Kawalec Paweł, Holko Przemysław, Gawin Małgorzata, Pilc Andrzej
Institute of Public Health, Faculty of Health Sciences, Jagiellonian University, Krakow, Poland.
Department of Food Biotechnology, Faculty of Food Technology, University of Agriculture, Krakow, Poland.
Arch Med Sci. 2018 Aug;14(5):1125-1136. doi: 10.5114/aoms.2018.77561. Epub 2018 Aug 13.
Clinical studies have revealed that fixed-dose combinations (FDCs) of drugs can have a better effect on blood pressure than free-equivalent combinations (FECs). Our objectives were to perform an up-to-date assessment of the effectiveness of FDCs and FECs in antihypertensive therapy, to provide more accurate results by using a stratified meta-analysis.
A systematic review was performed in PubMed, Web of Science, and Cochrane databases according to PRISMA guidelines. The outcomes were adherence (compliance), persistence to medication, reduction of blood pressure and the safety profile. We used the Newcastle Ottawa scale or the Delphi list for the assessment of the quality of cohort studies or clinical trials, respectively. Heterogeneity was assessed using the Cochrane test and statistic.
Of 301 abstracts screened, 26 primary studies and 2 other meta-analyses were identified, of which 12 studies were included in the meta-analyses and 3 studies were included in the narrative review. The FDC treatment is associated with a significant improvement in adherence and persistence in comparison with FEC treatment, e.g., the average medicine possession ratio increased with FDC by 13.1% ( < 0.001). For endpoints correlated with higher adherence (e.g., a reduction in blood pressure), a nonsignificant benefit was observed for FDCs. Moreover, it was demonstrated that higher adherence can lead to a lower risk of cardiovascular events.
In comparison with FECs, the FDC treatment is associated with a significant improvement in the cooperation between a doctor and a patient and with increased patients' adherence to the treatment schedule.
临床研究表明,药物的固定剂量组合(FDC)在血压控制方面可能比等效剂量自由组合(FEC)具有更好的效果。我们的目标是对FDC和FEC在抗高血压治疗中的有效性进行最新评估,通过分层荟萃分析提供更准确的结果。
根据PRISMA指南,在PubMed、科学网和Cochrane数据库中进行了系统综述。研究结果包括依从性(顺应性)、药物持续性、血压降低情况和安全性。我们分别使用纽卡斯尔渥太华量表或德尔菲列表来评估队列研究或临床试验的质量。使用Cochrane检验和统计量评估异质性。
在筛选的301篇摘要中,确定了26项主要研究和2项其他荟萃分析,其中12项研究纳入了荟萃分析,3项研究纳入了叙述性综述。与FEC治疗相比,FDC治疗在依从性和持续性方面有显著改善,例如,FDC使平均药物持有率提高了13.1%(P<0.001)。对于与较高依从性相关的终点(如血压降低),FDC显示出不显著的益处。此外,研究表明较高的依从性可导致较低的心血管事件风险。
与FEC相比,FDC治疗可显著改善医患合作,并提高患者对治疗方案的依从性。