Glezer Maria G, Vygodin Vladimir A
Department of Preventive and Emergency Cardiology, Sechenov First Moscow State Medical University, Moscow, Russia.
Laboratory of Biostatistics, National Medical Research Center for Preventive Medicine of the Ministry of Healthcare, Moscow, Russia.
Cardiol Ther. 2019 Jun;8(1):69-78. doi: 10.1007/s40119-019-0128-3. Epub 2019 Feb 18.
Trimetazidine (TMZ) has been shown to be efficacious for angina treatment. The TMZ 80-mg formulation allows one-daily (od) dosage, which could improve symptom control and adherence.
The 3-month, observational, multicenter, prospective ODA (antianginal effectiveness and tolerability of trimetazidine modified release 80 mg Once Daily in stable Angina patients in real-world practice) study assessed TMZ 80 mg od effectiveness in stable angina patients with persistent symptoms despite therapy. Two clinical situations were compared: patients who initiated treatment with TMZ 80 mg od (initiation group) and patients who were previously treated with TMZ 20 mg thrice daily (tid) or TMZ 35 mg MR twice daily (bid) and switched to TMZ 80 mg od (switch group). Number of angina attacks, short-acting nitrate (SAN) consumption, self-reported patient daily activity, Canadian Cardiovascular Society (CCS) class, adherence to antianginal therapy, overall efficacy and tolerability were assessed.
A significant decrease in weekly number of angina attacks was observed for both the initiation group (n = 1841 patients) from 4.8 ± 3.5 at baseline to 0.9 ± 1.4 at 3 months (M3) (P < 0.001), and the switch group (n = 1216 patients) from 4.4 ± 1.3 at baseline to 0.9 ± 1.3 at M3 (P < 0.001). Significant reduction in SAN consumption and improvement in CCS class were observed for both groups. Adherence to antianginal therapy improved in both groups at 1 month (M1) and M3. Overall effectiveness of TMZ 80 mg od was rated by physicians as "very good" (68% initiation group, 70% switch group), "good" (31% initiation group, 29% switch group), "moderate" (1%, both groups) or "poor" (< 1%, both groups). Overall tolerability of TMZ 80 mg od was rated by physicians as "very good" (75%), "good" (25%) or "moderate" (< 1%) in both groups.
TMZ 80 mg od, in association with other antianginal therapy, effectively reduced angina attacks and SAN consumption and improved physical activity and adherence to antianginal therapy both in patients initiating TMZ treatment and those switching from a bid or tid formulation.
ISRCTN registry Identifier, ISRCTN97780949.
Servier. Plain language summary available for this article.
曲美他嗪(TMZ)已被证明对心绞痛治疗有效。80毫克曲美他嗪制剂允许每日一次给药,这可以改善症状控制和依从性。
为期3个月的观察性、多中心、前瞻性ODA(曲美他嗪80毫克缓释片每日一次在稳定型心绞痛患者中的抗心绞痛有效性和耐受性)研究评估了80毫克曲美他嗪每日一次在尽管接受治疗但仍有持续症状的稳定型心绞痛患者中的有效性。比较了两种临床情况:开始使用80毫克曲美他嗪每日一次治疗的患者(起始组)和先前接受每日三次20毫克曲美他嗪或每日两次35毫克缓释曲美他嗪治疗并改为80毫克曲美他嗪每日一次治疗的患者(转换组)。评估了心绞痛发作次数、短效硝酸盐(SAN)消耗量、患者自我报告的日常活动、加拿大心血管学会(CCS)分级、抗心绞痛治疗的依从性、总体疗效和耐受性。
起始组(n = 1841例患者)每周心绞痛发作次数从基线时的4.8±3.5显著减少至3个月(M3)时的0.9±1.4(P < 0.001),转换组(n = 1216例患者)从基线时的4.4±1.3显著减少至M3时的0.9±1.3(P < 0.001)。两组患者的SAN消耗量均显著减少,CCS分级得到改善。两组在1个月(M1)和M3时抗心绞痛治疗的依从性均有所提高。医生将80毫克曲美他嗪每日一次的总体有效性评为“非常好”(起始组68%,转换组70%)、“好”(起始组31%,转换组29%)、“中等”(两组均为1%)或“差”(两组均<1%)。两组医生将80毫克曲美他嗪每日一次的总体耐受性评为“非常好”(75%)、“好”(25%)或“中等”(<1%)。
80毫克曲美他嗪每日一次与其他抗心绞痛治疗联合使用,可有效减少心绞痛发作次数和SAN消耗量,并改善开始曲美他嗪治疗的患者以及从每日两次或三次制剂转换而来的患者的身体活动和抗心绞痛治疗依从性。
ISRCTN注册标识符,ISRCTN97780949。
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