Choi Hyon K, Seeger John D, Kuntz Karen M
Department of Health Policy and Management, Boston, Massachusetts, USA.
Am J Med. 2004 May 1;116(9):621-9. doi: 10.1016/j.amjmed.2003.09.050.
The VIOXX Gastrointestinal Outcomes Research (VIGOR) trial showed a 53% decrease in the risk of upper gastrointestinal toxicity and a fivefold increase in the risk of myocardial infarction for rofecoxib (a selective cyclooxygenase-2 inhibitor) compared with naproxen. We examined the effects of these competing adverse events on life expectancy in patients with rheumatoid arthritis.
We used decision analysis to compare the life expectancy of a cohort of rheumatoid arthritis patients taking naproxen versus a similar cohort taking rofecoxib, using data from the VIGOR trial. We incorporated the competing risks of upper gastrointestinal toxicity and myocardial infarction, as well as their long-term health consequences, on the basis of population-based studies.
For 58-year-old women with rheumatoid arthritis (i.e., typical of participants in the VIGOR trial), naproxen was associated with a longer life expectancy than was rofecoxib (difference = 4.4 months). This difference was larger among 58-year-old men (7.8 months). The probability that naproxen is associated with a longer life expectancy than rofecoxib among 58-year-old patients was 92% for women and 98% for men. Life expectancy became the same between the two treatments when the risk of upper gastrointestinal toxicity was 70% higher or the risk of myocardial infarction was 40% lower than that of the base case among women, and when the risk of upper gastrointestinal toxicity was 4.4-fold higher or the risk of myocardial infarction was 70% lower among men.
Our analysis suggests that the competing risks of upper gastrointestinal toxicity and myocardial infarction shown in the VIGOR trial would project a longer life expectancy with naproxen than rofecoxib among patients with rheumatoid arthritis, except in those at low risk of myocardial infarction or at high risk of upper gastrointestinal toxicity.
万络胃肠道转归研究（VIGOR）试验表明，与萘普生相比，罗非昔布（一种选择性环氧化酶-2抑制剂）使上消化道毒性风险降低53%，但心肌梗死风险增加了五倍。我们研究了这些相互竞争的不良事件对类风湿关节炎患者预期寿命的影响。
我们使用决策分析方法，利用VIGOR试验的数据，比较服用萘普生的类风湿关节炎患者队列与服用罗非昔布的类似队列的预期寿命。我们基于人群研究纳入了上消化道毒性和心肌梗死的相互竞争风险及其长期健康后果。
对于58岁的类风湿关节炎女性患者（即VIGOR试验的典型参与者），萘普生与比罗非昔布更长的预期寿命相关（差异=4.4个月）。58岁男性中的这种差异更大（7.8个月）。在58岁患者中，萘普生比罗非昔布有更长预期寿命的概率，女性为92%，男性为98%。当女性上消化道毒性风险比基础病例高70%或心肌梗死风险比基础病例低40%时，以及男性上消化道毒性风险比基础病例高4.4倍或心肌梗死风险比基础病例低70%时，两种治疗的预期寿命变得相同。
我们的分析表明，VIGOR试验中显示的上消化道毒性和心肌梗死的相互竞争风险表明，在类风湿关节炎患者中，除了心肌梗死低风险或上消化道毒性高风险的患者外，萘普生的预期寿命比罗非昔布更长。
