Koylan Nevres, Bilge Ahmet Kaya, Adalet Kamil, Mercanoglu Fehmi, Büyüköztürk Kemalettin
Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology, Istanbul, Turkey.
Acta Cardiol. 2004 Dec;59(6):644-50. doi: 10.2143/AC.59.6.2005248.
A multicentre, double-blind comparative study was performed to compare the effects of trimetazidine with diltiazem on exercise performance in patients with stable angina pectoris.
A total of 116 male patients with documented coronary artery disease at 11 centres were randomized into trimetazidine and diltiazem groups both including 58 men (mean age 55.1+/-8.6 years and 54.9+/-6.6 years, respectively) in a prospective, multicentre, double-blind active treatment trial. The study consisted of a two-week placebo washout period and a four-week active treatment phase. Clinical examinations and exercise tests were performed at the beginning (D0) and at the end (D28) of the active treatment. Laboratory investigations were also performed at the beginning of the washout period (D-14) and at D28. Holter recordings were done in the mid of the washout period (D-7) and D28. Both trimetazidine and diltiazem decreased the number of anginal attacks per week (p < 0.0001 for both drugs) and weekly nitrate consumption (p = 0.0008 and p < 0.0001, respectively). Both trimetazidine and diltiazem improved the recovery of anginal pain (p = 0.0188 and p = 0.0079, respectively) and maximal ST-segment depression (p = 0.0134 and p = 0.0214, respectively) but none of the drugs significantly changed the time to 1 mm ST-segment depression and ST recovery time on exercise test. Diltiazem caused a slight prolongation of PR and QRS durations (p = 0.039) on ambulatory ECG whereas trimetazidine did not change these parameters significantly.
This study suggests that trimetazidine is an effective and safe alternative for diltiazem in the treatment of patients with stable angina pectoris. Although several other trials have shown that this drug can be used in combination with other antianginal drugs or instead of beta blockers or nifedipine in the symptomatic treatment of stable anginal syndromes, this study suggests that trimetazidine can be used instead of diltiazem, a well-known powerful antianginal drug.
进行一项多中心、双盲对照研究,比较曲美他嗪与地尔硫䓬对稳定型心绞痛患者运动能力的影响。
在11个中心,共116例有冠状动脉疾病记录的男性患者被随机分为曲美他嗪组和地尔硫䓬组,每组58例(平均年龄分别为55.1±8.6岁和54.9±6.6岁),这是一项前瞻性、多中心、双盲活性药物治疗试验。研究包括为期两周的安慰剂洗脱期和为期四周的活性药物治疗阶段。在活性药物治疗开始时(D0)和结束时(D28)进行临床检查和运动试验。在洗脱期开始时(D - 14)和D28也进行实验室检查。在洗脱期中期(D - 7)和D28进行动态心电图记录。曲美他嗪和地尔硫䓬均减少每周心绞痛发作次数(两种药物p均<0.0001)和每周硝酸酯类药物消耗量(分别为p = 0.0008和p < 0.0001)。曲美他嗪和地尔硫䓬均改善心绞痛疼痛恢复情况(分别为p = 0.0188和p = 0.0079)以及最大ST段压低情况(分别为p = 0.0134和p = 0.0214),但两种药物均未显著改变运动试验中ST段压低1mm的时间和ST段恢复时间。地尔硫䓬使动态心电图的PR间期和QRS时限略有延长(p = 0.039),而曲美他嗪未显著改变这些参数。
本研究表明,在治疗稳定型心绞痛患者时,曲美他嗪是地尔硫䓬有效且安全的替代药物。尽管其他一些试验表明该药物可与其他抗心绞痛药物联合使用,或在稳定型心绞痛综合征的症状治疗中替代β受体阻滞剂或硝苯地平,但本研究表明曲美他嗪可替代地尔硫䓬,一种知名的强效抗心绞痛药物。