France.
Br J Clin Pharmacol. 2010 Mar;69(3):295-302. doi: 10.1111/j.1365-2125.2009.03588.x.
To assess hospital admission rates for gastrointestinal (GI) or cardiovascular (CV) events in real-life use of nonsteroidal anti-inflammatory drugs (NSAIDs).
CADEUS is a real-life population-based cohort study of 23 535 coxib (celecoxib or rofecoxib) and 22 919 traditional NSAID (tNSAID) users. Each hospitalization reported between index day (NSAID delivery) and questionnaire submission (median = 75 days) was explored using hospital discharge summaries. An expert committee validated blindly serious GI and CV events according to predefined criteria.
Coxib users were older and had more GI history than tNSAID users. There were 21 hospitalizations for GI events, 12 in the coxib cohort and nine in the tNSAID cohort (respectively one and three upper GI haemorrhages and no ulcer perforations). Rates of GI events were 0.39 per 1000 patients [95% confidence interval (CI) 0.18, 0.75] for tNSAID users and 0.51 per 1000 patients (95% CI 0.26, 0.89) for coxib users. There were 21 hospitalizations for CV events, 13 in the coxib cohort and eight in the tNSAID cohort. None was fatal. Rates of CV events were, respectively, 0.59 (95% CI 0.24, 1.22), 0.51 (95% CI 0.19, 1.11) and 0.35 (95% CI 0.15, 0.69) per 1000 patients for celecoxib, rofecoxib and tNSAIDs. GI or CV event rates were not different between products even for patients >60 years old.
Hospitalization rates for GI bleeding were 10-20 times lower than expected from published randomized clinical trials, probably because of differences in drug usage and concomitant gastroprotection. CV event rates conformed to those expected from general population data. These results emphasize the necessity of developing population healthcare databases to explore such low event rates.
评估非甾体抗炎药（NSAIDs）在真实世界应用中的胃肠道（GI）或心血管（CV）事件的住院率。
CADEUS 是一项真实世界的基于人群的 COXIB（塞来昔布或罗非昔布）和传统 NSAID（tNSAID）使用者 23535 例和 22919 例的队列研究。每个住院事件都通过医院出院记录进行了探讨，住院事件发生在索引日（NSAID 交付）和问卷提交之间（中位数=75 天）。一个专家委员会根据预先确定的标准对严重 GI 和 CV 事件进行了盲法验证。
COXIB 使用者比 tNSAID 使用者年龄更大，且有更多的 GI 病史。GI 事件共发生 21 例住院，coxib 队列中有 12 例，tNSAID 队列中有 9 例（分别为 1 例和 3 例上消化道出血，无溃疡穿孔）。tNSAID 使用者的 GI 事件发生率为 0.39/1000 例患者（95%CI 0.18，0.75），coxib 使用者的发生率为 0.51/1000 例患者（95%CI 0.26，0.89）。CV 事件共发生 21 例住院，coxib 队列中有 13 例，tNSAID 队列中有 8 例。无致命病例。coxib、rofecoxib 和 tNSAIDs 的 CV 事件发生率分别为 0.59（95%CI 0.24，1.22）、0.51（95%CI 0.19，1.11）和 0.35（95%CI 0.15，0.69）/1000 例患者。即使对于年龄>60 岁的患者，不同产品的 GI 或 CV 事件发生率也无差异。
GI 出血的住院率比发表的随机临床试验预期的低 10-20 倍，这可能是由于药物使用和同时使用胃保护剂的差异所致。CV 事件发生率符合一般人群数据的预期。这些结果强调了开发人群健康数据库以探索此类低事件率的必要性。
