Ann Intern Med. 2013 Dec 17;159(12):797-805. doi: 10.7326/0003-4819-159-12-201312170-00004.
Whether high-dose multivitamins are effective for secondary prevention of atherosclerotic disease is unknown.
To assess whether oral multivitamins reduce cardiovascular events and are safe.
Double-blind, placebo-controlled, 2 x 2 factorial, multicenter, randomized trial. (ClinicalTrials.gov: NCT00044213) SETTING: 134 U.S. and Canadian academic and clinical sites.
1708 patients aged 50 years or older who had myocardial infarction (MI) at least 6 weeks earlier and had serum creatinine levels of 176.8 mol/L (2.0 mg/dL) or less.
Patients were randomly assigned to an oral, 28-component, high-dose multivitamin and multimineral mixture or placebo.
The primary end point was time to total death, recurrent MI, stroke, coronary revascularization, or hospitalization for angina.
The median age was 65 years, and 18% of patients were women. The qualifying MI occurred a median of 4.6 years (interquartile range [IQR], 1.6 to 9.2 years) before enrollment. Median follow-up was 55 months (IQR, 26 to 60 months). Patients received vitamins for a median of 31 months (IQR, 13 to 59 months) in the vitamin group and 35 months (IQR, 13 to 60 months) in the placebo group (P = 0.65). Totals of 645 (76%) and 646 (76%) patients in the vitamin and placebo groups, respectively, completed at least 1 year of oral therapy (P = 0.98), and 400 (47%) and 426 (50%) patients, respectively, completed at least 3 years (P = 0.23). Totals of 394 (46%) and 390 (46%) patients in the vitamin and placebo groups, respectively, discontinued the vitamin regimen (P = 0.67), and 17% of patients withdrew from the study. The primary end point occurred in 230 (27%) patients in the vitamin group and 253 (30%) in the placebo group (hazard ratio, 0.89 [95% CI, 0.75 to 1.07]; P = 0.21). No evidence suggested harm from vitamin therapy in any category of adverse events.
There was considerable nonadherence and withdrawal, limiting the ability to draw firm conclusions (particularly about safety).
High-dose oral multivitamins and multiminerals did not statistically significantly reduce cardiovascular events in patients after MI who received standard medications. However, this conclusion is tempered by the nonadherence rate.
National Institutes of Health.
高剂量多种维生素是否对动脉粥样硬化疾病的二级预防有效尚不清楚。
评估口服多种维生素是否能减少心血管事件且安全。
双盲、安慰剂对照、2×2 析因、多中心、随机临床试验。（ClinicalTrials.gov：NCT00044213）
美国和加拿大的 134 个学术和临床站点。
1708 名年龄在 50 岁或以上的患者，他们在至少 6 周前发生心肌梗死（MI），且血清肌酐水平为 176.8 μmol/L（2.0 mg/dL）或更低。
患者被随机分配口服 28 种成分的高剂量多种维生素和多种矿物质混合物或安慰剂。
主要终点是总死亡、复发性 MI、卒中和冠状动脉血运重建或因心绞痛住院的时间。
中位年龄为 65 岁，18%的患者为女性。符合条件的 MI 在入组前中位时间为 4.6 年（四分位距[IQR]，1.6 至 9.2 年）。中位随访时间为 55 个月（IQR，26 至 60 个月）。患者接受维生素治疗的中位时间为 31 个月（IQR，13 至 59 个月）在维生素组和 35 个月（IQR，13 至 60 个月）在安慰剂组（P=0.65）。分别有 645（76%）和 646（76%）名患者在维生素和安慰剂组完成了至少 1 年的口服治疗（P=0.98），分别有 400（47%）和 426（50%）名患者完成了至少 3 年的治疗（P=0.23）。分别有 394（46%）和 390（46%）名患者在维生素和安慰剂组停止了维生素治疗（P=0.67），17%的患者退出了研究。维生素组有 230（27%）名患者和安慰剂组有 253（30%）名患者发生了主要终点事件（风险比，0.89[95%CI，0.75 至 1.07]；P=0.21）。在任何类别的不良事件中，均未发现维生素治疗有害的证据。
存在大量的不依从和退出，限制了得出明确结论的能力（特别是关于安全性）。
在接受标准药物治疗的 MI 后患者中，高剂量口服多种维生素和多种矿物质并未显著降低心血管事件。然而，这种结论受到不依从率的影响。
美国国立卫生研究院。
