2026-01-21 08:29AM

Number Needed to Treat With Rosuvastatin to Prevent First Cardiovascular Events and Death Among Men and Women With Low Low-Density Lipoprotein Cholesterol and Elevated High-Sensitivity C-Reactive Protein: Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER)

方法和結果－

利用「他汀類藥物預防應用合理性：一項評估瑞舒伐他汀的干預試驗」（JUPITER）的數據，計算了一系列終點、時間範圍和亞組的絕對風險降低值和相應的需治療人數（NNT）值。 JUPITER是一項隨機對照試驗，評估了瑞舒伐他汀20 mg與安慰劑的療效，受試者為17802名低密度脂蛋白膽固醇<130 mg/dL且高敏C反應蛋白≥2 mg/L的健康男性和女性。此外，也進行了敏感性分析，以探討其他他汀類藥物方案可能對類似一級預防族群產生的影響。

對於心肌梗塞、中風、血管重建或死亡此終點，JUPITER試驗的5年NNT為20（95% CI，14至34）。所有亞組的5年NNT值均低於50。

例如，男性5年需治療人數（NNT）為17，女性為31；白人為21，非白人為19；體重指數≤25 kg/m²者為18，體重指數>25 kg/m²者為21 ；有冠心病家族史者為9，無冠心病家族史者為26；有代謝症候群者為19，無代謝症候群者為22；弗雷明漢風險評分大於10%者為14，弗雷明漢風險評分小於10%者為37。對於包含靜脈血栓栓塞在內的淨血管獲益終點，5年NNT為18（95% CI，13至29）。對於限制性「硬終點」（心肌梗塞、中風或死亡），5年NNT為29（95% CI，19至56）。在評估替代藥物理論效用的敏感性分析中，分別針對能達到JUPITER研究中觀察到的相對獲益75%和50%的他汀類藥物方案，估計其5年需治療人數（NNT）值分別為38和57。所有這些計算結果均優於先前報告的用於高血脂男性一級預防的他汀類藥物（5年NNT為40至70）、抗高血壓治療（5年NNT為80至160）或阿斯匹靈（5年NNT>300）的5年NNT值。
結論—對於高敏 C 反應蛋白升高和低密度脂蛋白膽固醇降低的患者，他汀類藥物治療的絕對風險降低和相應的 NNT 值與已發表的幾種廣泛接受的心血管疾病一級預防干預措施的 NNT 值相當，甚至更優，其中包括對明顯高脂血症患者使用他汀類藥物治療。

Abstract

Background— As recently demonstrated, random allocation to rosuvastatin results in large relative risk reductions for first cardiovascular events among apparently healthy men and women with low levels of low-density lipoprotein cholesterol but elevated levels of high-sensitivity C-reactive protein. However, whether the absolute risk reduction among such individuals justifies wide application of statin therapy in primary prevention is a controversial issue with broad policy and public health implications.

Methods and Results— Absolute risk reductions and consequent number needed to treat (NNT) values were calculated across a range of end points, timeframes, and subgroups using data from Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER), a randomized evaluation of rosuvastatin 20 mg versus placebo conducted among 17 802 apparently healthy men and women with low-density lipoprotein cholesterol <130 mg/dL and high-sensitivity C-reactive protein ≥2 mg/L. Sensitivity analyses were also performed to address the potential impact that alternative statin regimens might have on a similar primary prevention population. For the end point of myocardial infarction, stroke, revascularization, or death, the 5-year NNT within JUPITER was 20 (95% CI, 14 to 34). All subgroups had 5-year NNT values for this end point below 50; as examples, 5-year NNT values were 17 for men and 31 for women, 21 for whites and 19 for nonwhites, 18 for those with body mass index ≤25 kg/m2 and 21 for those with body mass index greater than 25 kg/m2, 9 and 26 for those with and without a family history of coronary disease, 19 and 22 for those with and without metabolic syndrome, and 14 and 37 for those with estimated Framingham risks greater or less than 10%. For the net vascular benefit end point that additionally included venous thromboembolism, the 5-year NNT was 18 (95% CI, 13 to 29). For the restricted “hard” end point of myocardial infarction, stroke, or death, the 5-year NNT was 29 (95% CI, 19 to 56). In sensitivity analyses addressing the theoretical utility of alternative agents, 5-year NNT values of 38 and 57 were estimated for statin regimens that deliver 75% and 50% of the relative benefit observed in JUPITER, respectively. All of these calculations compare favorably to 5-year NNT values previously reported in primary prevention for the use of statins among hyperlipidemic men (5-year NNT, 40 to 70), for antihypertensive therapy (5-year NNT, 80 to 160), or for aspirin (5-year NNT, >300).

Conclusions— Absolute risk reductions and consequent NNT values associated with statin therapy among those with elevated high-sensitivity C-reactive protein and low low-density lipoprotein cholesterol are comparable if not superior to published NNT values for several widely accepted interventions for primary cardiovascular prevention, including the use of statin therapy among those with overt hyperlipidemia.

Clinical Trial Registration— clinicaltrials.gov. Identifier NCT00239681.