在真实世界的实践中，每日一次服用曲美他嗪 80mg 控释片对稳定型心绞痛患者的抗心绞痛效果和耐受性。
Anti-Anginal Effectiveness and Tolerability of Trimetazidine Modified Release 80 Mg Once Daily in Stable Angina Patients in Real-World Practice.
机构信息
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.
出版信息
Adv Ther. 2018 Sep;35(9):1368-1377. doi: 10.1007/s12325-018-0756-3. Epub 2018 Aug 13.
INTRODUCTION
Trimetazidine (TMZ) was shown to reduce angina symptoms and increase the exercise capacity in stable angina (SA) patients. A new formulation allowing a once-daily (od) dosage could improve patients' satisfaction and adherence.
METHODS
ODA was a 3-month, observational, multicenter, prospective Russian study in SA patients with persistent symptoms despite therapy. Angina attack frequency, short-acting nitrate (SAN) consumption, adherence to antianginal medications, and overall efficacy and tolerability of TMZ 80 mg od were assessed in a real-world setting.
RESULTS
A total of 3066 patients were included (mean age 62.8, 48% male). After 3 months, TMZ 80 mg od treatment led to a significant (p < 0.001) decrease in angina attack frequency (from 4.7 ± 3.5 to 0.9 ± 1.3/week) and SAN use (from 4.5 ± 3.9 to 0.7 ± 1.3/week). Overall tolerability and effectiveness were rated as "very good" by the majority of physicians. Medication adherence improved significantly, with good adherence reported by 56% of patients (vs. 24% at baseline, p < 0.0001) and non-adherence by 3% (vs. 36% at baseline, p < 0.0001) at month 3. Patient satisfaction with TMZ od was 9.5 [on a scale of 1 to 10 (very satisfied)]. Patients reported improved physical activity: more patients reported no limitations (15% vs. 1% at baseline p < 0.01), slight limitation (46% vs. 5% at baseline, p < 0.001) or moderate limitation (30% vs. 23%, p < 0.01) and fewer patients reported substantial limitation (8% vs. 52% at baseline, p < 0.001) or very marked reduction (1% vs. 19% at baseline, p < 0.01) at month 3.
CONCLUSION
In this prospective, observational study, TMZ 80 mg od effectively reduced angina attacks and SAN consumption, improved physical activity and adherence and was well tolerated in chronic SA patients.
TRIAL REGISTRATION
ISRCTN registry Identifier, ISRCTN97780949.
FUNDING
Servier. Plain language summary available for this article.
介绍
曲美他嗪（TMZ）已被证明可减轻稳定型心绞痛（SA）患者的心绞痛症状并提高运动能力。一种新的每日一次（od）剂量制剂可提高患者的满意度和依从性。
方法
ODA 是一项为期 3 个月的、观察性的、多中心的、前瞻性的俄罗斯研究，纳入了尽管经过治疗仍持续存在心绞痛症状的 SA 患者。在真实环境中评估了 TMZ 80mg od 的心绞痛发作频率、短效硝酸酯（SAN）消耗、抗心绞痛药物的依从性以及总体疗效和耐受性。
结果
共纳入 3066 例患者（平均年龄 62.8 岁，48%为男性）。TMZ 80mg od 治疗 3 个月后，心绞痛发作频率（从 4.7±3.5 次/周降至 0.9±1.3 次/周）和 SAN 使用（从 4.5±3.9 次/周降至 0.7±1.3 次/周）显著降低（p<0.001）。大多数医生将整体耐受性和有效性评为“非常好”。药物依从性显著改善，56%的患者报告良好依从性（vs. 基线时的 24%，p<0.0001），3%的患者报告不依从（vs. 基线时的 36%，p<0.0001）。TMZ od 的患者满意度为 9.5[评分范围为 1 到 10（非常满意）]。患者报告身体活动改善：更多患者报告无限制（15% vs. 基线时的 1%，p<0.01）、轻微限制（46% vs. 基线时的 5%，p<0.001）或中度限制（30% vs. 基线时的 23%，p<0.01），较少患者报告严重限制（8% vs. 基线时的 52%，p<0.001）或非常明显减少（1% vs. 基线时的 19%，p<0.01）。
结论
在这项前瞻性观察性研究中，TMZ 80mg od 可有效减少心绞痛发作和 SAN 消耗，改善身体活动和依从性，并在慢性 SA 患者中耐受良好。
试验注册
ISRCTN 注册号，ISRCTN97780949。
资金
Servier。本文提供了通俗易懂的摘要。
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