Age and gender bias in statin trials
Age and gender bias in statin trials
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DOI：
10.1093/qjmed/94.3.127
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发表时间：
2001-03-01
影响因子：
13.3
通讯作者：
O'Mahony, MS
中科院分区：
文献类型：
--
作者：
Bandyopadhyay, S;Bayer, AJ;O'Mahony, MS
心血管疾病与年龄密切相关，是老年人死亡的主要原因。最近几项广为宣传的试验报告称，他汀类药物（HMG CoA还原酶抑制剂）可有效降低胆固醇，降低心肌梗死和中风的风险。为了确定这些试验的结果是否与我们的老龄化人口有关，我们检查了老年人和妇女在他汀类药物随机对照试验中的代表性。对1990年至1999年的医学文献进行了系统检索，以确定他汀类药物的随机安慰剂对照试验，这些试验评估了临床终点-心肌梗死、中风或死亡。我们确定了19项试验：15项二级预防和4项一级预防。确定了这些试验中参与者的平均年龄、年龄范围和性别。在二级预防试验中，随机化患者总数为31683例，合并平均年龄为58.1岁。没有试验招募年龄超过75岁的人，只有23%的试验人群是女性。四项一级预防试验共随机纳入14557例受试者，平均年龄为56.9岁。只有10%的研究参与者是女性。他汀类药物的试验受到年龄和性别偏见的影响，主要在中年男性人群中进行。将这些试验的证据外推到老年人和妇女需要进一步评估。
Cardiovascular disease is strongly age-related, and is the leading cause of death in older people, Several well-publicized trials have recently reported that statin drugs (HMG CoA reductase inhibitors) are effective in lowering cholesterol and in reducing the risk of myocardial infarction and stroke. In order to determine whether the results of these trials are relevant to our ageing population, we examined the representation of older people and women in randomized controlled trials of statin drugs. A systematic search of the medical literature from 1990 to 1999 was done to identify randomized placebo-controlled trials of statin drugs which evaluated clinical end-points-myocardial infarction, stroke or death. We identified 19 trials: 15 secondary prevention and four primary prevention. The mean age, age range and gender of the participants in these trials were determined. In the secondary prevention trials, the total number of patients randomized was 31 683, with a combined mean age of 58.1 years. No trial enrolled people beyond the age of 75 years, and only 23% of the trial population was female. The four primary prevention trials randomized a combined total of 14 557 subjects with a mean age of 56.9 years. Only 10% of study participants were female. Statin drug trials have suffered From age and gender bias, having been mainly conducted in middle-aged male populations. The extrapolation of evidence from these trials to older people and women needs further evaluation.