Department of Cardiology, Daping Hospital, The Third Military Medical University, Chongqing, P. R. China.
PLoS One. 2013 Jul 29;8(7):e70111. doi: 10.1371/journal.pone.0070111. Print 2013.
Aliskiren is a novel renin-angiotensin aldosterone system (RAAS) inhibitor, the combination therapy of aliskiren and amlodipine for blood pressure control have been reported recently. The primary objective of this analysis is to review recently reported randomized controlled trials (RCTs) to compare antihypertensive effects and adverse events between mono (amlodipine or aliskiren alone) and combination therapy of both medicines.
Databases for the search included Pubmed, Embase and the Cochrane Central Register of Controlled Trials. Revman v5.0 statistical program was used to analyze the data. Weighted mean differences (WMD) with a 95% confidence interval (CI) were used for the calculation of continuous data, and relative risk (RR) with a 95% CI was used for dichotomous data.
We analyzed the data from 7 RCTs for a total of 6074 participants in this meta-analysis. We found that the aliskiren/amlodipine combination therapy had a stronger effect in lowering blood pressure as compared with the monotherapy using aliskiren (SBP: WMD = -10.42, 95% CI -13.03∼-7.82, P<0.00001; DBP: WMD = -6.60, 95% CI -7.22∼-5.97, P<0.00001) or amlodipine (SBP: WMD = -4.85, 95% CI -6.88∼-2.81, P<0.00001; DBP: WMD = -2.91, 95% CI -3.85∼-1.97, P<0.00001). No differences were found in terms of adverse events between combination therapy and monotherapy, except for the rates of peripheral edema and hypokalaemia which were significantly lower in the combination therapy than in the amlodipine monotherapy (RR = 0.78, 0.66∼0.92, P = 0.004; RR = 0.51, 0.27∼0.97, P = 0.04). Similar antihypertensive effects were found in both obese (body mass index > = 30 kg/m(2)) hypertensive and non-obese (body mass index <30 kg/m(2)) hypertensive patients. Moreover, there was no difference with the blood pressure lowering or adverse effects with regards to the combination therapy in both subgroups.
We found that aliskiren/amlodipine combination therapy provided a more effective blood pressure reduction than monotherapy with either drug without increase in the occurrence of adverse events.
阿利吉仑是一种新型的肾素-血管紧张素-醛固酮系统（RAAS）抑制剂，最近有报道称阿利吉仑与氨氯地平联合治疗可控制血压。本分析的主要目的是回顾最近报道的随机对照试验（RCT），比较单药（氨氯地平或阿利吉仑单独使用）与两药联合治疗的降压效果和不良反应。
搜索数据库包括 Pubmed、Embase 和 Cochrane 对照试验中心注册库。使用 Revman v5.0 统计程序分析数据。使用加权均数差（WMD）和 95%置信区间（CI）计算连续数据，使用相对风险（RR）和 95%CI 计算二分类数据。
我们对 7 项 RCT 的数据进行了分析，共有 6074 名参与者纳入本荟萃分析。我们发现，与使用阿利吉仑单药治疗（SBP：WMD=-10.42，95%CI-13.03∼-7.82，P<0.00001；DBP：WMD=-6.60，95%CI-7.22∼-5.97，P<0.00001）或氨氯地平单药治疗（SBP：WMD=-4.85，95%CI-6.88∼-2.81，P<0.00001；DBP：WMD=-2.91，95%CI-3.85∼-1.97，P<0.00001）相比，阿利吉仑/氨氯地平联合治疗在降低血压方面效果更强。联合治疗与单药治疗在不良反应方面无差异，但联合治疗外周水肿和低钾血症的发生率明显低于氨氯地平单药治疗（RR=0.78，0.66∼0.92，P=0.004；RR=0.51，0.27∼0.97，P=0.04）。在肥胖（体重指数>230 kg/m2）和非肥胖（体重指数<30 kg/m2）高血压患者中，联合治疗均有相似的降压效果。此外，在降压或不良反应方面，联合治疗在这两个亚组中没有差异。
我们发现，与单药治疗相比，阿利吉仑/氨氯地平联合治疗可更有效地降低血压，且不增加不良反应的发生。
