Di Napoli Pericle, Di Giovanni Paolo, Gaeta Marta Assunta, Taccardi Alfonso A, Barsotti Antonio
Centre for Study and Treatment of Congestive Heart Failure, Department of Cardiology, Casa di Cura Villa Pini d'Abruzzo, Chieti, Italy.
J Cardiovasc Pharmacol. 2007 Nov;50(5):585-9. doi: 10.1097/FJC.0b013e31814fa9cb.
The goal of this study was to determine the effects of trimetazidine on all-cause mortality and heart failure hospitalizations in patients with ischemic cardiomyopathy. We performed an extension to 48 months and a post-hoc analysis of the Villa Pini d'Abruzzo trimetazidine trial; in this single-center, open-label, randomized trial with the metabolic inhibitor trimetazidine in chronic heart failure, 61 patients were randomized to either receive trimetazidine (20 mg tid) in addition to their conventional treatment or to continue their usual drug therapy for 4 years. Patients were evaluated at baseline and at 6, 12, 18, 24, 32, 36, 42, and 48 months with clinical examination, echocardiography, and 6-minute walking test. Trimetazidine added to usual treatment significantly reduces all-cause mortality (-56%; hazard ratio, 0.258; 95% CI, 0.097 to 0.687; log-rank test, P = 0.0047), heart failure hospitalization (-47%; log-rank test, P = 0.002), and improves patient functional status (NYHA class and 6-min walking test). In trimetazidine-treated patients, a significant increase of the left ventricle ejection fraction was also detected (LVEF P < 0.001 at 48 months). It is therefore concluded that long-term trimetazidine significantly reduces all-cause mortality and heart failure hospitalization in patients with ischemic cardiomyopathy. If confirmed in large-scale randomized trials, this treatment could be useful in the management of left ventricle dysfunction and remodeling in patients with ischemic heart disease.
本研究的目的是确定曲美他嗪对缺血性心肌病患者全因死亡率和心力衰竭住院率的影响。我们对Villa Pini d'Abruzzo曲美他嗪试验进行了为期48个月的扩展研究和事后分析;在这项针对慢性心力衰竭患者使用代谢抑制剂曲美他嗪的单中心、开放标签、随机试验中,61例患者被随机分为两组,一组在常规治疗基础上加用曲美他嗪(20毫克,每日三次),另一组继续其常规药物治疗,为期4年。在基线以及第6、12、18、24、32、36、42和48个月时,通过临床检查、超声心动图和6分钟步行试验对患者进行评估。在常规治疗基础上加用曲美他嗪可显著降低全因死亡率(-56%;风险比,0.258;95%置信区间,0.097至0.687;对数秩检验,P = 0.0047)、心力衰竭住院率(-47%;对数秩检验,P = 0.002),并改善患者功能状态(纽约心脏协会分级和6分钟步行试验)。在接受曲美他嗪治疗的患者中,还检测到左心室射血分数显著增加(48个月时左心室射血分数P < 0.001)。因此得出结论,长期使用曲美他嗪可显著降低缺血性心肌病患者的全因死亡率和心力衰竭住院率。如果在大规模随机试验中得到证实,这种治疗方法可能对缺血性心脏病患者左心室功能障碍和重塑的管理有用。