Therabel Pharma S.A./N.V., B-1180 Brussels, Belgium.
Adv Ther. 2008 Nov;25(11):1200-14. doi: 10.1007/s12325-008-0117-8.
Molsidomine, a direct nitric oxide donor, is frequently used in several European countries for the treatment of stable angina. The aim of this study was to compare the effects of a new once-daily 16-mg dose formulation, Coruno (Therabel Pharmaceuticals, Loughrea, Ireland), in patients with stable angina belonging to two distinct European ethnicities.
A total of 261 Hungarian and 267 Polish patients took part in this multicenter, randomized, double-blind, placebo-controlled clinical trial. Exercise testing was performed after the first administration of molsidomine and repeated after a 2-week treatment. Frequency of anginal attacks, short-acting nitroderivative tablet consumption, and incidence of adverse events were also evaluated.
Demographic and clinical characteristics were significantly different in Hungarian compared with Polish patients. Hungarian patients had a lower proportion of males, were shorter in stature, had less previous smoking experience, consumed more alcohol, had less severe coronary disease (electrocardiographic evidence, rate of anginal crises, and nitroderivative consumption), and higher exercise capacity. However, molsidomine-related improvement in exercise capacity at start of the study was similar in both cohorts. After a 2-week treatment, improvement was fully maintained in Polish and only minimally reduced in Hungarian patients. Furthermore, molsidomine reduced significantly more anginal episodes and nitroderivative consumption in the more severely affected Polish cohort. Proportions of patients reporting drug-related adverse events were similar on placebo and molsidomine in both cohorts. Most of the adverse events were not severe and resolved spontaneously. Less myocardial ischemia and gender (including height, a confounding covariate) acted positively and negatively, respectively, on the higher exercise capacity of Hungarian versus Polish patients.
The once-daily 16-mg molsidomine formulation is effective and has good tolerability in both patient cohorts. Molsidomine does not induce any meaningful tolerance issues in Hungarian or Polish patients with stable angina, despite significant demographic and clinical disparities.
亚甲蓝是一种直接的一氧化氮供体，常用于治疗稳定型心绞痛。本研究旨在比较每日一次 16mg 剂量的新型 Coruno（爱尔兰拉夫雷尔制药公司）在两个不同欧洲民族的稳定型心绞痛患者中的疗效。
261 名匈牙利患者和 267 名波兰患者参与了这项多中心、随机、双盲、安慰剂对照临床试验。在首次服用莫昔朵定后进行运动测试，并在 2 周治疗后重复。还评估了心绞痛发作频率、短效硝基衍生物片剂的消耗以及不良事件的发生率。
与波兰患者相比，匈牙利患者的性别比例、身高、吸烟史、饮酒量、冠心病严重程度（心电图证据、心绞痛发作率和硝基衍生物消耗）以及运动能力均较低。然而，莫昔朵定在研究开始时对运动能力的改善在两个队列中相似。治疗 2 周后，波兰患者的改善得到了完全维持，而匈牙利患者的改善则略有下降。此外，莫昔朵定显著减少了更严重的波兰队列中的心绞痛发作次数和硝基衍生物的消耗。在两个队列中，报告与药物相关的不良事件的患者比例在安慰剂和莫昔朵定组中相似。大多数不良事件不严重，可自行缓解。较少的心肌缺血和性别（包括身高，一个混杂的协变量）对匈牙利患者的更高运动能力产生了积极和消极的影响。
每日一次 16mg 的莫昔朵定制剂在两个患者队列中均有效且耐受性良好。莫昔朵定在有稳定型心绞痛的匈牙利和波兰患者中不会引起任何有意义的耐受问题，尽管存在显著的人口统计学和临床差异。
