Cedars-Sinai Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA 90048, USA.
Curr Atheroscler Rep. 2011 Oct;13(5):413-21. doi: 10.1007/s11883-011-0197-9.
The JUPITER trial is widely hailed as a landmark trial that has the potential to dramatically change the landscape of primary prevention of cardiovascular disease. Like most trials, however, it is not without its limitations. We address some of the common myths and misunderstandings that are underscored by the JUPITER trial. First, by its intentional and ill-advised exclusion of patients with low levels of high-sensitivity C-reactive protein (hsCRP), it is not possible to assess whether baseline hsCRP modifies treatment response to statins or whether it identifies patients most likely to benefit from statin therapy. Second, by stopping the trial early, one cannot rule out the possibility that the treatment benefit was overestimated and risk was underestimated, thereby precluding a reliable estimate of benefit/risk. Finally, as a consequence of early stopping, it is not possible to reliably assess the cost-effectiveness of primary prevention with rosuvastatin. Given these limitations, the attendant societal health policy implications remain largely unknown.
JUPITER 试验被广泛誉为一项具有改变心血管疾病一级预防格局潜力的标志性试验。然而，像大多数试验一样，它并非没有局限性。我们将讨论 JUPITER 试验所强调的一些常见的误解和错误观念。首先，由于该试验故意且不明智地排除了 hsCRP 水平较低的患者，因此无法评估基线 hsCRP 是否会改变他汀类药物的治疗反应，或者是否可以识别最有可能从他汀类药物治疗中获益的患者。其次，由于提前终止试验，不能排除治疗益处被高估和风险被低估的可能性，从而无法可靠估计获益/风险比。最后，由于提前终止试验，无法可靠评估使用瑞舒伐他汀进行一级预防的成本效益。鉴于这些局限性，相关的社会健康政策影响在很大程度上仍不得而知。
