Meiszterics Zsófia, Kónyi Attila, Hild Gábor, Sárszegi Zsolt, Gaszner Balázs
Coromed Kft., Private Cardiology Practice, Pécs, Hungary.
Heart Institute, University of Pécs, General Faculty of Medicine, Pécs, Hungary.
J Comp Eff Res. 2017 Nov;6(8):649-657. doi: 10.2217/cer-2017-0011. Epub 2017 Nov 17.
Aim & methods: This 6-month prospective, observational, noninterventional, open-label clinical study assessed the effectiveness/safety of trimetazidine in 737 patients with stable angina pectoris and Type 2 diabetes mellitus (OGYI/51534-1/2014).
Trimetazidine-based therapy was effective in stable coronary artery disease, with significant improvements from baseline (p < 0.05) in: number of angina attacks/week (2.9 ± 2.4 vs 1.1 ± 1.6), angina severity (Canadian Cardiovascular Society Classification 1.9 ± 0.8 vs 1.2 ± 0.8), exercise capacity (metabolic equivalents 6.1 ± 1.7 vs 6.5 ± 1.7), and exercise-induced myocardial ischemia (min 5.5 ± 2.5 vs 6.5 ± 2.6).
Trimetazidine treatment significantly (p < 0.05) improved glucose metabolism, lowered HbA1c (7.1 ± 1.1% vs 6.6 ± 1.0%), glucose levels (7.7 ± 2.1 mmol/l vs 6.9 ± 1.6 mmol/l) and decreased arterial stiffness (pulse wave velocity 11.2 ± 2.1 m/s vs 10.4 ± 2.2 m/s). In most patients, the tolerability of trimetazidine was rated as excellent to good, with a low incidence of adverse events.
目的与方法:这项为期6个月的前瞻性、观察性、非干预性、开放标签临床研究评估了曲美他嗪对737例稳定型心绞痛合并2型糖尿病患者的有效性/安全性(OGYI/51534-1/2014)。
基于曲美他嗪的治疗对稳定型冠状动脉疾病有效,与基线相比有显著改善(p<0.05),具体如下:每周心绞痛发作次数(2.9±2.4 vs 1.1±1.6)、心绞痛严重程度(加拿大心血管学会分级1.9±0.8 vs 1.2±0.8)、运动能力(代谢当量6.1±1.7 vs 6.5±1.7)以及运动诱发的心肌缺血(分钟数5.5±2.5 vs 6.5±2.6)。
曲美他嗪治疗显著(p<0.05)改善了葡萄糖代谢,降低了糖化血红蛋白(7.1±1.1% vs 6.6±1.0%)、血糖水平(7.7±2.1 mmol/l vs 6.9±1.6 mmol/l),并降低了动脉僵硬度(脉搏波速度11.2±2.1 m/s vs 10.4±2.2 m/s)。在大多数患者中,曲美他嗪的耐受性被评为优秀至良好,不良事件发生率较低。