Vascular events in healthy older women receiving calcium supplementation: randomised controlled trial
Vascular events in healthy older women receiving calcium supplementation: randomised controlled trial
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DOI：
10.1136/bmj.39440.525752.be
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发表时间：
2008-02-02
影响因子：
105.7
通讯作者：
Reid, Ian R.
中科院分区：
文献类型：
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作者：
Bolland, Mark J.;Barber, P. Alan;Reid, Ian R.
目的探讨补钙对健康绝经后妇女心肌梗死、中风和猝死的影响。设计随机、安慰剂对照试验。地点：新西兰一个城市的学术医学中心，参与者1471名绝经后妇女（平均年龄74岁）：732人被随机分配到钙补充剂组，739人被随机分配到安慰剂组。死亡、猝死、心肌梗死、心绞痛、其他胸痛、中风、短暂性脑缺血发作，以及心肌梗死、中风，结果心肌梗死在钙剂组比安慰剂组更常见（31例45起事件vs 14例19起事件，P=0.01）。心肌梗死、中风或猝死的复合终点在钙剂组中也更常见（69例女性发生101起事件，42例女性发生54起事件，P=0.008）。判定后，钙组心肌梗死仍然更常见（21例女性发生24起事件，10例女性发生10起事件，相对风险2.12，95%置信区间1.01至4.47）。对于复合终点，钙剂组51名妇女中证实了61起事件，安慰剂组35名妇女中证实了36起事件（相对风险1.47，0.97至2.23）。当从新西兰国家入院数据库中添加未报告的事件时，心肌梗死的相对风险为1.49（0.86 - 2.57），复合终点的相对风险为1.21（0.84 - 1.74）。相应的率比为1.67（95%置信区间0.98至2.87）和1.43（1.01至2.04）;事件发生率：安慰剂16.3/1000人年，钙23.3/1000人年。脑卒中（包括未报告事件）的相对危险度为1.37（0.83 ~ 2.28），率比为1.45（0.88 ~ 2.49）。结论健康绝经后妇女补钙与心血管事件发生率呈上升趋势。这种潜在的有害影响应该与钙对骨骼的可能益处相平衡。试验注册澳大利亚临床试验注册处ACTRN 012605000242628。
Objective To determine the effect of calcium supplementation on myocardial infarction, stroke, and sudden death in healthy postmenopausal women.Design Randomised, placebo controlled trial. Setting Academic medical centre in an urban setting in New Zealand.Participants 1471 postmenopausal women (mean age 74): 732 were randomised to calcium supplementation and 739 to placebo.Main outcome measures Adverse cardiovascular events over five years: death, sudden death, myocardial infarction, angina, other chest pain, stroke, transient ischaemic attack, and a composite end point of myocardial infarction, stroke, or sudden death.Results Myocardial infarction was more commonly reported in the calcium group than in the placebo group (45 events in 31 women v19 events in 14 women, P=0.01). The composite end point of myocardial infarction, stroke, or sudden death was also more common in the calcium group (101 events in 69 women v 54 events in 42 women, P=0.008). After adjudication myocardial infarction remained more common in the calcium group (24 events in 21 women v 10 events in 10 women, relative risk 2.12, 95% confidence interval 1.01 to 4.47). For the composite end point 61 events were verified in 51 women in the calcium group and 36 events in 35 women in the placebo group (relative risk 1.47, 0.97 to 2.23). When unreported events were added from the national database of hospital admissions in New Zealand the relative risk of myocardial infarction was 1.49 (0.86 to 2.57) and that of the composite end point was 1.21 (0.84 to 1.74). The respective rate ratios were 1.67 (95% confidence intervals 0.98 to 2.87) and 1.43 (1.01 to 2.04); event rates: placebo 16.3/1000 person years, calcium 23.3/1000 person years. For stroke (including unreported events)the relative risk was 1.37 (0.83 to 2.28) and the rate ratio was 1.45 (0.88 to 2.49).Conclusion Calcium supplementation in healthy postmenopausal women is associated with upward trends in cardiovascular event rates. This potentially detrimental effect should be balanced against the likely benefits of calcium on bone.Trial registration Australian Clinical Trials Registry ACTRN 012605000242628.