Trends in prevalence of comorbidities in heart failure clinical trials.

Trends in prevalence of comorbidities in heart failure clinical trials.
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DOI:
10.1002/ejhf.1818
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发表时间:
2020-06
影响因子:
18.2
通讯作者:
Butler J
Butler J
中科院分区:
医学1区
文献类型:
--
作者:
Khan MS;Samman Tahhan A;Vaduganathan M;Greene SJ;Alrohaibani A;Anker SD;Vardeny O;Fonarow GC;Butler J

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本系统综述的主要目的是评估心力衰竭(HF)临床试验中报告的慢性共病的患病率和时间变化。我们在MEDLINE中检索了2001年至2016年期间发表的招募了400多名患者的HF试验。试验分为射血分数降低的HF(HFrEF)、射血分数保留的HF(HFpEF)或不考虑射血分数的试验。基线慢性共病的患病率根据慢性疾病数据仓库提出的算法进行分类,该算法用于分析医疗保险数据。为了检验合并症患病率的趋势,使用线性回归模型评估合并症患病率的时间趋势。总体而言,纳入了118项临床试验,累计招募了215508例患者。在检查的所有合并症中,平均35%的试验报告了数据,在研究期间没有显著改善。与HFpEF试验(27%)相比,HFrEF试验(51%)中合并症的报告更常见。在报告数据的试验中,高血压(63%)、缺血性心脏病(44%)、糖尿病(48%)、糖尿病(33%)、慢性肾脏疾病(25%)和房颤(25%)是主要合并症。在HFrEF试验中,合并症(包括高血压、房颤和慢性肾脏疾病)的患病率随时间推移而增加,而吸烟的患病率下降。许多HF试验未报告基线合并症。未来的临床试验需要采用更严格、系统和标准化的框架,以确保充分的合并症报告,并改善多发病HF患者的招募。
The primary objective of this systematic review was to estimate the prevalence and temporal changes in chronic comorbid conditions reported in heart failure (HF) clinical trials. We searched MEDLINE for HF trials enrolling more than 400 patients published between 2001 and 2016. Trials were divided into HF with reduced ejection fraction (HFrEF), HF with preserved ejection fraction (HFpEF), or trials enrolling regardless of ejection fraction. The prevalence of baseline chronic comorbid conditions was categorized according to the algorithm proposed by the Chronic Conditions Data Warehouse, which is used to analyse Medicare data. To test for a trend in the prevalence of comorbid conditions, linear regression models were used to evaluate temporal trends in prevalence of comorbidities. Overall, 118 clinical trials enrolling a cumulative total of 215 508 patients were included. Across all comorbidities examined, data were reported in a mean of 35% of trials, without significant improvement during the study period. Reporting of comorbidities was more common in HFrEF trials (51%) compared with HFpEF trials (27%). Among trials reporting data, hypertension (63%), ischaemic heart disease (44%), hyperlipidaemia (48%), diabetes (33%), chronic kidney disease (25%) and atrial fibrillation (25%) were the major comorbidities. The prevalence of comorbidities including hypertension, atrial fibrillation and chronic kidney disease increased over time while the prevalence of smoking decreased in HFrEF trials. Many HF trials do not report baseline comorbidities. A more rigorous, systematic, and standardized framework needs to be adopted for future clinical trials to ensure adequate comorbidity reporting and improve recruitment of multi-morbid HF patients.
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