乌克兰冠心病和稳定型心绞痛患者的特征,根据 GO-OD 多中心研究对其治疗方法的评估

O. M. Parkhomenko, S. A. Tykhonova, O. Koval, M. Y. Kolesnyk
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The GO-OD study is a 3-month, non-interventional, observational, multicenter prospective study conducted in Ukraine in a real-world outpatient cardiology practice during February – August 2021. Physicians were instructed to continue monitoring and treating patients in accordance with usual practice and international guidelines. No additional diagnostic or monitoring procedures were performed. Clinical, instrumental and laboratory data, frequency of angina attacks, consumption of short-acting nitrates (SAN), adherence to antianginal drugs, as well as the overall efficacy, tolerability of TMZ OD 80 mg in real-world clinical practice were analyzed. The observation includes regular assessment of patients` clinical status, treatment optimization and its effectiveness at follow up visits.Results. The study included 1529 patients (mean age 62.5 years, 56 % men). In the absence of adequate control of risk factors, pharmacological control of symptoms, and limited use of interventional and surgical treatments, the frequency of angina episodes was high, most patients had a pronounced angina functional class according to the Canadian Society of Cardiology classification (10.5 % – CCS I, 60.1 % – CCS II, 29.5 % – CCS III). Thus, the average number of angina attacks per week in CCS I was 3.7, in CCS II – 5.2, and in CCS III – 7, 97 attacks. In addition to the severity of symptoms, the following pattern was observed: the higher the angina class, the more risk factors and comorbidities patients had. After 3 months of follow-up due to optimization of therapy, there was a significant (p<0.001) decrease in the frequency of angina attacks – from (5.8±4.7 to 1.6±2.0)/week, and the use of SAN – from (4.2±4.3 to 0.8±1.6)/week). At the same time, in 3 month the % of patients with CCS II and III significantly decreased, while the % of patients with CCS I increased (48.4 % – CCS I, 45.7 % – CCS II, 6 % – CCS III). Adherence to medication was improved: 49 % of patients reported high adherence (vs. 18 % at baseline) and 12 % – low adherence (vs. 52 % at baseline). After 3 months of follow-up most of doctors rated the overall tolerability and effectiveness of the therapy as «very satisfied». Patients’ satisfaction with TMZ OD 80 mg therapy after 3 months of follow-up was 9.5 points [on a scale of 1 to 10 (very satisfied)]. Patients’ assessment of daily physical activity increased significantly: 2.42 versus 5.89 points at baseline (on a scale of 1 to 10 (severe limitation)).Conclusions. In general, the management of outpatients with CAD and stable angina in the current cardiologists’ practice, which was complicated by the COVID-19 pandemic, was not effective enough, resulting in a high frequency of angina attacks – almost 6 per week, and a significant limitation of daily activity due to angina symptoms.Significant deficiency in the management of studied population was insufficient correction of such important risk factors as hypertension, heart rate, dyslipidemia, and lifestyle-related risk factors (overweight and obesity, low level of physical activity). The baseline therapy of patients in the study was in line with current guidelines, but with an insufficient frequency of statin prescription (78 %) and ACE inhibitors (54.5 %); antianginal treatment with an average of 2 or more antianginal drugs was not optimal for controlling angina symptoms, and the frequency of coronary revascularization procedures was also insufficient, mostly during acute MI (58.0 %).Optimization of drug therapy as the first step in correcting the condition of patients with CAD and stable angina in accordance with all current recommendations with the inclusion of the original trimetazidine OD 80 mg once daily among antianginal drugs, as well as active monitoring of patients for 3 months allowed to reduce the frequency of angina attacks regardless of its initial FC, increase patient adherence to treatment and their functional activity. ","PeriodicalId":23419,"journal":{"name":"Ukrainian Journal of Cardiology","volume":"7 23","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Характеристика пацієнтів з ішемічною хворобою серця та стабільною стенокардією в Україні, оцінка підходів до їх лікування за даними багатоцентрового дослідження GO-OD\",\"authors\":\"O. 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In the absence of adequate control of risk factors, pharmacological control of symptoms, and limited use of interventional and surgical treatments, the frequency of angina episodes was high, most patients had a pronounced angina functional class according to the Canadian Society of Cardiology classification (10.5 % – CCS I, 60.1 % – CCS II, 29.5 % – CCS III). Thus, the average number of angina attacks per week in CCS I was 3.7, in CCS II – 5.2, and in CCS III – 7, 97 attacks. In addition to the severity of symptoms, the following pattern was observed: the higher the angina class, the more risk factors and comorbidities patients had. After 3 months of follow-up due to optimization of therapy, there was a significant (p<0.001) decrease in the frequency of angina attacks – from (5.8±4.7 to 1.6±2.0)/week, and the use of SAN – from (4.2±4.3 to 0.8±1.6)/week). 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引用次数: 0

摘要

冠状动脉疾病(CAD)和稳定型心绞痛的治疗包括改变生活方式、药物治疗和侵入性干预,以达到病情稳定或缓解的目的。为了进一步优化治疗,有必要了解药物治疗的使用现状并评估其有效性。三甲脒(TMZ)曾被证明可减轻 CAD 和稳定型心绞痛患者的心绞痛症状并提高运动耐量,可能是优化抗心绞痛治疗的一种选择。然而,长期治疗的效果取决于患者的依从性,因此每天一次(OD)使用 80 毫克剂量的 TMZ 可提高 CAD 和稳定型心绞痛患者的满意度和依从性。GO-OD研究是一项为期3个月、非干预性、观察性、多中心前瞻性研究,于2021年2月至8月期间在乌克兰的一家真实世界心脏病门诊诊所进行。医生被要求继续按照惯例和国际指南对患者进行监测和治疗。没有进行额外的诊断或监测程序。分析了临床、仪器和实验室数据、心绞痛发作频率、短效硝酸盐(SAN)消耗量、抗心绞痛药物的依从性以及 TMZ OD 80 毫克在实际临床实践中的总体疗效和耐受性。观察内容包括定期评估患者临床状态、优化治疗以及随访疗效。研究共纳入1529名患者(平均年龄62.5岁,56%为男性)。在危险因素未得到充分控制、症状未得到药物控制、介入治疗和手术治疗使用有限的情况下,心绞痛发作的频率很高,根据加拿大心脏病学会的分类,大多数患者的心绞痛功能分级明显(10.5% - CCS I,60.1% - CCS II,29.5% - CCS III)。因此,CCS I 的心绞痛平均每周发作 3.7 次,CCS II 的平均每周发作 5.2 次,CCS III 的平均每周发作 797 次。除了症状的严重程度外,还观察到以下模式:心绞痛分级越高,患者的危险因素和合并症越多。由于优化了治疗方案,随访 3 个月后,心绞痛发作频率明显降低(p<0.001),从(5.8±4.7)次/周降至 1.6±2.0)次/周,SAN 的使用也从 4.2±4.3 次/周降至 0.8±1.6)次/周。同时,在三个月内,CCS II 和 III 患者的比例明显下降,而 CCS I 患者的比例则有所上升(48.4% - CCS I,45.7% - CCS II,6% - CCS III)。坚持服药的情况有所改善:49%的患者表示服药依从性高(与基线时的 18%相比),12%的患者表示服药依从性低(与基线时的 52%相比)。经过 3 个月的随访,大多数医生对治疗的总体耐受性和有效性表示 "非常满意"。随访3个月后,患者对TMZ OD 80毫克疗法的满意度为9.5分[1至10分(非常满意)]。患者对日常体力活动的评估显著增加:2.42分,而基线时为5.89分(1至10分(严重受限))。总体而言,目前心脏病专家对门诊患有 CAD 和稳定型心绞痛的患者的管理不够有效,导致心绞痛发作频率很高(每周近 6 次),心绞痛症状严重限制了患者的日常活动。研究中患者的基线治疗符合现行指南,但他汀类药物(78%)和 ACE 抑制剂(54.5%)的处方频率不足;平均使用 2 种或更多抗心绞痛药物的抗心绞痛治疗并非控制心绞痛症状的最佳方法,冠状动脉血管重建手术的频率也不足,主要是在急性心肌梗死期间(58.0%)。根据目前的所有建议,将优化药物治疗作为纠正 CAD 和稳定型心绞痛患者病情的第一步,并在抗心绞痛药物中加入了最初的曲美他嗪 OD 80 毫克,每天一次,同时对患者进行为期 3 个月的积极监测,从而降低了心绞痛发作的频率(无论其最初的 FC 如何),提高了患者对治疗的依从性及其功能活动。
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Характеристика пацієнтів з ішемічною хворобою серця та стабільною стенокардією в Україні, оцінка підходів до їх лікування за даними багатоцентрового дослідження GO-OD
Treatment of coronary artery disease (CAD) and stable angina, includes lifestyle modification, pharmacological therapy and invasive interventions to achieve stabilization or regression of the disease. Knowledge of the current situation regarding the use of pharmacological therapy and evaluation of its effectiveness is necessary for further management optimization. Trimetazidine (TMZ) has previously been shown to reduce angina symptoms and increase exercise tolerance in patients with CAD and stable angina and may be among an option for optimizing antianginal treatment. However, the effectiveness of long-term treatment depends on patient adherence, so the use of TMZ once daily (OD) at a dose of 80 mg may improve satisfaction and adherence in patients with CAD and stable angina.Methods. The GO-OD study is a 3-month, non-interventional, observational, multicenter prospective study conducted in Ukraine in a real-world outpatient cardiology practice during February – August 2021. Physicians were instructed to continue monitoring and treating patients in accordance with usual practice and international guidelines. No additional diagnostic or monitoring procedures were performed. Clinical, instrumental and laboratory data, frequency of angina attacks, consumption of short-acting nitrates (SAN), adherence to antianginal drugs, as well as the overall efficacy, tolerability of TMZ OD 80 mg in real-world clinical practice were analyzed. The observation includes regular assessment of patients` clinical status, treatment optimization and its effectiveness at follow up visits.Results. The study included 1529 patients (mean age 62.5 years, 56 % men). In the absence of adequate control of risk factors, pharmacological control of symptoms, and limited use of interventional and surgical treatments, the frequency of angina episodes was high, most patients had a pronounced angina functional class according to the Canadian Society of Cardiology classification (10.5 % – CCS I, 60.1 % – CCS II, 29.5 % – CCS III). Thus, the average number of angina attacks per week in CCS I was 3.7, in CCS II – 5.2, and in CCS III – 7, 97 attacks. In addition to the severity of symptoms, the following pattern was observed: the higher the angina class, the more risk factors and comorbidities patients had. After 3 months of follow-up due to optimization of therapy, there was a significant (p<0.001) decrease in the frequency of angina attacks – from (5.8±4.7 to 1.6±2.0)/week, and the use of SAN – from (4.2±4.3 to 0.8±1.6)/week). At the same time, in 3 month the % of patients with CCS II and III significantly decreased, while the % of patients with CCS I increased (48.4 % – CCS I, 45.7 % – CCS II, 6 % – CCS III). Adherence to medication was improved: 49 % of patients reported high adherence (vs. 18 % at baseline) and 12 % – low adherence (vs. 52 % at baseline). After 3 months of follow-up most of doctors rated the overall tolerability and effectiveness of the therapy as «very satisfied». Patients’ satisfaction with TMZ OD 80 mg therapy after 3 months of follow-up was 9.5 points [on a scale of 1 to 10 (very satisfied)]. Patients’ assessment of daily physical activity increased significantly: 2.42 versus 5.89 points at baseline (on a scale of 1 to 10 (severe limitation)).Conclusions. In general, the management of outpatients with CAD and stable angina in the current cardiologists’ practice, which was complicated by the COVID-19 pandemic, was not effective enough, resulting in a high frequency of angina attacks – almost 6 per week, and a significant limitation of daily activity due to angina symptoms.Significant deficiency in the management of studied population was insufficient correction of such important risk factors as hypertension, heart rate, dyslipidemia, and lifestyle-related risk factors (overweight and obesity, low level of physical activity). The baseline therapy of patients in the study was in line with current guidelines, but with an insufficient frequency of statin prescription (78 %) and ACE inhibitors (54.5 %); antianginal treatment with an average of 2 or more antianginal drugs was not optimal for controlling angina symptoms, and the frequency of coronary revascularization procedures was also insufficient, mostly during acute MI (58.0 %).Optimization of drug therapy as the first step in correcting the condition of patients with CAD and stable angina in accordance with all current recommendations with the inclusion of the original trimetazidine OD 80 mg once daily among antianginal drugs, as well as active monitoring of patients for 3 months allowed to reduce the frequency of angina attacks regardless of its initial FC, increase patient adherence to treatment and their functional activity. 
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