Elliott Henry L, Meredith Peter A
Henry L Elliott, Institute of Pharmaceutical and Biomedical Sciences, University of Strathclyde, Glasgow G4 0RE, United Kingdom.
World J Cardiol. 2014 Jun 26;6(6):507-13. doi: 10.4330/wjc.v6.i6.507.
To undertake a review of the evidence that nifedipine GITS and lercanidipine are therapeutically equivalent in the management of essential hypertension.
A systematic review of the published literature was prompted by the findings of two meta-analyses which indicated that there was a lower incidence of peripheral (ankle) oedema with lercanidipine. However, neither meta-analysis gave detailed attention to comparative antihypertensive efficacy or cardiovascular protection. Accordingly, a systematic, detailed and critical review was undertaken of individual published papers. The review started with those studies incorporated into the 2 meta-analyses and then all other salient and directly relevant papers identified through the following search criteria: all randomized controlled trials in which the therapeutic profile and antihypertensive effects of lercanidipine were directly compared with those of nifedipine GITS (in hypertensive patients). The search strategy was focused on the reports of clinical trials of lercanidipine vs nifedipine GITS, which were identified through a systematic search of PubMed (from 1966 to October 2012), Embase (from 1980 to October 2012) and the Cochrane library (from 1 October 2008 to end October 2013). The search combined terms related to lercanidipine vs nifedipine GITS (including MeSH search using calcium antagonists, calcium channel blockers and dihydropyridines).
With regard to blood pressure (BP) control and the consistency of BP control throughout 24-h, there is limited published evidence. However, two studies using 24 h ambulatory blood pressure monitoring clearly identified the dose-dependency of BP lowering with lercanidipine and its variably sustained 24-h efficacy. In contrast, there is evidence of a consistent antihypertensive effect throughout 24 h with nifedipine GITS. The incidence of the most common "side effect", i.e., peripheral (ankle) oedema can be estimated as follows. For every 100 patients treated with lercanidipine, 2.5 will report oedema compared to 6 patients treated with nifedipine GITS. However, 98 or 99 patients will continue treatment with nifedipine GITS, compared with 99.5 patients on lercanidipine. Finally, with regard to outcome studies of cardiovascular (CV) morbidity and mortality, there is definitive outcome evidence for nifedipine GITS but there is no evidence that treatment with lercanidipine leads to reductions in CV morbidity and mortality.
There is no evidence in terms of long-term BP control and CV protection to justify the contention that lercanidipine is therapeutically equivalent to nifedipine GITS.
对硝苯地平控释片和乐卡地平在原发性高血压治疗中疗效相当的证据进行综述。
两项荟萃分析的结果提示了对已发表文献进行系统综述，这两项荟萃分析表明乐卡地平引起外周（脚踝）水肿的发生率较低。然而，两项荟萃分析均未详细关注比较降压疗效或心血管保护作用。因此，对已发表的单篇论文进行了系统、详细且严谨的综述。综述从纳入两项荟萃分析的研究开始，然后通过以下检索标准确定所有其他相关且直接相关的论文：所有将乐卡地平与硝苯地平控释片（在高血压患者中）的治疗概况和降压效果直接进行比较的随机对照试验。检索策略聚焦于乐卡地平与硝苯地平控释片对比的临床试验报告，这些报告通过对PubMed（1966年至2012年10月）、Embase（1980年至2012年10月）和Cochrane图书馆（2008年10月1日至2013年10月底）进行系统检索得以确定。检索结合了与乐卡地平对比硝苯地平控释片相关的术语（包括使用钙拮抗剂、钙通道阻滞剂和二氢吡啶类的医学主题词检索）。
关于血压（BP）控制及24小时内血压控制的一致性，已发表的证据有限。然而，两项使用24小时动态血压监测的研究明确证实了乐卡地平降压的剂量依赖性及其24小时内变化的持续疗效。相比之下，有证据表明硝苯地平控释片在24小时内具有持续的降压作用。最常见“副作用”即外周（脚踝）水肿的发生率可估计如下。每100例接受乐卡地平治疗的患者中，2.5例将报告出现水肿，而接受硝苯地平控释片治疗的患者为6例。然而，98或99例接受硝苯地平控释片治疗的患者将继续治疗，而接受乐卡地平治疗的患者为99.5例。最后，关于心血管（CV）发病率和死亡率的结局研究，硝苯地平控释片有确切的结局证据，但没有证据表明乐卡地平治疗可降低CV发病率和死亡率。
就长期血压控制和心血管保护而言，没有证据支持乐卡地平与硝苯地平控释片疗效相当这一论点。
