Galderisi M, Celentano A, Tammaro P, Garofalo M, Mureddu G F, de Divitiis O
Cardioangiology Department-2nd Medical School, University of Naples, Italy.
Int J Clin Pharmacol Ther Toxicol. 1990 Oct;28(10):410-5.
The aim of the study was to compare the effect of slow-release (SR) nicardipine, placebo and chlorthalidone on hypertension-related arrhythmias evaluating 24-h ambulatory ECG. After a 2-week placebo run-in, the patients were randomized according to a double-blind design and treated with either SR nicardipine (40 mg b.i.d.) or chlorthalidone (25 mg once daily) for 8 weeks. At the end of this period, the patients were again treated with placebo for an additional 2 weeks and then crossed over and treated with either SR nicardipine or chlorthalidone for another 8 weeks. Three patients were withdrawn from the study at the end of the first period (1 after SR nicardipine and 2 after chlorthalidone) because of severe arrhythmias (Lown's class 4B) requiring antiarrhythmic therapy. The statistical evaluation was performed on data from 36 patients. SR nicardipine and chlorthalidone determined a significant reduction of both systolic and diastolic BP, with greater decrease with SR nicardipine and without modification of HR. Twenty-four-h ambulatory ECG showed a reduction of both supraventricular and ventricular arrhythmias by SR nicardipine not only compared to placebo but also vs chlorthalidone. Similarly, the severity of ventricular arrhythmias, according to Lown's classes, was reduced only after SR nicardipine. These results were confirmed also dividing the patients according to echocardiographic criteria of LVH. The adverse effects were slight and well tolerated with both drugs. Among hematochemical data, only chlorthalidone induced significant reduction of blood potassium (with 3 cases of hypokalemia). In conclusion, SR nicardipine was found to be more efficacious than chlorthalidone in controlling not only BP but also the arrhythmic events related to hypertension.
该研究的目的是通过评估24小时动态心电图,比较缓释(SR)尼卡地平、安慰剂和氯噻酮对高血压相关心律失常的影响。在进行2周的安慰剂导入期后,患者按照双盲设计随机分组,接受SR尼卡地平(40毫克,每日两次)或氯噻酮(25毫克,每日一次)治疗8周。在此期间结束时,患者再次接受2周的安慰剂治疗,然后交叉接受SR尼卡地平或氯噻酮治疗另外8周。在第一阶段结束时,有3名患者退出研究(1名在接受SR尼卡地平治疗后,2名在接受氯噻酮治疗后),原因是严重心律失常(洛恩4B级)需要抗心律失常治疗。对36名患者的数据进行了统计评估。SR尼卡地平与氯噻酮均能显著降低收缩压和舒张压,其中SR尼卡地平的降压效果更显著,且心率无变化。24小时动态心电图显示,SR尼卡地平不仅与安慰剂相比,而且与氯噻酮相比,均可减少室上性和室性心律失常。同样,根据洛恩分级,仅SR尼卡地平治疗后室性心律失常的严重程度有所降低。根据左心室肥厚的超声心动图标准对患者进行分组后,这些结果也得到了证实。两种药物的不良反应均轻微且耐受性良好。在血液化学数据中,只有氯噻酮导致血钾显著降低(有3例低钾血症)。总之,发现SR尼卡地平在控制血压以及与高血压相关的心律失常事件方面比氯噻酮更有效。