Women, older persons, and ethnic minorities: factors associated with their inclusion in randomised trials of statins 1990 to 2001
Women, older persons, and ethnic minorities: factors associated with their inclusion in randomised trials of statins 1990 to 2001
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DOI：
10.1136/heart.89.3.327
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发表时间：
2003-03-01
期刊：
影响因子：
5.7
通讯作者：
Egger, M
中科院分区：
文献类型：
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作者：
Bartlett, C;Davey, P;Egger, M
方法：我们进行了一项Medline检索，截至2001年8月1日，在成人中使用他汀类药物的随机试验，最短治疗时间为6个月（或26周），报告了脂质变化或狭窄变化或心血管事件。我们考虑了未发表的非英语语言研究，并检查了相关论文中的参考文献。为了符合条件，试验必须将他汀类药物与非他汀类药物、非活性对照或“常规护理”进行比较。在试验期间，对于血脂过高的辅助药物治疗是可以接受的。如果可以获得适当的数据，我们纳入了析因试验。所有患者均患有肾衰竭或糖尿病的试验不符合条件。为了清楚起见，我们每项试验仅进行一次治疗比较（例如，他汀类药物组与安慰剂组），采用首次报告的比较。数据由一名研究人员（CB）提取，关键变量由一名同事重复提取。如果所有或部分患者位于美国，我们将试验编码为“美国”。我们还根据制药业是否提供了支持对试验进行了编码。测量冠状动脉或颈动脉狭窄的试验我们编码为“血管造影”。使用Fisher精确检验和Kruskal沃利斯检验在STATA 7中进行分析。我们报告了p≤ 0.05的概率值。在1990年至2001年（含）期间发表的47项随机对照试验（RCT）中，共有47项符合条件。平均随访时间为2年。病人总数为50 245人，中位数为270人。涉及的他汀类药物有：普伐他汀（22项试验）、洛伐他汀（12项）、辛伐他汀（9项）、氟伐他汀（3项）和阿托伐他汀（1项）。大多数试验（38项）为二级或混合一级/二级预防。如表1所示，8项试验（17%）报告完全排除了女性，纳入女性的中位百分比仅为18.6%（四分位距（IQR）11.8-30%）。虽然14项试验报告了女性的单独结局信息，但其中只有7项报告了心血管事件数据，而且往往是以肤浅的方式;只有两项试验在报告不良事件时区分了男性和女性。总共有31项试验报告设定了明确的年龄上限，中位数为70岁，但其余11项试验对此模棱两可。65岁以上人群的百分比很少报告（13项试验），中位数百分比为零。11项试验按年龄组报告了结局信息，尽管这通常是最小的。只有8项试验（17%）报告了各自样本中少数民族的比例。
METHODSWe conducted a Medline search up to 1 August 2001 for randomised trials of statins in adults with a minimum treatment duration of six months (or 26 weeks) which reported lipid changes or stenosis change or cardiovascular events. We considered unpublished and non-English language studies and checked references in relevant papers. To be eligible, trials had to compare a statin with a non-statin drug, an inactive control or “usual care”. Adjuvant drug treatment for excessively high lipids during the trial was acceptable. We included factorial trials if appropriate data could be derived. Trials in which all patients had renal failure or diabetes were not eligible. For clarity, we drew upon only one treatment comparison (for example, statin arm versus placebo arm) per trial, taking the comparison first reported. Data were extracted by one researcher (CB), with extraction duplicated by a colleague for key variables. We coded trials to “USA” if all or some of the patients were located in the USA. We also coded trials according to whether support had been provided by the pharmaceutical industry. Trials in which coronary or carotid artery stenosis was measured we coded to “angiographic”. Analysis was in STATA 7, using Fisher‘s exact test and the Kruskal Wallis test. We report probability values of p≤ 0.05.RESULTSIn total, 47 randomised controlled trials (RCTs) published in the period 1990 to 2001 inclusive were eligible. The mean follow up period was two years. The total number of patients was 50 245, the median being 270. The statins involved were: pravastatin (22 trials), lovastatin (12), simvastatin (9), fluvastatin (3), and atorvastatin (1). Most trials (38) were secondary or mixed primary/secondary prevention. As table 1 shows, eight trials (17%) reported complete exclusion of women, and the median percentage of women included was only 18.6%(interquartile range (IQR) 11.8–30%). While 14 trials reported separate outcome information for women, only seven of these reported cardiovascular event data, often in a superficial way; only two trials distinguished between men and women in reporting adverse events. In all, 31 trials reported setting a definite upper limit for age, the median being 70 years, but 11 of the remaining trials were equivocal about this. The percentage of people aged 65+ was infrequently reported (13 trials), the median percentage being zero. Eleven trials reported outcome information by age group, although this was often minimal. Only eight trials (17%) reported the ethnic minority proportion in their respective samples.