Simvastatin for patients with acute respiratory distress syndrome: long-term outcomes and cost-effectiveness from a randomised controlled trial.
Simvastatin for patients with acute respiratory distress syndrome: long-term outcomes and cost-effectiveness from a randomised controlled trial.
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DOI：
10.1186/s13054-017-1695-0
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发表时间：
2017-05-17
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影响因子：
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通讯作者：
McAuley DF
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作者：
Agus A;Hulme C;Verghis RM;McDowell C;Jackson C;O'Kane CM;Laffey JG;McAuley DF
辛伐他汀治疗急性呼吸窘迫综合征(ARDS)被证明是安全的，相关的不良反应很小，但它并不能改善临床结果。这项研究的目的是报告12个月后ARDS患者辛伐他汀的死亡率和成本效益。这是一项成本效用分析，同时在英国和爱尔兰进行了一项多中心、双盲、随机对照试验。540例接受气管插管和机械通气的急性呼吸窘迫综合征患者被随机分配(1：1)，每天接受一次辛伐他汀(剂量80 mg)或相同的安慰剂片剂肠内注射，最长28天。12个月时，辛伐他汀组的死亡率(31.8%，95%可信区间(CI)26.1-37.5)低于安慰剂组(37.3%，95%可信区间(31.6-43.0))，尽管这并不显著。与安慰剂相比，辛伐他汀与统计上显著的质量调整生命年(QALY增量0.064，95%可信区间0.002-0.127)相关。辛伐他汀的成本也更低(增加的总成本-GB 3601，95%CI-8061至859)。在每QALY 20,000 GB的支付意愿阈值下，辛伐他汀具有成本效益的可能性为99%。敏感性分析表明，结果对方法学假设的变化是稳健的，成本效益的概率从未降至90%以下。辛伐他汀被发现是治疗ARDS的具有成本效益的药物，它与显著的QALY增加和成本节省有关。ISRCTN，88244364，12个月的死亡率没有显著下降。已于2010年11月26日注册。本文的在线版本(doi：10.1186/s13054-0171695-0)包含补充材料，授权用户可以使用。
Simvastatin therapy for patients with acute respiratory distress syndrome (ARDS) has been shown to be safe and associated with minimal adverse effects, but it does not improve clinical outcomes. The aim of this research was to report on mortality and cost-effectiveness of simvastatin in patients with ARDS at 12 months. This was a cost-utility analysis alongside a multicentre, double-blind, randomised controlled trial carried out in the UK and Ireland. Five hundred and forty intubated and mechanically ventilated patients with ARDS were randomly assigned (1:1) to receive once-daily simvastatin (at a dose of 80 mg) or identical placebo tablets enterally for up to 28 days. Mortality was lower in the simvastatin group (31.8%, 95% confidence interval (CI) 26.1–37.5) compared to the placebo group (37.3%, 95% CI 31.6–43.0) at 12 months, although this was not significant. Simvastatin was associated with statistically significant quality-adjusted life year (QALY) gain (incremental QALYs 0.064, 95% CI 0.002–0.127) compared to placebo. Simvastatin was also less costly (incremental total costs –£3601, 95% CI –8061 to 859). At a willingness-to-pay threshold of £20,000 per QALY, the probability of simvastatin being cost-effective was 99%. Sensitivity analyses indicated that the results were robust to changes in methodological assumptions with the probability of cost-effectiveness never dropping below 90%. Simvastatin was found to be cost-effective for the treatment of ARDS, being associated with both a significant QALY gain and a cost saving. There was no significant reduction in mortality at 12 months, ISRCTN, 88244364. Registered 26 November 2010. The online version of this article (doi:10.1186/s13054-017-1695-0) contains supplementary material, which is available to authorized users.