Ruzyllo W, Szwed H, Sadowski Z, Elikowski W, Grzelak-Szafranska H, Orszulak W, Szymczak K, Winter M
Department of General Cardiology, National Institute of Cardiology, Warsaw, Poland.
Curr Med Res Opin. 2004 Sep;20(9):1447-54. doi: 10.1185/030079904X2637.
The revascularization procedures become more and more popular to treat coronary artery disease, in many countries. Some patients are free of angina after revascularization, without any documented re-stenosis present with recurrent angina symptoms after a period of time. The aim of this work was to assess the efficacy of trimetazidine in the subpopulation of patients with a history of PTCA or CABG, who were included in the TRIMPOL II study.
A subgroup of 94 patients was retrospectively analysed from the TRIMPOL II study, a multicentre, double-blind randomised placebo-controlled trial in 426 patients with stable effort angina. These patients have a history of revascularization for coronary artery disease, and they are still symptomatic after 6 months despite a treatment with metoprolol (50 mg twice daily). They were randomly allocated to receive either trimetazidine (20 mg 3 times daily) or placebo for 12 weeks, on top of the beta-blocker. Exercise test parameters, clinical efficacy and safety were assessed. Results were analysed using the Student test, the Mann-Whitney test or the Shapiro-Wilk test.
Compared to placebo, the 12-week treatment with trimetazidine significantly improved: time to 1 mm ST segment depression (385.1 s +/- 144.6 s versus 465.0 s +/- 143.8 s [p < 0.01]); exercise test duration (466.9 s +/- 144.8 s versus 524.4 s +/- 131.5 s [p = 0.048]), total workload (9.0 m.e. +/- 2.4 m.e versus 10.1 m.e. +/- 2.4 m.e [p = 0.035]) as well as time to onset of angina (433.6 s +/- 164 s versus 508.1 s +/- 132.4 s [p = 0.031]). Weekly number of angina attacks and nitrate consumption were significantly reduced in the trimetazidine group when compared to placebo. Three mild gastro-intestinal side-effects were reported in the trimetazidine group.
These results show that trimetazidine provides anti-anginal efficacy in post-revascularized patients with recurrent angina despite a monotherapy with metoprolol. The treatment was well accepted.
在许多国家,血运重建术治疗冠状动脉疾病越来越普遍。一些患者在血运重建术后无心绞痛症状,一段时间后也无再狭窄及复发性心绞痛症状的记录。本研究旨在评估曲美他嗪对纳入TRIMPOL II研究的曾接受经皮冠状动脉腔内血管成形术(PTCA)或冠状动脉旁路移植术(CABG)患者亚群的疗效。
对TRIMPOL II研究中的94例患者进行回顾性分析,该研究是一项针对426例稳定型劳力性心绞痛患者的多中心、双盲、随机、安慰剂对照试验。这些患者有冠状动脉疾病血运重建史,尽管接受美托洛尔(每日两次,每次50毫克)治疗6个月后仍有症状。他们被随机分配接受曲美他嗪(每日3次,每次20毫克)或安慰剂治疗12周,在β受体阻滞剂基础上用药。评估运动试验参数、临床疗效和安全性。结果采用学生检验、曼-惠特尼检验或夏皮罗-威尔克检验进行分析。
与安慰剂相比,曲美他嗪12周治疗显著改善:ST段压低1毫米的时间(385.1秒±144.6秒对465.0秒±143.8秒 [p < 0.01]);运动试验持续时间(466.9秒±144.8秒对524.4秒±131.5秒 [p = 0.048]),总工作量(9.0代谢当量±2.4代谢当量对10.1代谢当量±2.4代谢当量 [p = 0.035])以及心绞痛发作时间(433.6秒±164秒对508.1秒±132.4秒 [p = 0.031])。与安慰剂相比,曲美他嗪组每周心绞痛发作次数和硝酸酯类药物消耗量显著减少。曲美他嗪组报告了3例轻度胃肠道副作用。
这些结果表明,尽管患者接受了美托洛尔单一疗法,但曲美他嗪对血运重建术后复发性心绞痛患者具有抗心绞痛疗效。该治疗耐受性良好。