Siddiqui M Asif A, Keam Susan J
Adis International Limited, Auckland, New Zealand.
Drugs. 2006;66(5):693-710. doi: 10.2165/00003495-200666050-00010.
Ranolazine (Ranexa), a piperazine derivative, is a new antianginal agent approved for the treatment of chronic stable angina pectoris for use as combination therapy when angina is not adequately controlled with other antianginal agents. While the exact mechanism of action of ranolazine is not known, its antianginal and anti-ischaemic effects do not appear to depend upon changes in blood pressure or heart rate. An extended-release (ER) oral formulation of ranolazine has been developed to facilitate twice-daily administration whilst maintaining therapeutically effective plasma concentrations. In patients with chronic stable angina, ranolazine ER monotherapy was shown to improve exercise duration at trough plasma drug concentration in a dose-dependent manner compared with placebo. The drug was effective as adjunctive therapy in patients with chronic stable angina whose condition was not controlled adequately with conventional antianginal therapy. In randomised clinical trials, ranolazine ER was well tolerated, with no overt effects on cardiovascular haemodynamics or conduction, apart from a modest increase in corrected QT (QTc) interval (but no torsades de pointes). Importantly, the efficacy and tolerability of ranolazine ER were not affected by comorbid conditions, including old age, heart failure (HF) or diabetes mellitus. Comparative trials of ranolazine ER with other antianginal agents and trials examining its effects on long-term morbidity and mortality in patients with ischaemic heart disease are required to determine with greater certainty the place of the drug in current antianginal therapy. Nevertheless, ranolazine ER may well prove to be a useful alternative and adjunct to conventional haemodynamic antianginal therapy in the treatment of chronic stable angina.
雷诺嗪(Ranexa)是一种哌嗪衍生物,是一种新型抗心绞痛药物,被批准用于治疗慢性稳定型心绞痛,当使用其他抗心绞痛药物不能充分控制心绞痛时可作为联合治疗用药。虽然雷诺嗪的确切作用机制尚不清楚,但其抗心绞痛和抗缺血作用似乎并不依赖于血压或心率的变化。已开发出一种缓释(ER)口服制剂的雷诺嗪,以方便每日两次给药,同时维持治疗有效的血浆浓度。在慢性稳定型心绞痛患者中,与安慰剂相比,雷诺嗪ER单药治疗在谷值血浆药物浓度时可呈剂量依赖性地改善运动持续时间。该药物对常规抗心绞痛治疗控制不佳的慢性稳定型心绞痛患者作为辅助治疗有效。在随机临床试验中,雷诺嗪ER耐受性良好,除了校正QT(QTc)间期有适度增加(但无尖端扭转型室速)外,对心血管血流动力学或传导无明显影响。重要的是,雷诺嗪ER的疗效和耐受性不受合并症的影响,包括老年、心力衰竭(HF)或糖尿病。需要进行雷诺嗪ER与其他抗心绞痛药物的对比试验以及研究其对缺血性心脏病患者长期发病率和死亡率影响的试验,以更确切地确定该药物在当前抗心绞痛治疗中的地位。尽管如此,雷诺嗪ER很可能被证明是治疗慢性稳定型心绞痛的传统血流动力学抗心绞痛治疗的一种有用的替代药物和辅助药物。