Pinto Brian, Kulkarni Girish R, Kumar Soumitra, Deb Arup, Fischer Louie, Khandelwal Amit, Korukonda Krishnaprasad R, Nair Rathish
Cardiology, Swarna, Mumbai, IND.
Medical Affairs, Torrent Pharmaceuticals Ltd., Ahmedabad, IND.
Cureus. 2024 Dec 3;16(12):e75021. doi: 10.7759/cureus.75021. eCollection 2024 Dec.
Elevated central aortic pressure, cardiac output and peripheral vascular resistance contribute to high morbidity in relation to end organ dysfunction in obstructive and non-obstructive coronary artery disease (NOCAD) cases despite revascularization. Bisoprolol preempts further progression of left ventricular dysfunction in such cases due to anti-ischemic and anti-hypertensive effects, further extending its evaluation in local Indian settings.
Post-hoc analyses of NOCAD patients with epicardial stenosis (N=378, 30 to 70% stenosis) from cross-sectional analyses conducted across eighty centers in India. Local ethics approval for study documents and endpoints for analyses was conducted in adherence to ICH-Good Clinical Practice (GCP) and Declaration of Helsinki guidelines. Descriptive and analytical statistics were performed using SPSS Version 29.0.1.0 (IBM Corp., Armonk, NY, USA).
Per-protocol analyses of NOCAD (N=378) showed (mean) age: 58.63 years (286 males and 92 females); mean weight: 75.49kg; mean BMI: 27.78kg/m and baseline left ventricular ejection fraction (LVEF): (46.85%). Prevalent risk factors include hypertension (100%), dyslipidemia (51.85%), smoking (24.07%), type 2 diabetes (59.52%), stroke (20.37%) and peripheral artery disease (4.76%). In overall population (n=800), bisoprolol (2.5 to 5mg/day) showed significant reduction in resting heart rate (RHR) (14bpm), and LVEF (5.08%). Similarly, in NOCAD cases significant changes in RHR (12.14bpm), and LVEF (4.68%) were noted at 24 weeks. Adverse events included chest congestion (6.61%), asthenia (5.03%), hypotension (4.76%), muscular weakness (3.70%), and bradycardia (1.85%) that were mild to moderate with none requiring treatment withdrawal.
Bisoprolol remains a clinically feasible option in Indian patients with NOCAD cases following percutaneous coronary intervention (PCI) as it reduces RHR and improves LVEF. Despite high rates of cardiovascular risk factors like age, type 2 diabetes and diffuse polyvascular disease, the drug was well-tolerated, with fewer adverse events. These results support the use of bisoprolol in managing NOCAD in Indian patients, highlighting its potential therapeutic uses to prevent further cardiac dysfunction.
尽管进行了血运重建，但在阻塞性和非阻塞性冠状动脉疾病（NOCAD）病例中，中心主动脉压、心输出量和外周血管阻力升高与终末器官功能障碍导致的高发病率相关。比索洛尔由于其抗缺血和抗高血压作用，可预防此类病例中左心室功能障碍的进一步进展，这进一步扩大了其在印度当地环境中的评估。
对来自印度80个中心的经截面分析的患有心外膜狭窄（N = 378，狭窄程度为30%至70%）的NOCAD患者进行事后分析。按照国际人用药品注册技术协调会 - 良好临床实践（ICH - GCP）和《赫尔辛基宣言》指南，对研究文件和分析终点进行了当地伦理批准。使用SPSS 29.0.1.0版（美国纽约州阿蒙克市IBM公司）进行描述性和分析性统计。
对NOCAD（N = 378）的符合方案分析显示，（平均）年龄：58.63岁（男性286例，女性92例）；平均体重：75.49kg；平均体重指数：27.78kg/m²，基线左心室射血分数（LVEF）：（46.85%）。常见危险因素包括高血压（100%）、血脂异常（51.85%）、吸烟（24.07%）、2型糖尿病（59.52%）、中风（20.37%）和外周动脉疾病（4.76%）。在总体人群（n = 800）中，比索洛尔（2.5至5mg/天）显示静息心率（RHR）显著降低（14次/分钟），LVEF升高（5.08%）。同样，在NOCAD病例中，24周时RHR（12.14次/分钟）和LVEF（4.68%）有显著变化。不良事件包括胸部充血（6.61%）、乏力（5.03%）、低血压（4.76%）、肌肉无力（3.70%）和心动过缓（1.85%），均为轻度至中度，无一例需要停药。
比索洛尔在印度接受经皮冠状动脉介入治疗（PCI）的NOCAD患者中仍然是一种临床可行的选择，因为它可降低RHR并改善LVEF。尽管存在年龄、2型糖尿病和弥漫性多血管疾病等心血管危险因素的高发生率，但该药物耐受性良好，不良事件较少。这些结果支持在印度患者中使用比索洛尔治疗NOCAD，突出了其预防进一步心脏功能障碍的潜在治疗用途。
