Steinhubl Steven R, Bhatt Deepak L, Brennan Danielle M, Montalescot Gilles, Hankey Graeme J, Eikelboom John W, Berger Peter B, Topol Eric J
The Medicines Company, Balsberg, 8058 Zurich-Flughafen, Switzerland.
Ann Intern Med. 2009 Mar 17;150(6):379-86. doi: 10.7326/0003-4819-150-6-200903170-00006.
The optimal aspirin dose for the prevention of cardiovascular events remains controversial.
To assess the incidence of and risk factors for adverse clinical outcomes by investigator-determined aspirin dose in a primary prevention trial.
Post hoc observational analyses of data from a double-blind, placebo-controlled, randomized trial.
Outpatient.
15 595 patients with cardiovascular disease or multiple risk factors.
Clopidogrel, 75 mg/d, or placebo, with aspirin, 75 to 162 mg/d, as selected by the investigators.
Incidence of the composite outcome of myocardial infarction, stroke, or cardiovascular death (efficacy end point), and incidence of severe or life-threatening bleeding (safety end point), at a median of 28 months (interquartile range, 23 to 31 months) of follow-up.
Daily aspirin doses were categorized as less than 100 mg (75 or 81 mg) (n = 7180), 100 mg (n = 4961), and greater than 100 mg (150 or 162 mg) (n = 3454). The hazard of the primary efficacy end point was the same regardless of dose (adjusted hazard ratio, 0.95 [95% CI, 0.80 to 1.13] for 100 mg vs. less than 100 mg, and 1.0 [CI, 0.85 to 1.18] for greater than 100 mg vs. less than 100 mg). The hazard of the primary safety end point also did not depend on dose (adjusted hazard ratio, 0.85 [CI, 0.57 to 1.26] for 100 mg vs. less than 100 mg and 1.05 [CI, 0.74 to 1.48] for greater than 100 mg vs. less than 100 mg). In patients also receiving clopidogrel, daily aspirin doses greater than 100 mg seemed to be non-statistically significantly associated with reduced efficacy (adjusted hazard ratio, 1.16 [CI, 0.93 to 1.44]) and increased harm (adjusted hazard ratio, 1.30 [CI, 0.83 to 2.04]).
The analysis was post hoc, and aspirin use was not randomized or blinded.
Daily aspirin doses of 100 mg or greater were associated with no clear benefit in patients taking aspirin only and possibly with harm in patients taking clopidogrel. Daily doses of 75 to 81 mg may optimize efficacy and safety for patients requiring aspirin for long-term prevention, especially for those receiving dual antiplatelet therapy.
None.
预防心血管事件的最佳阿司匹林剂量仍存在争议。
在一项一级预防试验中，根据研究者确定的阿司匹林剂量评估不良临床结局的发生率及危险因素。
对一项双盲、安慰剂对照、随机试验的数据进行事后观察分析。
门诊。
15595例患有心血管疾病或有多种危险因素的患者。
研究者选择氯吡格雷75mg/d或安慰剂，联合阿司匹林75至162mg/d。
在中位随访28个月（四分位间距为23至31个月）时，心肌梗死、中风或心血管死亡的复合结局发生率（疗效终点）以及严重或危及生命的出血发生率（安全性终点）。
每日阿司匹林剂量分为小于100mg（75或81mg）（n = 7180）、100mg（n = 4961）和大于100mg（150或162mg）（n = 3454）。无论剂量如何，主要疗效终点的风险相同（100mg与小于100mg相比，调整后风险比为0.95[95%CI，0.80至1.13]；大于100mg与小于100mg相比，调整后风险比为1.0[CI，0.85至1.18]）。主要安全性终点的风险也不取决于剂量（100mg与小于100mg相比，调整后风险比为0.85[CI，0.57至1.26]；大于100mg与小于100mg相比，调整后风险比为1.05[CI，0.74至1.48]）。在同时接受氯吡格雷治疗的患者中，每日阿司匹林剂量大于100mg似乎与疗效降低（调整后风险比为1.16[CI，0.93至1.44]）和危害增加（调整后风险比为1.30[CI，0.83至2.04]）无统计学显著关联。
该分析为事后分析，阿司匹林的使用未随机分组且未设盲。
对于仅服用阿司匹林的患者，每日100mg或更高剂量的阿司匹林无明显益处，而对于服用氯吡格雷的患者可能有害。对于需要长期服用阿司匹林预防的患者，尤其是接受双联抗血小板治疗的患者，每日75至81mg的剂量可能使疗效和安全性达到最佳。
无。
